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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, specifically the PICO Single Use Negative Pressure Wound Therapy System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study on its performance in treating wounds.

Therefore, the information typically found in a clinical study report proving device performance against acceptance criteria (such as sample size, expert adjudication, MRMC studies, ground truth establishment for training, etc.) is not present in this type of regulatory submission. The document explicitly states:

"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."

Instead of a new clinical performance study, the document focuses on:

Comparison of Technological Characteristics: Demonstrating that the subject device's features, indications for use, environment of use, patient population, materials, sterilization methods, biocompatibility, pump type, and electrical safety testing methods are the same as the predicate device.
Minor Changes and Supporting Data: Addressing specific minor changes in the device (updated magnet warning text, removal of pump warning label) and providing additional data to support these changes. This additional data includes:
- Bench testing: For magnetic field strength.
- Analysis of postmarket surveillance: Including a systematic literature review on IMDs and magnetic interference, and a review of MAUDE database and company complaint data.
- Risk analysis: Updating the risk assessment based on the above.

Based on the provided text, here's what can be extracted and what information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria in the traditional sense of a clinical trial (e.g., Sensitivity X%, Specificity Y%). Instead, the "acceptance" for this 510(k) is based on demonstrating substantial equivalence to the predicate device for various technical and clinical characteristics. The "performance" is primarily demonstrated by showing that the characteristics are identical or that any changes do not raise new questions of safety or effectiveness.

Characteristic	Predicate Device (PICO 7)	Subject Devices (PICO 7, 7Y, 14, Fluid Management Pack)	Comparison/ "Performance"
Indications For Use	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 (diabetic or pressure), Flaps and grafts, Closed surgical incisions. Suitable for use both in a hospital and homecare setting.	Same as predicate, extended to PICO 7 (K180698), PICO 7Y (K182323), PICO 14 (K191760) and PICO Fluid Management Pack.	Same
Environment of use	Hospital, home	Hospital, home	Same
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	Old text for magnet warning, no MRI warning.	Updated/added text for magnet warning and MRI warnings ("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."). Text amended in "Important Information Section" and "Glossary of Symbols" regarding magnet proximity warnings, specifically removing language about "death" and adding "As with all electrical medical equipment, failure to maintain appropriate distance may disrupt the operation of nearby medical devices."	Changed (supported by additional testing)
Warning Label on front of Pump	Present	No warning label on the front of the pump.	Removed (supported by analysis)
Magnetic Field Strength	(Implied to be similar or stronger than current)	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).	Assessed (Supported changes)
Post Market and Risk Analysis	N/A	Systematic literature review of IMDs and magnetic interference conducted, confirming risk not as high as originally assessed. Comprehensive review of over 60,000 records from MAUDE database and company complaint data confirmed literature review outcome (no reported deaths/serious harms related to magnetic interference from PICO devices).	Assessed (Supported changes)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set (for the current K202157 submission):
- Magnetic Field Testing: This was bench testing, not involving human subjects. The sample size for devices tested is not specified, but it implies a measurement on the PICO Family pumps.
- Post Market and Risk Analysis: Reviewed over 60,000 records from the MAUDE database (USA, retrospective) and Smith +Nephew PICO devices complaint data (provenance not specified, but likely global, retrospective).
Provenance: MAUDE data is from the United States. The literature review is not geographically specified but typically covers international publications. Smith +Nephew complaint data is likely global. All are retrospective analyses.
The document states that clinical performance data was provided in previously cleared 510(k)s. This suggests the initial clinical data was obtained for those initial clearances, not for this specific submission which focuses on minor labelling changes and supporting evidence for those changes through non-clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable to this 510(k) submission. This is not a study assessing diagnostic or clinical performance against expert ground truth. The "ground truth" for the current changes is based on:
- Bench testing results (magnetic field strength)
- Regulatory requirements (for labeling updates)
- Analysis of real-world adverse event data (MAUDE database, company complaints) and scientific literature review. This analysis would have been performed by internal regulatory/safety/scientific experts, but the specifics of their number or qualifications are not provided as it's not a reader study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document describes a substantial equivalence claim for a physical medical device, not an AI/imaging algorithm requiring adjudication of interpretations. The analysis of post-market data and literature would involve methods of synthesizing evidence and risk assessment, but not "adjudication" in the context of clinical interpretation.

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

Not applicable. This device is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its clearance.

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

Not applicable. This is a physical medical device, not software or an algorithm with standalone performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the magnetic field testing, the "ground truth" is measured physical properties based on calibrated equipment.
For the post-market surveillance and risk analysis, the "ground truth" is derived from:
- Reported adverse events/complaints (MAUDE database, company data). These are real-world reported events, which serve as evidence of actual outcomes (or lack thereof).
- Published scientific literature on magnetic interference with implantable medical devices. This represents the established scientific understanding and reported cases in medical literature.

8. The sample size for the training set

Not applicable. This device does not use machine learning where a "training set" would be relevant.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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.

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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

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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

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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.

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

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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.

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.

