The RENASYS White Foam NPWT Dressing is a moist, sterile, polyvinyl alcohol (PVA) foam intended to be used in conjunction with Smith & Nephew RENASYS TOUCH and RENASYS GO Negative Pressure Wound Therapy (NPWT) Systems.

The Smith & Nephew RENASYS system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy) as it may promote wound healing via the removal of wound fluids, including irrigation of body fluids, wound exudates and infectious materials.

Appropriate wound types include:

· Chronic
Acute
· Traumatic
Sub-Acute and dehisced wounds
· Ulcers (such as pressure or diabetic)
· Partial-thickness burns
· Flaps
· Grafts

Device Description

RENASYS™-WF White Foam NPWT Dressing for use as a wound filler in conjunction with the RENASYS Touch or GO Negative Pressure Wound Therapy System and compatible components.

AI/ML Overview

The provided FDA 510(k) Premarket Notification is for a medical device (RENASYS™-WF White Foam NPWT Dressing) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to meet explicit quantitative performance acceptance criteria as might be seen for an AI/ML device.

Here's an analysis based on the provided document, addressing the requested points where applicable:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) that an AI/ML device would typically have, because this is not an AI/ML device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device. The performance is assessed through non-clinical testing comparing the subject device to the predicate device in terms of physical characteristics, intended use, indications, contraindications, materials, sterility, and packaging.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance
Intended Use Equivalence: Subject device has comparable intended use to the predicate.	Verdict: Yes - The subject device's intended use for open wounds is the same as the predicate device. Closed wounds are not listed for the subject device. Compatible NPWT systems are different (manufacturer specific).
Indications for Use Equivalence: Subject device has comparable indications for use to the predicate.	Verdict: Yes - The indicated wound types for the subject device are the same as the predicate device, with the exception that the predicate specifically states "Venous insufficiency ulcers," which is not included for the subject device to align with compatible RENASYS devices.
Contraindications Equivalence: Subject device has comparable contraindications to the predicate.	Verdict: Yes - The subject device contains the same contraindications as the predicate device for open wounds.
Sterility: Subject device maintains same sterility method as predicate.	Verdict: Yes - Sterilized by Gamma Irradiation (same as predicate).
Packaging: Subject device has comparable packaging to the predicate.	Verdict: Yes - Polyethylene inner and Aluminum foil outer pouch (same as predicate).
Materials: Subject device uses comparable materials to the predicate.	Verdict: Yes - PVA Foam, moistened with water (same as predicate).
Status: Subject device has the same prescription status as predicate.	Verdict: Yes - Rx Only (same as predicate).
Environment of Use: Subject device is suitable for comparable environments of use as predicate.	Verdict: Yes - Clinical and Home Environments (same as predicate).
Physical Composition & Dimensions: Subject device has comparable physical composition and dimensions.	Verdict: Yes - Both are made of Polyvinyl Alcohol (PVA) foam, moistened with water, sterilized by gamma irradiation, and share the same dimensions (7.5 X 10 X 1 cm and 15 X 10 X 1 cm).
Non-clinical Performance: Subject device performs as intended in challenge conditions and comparably to the predicate in wound model testing.	Reported: Wound model testing in challenge conditions using compatible components; Comparative wound model testing between the subject and predicate device; Testing in accordance with relevant parts of ISO 10993. Conclusion: Testing indicates the subject device performs as intended and on an equivalence basis with the predicate device.

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

This information is not provided in the document. The document refers to "wound model testing in challenge conditions" and "comparative wound model testing," which suggests non-clinical bench testing rather than human subject data. Therefore, concepts like sample size for a test set (in the context of patient data) and data provenance (country of origin, retrospective/prospective) are not applicable or detailed here.

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)

This is not applicable as the study involved non-clinical wound model testing, not expert-adjudicated patient data.

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

This is not applicable for the same reason as point 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

This is not applicable as the device is a medical dressing, not an AI/ML diagnostic tool involving human readers.

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

This is not applicable as the device is a medical dressing, not an algorithm.

