Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a negative pressure wound therapy system that uses a software-controlled pump to apply continuous negative pressure. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies rely on meta-analysis of clinical trials, not on AI/ML model performance metrics.

Therapeutic

Yes
The device is clearly indicated for promoting wound healing and reducing complications like infections and seroma, which are therapeutic functions.

Diagnostic

No

This device is a therapeutic device intended to promote wound healing and reduce complications like surgical site infections, seroma, and dehiscence through negative pressure wound therapy, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a PICO Pump, dressing(s), fixation strips, batteries, and connection tubing, in addition to being software-controlled. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Device Function: The PICO Single Use Negative Pressure Wound Therapy System is a suction device that applies negative pressure to wounds to promote healing by removing exudate and infectious materials. It is a physical therapy applied directly to the body.
Intended Use: The intended use clearly describes the device's application to various wound types and closed surgical incisions to aid in healing and reduce complications like infections, seroma, and dehiscence. This is a therapeutic application, not an in vitro diagnostic test.
Device Description: The description details a pump, dressing, and other components that work together to apply negative pressure externally to the wound. There is no mention of analyzing biological specimens.
Performance Studies: The performance studies focus on the clinical outcomes of using the device on patients (reduction in infection, seroma, dehiscence), not on the accuracy or performance of an in vitro test.

Therefore, the PICO Single Use Negative Pressure Wound Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

PICO Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
Acute
Traumatic
Subacute and dehisced wounds
Partial-thickness burns
Ulcers (such as diabetic or pressure)
Flaps and grafts
Closed surgical incisions

When used on closed surgical incisions, PICO Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
Post-operative seroma
Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore. Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 7 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
Acute
Traumatic
Subacute and dehisced wounds
Partial-thickness burns
Ulcers (such as diabetic or pressure)
Flaps and grafts
Closed surgical incisions

When used on closed surgical incisions, PICO 7 Single Use Negative Wound Therapy System is intended to aid in reducing the incidence of:

Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
Post-operative seroma
Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 7Y Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
Acute
Traumatic
Subacute and dehisced wounds
Partial-thickness burns
Ulcers (such as diabetic or pressure)
Flaps and grafts
Closed surgical incisions

When used on closed surgical incisions, PICO 7Y Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

Superficial incisional surgical site infections for high risk patients in Class I wounds
Post-operative seroma
Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class II (Clean/ Contaminated), Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

PICO 14 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
Acute
Traumatic
Subacute and dehisced wounds
Partial-thickness burns
Ulcers (such as diabetic or pressure)
Flaps and grafts
Closed surgical incisions

When used on closed surgical incisions for up to 7 days, PICO 14 Single Use Negative Pressure Wound Therapy is intended to aid in reducing the incidence of:

Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
Post-operative seroma
Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

Product codes

OFC

Device Description

The PICO Family of devices, PICO (cleared under K163387), PICO 7 (cleared under K180698), PICO 7Y (cleared under K182323), PICO 14 (cleared under K191760) all have the same main function of management of fluid through dressing absorbency and evaporation with added benefit of negative pressure. The pump provides a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. The PICO Single Use Negative Therapy Systems consist of:

PICO Pump
Dressing (s)
Fixation strips
Batteries
Connection tubing
Instructions for Use

The system is a canister-less system - fluid is managed by the dressing. The pump that delivers the NPWT is a portable, battery-powered, software-controlled system that can provide continuous application of negative pressure to the wound as a delivery pressure at a nominal value of -80mmHg. The PICO Systems are designed to be used at home or within a healthcare setting by an appropriate healthcare professional.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wounds (Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (such as diabetic or pressure), Flaps and grafts), Closed surgical incisions.

Indicated Patient Age Range

Not Found. It is stated that "Safety and effectiveness in pediatric population (

Regulation Number and Section

§ 878.4783 Negative pressure wound therapy device for reduction of wound complications.

(a)
Identification. A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under § 878.4780. This classification does not include devices intended for organ space wounds.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:
(i) Wound complication rates; and
(ii) All adverse events.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(5) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the instructions for use.
(6) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested in a worst-case scenario for the intended use life:
(i) Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life;
(ii) Fluid removal rate consistent with the wound types specified in the indications for use; and
(iii) Timely triggering of all alarms.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include the following:
(i) Instructions for use;
(ii) A summary of the device technical specifications, including pressure settings, modes (
e.g., continuous or intermittent), alarms, and safety features;(iii) Compatible components and devices;
(iv) A summary of the clinical evidence for the indications for use;
(v) A shelf life for sterile components; and
(vi) Use life and intended use environments.
(10) For devices intended for use outside of a healthcare facility, patient labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) Information on when to contact a healthcare professional; and
(iii) Use life.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Underneath that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2021

Smith and Nephew Medical Limited Steeve Lamvohee Director, Regulatory Affairs, Advanced Wound Management 101 Hessle Road Hull, Yorkshire HU3 2BN United Kingdom

Re: K203716

Trade/Device Name: PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4783 Regulation Name: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Regulatory Class: Class II Product Code: OFC Dated: June 1, 2021 Received: June 14, 2021

Dear Steeve Lamvohee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known) K203716

Device Name

PICO Single Use Negative Pressure Wound Therapy System

Indications for Use (Describe)

PICO Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
· Acute
Traumatic
Subacute and dehisced wounds
· Partial-thickness burns
· Ulcers (such as diabetic or pressure)
Flaps and grafts
· Closed surgical incisions

When used on closed surgical incisions, PICO Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

· Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
· Post-operative seroma
· Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore. Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

3

510(k) Number (if known) K203716

Device Name

PICO 7 Single Use Negative Pressure Wound Therapy System

Indications for Use (Describe)

PICO 7 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
· Acute
Traumatic
Subacute and dehisced wounds
· Partial-thickness burns
· Ulcers (such as diabetic or pressure)
Flaps and grafts
· Closed surgical incisions

When used on closed surgical incisions, PICO 7 Single Use Negative Wound Therapy System is intended to aid in reducing the incidence of:

· Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
· Post-operative seroma
· Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

4

510(k) Number (if known) K203716

Device Name

PICO 7Y Single Use Negative Pressure Wound Therapy System

Indications for Use (Describe)

PICO 7Y Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
· Acute
Traumatic
Subacute and dehisced wounds
· Partial-thickness burns
· Ulcers (such as diabetic or pressure)
Flaps and grafts
· Closed surgical incisions

When used on closed surgical incisions, PICO 7Y Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

· Superficial incisional surgical site infections for high risk patients in Class I wounds
· Post-operative seroma
· Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class II (Clean/ Contaminated), Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

5

510(k) Number (if known) K203716

Device Name

PICO 14 Single Use Negative Pressure Wound Therapy System

Indications for Use (Describe)

PICO 14 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
· Acute
Traumatic
Subacute and dehisced wounds
· Partial-thickness burns
· Ulcers (such as diabetic or pressure)
Flaps and grafts
· Closed surgical incisions

When used on closed surgical incisions for up to 7 days, PICO 14 Single Use Negative Pressure Wound Therapy is intended to aid in reducing the incidence of:

· Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
· Post-operative seroma
Dehiscence

Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

6

510(k) Summary

21 CFR 807.92 (a)(1): Submitter's Information
510(k) Owner Name	Smith & Nephew Medical Ltd
Address	101 Hessle Road, Hull, HU3 2BN, United Kingdom
Establishment
Registration Number	8043484
Contact Name	Dr Steeve Lamvohee, Regulatory Affairs Director
Date Prepared	23 Sept 2021
21 CFR 807.92 (a)(2): Device Information
Device Name
(Trade/Proprietary Name)	PICO Single Use Negative Pressure Wound Therapy System
PICO 7 Single Use Negative Pressure Wound Therapy System
PICO 7Y Single Use Negative Pressure Wound Therapy System
PICO 14 Single Use Negative Pressure Wound Therapy System
Common Name	Negative pressure wound therapy device for reduction of wound
complications
Review Panel	General and Plastic Surgery
Regulation Number	21 CFR 878.4783
Regulatory Class	Class II
Product Code	QFC
21 CFR 807.92 (a)(3):
Legally marketed device to
which equivalence is
claimed	DeNovo Number: DEN180013
Device Name: PREVENATM 125 and PREVENA PLUSTM
125 (PREVENA)

21 CFR 807.92 (a)(4): Device Description

The PICO Family of devices, PICO (cleared under K163387), PICO 7 (cleared under K180698), PICO 7Y (cleared under K182323), PICO 14 (cleared under K191760) all have the same main function of management of fluid through dressing absorbency and evaporation with added benefit of negative pressure. The pump provides a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. The PICO Single Use Negative Therapy Systems consist of:

PICO Pump
· Dressing (s)
· Fixation strips
· Batteries
· Connection tubing
Instructions for Use

The system is a canister-less system - fluid is managed by the dressing. The pump that delivers the NPWT is a portable, battery-powered, software-controlled system that can provide continuous application of negative pressure to the wound as a delivery pressure at a nominal value of -80mmHg. The PICO Systems are designed to be used at home or within a healthcare setting by an appropriate healthcare professional.

7

The dressing and amount of negative pressure delivered across all systems remain the same. Table 1 provides details of products within the PICO Family.

In the context of the proposed Indications for Use, see the definitions provided:

According to the latest recommendations (CDC 2020), superficial and deep incisional SSIs are defined as follows:

A superficial incisional SSI involves only skin and subcutaneous tissue of the incision . and occurs within 30 days after any National Healthcare Safety Network (NHSN) operative procedure.
A deep incisional SSI involves deep soft tissues of the incision (for example, fascial and . muscle layers) and occurs within 30 or 90 days after the NHSN operative procedure.

Reference:

CDC 2020. SSI – Procedure-associated Module 2020. Available from: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf. [Accessed 04/11/2020].

8

| | PICO
(PICO 1.6) | PICO 7 | PICO 7Y | PICO 14 |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | PICO Single Use Negative Pressure
Wound Therapy System is indicated
for patients who would benefit from
a suction device (negative pressure
wound therapy) as it may promote
wound healing via removal of low
to moderate levels of exudate and
infectious materials. PICO Single
Use Negative Pressure Wound
Therapy Systems are suitable for use
both in a hospital and homecare
setting. Appropriate wound types
include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or
pressure)
• Flaps and grafts
• Closed surgical incisions

When used on closed surgical
incisions, PICO Single Use
Negative Pressure Wound Therapy
System is intended to aid in
reducing the incidence of:
• Superficial and deep
incisional surgical site | Same as PICO (PICO 1.6) | PICO 7Y Single Use Negative
Pressure Wound Therapy System is
indicated for patients who would
benefit from a suction device
(negative pressure wound therapy)
as it may promote wound healing
via removal of low to moderate
levels of exudate and infectious
materials. PICO 7Y Single Use
Negative Pressure Wound Therapy
Systems are suitable for use
both in a hospital and homecare
setting. Appropriate wound types
include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or
pressure)
• Flaps and grafts
• Closed surgical incisions

When used on closed surgical
incisions, PICO 7Y Single Use
Negative Pressure Wound Therapy
System is intended to aid in
reducing the incidence of:
• Superficial incisional surgical site | PICO 14 Single Use Negative
Pressure Wound Therapy System is
indicated for patients who would
benefit from a suction device
(negative pressure wound therapy)
as it may promote wound healing
via removal of low to moderate
levels of exudate and infectious
materials. PICO 14 Single Use
Negative Pressure Wound Therapy
Systems are suitable for use
both in a hospital and homecare
setting. Appropriate wound types
include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or
pressure)
• Flaps and grafts
• Closed surgical incisions

When used on closed surgical
incisions for up to 7 days, PICO 14
Single Use Negative Pressure
Wound Therapy is intended to aid
in reducing the incidence of:
• Superficial and deep incisional |
| | PICO
(PICO 1.6) | PICO 7 | PICO 7Y | PICO 14 |
| | infections for high risk
patients in Class I and Class
II wounds | | infections for high risk patients in
Class I wounds | surgical site infections for high risk
patients in Class I and Class II
wounds |
| | • Post-operative seroma | | • Post-operative seroma | • Post-operative seroma |
| | • Dehiscence | | • Dehiscence | • Dehiscence |
| | Note: When used on closed
incisions for the reduction of SSI,
the safety and effectiveness for
Class III (contaminated) and Class
IV (Dirty/Infected) wounds have
not been demonstrated.
Furthermore, Class IV surgical
wounds are not expected to be
closed primarily. The device has not
been demonstrated to reduce organ
space surgical site infections. The
device is intended to aid in reducing
the incidence of, but not treat,
seroma, dehiscence, or infected
wounds - the use of PICO does not
preclude the need to develop and
follow a comprehensive infection
management protocol. | | Note: When used on closed
incisions for the reduction of SSI,
the safety and effectiveness for
Class II (Clean/Contaminated),
Class III (contaminated) and Class
IV (Dirty/Infected) wounds have
not been demonstrated.
Furthermore, Class IV surgical
wounds are not expected to be
closed primarily. The device has not
been demonstrated to reduce organ
space surgical site infections. The
device is intended to aid in reducing
the incidence of, but not treat,
seroma, dehiscence, or infected
wounds - the use of PICO does not
preclude the need to develop and
follow a comprehensive infection
management protocol. | Note: When used on closed
incisions for the reduction of SSI,
the safety and effectiveness for
Class III (contaminated) and Class
IV (Dirty/Infected) wounds have
not been demonstrated.
Furthermore, Class IV surgical
wounds are not expected to be
closed primarily. The device has not
been demonstrated to reduce organ
space surgical site infections. The
device is intended to aid in reducing
the incidence of, but not treat,
seroma, dehiscence, or infected
wounds - the use of PICO does not
preclude the need to develop and
follow a comprehensive infection
management protocol. |
| Technological
principal for
delivering the
negative pressure
wound therapy | Removal of air from
dressing and wound creating
NPWT effect. Dressing
absorbs exudate from wound
which then evaporates | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| | PICO
(PICO 1.6) | PICO 7 | PICO 7Y | PICO 14 |
| Physical components
of the pumps | Electric motor driven twin-diaphragm vacuum pump controlled by Microprocessor | Custom designed "voice-coil" Pump containing a magnet controlled by Microprocessor | Same as PICO 7 | Same as PICO 7 |
| Physical components
of Dressing | Dressing: High Moisture Vapor Permeability polyurethane (MVP PU) top film, polyester spacer layer, air laid super absorbent, silicone wound contact layer, Soft Port tube
Secondary fixation strips: High MVP film with acrylic adhesive | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| Tubing/Dressing
connector | Single – used to connect a single dressing to the device using PVC tubing | Same as PICO (PICO 1.6) | Y shaped - used to connect two dressings to the device using two sets of PVC tubing; same amount of negative pressure delivered to each wound as PICO (PICO 1.6), PICO 7, and PICO 14 | Same as PICO (PICO 1.6) |
| Batteries | AA Lithium (2) | AA Alkaline (2) | Same as PICO (PICO 1.6) | AA Alkaline (2) + 2 spares provided |
| Software Controlled | Yes | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| Dressing Wear Time | Up to 7 Days | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| Pump Lifetime | 7 Days | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | 14 Days |
| User Interface | After dressing application, the user would interact with the pump device that is attached to the dressing via a soft-port. The pump | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| | PICO
(PICO 1.6) | PICO 7 | PICO 7Y | PICO 14 |
| | device has a start/stop therapy
button and indicators. | | | |
| Electrical Safety and
Electro-magnetic
Compatibility (EMC) | Complies with IEC 60601-1, IEC
60601-1-2, IEC 60601-1-11, IEC
60601-1-6, IEC 62366 | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| Dimensions | 63mm x 70mm x 18mm | 2.6 x 3.2 x 0.9" | Same as PICO 7 | Same as PICO 7 |
| Operating Pressure at
Wound Treatment
Location | Nominal -80mmHg | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |

TABLE 1: Comparison of PICO Family

9

10

11

12

21 CFR 807.92 (a)(5): Intended Use / Indications for Use

PICO and PICO 7

PICO/PICO 7 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO / PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use

both in a hospital and homecare setting. Appropriate wound types include:

Chronic
Acute
Traumatic
Subacute and dehisced wounds
Partial-thickness burns
· Ulcers (such as diabetic or pressure)
Flaps and grafts
· Closed surgical incisions

When used on closed surgical incisions, PICO/ PICO 7 Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

· Superficial and deep incisional surgical site infections for high risk patients in Class I and Class II wounds

Post-operative seroma
Dehiscence

PICO 7Y

PICO 7Y Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. Appropriate wound types include:

Chronic
Acute
Traumatic
Subacute and dehisced wounds
Partial-thickness burns
· Ulcers (such as diabetic or pressure)
Flaps and grafts
Closed surgical incisions

When used on closed surgical incisions, PICO 7Y Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:

· Superficial incisional surgical site infections for high risk patients in Class I wounds
· Post-operative seroma
Dehiscence

13

PICO 14

PICO 14 Single Use Negative Pressure Wound Therapy System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use

both in a hospital and homecare setting. Appropriate wound types include:

Chronic
Acute
Traumatic
Subacute and dehisced wounds
· Partial-thickness burns
· Ulcers (such as diabetic or pressure)
Flaps and grafts
· Closed surgical incisions

When used on closed surgical incisions for up to 7 days, PICO 14 Single Use Negative Pressure Wound Therapy is intended to aid in reducing the incidence of:

· Superficial and deep incisional surgical site infections for high risk patients in Class I and Class II wounds

· Post-operative seroma
· Dehiscence

21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices

The PICO Family and the cleared PREVENA device have very similar indications for use, similar technological characteristics and the same principles of operation. While there are minor technological differences between the PICO Family and PREVENA with respect to exudate management, therapeutic pressure setting, device sterility status and dimensions, these differences do not raise any new or different questions of safety and effectiveness compared to the predicate device, see Table 2 below.

14

	PREVENA (Predicate Device)	PICO Family (Subject Device)
Product Type	Single patient / Disposable	Single patient / Disposable
Product Code	QFC (21 C.F.R. § 878.4783)	QFC (21 C.F.R. § 878.4783)
Product Classification	Reclassified as Class II	Class II
Exudate management system	Canister	Absorbent dressing
Therapeutic pressure	-125mmHg	-80mmHg
Dressing Wear Time	7 days	Up to 7 days
Intended Use	Indicated for patients who would benefit from a suction device
(NPWT) to promote wound healing via removal of low to moderate
levels of exudate and infectious materials.	Indicated for patients who would benefit from a suction device
(NPWT) to promote wound healing via removal of low to moderate
levels of exudate and infectious materials.
Indications for use	PREVENA 125 and PREVENA PLUS 125 Therapy Units manage
the environment of closed surgical incisions and remove fluid away
from the surgical incision via the application of -125mmHg
continuous negative pressure. When used with legally marketed
compatible dressings, PREVENA 125 and PREVENA PLUS 125
Therapy Units are intended to aid in reducing the incidence of
seroma and, in patients at high risk for post-operative infections, aid
in reducing the incidence of superficial surgical site infection in
Class I and Class II wounds	PICO Single Use Negative Pressure Wound Therapy System is
indicated for patients who would benefit from a suction device
(negative pressure wound therapy) as it may promote wound healing
via removal of low to moderate levels of exudate and infectious
materials. PICO Single Use Negative Pressure Wound Therapy
Systems are suitable for use both in a hospital and homecare setting.
Appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
· Ulcers (such as diabetic or pressure)
• Flaps and grafts
· Closed surgical incisions

Table 2: Comparison of PICO Family against PREVENA

15

When used on closed surgical incisions, PICO Single Use Negative
Pressure Wound Therapy System is intended to aid in reducing the
incidence of:
· Superficial and deep incisional surgical site infections for high risk
patients in Class I and Class II wounds
· Post-operative seroma
• Dehiscence
PICO 7 Single Use Negative Pressure Wound Therapy System is
indicated for patients who would benefit from a suction device
(negative pressure wound therapy) as it may promote wound healing
via removal of low to moderate levels of exudate and infectious
materials. PICO 7 Single Use Negative Pressure Wound Therapy
Systems are suitable for use both in a hospital and homecare setting.
Appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions
When used on closed surgical incisions, PICO 7 Single Use
Negative Pressure Wound Therapy System is intended to aid in
reducing the incidence of:
· Superficial and deep incisional surgical site infections for high risk
patients in Class I and Class II wounds
· Post-operative seroma
• Dehiscence
PICO 7Y Single Use Negative Pressure Wound Therapy System is
indicated for patients who would benefit from a suction device
(negative pressure wound therapy) as it may promote wound healing
via removal of low to moderate levels of exudate and infectious

materials. PICO 7Y Single Use Negative Pressure Wound Therapy
Systems are suitable for use both in a hospital and homecare setting.
Appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions
When used on closed surgical incisions, PICO 7Y Single Use
Negative Pressure Wound Therapy System is intended to aid in
reducing the incidence of:
· Superficial incisional surgical site infections for high risk patients
in Class I wounds
· Post-operative seroma
• Dehiscence
PICO 14 Single Use Negative Pressure Wound Therapy System is
indicated for patients who would benefit from a suction device
(negative pressure wound therapy) as it may promote wound healing
via removal of low to moderate levels of exudate and infectious
materials. PICO 14 Single Use Negative Pressure Wound Therapy
Systems are suitable for use both in a hospital and homecare setting.
Appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions

16

17

| | | When used on closed surgical incisions for up to 7 days, PICO 14
Single Use Negative Pressure Wound Therapy is intended to aid in
reducing the incidence of: |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | The device is not intended to treat surgical site infection or seroma. Safety and effectiveness in pediatric population ( 50%) of patients treated with PICO in that study presented with at least one 'intrinsic' or 'extrinsic' risk factor, as defined by the American College of Surgeons (ACS) and Surgical Infection Society's Surgical Site Infection Guidelines25.

