PICO 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.

Product Codes: 66800862, 66800863,66800865 and 66800866 are indicated for use on low and moderately exuding wounds.

Examples of appropriate wound types include:

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

PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

PICO 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 levels of exudate and infectious materials.

Product Codes: 66800864, 66800867,66800868 and 66800869 are indicated for use on low exuding wounds,

Examples of 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 .

PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

Device Description

PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of a electric motor driven, twindiaphraqm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump is supplied non-sterile and single use, the dressing and secondary fixations strips are supplied sterile and single use. The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place. When the suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing. The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (7 days) of battery life depending upon leak rate. The batteries can be replaced if required. The pump is designed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with new batteries. Negative pressure will not be applied at this point. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. A carry bag is not provided with the system however will be available to order separately.

AI/ML Overview

The provided document describes the PICO Single Use Negative Pressure Wound Therapy System and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in terms of performance metrics. The document focuses on demonstrating safety and general functionality through non-clinical testing.

Here's an analysis of the provided information based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Cytotoxicity: All non-cytotoxic (Grade 0) for PICO Dressing and Secondary Fixation Strips (tested per ISO 10993-5).
	Sensitization: Non-sensitizing for PICO Dressing and Secondary Fixation Strips (tested per ISO 10993-10).
	Irritation: PII SC = 0.0 and PII SC = 0.1 (Negligible irritant) for PICO Dressing; Primary Irritation Index: 0.11 (Negligible) for Secondary Fixation Strips (tested per ISO 10993-10).
Electrical Safety	Testing completed in accordance with IEC / UL 60601-1 (General Requirements for Safety of Electrical Medical Equipment) and IEC 60601-1-2 (Electromagnetic Safety Requirements).
Software Validation	Completed in accordance with IEC 62304 (Software for Medical Devices).
Battery Life	Up to 168 hours (7 days) depending upon leak rate.
Operational Lifetime	Pump designed to stop working after 168 hours (7 days) of use and not re-start.
Wound Contact Layer Effects	Assessed during a wound healing study on ALLEVYN Gentle Border dressings (which have the same wound contact layer as PICO). (Specific results are not provided in this summary, only that it was assessed).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical performance or a machine learning model. The testing described (biocompatibility, electrical safety, software validation) generally involves material samples, device prototypes, and software code, not a patient-based test set or an imaging dataset. Therefore, information about sample size and data provenance (country, retrospective/prospective) related to a clinical or AI-based test set is not applicable to this 510(k) summary as presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes non-clinical testing for safety and electrical/software compliance, not a study involving human interpretation of data where ground truth would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as points 2 and 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. The PICO device is a physical, mechanical negative pressure wound therapy system, not an AI-assisted diagnostic or interpretative tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The Type of Ground Truth Used

For the biocompatibility tests:

Cytotoxicity, Sensitization, Irritation: The "ground truth" is established by the standardized methods of ISO 10993-5 and ISO 10993-10, which provide criteria for classifying materials as cytotoxic, sensitizing, or irritating. The results (e.g., "Grade 0," "Non-sensitizing," "Negligible irritant") are determined by adherence to these established biological assessment protocols.

For the electrical safety and software validation:

Electrical Safety: Compliance is judged against the requirements specified in IEC / UL 60601-1 and IEC 60601-1-2. The "ground truth" is conformance to these international and national standards.
Software Validation: Compliance is judged against IEC 62304. The "ground truth" is conformance to this software standard.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as this is not an AI/machine learning device.

Summary

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K111170

DEC 1 5 2011

pg 10+6

510(k) SUMMARY

PICO Single Use Negative Pressure Wound Therapy System

1. Submitter:	Smith & Nephew, Inc.
	970 Lake Carillon Drive, Suite 110
	St. Petersburg, FL 33716

1. Contact: Terry McMahon Director of Regulatory Affairs & Quality, North America 727-399-3785 Email: terry.mcmahon@smith-nephew.com
1. Device name: PICO Single Use Negative Pressure Wound Therapy System Common name: Negative Pressure Wound Therapy powered suction pump Classification name: Powered suction pump (21 CFR 878.4780) Product Classification/Code: Class II, OMP
1. Date summary prepared: December 15, 2011
1. Predicate Device Information: NPD 1000 Negative Pressure Wound Therapy System (K080275) Kalypto Medical 6393 Oakgreen Avenue Hastings, MN 55033

Renasys Go (K083375) Smith & Nephew Inc, St. Petesburg, FL

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KIIII70

Prevena Incision Management System (K100821) KCI USA, INC. 6203 Farinon Dr. San Antonio, TX 78249

6. Device Description:

{2}------------------------------------------------

KIIII70

pg 3 of fo

7. Intended Use

7a. Low and moderately exuding wounds

Product Codes: 66800862, 66800863, 66800865 and 66800866 are indicated for use on low and moderately exuding wounds.

