(88 days)
No
The summary describes a standard negative pressure wound therapy system and does not mention any AI or ML components or capabilities.
Yes
The device is used for Negative Pressure Wound Therapy (NPWT) to promote wound healing by removing exudate and infectious materials, which is a therapeutic function.
No
The device is a suction device for wound therapy and promotes healing; it does not diagnose conditions.
No
The device description explicitly states it is a "canister-free single-use Negative Pressure Wound Therapy (NPWT) System" that uses an "absorbent dressing connected to a small NPWT pump by a tubing and port." This clearly indicates the presence of physical hardware components (dressing, tubing, port, pump) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies negative pressure to a wound to promote healing by removing exudate and infectious materials. This is a therapeutic function performed directly on the patient's body.
- Device Description: The description details a pump, tubing, and dressing that work together to apply negative pressure to a wound. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition. The device's function is entirely focused on treating a wound in vivo.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
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. 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 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting.
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. 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 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a homecare setting.
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. 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 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a homecare setting.
PICO single use negative pressure systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as they may promote wound healing via removal of low to moderate levels of exudate and infectious materials. 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 systems are suitable for use both in a hospital and homecare setting.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
All of the PICO devices (PICO 7 (K180698), PICO 7Y (K182323), and PICO 14 (K191760) are canister-free single-use Negative Pressure Wound Therapy (NPWT) Systems and use an absorbent dressing connected to a small NPWT pump by a tubing and port. The dressing manages wound exudate by a combination of absorption and evaporation. The pump provides for a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. PICO Fluid Management Pack are packs of 5 individually packaged PICO Dressings designed for use with PICO devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting.
PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a homecare setting.
PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a homecare setting.
PICO single use negative pressure systems are suitable for use both in a hospital and homecare setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data provided in previously cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack) continue to support substantial equivalence. Additional data is provided to support the proposed change including testing of magnetic field, an analysis of postmarket surveillance, and a risk analysis. In the cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack), the device met requirements for: Biocompatibility: FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Testing included the following: Cytotoxicity Sensitization Irritation Systemic toxicity Pyrogen Testing. Electrical Safety and Electromagnetic Compatibility: IEC 60601-1 IEC 60601-1-11 IEC 60601-1-6 IEC 60601-1-2. Wound model testing: Wound exudate Wound size NPWT Wound flow rate Testing duration Pressure sampling rates. Magnetic Field Testing: Bench testing demonstrated that the average magnetic field strength of PICO Family pump is weaker than multiple everyday devices (e.g. laptops, phones, tablets, and headphones). These products are abundant in today's society and do not pose an unacceptable risk to patients with implantable medical devices (IMDs). The PICO pump does not significantly change the magnetic environment an IMD user may encounter. Post Market and Risk Analysis: A systematic literature review was conducted of IMDs and magnetic interference and this demonstrated that although the risk of magnetic interference with implantable medical devices exists, the risk is not as high as had been originally assessed. Magnetic fields are present in the everyday environment which are comparable with those presented by the PICO devices, however, there are no risks that have been reported in the clinical literature that relate to actual death or serious harm. A comprehensive review of over 60,000 records from the MAUDE database as well as the Smith +Nephew PICO devices complaint data confirmed the literature review outcome.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 30, 2020
Smith & Nephew Medical Limited Steeve Lamvohee Regulatory Affairs Director 101 Hessle Road Hull, Yorkshire HU3 2BN United Kingdom
Re: K202157
Trade/Device Name: 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, PICO Fluid Management Pack Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II
Product Code: OMP Dated: July 31, 2020 Received: August 3, 2020
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.
1
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 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.