Literature Support (Reduction in SSI for High Risk Patients)

Meta-analysis of the seventeen (17) studies relevant to SSI demonstrates a statistically significant reduction in the odds of developing an infection when using PICO Family therapy in comparison to standard surgical dressing (SOC). Of the seventeen (17) prospective studies included in the meta-analysis for infection:

· Twelve (12) studies were randomized controlled trials and considered Level I evidence
· Five (5) studies were considered Level II evidence, which are non-randomized prospective observational studies

See Table 3 below for a complete description of these studies.

24

| Study | Study
design | Surgical
Procedure | Identified
potential risk
factors for
surgical site
infections | Study
duration | Incisional
dressings used | No. of
Subjects | Treatment
duration |
|--------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gillespie et
al 2015 | RCT | Elective
primary hip
arthroplasty
patients | The majority of
patients had a
ASA score of ≥2 | 6 weeks | PICO dressing | 35 | 5 days |
| | | | | | Comfeel
dressing
reinforced with
2 absorbent
dressings, and
then with a
self-adhesive,
non-woven
tape | 35 | Left intact and
patients were
discharged with
their original
dressing |
| Hyldig et al
2018 | RCT | Elective and
emergency
caesarean
section patients | Inclusion
criterion of BMI
≥30kg/m² | 30 days | PICO dressing | 432 | 5 days |
| | | | | | Standard
postoperative
dressing | 444 | The dressing was
left in situ for at
least 24 hours |
| Karlakki et
al 2016 | RCT | Patients
undergoing
elective hip and
knee
arthroplasty | The majority of
patients had a
raised BMI and
ASA score.
The mean age of
participants was

65 years old | 6 weeks | PICO dressing | 102 | 4 days or longer |
| | | | | | Comfeel
dressing | 107 | Dressing was left
on for 4 days, or
longer if drainage
continued, unless
soiled or
dislodged. |
| Study | Study design | Surgical Procedure | Identified potential risk factors for surgical site infections | Study duration | Incisional dressings used | No. of Subjects | Treatment duration |
| O'Leary et al 2017 | RCT | Laparotomy patients who received open abdominal surgery | The majority of patients had a raised BMI and ASA score
Type of surgery | 30 days | PICO dressing
Transparent waterproof dressing
(Smith & Nephew) | 24
25 | 4 days
4 days |
| Uchino et al 2016 | RCT | Patients with ulcerative colitis undergoing elective ileostomy closure | All patients had a raised ASA score; inclusion criterion of patients with ulcerative colitis | Patients visited the clinic 4 weeks after the discharge, and every 4 weeks thereafter if they presented with complications | PICO dressing
Simple adhesive plaster | 28
31 | Continued for 2 weeks, with exchange every 3-4 days
Not Reported |
| Witt-Majchrzak et al 2015 | RCT | Patients undergoing coronary artery bypass grafting surgery | The majority of patients had a raised BMI and co-morbidities; Prolonged | 6 weeks | PICO dressing | 40 | Applied for up to 6 days. Dressing changed on day 2 or 3 and removed on day 5 or 6 after surgery |
| Study | Study design | Surgical Procedure | Identified potential risk factors for surgical site infections | Study duration | Incisional dressings used | No. of Subjects | Treatment duration |
| | | | duration of surgery | | Conventional dressing | 40 | Dressings changed daily |
| | | | | | Conventional dressing | 92 | Dressings remained in situ for seven days, or until the day of discharge if they went home earlier, unless there was suspicion of infection or the dressing was soaked or leaking. |
| Hasselmann et al 2019 | RCT | Patients undergoing elective open vascular surgery with inguinal incisions | The majority of patients had pre-existing co-morbidities | 90 days | PICO dressing | 78 | The PICO device and dressing was left in place for seven days post-operatively, after which patients were instructed to remove it |
| | | | | | Vitri Pad; ViTri Medical, | 80 | Unless an unplanned change |
| Study | Study design | Surgical Procedure | Identified potential risk factors for surgical site infections | Study duration | Incisional dressings used | No. of Subjects | Treatment duration |
| | | | | | Saltsjö-Boo, Sweden or OPSITE Post-Op Visible; Smith and Nephew, London, UK | | had to be conducted, the standard dressing was left in place for at least 48 hours, although changes due to moisture build-up was an issue on the standard dressing side and dressing changes did sometimes happen prior to 48 hours post-operatively |
| Keeney et al 2019 | RCT | Patients undergoing primary or revision lower extremity TJA | 43.0% of hip patients and 55.5% of knee patients had a BMI > 35 kg/m $^{2}$ | 35 days | PICO dressing
Non-adherent incisional cover (Adaptic or Xeroform gauze) | 185
213 | Initial period of 7 days
Dressings were changed on postoperative day 2 with subsequent dressing changes performed at 3- to |
| Study | Study design | Surgical Procedure | Identified potential risk factors for surgical site infections | Study duration | Incisional dressings used | No. of Subjects | Treatment duration |
| | | | | | | | 5-day intervals until the incision was dry |
| Dingemans
et al 2018 | Prospective and
historical
controlled | Patients with foot or ankle fractures | Type of surgery | 30 days | PICO dressing
Conventional surgical dressings | 47
47 | 7 days
For the control arm of the study, patients received a pressure bandage with gauze placed underneath, usually for three days duration. |
| Pellino et al
2014a | Prospective observational study | Patients (50 undergoing breast surgery, 50 colorectal surgery) | Type of surgery
Prolonged duration of surgery | 3 months | PICO dressing
Basic wound contact absorbent dressings | 50
50 | 7 days
Sterile removal for control after 48 h. On post-operative day 3, gauzes were removed sterilely and wounds left |
| Study | Study design | Surgical Procedure | Identified potential risk factors for surgical site infections | Study duration | Incisional dressings used | No. of Subjects | Treatment duration |
| Pellino et al 2014b | Prospective observational | Crohn's disease patients undergoing small bowel resection | Type of surgery The majority of patients had co-morbidities and raised ASA score | 3 months | PICO dressing
Basic wound contact absorbent dressings | 13
17 | exposed if no complications occurred.
7 days
Sterile removal for control after 48 h. On postoperative day 3, gauzes were removed sterilely and wounds left exposed if no complications occurred |
| Selvaggi et al 2014 | Prospective observational study | Crohn's disease patients undergoing abdominal surgery | Type of surgery The majority of patients had co-morbidities | 3 months | PICO dressing
Basic wound contact absorbent dressings | 25
25 | 7 days
Sterile removal for control after 48 h. On postoperative day 3, gauzes were removed sterilely and wounds left. |
| Study | Study design | Surgical Procedure | Identified potential risk factors for surgical site infections | Study duration | Incisional dressings used | No. of Subjects | Treatment duration |
| Tuuli et al 2017 | RCT / Conference Abstract | Caesarean section patients | Inclusion criterion of a $BMI ≥30kg/m²$ | 30 days | PICO dressing | 60 | Removed at discharge (usually on day 4) |
| | | | | | Standard wound dressing | 60 | The dressing was removed after hours |
| Martin and O'Neil 2020 | RCT / Conference Abstract | Patients undergoing hepatectomy and pancreatectomy. | The average age among all participants was 60.82 years and $BMI$ was 31.7. | 1 year | PICO dressing | 20 | For the PICO arm of the study, the PICO device was left in place for a total of 7 days. |
| | | | | | Sterile island dressing | 20 | For the control arm of the study, the length of time the dressing was left in place for was a median on 5 days (range 2-5 days). |
| Helito et al 2020 | Prospective and historical controlled | Patients undergoing total knee arthroplasty | The majority of patients (51.7%) had at least one risk factor for | 12 months | PICO dressing | 97 | Applied with an intentional duration of 7 days. |
| Study | Study design | Surgical Procedure | Identified potential risk factors for surgical site infections | Study duration | Incisional dressings used | No. of Subjects | Treatment duration |
| | | | surgical wound complications | | Conventional surgical dressings | 199 | Applied with an intentional duration of 7 days. |
| Costa et al 2020 | RCT | Patients undergoing surgery for lower limb fractures associated with major trauma | Type of surgery | 6 months | PICO dressing | 770 | Applied according to surgeon's normal practice and the manufacturer's instructions (up to 7 days of treatment). |
| | | | | | Sterile dressings (varied by treatment centre – details not given) | 749 | Varied based on routine local care. |
| Masters et al 2021 | RCT | Patients undergoing surgery for hip fractures | Type of surgery, median age (>84 years) | 120 days | PICO dressing | 232 | Applied according to surgeon's normal practice and the manufacturer's |
| Study | Study
design | Surgical
Procedure | Identified
potential risk
factors for
surgical site
infections | Study
duration | Incisional
dressings used | No. of
Subjects | Treatment
duration |
| | | associated with
trauma | | | | | instructions (up to
7 days of
treatment).
Varied based on
routine local care. |
| | | | | | Sterile
dressings
(varied by
treatment
centre – details
not given) | 230 | |
| Bueno-
Lledo et al
2020 | RCT | Patients
undergoing
incisional
hernia repair | Obese patients
undergoing
incisional hernia
repair (BMI >
30; total pop:
n=37/150) | 30 days | PICO dressing | 72 | Applied with an
intentional
duration of six
days. |
| | | | | | Conventional
sterile dressing
(MEPORE pro;
Molnlycke,
Goteborg,
Sweden) | 74 | Applied with an
intentional
duration of six
days. |
| Andrianello
et al 2020 | RCT | Patients
undergoing
pancreatic
resection | Type of surgery | 90 days | PICO dressing | 46 | Applied with an
intentional
duration of seven
days |
| Study | Study design | Surgical Procedure | Identified potential risk factors for surgical site infections | Study duration | Incisional dressings used | No. of Subjects | Treatment duration |
| | | | | | Sterile gauze until post-op day 3, then sterile island dressing (OPSITE Post-Op Visible; Smith & Nephew) | 49 | Dressing (OPSITE) was changed according to clinical judgement. |