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
OwnerName/Address:	Smith &Nephew Medical Limited101 Hessle RoadHullHU3 2BNUnited Kingdom
EstablishmentRegistrationNumber:	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 SystemPICO 7Y Single Use Negative Pressure Wound Therapy SystemPICO 14 Single Use Negative Pressure Wound Therapy SystemPICO Fluid Management Pack
Common or UsualName:	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

V. Indications for Use

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 NegativePressure Wound TherapySystem, PICO 7Y Single UseNegative Pressure WoundTherapy System, PICO 14 SingleUse Negative Pressure WoundTherapy System, PICO FluidManagement Pack	Predicate Device:PICO 7 Single UseNegative PressureWound Therapy System	Comparison
Indications ForUse	PICO 7 Single Use NegativePressure Wound TherapySystem, PICO 7Y Single UseNegative Pressure WoundTherapy System, PICO 14 SingleUse Negative Pressure WoundTherapy System, and PICO FluidManagement Pack areindicated for patients who wouldbenefit from a suction device(NPWT) as it may promotewound healing via removal oflow to moderate levels ofexudate and infectious materials.Appropriate wound typesinclude:ChronicAcuteTraumaticSubacute and dehisced woundsPartial-thickness burnsUlcers (such as diabetic orpressure)Flaps and graftsClosed surgical incisionsPICO 7, PICO 7Y, PICO 14Single Use Negative PressureWound Therapy Systems andPICO Fluid Management Pack issuitable for use both in a hospitaland homecare setting.	PICO 7 Single UseNegative PressureWound Therapy Systemis indicated for patientswho would benefit froma suction device(NPWT) as it maypromote wound healingvia removal of low tomoderate levels ofexudate and infectiousmaterials. Appropriatewound types include:ChronicAcuteTraumaticSubacute and dehiscedwoundsPartial-thickness burns• Ulcers (such as diabeticor pressure)Flaps and graftsClosed surgical incisionsPICO 7 Single UseNegative PressureWound Therapy Systemis suitable for use both ina hospital and homecaresetting.	Same
Environment ofuse	Hospital, home	Hospital, home	Same
Items	Subject Devices:PICO 7 Single Use NegativePressure Wound TherapySystem, PICO 7Y Single UseNegative Pressure WoundTherapy System, PICO 14 SingleUse Negative Pressure WoundTherapy System, PICO FluidManagement Pack	Predicate Device:PICO 7 Single UseNegative PressureWound Therapy System	Comparison
PatientPopulation	Patients who would benefit froma suction device (negativepressure wound therapy)	Patients who wouldbenefit from a suctiondevice (negativepressure wound therapy)	Same
Materials	PU Plastic pump casing	PU Plastic pump casing	Same
Single-use orReusable	Single use	Single use	Same
Method ofSterilization	Pump, dressing and fixationstrips sterilized by ethylene oxide	Pump, dressing andfixation strips sterilizedby ethylene oxide	Same
Biocompatibility	Dressing complies with ISO10993	Dressing complies withISO 10993	Same
Type of Pump	Custom designed "voice-coil"pump controlled bymicroprocessor	Custom designed"voice-coil" pumpcontrolled bymicroprocessor	Same
Electrical SafetyTesting	Complies with IEC 60601-1, IEC60601-1-2, IEC 60601-1-11	Complies with IEC60601-1, IEC 60601-1-2, IEC 60601-1-11	Same
Instructions forUse	Addition of the word medical• If you have an electronicmedical device and are helpingtake care of somebody else usingthe PICO 7 system.As requested by the FDA,addition of "MR Unsafe. Youmust remove the PICO 7 pumpfrom the dressing before enteringthe MRI suite. Do not bringPICO 7 into the MRI scan room.The device presents a projectilehazard."	• If you have anelectronic device and arehelping take care ofsomebody else using thePICO 7 systemN/A	Magnet warningbox in HCP andPatient IFUchangedAddition ofwarning to HCPand Patient IFU
	Texts amended in "ImportantInformation Section" and"Glossary of Symbols"	The PICO [#] pumpscontain a MAGNET.Keep the PICO [#]	ImportantInformation andGlossary of
Items	Subject Devices:PICO 7 Single Use NegativePressure Wound TherapySystem, PICO 7Y Single UseNegative Pressure WoundTherapy System, PICO 14 SingleUse Negative Pressure WoundTherapy System, PICO FluidManagement Pack	Predicate Device:PICO 7 Single UseNegative PressureWound Therapy System	Comparison
	The PICO [#] pumps contain aMAGNET. Keep the PICO [#]pumps at least 4 inches (10 cm)away from other medical devicesat all times. As with all electricalmedical equipment, failure tomaintain appropriate distancemay disrupt the operation ofnearby medical devices.	pumps at least 4 inches(10 cm) away from othermedical devices at alltimes. Failure to do socan cause the othermedical device to failwhich can result inserious harm includingdeath.	Symbols in HCPand Patient IFUchanged.Texts removed"Failure to do socan cause theother medicaldevice to failwhich can resultin serious harmincluding death."Texts added "Aswith all electricalmedicalequipment,failure tomaintainappropriatedistance maydisrupt theoperation ofnearby medicaldevices."
Warning Labelon front of Pump	No warning label on the front ofthe pump.		Warning LabelRemoved
		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.

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.