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) 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) K202157
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. 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 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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) K202157
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. 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 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a homecare setting.
| Type of Use (Select one or both, as applicable) |
|---|
| 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) K202157
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. 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 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a homecare setting.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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)
K202157
Device Name PICO Fluid Management Pack
Indications for Use (Describe)
PICO single use negative pressure systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as they may promote wound healing via removal of low to moderate levels of exudate and infectious materials. 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 systems are suitable for use both in a hospital and homecare setting.
| 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
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, and the PICO Fluid Management Pack.
| I. Submitter | |
|---|---|
| Owner | |
| Name/Address: | Smith &Nephew Medical Limited |
| 101 Hessle Road | |
| Hull | |
| HU3 2BN | |
| United Kingdom | |
| Establishment | |
| Registration | |
| Number: | 8043484 |
| Contact Person: | Dr Steeve Lamvohee, Regulatory Affairs Director |
| Phone Number: | +44 7583 048727 |
| Date Prepared: | 08 Sep 2020 |
| II. Device | |
| Trade Names: | 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 | |
| PICO Fluid Management Pack | |
| Common or Usual | |
| Name: | Negative Pressure Wound Therapy powered suction pump |
| Classification Name: | Powered suction pump (21 CFR 878.4780) |
| Regulatory Class: | Class II |
| Product Code: | OMP |
| 510(k) Number: | K202157 |
| III. Predicate Device | |
| 510(k) Number: | K180698 |
| Device name: | PICO 7 Single Use Negative Pressure Wound Therapy System |
| Clearance Date: | 21 August 2018 |
| Recall Information: | The predicate has not been the subject of any recall |
7
Use Negative Pressure Wound Therapy Systems
Traditional 510(k) Premarket Notification K202157
IV. Device Description
All of the PICO devices (PICO 7 (K180698), PICO 7Y (K182323), and PICO 14 (K191760) are canister-free single-use Negative Pressure Wound Therapy (NPWT) Systems and use an absorbent dressing connected to a small NPWT pump by a tubing and port. The dressing manages wound exudate by a combination of absorption and evaporation. The pump provides for a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. PICO Fluid Management Pack are packs of 5 individually packaged PICO Dressings designed for use with PICO devices.
V. Indications for Use
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. and the PICO Fluid Management Pack are 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.
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 7, PICO 7 Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use in both a hospital and homecare setting.
VI. Comparison of Technological Characteristics with the Predicate Device
The technological principle for delivering the negative wound therapy for the subject devices and predicate device are identical. The differences between the subject devices and the predicate device are:
- · Updated text for Magnet Warning
- · Removal of Pump warning label
8
Smith Nephew
Traditional 510(k) Premarket Notification K202157
| Items | Subject Devices:
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, PICO Fluid
Management Pack | Predicate Device:
PICO 7 Single Use
Negative Pressure
Wound Therapy System | Comparison |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | 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, and PICO Fluid
Management Pack are
indicated for patients who would
benefit from a suction device
(NPWT) as it may promote
wound healing via removal of
low to moderate levels of
exudate and infectious materials.
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 7, PICO 7Y, PICO 14
Single Use Negative Pressure
Wound Therapy Systems and
PICO Fluid Management Pack is
suitable for use both in a hospital
and homecare setting. | PICO 7 Single Use
Negative Pressure
Wound Therapy System
is indicated for patients
who would benefit from
a suction device
(NPWT) as it may
promote wound healing
via removal of low to
moderate levels of
exudate and infectious
materials. 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 7 Single Use
Negative Pressure
Wound Therapy System
is suitable for use both in
a hospital and homecare
setting. | Same |
| Environment of
use | Hospital, home | Hospital, home | Same |
| Items | Subject Devices:
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, PICO Fluid
Management Pack | Predicate Device:
PICO 7 Single Use
Negative Pressure
Wound Therapy System | Comparison |
| Patient
Population | Patients who would benefit from
a suction device (negative
pressure wound therapy) | Patients who would
benefit from a suction
device (negative
pressure wound therapy) | Same |
| Materials | PU Plastic pump casing | PU Plastic pump casing | Same |
| Single-use or
Reusable | Single use | Single use | Same |
| Method of
Sterilization | Pump, dressing and fixation
strips sterilized by ethylene oxide | Pump, dressing and
fixation strips sterilized
by ethylene oxide | Same |
| Biocompatibility | Dressing complies with ISO
10993 | Dressing complies with
ISO 10993 | Same |
| Type of Pump | Custom designed "voice-coil"
pump controlled by
microprocessor | Custom designed
"voice-coil" pump
controlled by
microprocessor | Same |
| Electrical Safety
Testing | Complies with IEC 60601-1, IEC
60601-1-2, IEC 60601-1-11 | Complies with IEC
60601-1, IEC 60601-1-
2, IEC 60601-1-11 | Same |
| Instructions for
Use | Addition of the word medical
• If you have an electronic
medical device and are helping
take care of somebody else using
the PICO 7 system.