Table 3. Published Studies Evaluating Reduction in Infection for High Risk Patients

25

26

27

28

29

30

31

32

33

34

Together, the seventeen (17) studies contained 1,354 evaluable patients receiving the PICO Family (treatment group) and 1,516 patients receiving conventional wound dressings (control group). The conventional wound dressings used in each study can be seen in Table 3 and ranged from standard transparent dressings to basic wound contact absorbent dressings. The endpoint in the studies was the incidence of infection in the treatment group compared to the control group, with follow-up of patients for at least 30 days following surgery as per CDC guidance. The treatment effect for each study was summarized using odds ratio (OR), which was calculated using the following formula: OR = AD/BC, where

· A = the number of subjects with Infection events for the treatment group
· B = the number of subjects without Infection events for the treatment group
· C = the number of subjects with Infection events for the control group
· D = the number of subjects without Infection events for the control group

An OR of less than 1 suggests a favorable effect by the treatment in reducing the incidence of infection in high risk patients, whereas an OR greater than 1 suggests a favorable effect by the conventional wound dressings. The 95% confidence interval (95% CI) for the odds ratio is calculated based on the standard error of Log(OR).

As demonstrated in Figure 3, there is an observable trend supporting a favorable effect by the PICO Family in reducing the incidence of infection compared to the control group.

Study	Experimental		Control		Odds Ratio	OR	95%-CI	Weight
	Events	Total	Events	Total
Gillespie et al 2015	2	35	3	35		0.65	[0.10; 4.13]	1.8%
Hasselmann et al 2019	8	78	22	80		0.30	[0.12; 0.73]	12.6%
Hyldig et al 2018	20	432	41	444		0.48	[0.27; 0.83]	24.9%
Karlakki et al 2016	1	102	6	107		0.17	[0.02; 1.41]	3.7%
Keeney et al 2019	7	185	8	213		1.01	[0.36; 2.83]	4.6%
O'Leary et al 2017	2	24	8	25		0.19	[0.04; 1.03]	4.6%
Uchino et al 2016	3	28	1	31		3.60	[0.35; 36.80]	0.5%
Witt-Majchrzak et al 2015	1	40	7	40		0.12	[0.01; 1.03]	4.4%
Dingemans et al 2018	2	47	7	47		0.25	[0.05; 1.29]	4.3%
Selvaggi et al 2014	2	25	12	25		0.09	[0.02; 0.49]	7.1%
Pellino et al 2014a	4	50	20	50		0.13	[0.04; 0.42]	11.9%
Pellino et al 2014b	1	13	8	17		0.09	[0.01; 0.89]	4.1%
Tuuli et al 2017	3	60	2	60		1.53	[0.25; 9.48]	1.2%
Martin & O'Neil 2019	3	20	6	20		0.41	[0.09; 1.95]	3.3%
Helito et al 2020	0	97	7	199		0.13	[0.01; 2.33]	3.2%
Andrianello et al 2020	5	46	6	49		0.87	[0.25; 3.09]	3.3%
Bueno-Lledo et al 2020	0	72	6	74		0.07	[0.00; 1.31]	4.1%
Fixed effect model		1354		1516		0.36 [0.27; 0.49]		100.0%
Heterogeneity: I2 = 34%, τ2 = 0.2474, p = 0.09
					0.01	0.1	1	10 100

					Figure 3: Forest plot showing Infections in patients treated with PICO compared to SOC

Adverse events (AEs) or other potential device-related problems, ranging from patient reported noise concerns and vacuum failure to reports of pain and adverse skin reactions, were detailed in

35

fifteen (15) of the seventeen (17) studies included in the meta-analyses.

Literature Supports Reduction in Infection for Class I and II Wounds

To analyze the effect of the PICO Family on infection in wounds of different degrees of contamination, a wound classification designation was applied following the Center for Disease Control and Prevention (CDC) guidelines24 .