Examples of 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 .

PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

{3}------------------------------------------------

K111170

7b. Low exuding wounds

PICO 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 levels of exudate and infectious materials.

Product Codes: 66800864, 66800867, 66800868 and 66800869 are indicated for use on low exuding wounds,

Examples of 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 .

PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

8. Summary of Non-Clinical Testing

The biocompatibility of the PICO Single Use Negative Pressure Wound Therapy System has been demonstrated through assessment according to ISO 10993-1: 2003 and appropriate in vivo and in vitro tests have been conducted using product that has been packaged and sterilised. These tests include cytotoxicity, sensitization and irritation and cover the PICO dressing and secondary fixation strips. These studies indicated that the PICO Single Use Negative Pressure Wound Therapy System is safe for its intended use.

{4}------------------------------------------------

KIIII70.

pg 5 of 6

Test	Description of Method	Result
Cytotoxicity	PICO DressingIn order to determine the cytotoxic potentialof the dressing, a Minimum EssentialMedium (MEM) elution assay wasconducted in accordance with ISO 10993-5.	N to 1:16, all non-cytotoxic(Grade 0)
	Secondary Fixation StripsCytotoxicity testing has been performed onthe secondary fixation strips, tested inaccordance with ISO 10993-5. The testarticle extract was diluted in supplementedEMEM 1X and placed onto triplicateconfluent monolayers of L-929 mousefibroblast cells at the 100%, 50%, 25% and5% solutions (v/v).	N to 1:16, all non-cytotoxic(Grade 0)
Sensitisation	PICO DressingA Guinea Pig Maximisation Test wasperformed on the dressing in accordancewith ISO 10993-10.	Non-sensitising
	Secondary Fixation StripsA guinea pig maximisation test wasperformed on the secondary fixation stripsin accordance with ISO 10993-10.	Non-sensitising
Irritation	PICO DressingThe dressing was evaluated for irritation inaccordance with ISO 10993-10.	PII SC = 0.0PII SC = 0.1Negligible irritant
	Secondary Fixation StripsIrritation testing has been performed on thesecondary fixation strips in accordancewith ISO 10993-10.	0.9% NaCl extract: PrimaryIrritation Index: 0.11(Negligible)

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Additionally, the effects of the dressing wound contact layer have been assessed during a wound healing study on ALLEVYN Gentle Border dressings, report reference which have the same wound contact layer as the dressing included in the PICO Single Use Negative Pressure Wound Therapy System.

604 6

ုးရှိ

Testing has been completed in accordance with IEC / UL 60601-1; General Requirements for Safety of Electrical Medical Equipment and IEC 60601-1-2; Electromagnetic Safety Requirements For Electrical Medical Equipment. Software validation has been completed in accordance with IEC 62304 Software for Medical Devices.

9. Conclusions Drawn

Based on results of testing performed the subject device is substantially equivalent to the predicate devices NPD 1000 Negative Pressure Wound Therapy System (K080275), Renasys Go (K083375) and Prevena Incision Management System (K100821).

PICO has similar design characteristics and provides similar functions to NPD 1000 Negative Pressure Wound Therapy System (K080275), Renasys Go (K083375) and Prevena Incision Management System (K100821). The intended use, indications and instructions for use for the subject and predicate devices are similar.
PICO does not raise any new issues of safety and effectiveness.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 5 2011

Smith and Nephew, Inc. % Mr. Terry McMahon 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716

Re: K111170

Trade/Device Name: PICO Single Use Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: December 12, 2011 Received: December 13, 2011

Dear Mr. McMahon:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 statutes and regulations administered by other Federal agencies. You must

{7}------------------------------------------------

Page 2 - Mr. Terry McMahon

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

F-n Patinir C.C., A

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K111170

Device Name: PICO Single Use Negative Pressure Wound Therapy System

Indications for Use:

Product Codes: 66800862, 66800863,66800865 and 66800866 are indicated for use on low and moderately exuding wounds.

Examples of appropriate wound types include:

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

PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

AND/OR Prescription Use X

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Kane for MKM
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111170

{9}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K111170

Device Name: PICO Single Use Negative Pressure Wound Therapy System

Indications for Use:

PICO 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 levels of exudate and infectious materials.

Product Codes: 66800864, 66800867,66800868 and 66800869 are indicated for use on low exuding wounds,

Examples of 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 .

PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

Prescription Use X AND/OR Over-The-Counter Use

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for MXM

(Division Sign-On)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K11170

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.