As requested by the FDA,
addition of "MR Unsafe. You
must remove the PICO 7 pump
from the dressing before entering
the MRI suite. Do not bring
PICO 7 into the MRI scan room.
The device presents a projectile
hazard." | • If you have an
electronic device and are
helping take care of
somebody else using the
PICO 7 system
N/A | Magnet warning
box in HCP and
Patient IFU
changed
Addition of
warning to HCP
and Patient IFU |
| | Texts amended in "Important
Information Section" and
"Glossary of Symbols" | The PICO [#] pumps
contain a MAGNET.
Keep the PICO [#] | Important
Information and
Glossary of |
| Items | Subject Devices:
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, PICO Fluid
Management Pack | Predicate Device:
PICO 7 Single Use
Negative Pressure
Wound Therapy System | Comparison |
| | The PICO [#] pumps contain a
MAGNET. Keep the PICO [#]
pumps at least 4 inches (10 cm)
away from other medical devices
at all times. As with all electrical
medical equipment, failure to
maintain appropriate distance
may disrupt the operation of
nearby medical devices. | pumps at least 4 inches
(10 cm) away from other
medical devices at all
times. Failure to do so
can cause the other
medical device to fail
which can result in
serious harm including
death. | Symbols in HCP
and Patient IFU
changed.
Texts removed
"Failure to do so
can cause the
other medical
device to fail
which can result
in serious harm
including death."
Texts added "As
with all electrical
medical
equipment,
failure to
maintain
appropriate
distance may
disrupt the
operation of
nearby medical
devices." |
| Warning Label
on front of Pump | No warning label on the front of
the pump. |
| Warning Label
Removed |
| | | Image: PICO 7 pump | |
9
Smith Nephew
Traditional 510(k) Premarket Notification K202157
10
Traditional 510(k) Premarket Notification K202157
VII. Performance Data
Performance data provided in previously cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack) continue to support substantial equivalence. Additional data is provided to support the proposed change including testing of magnetic field, an analysis of postmarket surveillance, and a risk
11
Traditional 510(k) Premarket Notification K202157
analysis. In the cleared 510(k)s for PICO 7, PICO 7Y and PICO 14 Single Use Negative Pressure Wound Therapy Systems (including PICO Fluid Management Pack), the device met requirements for:
Biocompatibility:
- FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological ● Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995,
- International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: ● Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Testing included the following:
- Cytotoxicity
- Sensitization
- . Irritation
- Systemic toxicity
- Pyrogen Testing
Electrical Safety and Electromagnetic Compatibility:
- IEC 60601-1 ●
- IEC 60601-1-11
- IEC 60601-1-6 ●
- IEC 60601-1-2
Wound model testing:
- Wound exudate ●
- Wound size
- NPWT Wound flow rate ●
- Testing duration
- Pressure sampling rates ●
Magnetic Field Testing:
Bench testing demonstrated that the average magnetic field strength of PICO Family pump is weaker than multiple everyday devices (e.g. laptops, phones, tablets, and headphones). These products are abundant in today's society and do not pose an unacceptable risk to patients with implantable medical devices (IMDs). The PICO pump does not significantly change the magnetic environment an IMD user may encounter.
Post Market and Risk Analysis:
A systematic literature review was conducted of IMDs and magnetic interference and this demonstrated that although the risk of magnetic interference with implantable medical devices exists, the risk is not as high as had been originally assessed. Magnetic fields are present in the everyday environment which are comparable with those presented by the PICO devices, however, there are no risks that have been reported in the clinical literature that relate to actual death or serious harm. A comprehensive review of over 60,000 records from the MAUDE database as well as the Smith +Nephew PICO devices complaint data confirmed the literature review outcome.
VIII. Conclusion
Data to confirm substantial equivalence to the predicate were provided in the FDA cleared 510(k) for PICO Family of Single Use Negative Pressure Wound Therapy Systems. The proposed labeling changes are supported by updated IFUs, evaluation of risk and updated risk analysis, and magnetic strength testing. The subject devices are substantially equivalent to the predicate device.