Literature Support: Reduction in Superficial and Deep Surgical Site Infection (Infection Depth) The definitions of "superficial" and "deep" incisional surgical site infections (SSIs) utilized within this analysis are based on the established and recognized definitions provided by the Centers for Disease Control and Prevention (CDC). According to the latest recommendations24, superficial and deep incisional SSIs are briefly defined as follows:

· A superficial incisional SSI involves only skin and subcutaneous tissue of the incision and occurs within 30 days after any NHSN operative procedure.
· A deep incisional SSI involves deep soft tissues of the incision (for example, fascial and muscle layers) and occurs within 30 or 90 days after the NHSN operative procedure.

Meta-analysis of appropriate studies from Class I or Class II wound studies show a reduction in infection for superficial and deep infection when using the PICO Family compared to standard surgical dressing (SOC).. Specifically, to analyze the effect of the PICO Family on infections of different depths, subgroup analyses were performed using studies where the authors stated the use of the CDC criteria discussed above for superficial and deep SSIs26.

Meta-analyses of the relevant studies show a statistically significant reduction in infection for both superficial and deep incisional infections for class I/II wounds when comparing use of the PICO Family to SOC (Figures 4 and 5). The meta-analysis for superficial SSI includes eight (8) studies (5 RCTs, 3 prospective observational) containing a total of 723 evaluable patients, of which 356 received the PICO Family (treatment group) and 367 received conventional wound dressings (control group). The deep SSI analysis includes six (6) studies (4 RCTs, 2 prospective observational) containing a total of 2,284 evaluable patients, of which 1,146 received the PICO Family (treatment group) and 1,138 received conventional wound dressings (control group). The conventional wound dressings used in each study can be found in Table 3 and range from standard transparent dressings to simple adhesive plasters. The endpoint in the studies was the incidence of SSI (superficial and/or deep) in the treatment group compared to the control group.

Figure 4: Forest plot showing superficial SSI defined in patients treated with PICO Family compared to SOC

36

Study	Experimental		Control		OR	95%-CI	Weight
	Events	Total	Events	Total
Gillespie et al 2015	1	35	3	35	0.31	[0.03; 3.17]	6.1%
Hasselmann et al 2019	7	78	18	80	0.34	[0.13; 0.87]	33.6%
Selvaggi et al 2014	2	25	6	25	0.28	[0.05; 1.53]	11.5%
Pellino et al 2014b	1	13	4	17	0.27	[0.03; 2.78]	6.7%
Dingemans et al 2018	0	47	4	47	0.10	[0.01; 1.95]	9.3%
Witt-Majchrzak et al 2015	1	40	7	40	0.12	[0.01; 1.03]	14.2%
Andrianello et al 2020	4	46	3	49	1.46	[0.31; 6.91]	5.5%
Bueno-Lledo et al 2020	0	72	6	74	0.07	[0.00; 1.31]	13.2%
Fixed effect model		356		367	0.30	[0.17; 0.53]	100.0%
Heterogeneity: I2 = 0%, τ2 = 0, p = 0.52

Figure 5: Forest plot showing deep SSI defined in patients treated with PICO Family compared to SOC

Image /page/36/Figure/9 description: This image is a forest plot, displaying the results of a meta-analysis. The plot includes data from several studies, including Hasselmann et al 2019, Selvaggi et al 2014, Pellino et al 2014b, Masters et al 2021, Costa et al 2020, and Andrianello et al 2020. For each study, the plot shows the odds ratio (OR) with its 95% confidence interval (CI) and weight. The fixed effect model has an OR of 0.67 with a 95% CI of [0.46; 0.96] and a weight of 100.0%.

3. POST-OPERATIVE SEROMA

A review of literature is included to demonstrate that the PICO Family is intended to reduce the incidence of post-operative seroma for closed surgical incisions. Studies assessing seroma were only included if they had at least 10 days of follow-up time (see Table 4).

Literature Review

A meta-analysis of ten (10) studies demonstrated a statistically significant reduction in the odds of developing a seroma when using PICO in comparison to standard of care (SOC). Of the ten (10) prospective studies included in the meta-analysis for seroma:

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· Seven (7) studies were randomized controlled trials and considered Level I evidence.
· Three (3) studies were considered Level II evidence, which are non-randomized prospective observational studies.

See Table 4 below for a complete description of these studies.

The ten (10) studies contained 608 evaluable patients receiving the PICO Family (treatment group) and 618 patients receiving conventional wound dressings (control group). The conventional wound dressings used in each study can be found in Table 4 and range from standard transparent dressings to basic wound contact absorbent dressings. The endpoint in the studies was the incidence of postoperative seroma in the treatment group compared to the control group for at least 10 days following surgery.

As demonstrated in Figure 6, there is an observable trend supporting a favorable effect by the PICO Family in reducing the incidence of seroma.

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Study	Study design	Surgical Procedure	Follow up period	Incisional dressings used
Chaboyer et al 2014	Randomized Controlled Trial (RCT)	Elective caesarean section patients	6 weeks	PICO dressing
Comfeel dressing	44
43	4 days or more
Dressing was left on for 4 days, or longer if drainage continued, unless soiled or dislodged
Galiano et al 2018	RCT	Bilateral reduction mammoplasty patients	21 days (90 days)	PICO dressing

3M STERI-Strip
(3M Health Care, St. Paul, Minn.). | 185

185 | The overall duration of PICO treatment was a median of 7 days

Table 4. Published Studies Evaluating Reduction in Seroma.

39

40

41

42

Image /page/42/Figure/0 description: This image is a forest plot, which is a type of graph used in meta-analysis to display the results of multiple studies. The plot shows the odds ratio (OR) and 95% confidence interval (CI) for each study, as well as the overall effect size. The studies included are Chaboyer et al 2014, Galiano et al 2018, Gillespie et al 2015, Pellino et al 2014a, Pellino et al 2014b, Selvaggi et al 2014, Hasselmann et al 2019, Tuuli et al 2017, Andrianello et al 2020, and Bueno-Lledo et al 2020. The random effects model shows an overall effect size of 0.37 [0.16; 0.86] with a weight of 100.0%.

Figure 6: Forest plot showing Seroma in patients treated with PICO compared to SOC

Device related adverse events (AEs) or other potential device-related problems, ranging from sealing issues to reports of pain and adverse skin reactions, were reported in eight (8) of the ten (10) studies included in the meta-analysis.

4. DEHISCENCE

A review of literature is included to demonstrate that the PICO Family is intended to reduce the incidence of dehiscence in closed surgical incisions. Studies assessing dehiscence were only included if they had at least 10 days of follow-up time (see Table 5).

Literature Support

In accordance with the literature review process described above, seven (7) prospective studies demonstrated a statistically significant reduction in developing dehiscence when using PICO in comparison to standard of care. Of the seven (7) studies included in the meta-analysis for dehiscence:

· Six (6) studies were randomized controlled trials and considered Level I evidence.
· One (1) study was considered level II evidence, which are non-randomized prospective observational studies.

See Table 5 below for a complete description of these studies.

The seven (7) studies contained 551 evaluable patients receiving the PICO Family (treatment group) and 656 patients receiving conventional wound dressings (control group). The conventional wound dressings used in each study can be found in Table 5 and range from standard sterile dressings to fixation strips. The endpoint in the studies was the incidence of dehiscence in the treatment group compared to the control group for at least 10 days following surgery.

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As demonstrated in Figure 7, there is an observable trend supporting a favorable effect by the PICO Family in reducing the incidence of dehiscence.

44

| Study | Study design | Surgical
Procedure | Follow
up
period | Incisional dressings
used | No. of
Subjects | Treatment duration |
|----------------------------------|-----------------------------------------|----------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chaboyer et
al 2014 | Randomized
Controlled
Trial (RCT) | Elective caesarean
section patients | 6 weeks | PICO dressing
Comfeel dressing | 44
43 | 4 days or more
Dressing was left on for 4
days, or longer if drainage
continued, unless soiled or
dislodged |
| Galiano et al
2018 | RCT | Bilateral reduction
mammoplasty
patients | 21 days
(90
days) | PICO dressing or 3M
STERI-Strip (3M
Health Care, St. Paul,
Minn.). | 185
185 | The overall duration of PICO
treatment was a median of 7
days
Not Reported |
| Gillespie et
al 2015 | RCT | Elective primary
hip arthroplasty
patients | 6 weeks | PICO dressing or
Comfeel dressing
reinforced with 2
absorbent dressings,
and then with a self-
adhesive, non-woven
tape | 35
35
417 | 5 days
Left intact and patients were
discharged with their original
dressing
The dressing was left in situ
for at least 24 hours |
| Witt-
Majchrzak et
al 2015 | RCT | Patients
undergoing
coronary artery
bypass grafting
surgery | 6 weeks | PICO dressing
Conventional dressing | 40
40 | Dressing changed on day 2 or
3 and on day 5 or 6 after
surgery
Dressings changed daily |
| Study | Study design | Surgical Procedure | Follow up period | Incisional dressings used | No. of Subjects | Treatment duration |
| Hasselmann
et al 2019 | RCT | Patients undergoing elective open vascular surgery with inguinal incisions | 90 days | PICO dressing | 78 | The PICO device and dressing was left in place for seven days post-operatively, after which patients were instructed to remove it. |
| | | | | (Vitri Pad; ViTri Medical, Saltsjo¨-Boo, Sweden or OPSITE Post-Op Visible; Smith and Nephew, London, UK) | 80 | The standard dressing was left in place for at least 48 hours, although changes due to moisture build-up was an issue on the standard dressing side and dressing changes did sometimes happen prior to 48 hours post-operatively. |
| | | | | Sterile island dressing | 20 | Not Reported |
| Helito et al 2020 | Prospective and historical controlled | Patients undergoing total knee arthroplasty | 12 months | PICO dressing | 97 | Applied with an intentional duration of 7 days. |
| | | | | Conventional surgical dressings | 199 | Applied with an intentional duration of 7 days. |
| Bueno-Lledo
et al 2020 | RCT | Patients undergoing incisional hernia repair | 30 days | Conventional sterile dressing (MEPORE pro; Molnlycke, Goteborg. Sweden) | 74 | Applied with an intentional duration of six days |
| Study | Study design | Surgical
Procedure | Follow
up
period | Incisional dressings
used | No. of
Subjects | Treatment duration |
| | | | | PICO dressing | 72 | Applied with an intentional
duration of six days |

Table 5. Studies Evaluating Reduction in Dehiscence in Closed Surgical Incisions.

45

46

47

| Study | Experimental
Events | Total | Control
Events | Total | Odds Ratio | OR | 95%-CI | Weight |
|----------------------------------------------------------------------|------------------------|-------|-------------------|-------|------------|------|---------------|--------|
| Chaboyer et al 2014 | 0 | 44 | 0 | 43 | | | | 0.0% |
| Galiano et al 2018 | 32 | 185 | 52 | 185 | | 0.53 | [0.33; 0.88] | 62.5% |
| Gillespie et al 2015 | 1 | 35 | 1 | 35 | | 1.00 | [0.06; 16.65] | 1.4% |
| Witt-Majchrzak et al 2015 | 1 | 40 | 1 | 40 | | 1.00 | [0.06; 16.56] | 1.4% |
| Hasselmann et al 2019 | 14 | 78 | 9 | 80 | | 1.73 | [0.70; 4.26] | 10.6% |
| Helito et al 2020 | 3 | 97 | 20 | 199 | | 0.29 | [0.08; 0.99] | 18.5% |
| Bueno-Lledo et al 2020 | 2 | 72 | 4 | 74 | | 0.50 | [0.09; 2.82] | 5.6% |
| Fixed effect model
Heterogeneity: I2 = 29%, τ2 = 0.1449, p = 0.22 | | 551 | | 656 | | 0.63 | [0.43; 0.92] | 100.0% |

Figure 7: Forest plot showing dehiscence in patients treated with PICO compared to SOC

Device related adverse events (AEs) or other potential device-related problems, ranging from sealing issues to reports of pain and adverse skin reactions, were reported in five (5) of the seven (7) studies included in the meta-analysis.

5. LIMITATIONS OF THE CLINICAL EVIDENCE

There can be many inherent limitations to meta-analyses, such as publication bias, selection bias, and varying quality of the underlying studies. Efforts were made in the study identification and selection process to reduce potential biases by selecting higher quality level I and level II studies. The criteria used to assess quality within the identified studies is detailed earlier in the methodology of the systematic literature review (Section 1 and Table 2). Another potential bias affecting studies included in meta-analyses is publication bias, whereby studies with statistically significant results are more likely to be published. This may also occur in the context of selective outcome reporting in which only significant outcomes are reported at study publication. To address this, searches were also conducted on ClinicalTrials.gov to check for completed trials with results available that had not been published.

Most studies (16/25) included in the systematic literature review were at higher risk of bias or the risk for bias was unclear. Specifically, many level I studies failed to include an intention to treat (ITT) analysis and often only reported on the per protocol (PP) analysis. Deficiencies in level II prospective observational studies included a lack of reporting of confidence intervals or p-values. Additional sources of bias included the variability between studies in the length of follow-up time for assessment of surgical site complications such as SSI. While inclusion for analysis required a follow-up period of at least 30 days post-operatively (as per CDC definitions), some studies exceeded this threshold sometimes by a few weeks. As a result, this may have impacted on the number of detected SSIs during the specified clinical endpoint. Some studies (Van der Valk et al 2017; Dingemans et al 2018; Helito et al 2020) included in the analysis used a historical cohort

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group as the control arm. There can be problems with interpreting data based on historical comparators. Namely, clinical practice, such as the use of technologies, procedures or care pathways, may have changed over time since the original data was collected meaning that any clinical improvement in the intervention arm may be attributable to these medical advances, rather than just the intervention alone. The systematic literature review also only included studies published in the English language. As such, there is the possibility of excluding valid data published in a different language.

Although these limitations should be considered when examining the results from these metaanalyses, the depth and breadth of the evidence provided gives reassurance to the conclusions reached for each of the outcomes assessed for the proposed Indications For Use. In addition, by the very nature of the inclusion criteria used for the systematic literature review, only studies considered methodologically robust (i.e., prospective and comparative) were selected for these analyses.

The device has not been demonstrated to be effective in reducing the incidence of surgical site infection, seroma, and dehiscence in all surgical procedures and patient populations; therefore, the device may not be recommended for routine use to reduce surgical site infection, seroma, and dehiscence. Surgeons should continue to follow the 'Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection'31 and the 'American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines'33 for best practices in preventing surgical site infection.

6. BIBLIOGRAPHY

1. CRD's guidance for undertaking reviews in health care systematic reviews. 2018. https://www.york.ac.uk/media/crd/Systematic Reviews.pdf. Accessed 19/11/2020.
Study Study Checklist. https://casp-uk.net/wp-2. CASP. CASP Cohort 2018. content/uploads/2018/03/CASP-Cohort-Study-Checklist-2018 fillable form.pdf. Accessed 19/11/2020.
1. Chaboyer W, Anderson V, Webster J, Sneddon A, Thalib L, Gillespie BM. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT. Healthcare (Basel). 2014;2(4):417-428.
1. Dingemans SA, Birnie MFN, Backes M, et al. Prophylactic negative pressure wound therapy after lower extremity fracture surgery: a pilot study. Int Orthop. 2018;42(4):747-753.
1. Galiano RD, Hudson D, Shin J, et al. Incisional Negative Pressure Wound Therapy for Prevention of Wound Healing Complications Following Reduction Mammaplasty. Plast Reconstr Surg Glob Open. 2018;6(1):e1560.

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1. Gillespie BM, Rickard CM, Thalib L, et al. Use of Negative-Pressure Wound Dressings to Prevent Surgical Site Complications After Primary Hip Arthroplasty: A Pilot RCT. Surg Innov. 2015;22(5):488-495.
1. Hasselmann J. Björk J. Svensson-Björk R. Acosta S. Inguinal Vascular Surgical Wound Protection by Incisional Negative Pressure Wound Therapy: A Randomized Controlled Trial-INVIPS Trial. Ann Surg. 2020;271(1):48-53.
1. Helito CP, Sobrado MF, Giglio PN, et al. The use of negative-pressure wound therapy after total knee arthroplasty is effective for reducing complications and the need for reintervention. BMC Musculoskeletal Disorders. 2020;21(1):490.
1. Holt R. Murphy J. PICO™ incision closure in oncoplastic breast surgery: a case series. Br J Hosp Med (Lond). 2015;76(4):217-223.
1. Hyldig N, Vinter CA, Kruse M, et al. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. Bjog. 2019;126(5):628-635.
1. Irwin GW, Boundouki G, Fakim B, et al. Negative Pressure Wound Therapy Reduces Wound Breakdown and Implant Loss in Prepectoral Breast Reconstruction. Plast Reconstr Surg Glob Open. 2020:8(2):e2667.
1. Karlakki SL, Hamad AK, Whittall C, Graham NM, Banerjee RD, Kuiper JH. Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res. 2016;5(8):328-337.
1. Keeney JA, Cook JL, Clawson SW, Aggarwal A, Stannard JP. Incisional Negative Pressure Wound Therapy Devices Improve Short-Term Wound Complications, but Not Long-Term Infection Rate Following Hip and Knee Arthroplasty. J Arthroplasty. 2019;34(4):723-728.
1. O'Leary DP, Peirce C, Anglim B, et al. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds Following Abdominal Operations: A Randomized, Controlled, Openlabel Trial: The P.I.C.O. Trial. Ann Surg. 2017;265(6):1082-1086.
1. O'Neill CH, Martin RCG, 2nd. Negative-pressure wound therapy does not reduce superficial SSI in pancreatectomy and hepatectomy procedures. J Surg Oncol. 2020;122(3):480-486.
1. Pellino G. Sciaudone G. Candilio G. Campitiello F. Selvaggi F. Canonico S. Effects of a new pocket device for negative pressure wound therapy on surgical wounds of patients affected with Crohn's disease: a pilot trial. Surg Innov. 2014;21(2):204-212.
1. Pellino G, Sciaudone G, Candilio G, et al. Preventive NPWT over closed incisions in general surgery: does age matter? Int J Surg. 2014;12 Suppl 2:S64-s68.
1. Selvaggi F, Pellino G, Sciaudone G, et al. New advances in negative pressure wound therapy (NPWT) for surgical wounds of patients affected with Crohn's disease. Surg Technol Int. 2014:24:83-89.
1. Tuuli MG, Martin S, Stout MJ, et al. 412: Pilot randomized trial of prophylactic negative pressure wound therapy in obese women after cesarean delivery. American Journal of Obstetrics & Gynecology. 2017;216(1):S245.

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1. Uchino M, Hirose K, Bando T, Chohno T, Takesue Y, Ikeuchi H. Randomized Controlled Trial of Prophylactic Negative-Pressure Wound Therapy at Ostomy Closure for the Prevention of Delayed Wound Healing and Surgical Site Infection in Patients with Ulcerative Colitis. Dig Surg. 2016;33(6):449-454.
1. van der Valk MJM, de Graaf EJR, Doornebosch PG, Vermaas M. Incisional Negative-Pressure Wound Therapy for Perineal Wounds After Abdominoperineal Resection for Rectal Cancer, a Pilot Study. Adv Wound Care (New Rochelle). 2017;6(12):425-429.
1. Witt-Majchrzak A, Zelazny P, Snarska J. Preliminary outcome of treatment of postoperative primarily closed sternotomy wounds treated using negative pressure wound therapy. Pol Przegl Chir. 2015;86(10):456-465.
1. Zotes V, Mier JM, Cortes G. P-187NEGATIVE PRESSURE WOUND THERAPY IN A POTENTIALLY INFECTED WOUND AFTER EMPYEMA SURGERY. Interactive CardioVascular and Thoracic Surgery. 2015;21(suppl 1):S51-S51.
Procedure-associated 24. CDC. देश Module. 2020. https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf. Accessed 04/11/2020.
1. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017;224(1):59-74.
1. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR, Committee HICPA. Guideline for prevention of surgical site infection, 1999. Infection Control & Hospital Epidemiology. 1999;20(4):247-280.
1. Andrianello S, Landoni L, Bortolato C, et al. Negative pressure wound therapy for prevention of surgical site infection in patients at high risk after clean-contaminated major pancreatic resections: A single-center, phase 3, randomized clinical trial. Surgerv. 2020.
1. Bueno-Lledó J, Franco-Bernal A, Garcia-Voz-Mediano MT, Torregrosa-Gallud A, Bonafé S. Prophylactic Single-use Negative Pressure Dressing in Closed Surgical Wounds After Incisional Hernia Repair: A Randomized, Controlled Trial. Ann Surg. 2020.
1. Costa ML, Achten J, Knight R, et al. Effect of Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing on Deep Surgical Site Infection after Surgery for Lower Limb Fractures Associated with Major Trauma: The WHIST Randomized Clinical Trial. JAMA -Journal of the American Medical Association. 2020;323(6):519-526.
1. Masters J, Cook J, Achten J, Costa ML. A feasibility study of standard dressings versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures: the WHISH randomized controlled trial. Bone Joint J. 2021;103-b(4):755-761.
1. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection. 2017. JAMA Surg. 2017;152(8):784-791. doi:10.1001/jamasurg.2017.0904

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21 CFR 807.92 (b)(3): Conclusions drawn

Based on the clinical and non-clinical supporting information provided in this submission, the subject device is substantially equivalent to the legally marketed predicate device (PREVENA). To the extent that there are differences between the subject device and the predicate, these differences do not raise new or different questions of safety or effectiveness.