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

For the non-clinical testing, the "ground truth" would be established by the defined parameters and expected outcomes of the wound models, adherence to ISO standards (e.g., ISO 10993 for biocompatibility), and direct comparison of physical and functional properties against the predicate device. This is more akin to engineering and material performance standards than clinical ground truth obtained from patients.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

Summary

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February 10, 2023

Smith and Nephew Medical Limited Thomas Robinson Senior Regulatory Affairs Specialist 101 Hessle Road Hull, Yorkshire HU3 2BN United Kingdom

Re: K213853

Trade/Device Name: RENASYS™-WF White Foam NPWT Dressing Small RENASYS™-WF White Foam NPWT Dressing Large Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: January 11, 2023 Received: January 17, 2023

Dear Thomas Robinson:

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.

Julie A. Morabito -S

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213853

Device Name

RENASYSTM-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large

Indications for Use (Describe)

Appropriate wound types include:

· Chronic
Acute
· Traumatic
Sub-Acute and dehisced wounds
· Ulcers (such as pressure or diabetic)
· Partial-thickness burns
· Flaps
· Grafts

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)

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RENASYS™-WF White Foam NPWT Dressing Traditional 510(k) Premarket Notification

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
EstablishmentRegistration Number	8043484
Contact Name	Thomas Robinson, Senior Regulatory Affairs Specialist
Telephone Number	+44 7985681790
Date Prepared	February 10, 2023
21 CFR 807.92 (a)(2): Device Information
Device Name(Trade/Proprietary Name)	RENASYSTM-WF White Foam NPWT Dressing SmallRENASYSTM-WF White Foam NPWT Dressing Large
Common Name	Negative Pressure Wound Therapy Powered suction pump
Review Panel	General and Plastic Surgery
Regulation Number	Powered suction pump; 21 CFR 878.4780
Regulatory Class	Class II
Product Code	OMP
21 CFR 807.92 (a)(3):Legally marketed device towhich equivalence isclaimed	510(k) Number: K133276Device Name: V.A.C.® Negative Pressure Wound Therapy System,including the V.A.C.® WHITEFOAM™ Dressing Kits
21 CFR 807.92 (a)(4): Device Description

RENASYS™-WF White Foam NPWT Dressing for use as a wound filler in conjunction with the RENASYS Touch or GO Negative Pressure Wound Therapy System and compatible components.

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RENASYS™-WF White Foam NPWT Dressing Traditional 510(k) Premarket Notification

21 CFR 807.92 (a)(5): Indications For Use

The RENASYS™-WF White Foam NPWT Dressing is a moist, sterile, polyvinyl alcohol (PVA) foam intended to be used in conjunction with Smith & Nephew RENASYS TOUCH and RENASYS GO Negative Pressure Wound Therapy (NPWT) Systems.

The Smith & Nephew RENASYS NPWT System is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy) as it may promote wound healing via the removal of fluids including irrigation and body fluids, wound exudate and infectious materials.

Appropriate wound types include:

Chronic
Acute
Traumatic
Sub-Acute and dehisced wounds
· Ulcers (such as pressure or diabetic)
Partial-thickness burns
· Flaps
Grafts

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

The subject device and predicate device have the same physical composition; they are both made of foam material Polyvinyl Alcohol (PVA), moistened with water, sterilised by gamma irradiation and share the same dimensions (cm):

7.5 X 10 X 1 ●
15 X 10 X 1

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RENASYS™-WF White Foam NPWT Dressing Traditional 510(k) Premarket Notification

Comparison of the Intended Uses, Indications for use, Wound Types, Contraindications, Kit Components, Materials and Packaging of the Subject and Predicate Devices

Characteristic(s)	Subject Device:	Predicate Device:	Comparison Verdict - SubstantiallyEquivalent
	RENASYSTM-WF White Foam NPWT Dressing	V.A.C Whitefoam Dressing
Intended Use	The RENASYS White Foam NPWTDressing is a moist, sterile, polyvinyl alcohol(PVA) foam intended to be used inconjunction with Smith & NephewRENASYS TOUCH and RENASYS GONegative Pressure Wound Therapy (NPWT)Systems.The Smith & Nephew RENASYS system isindicated for patients who would benefitfrom a suction device (negative pressurewound therapy) as it may promote woundhealing via the removal of fluids, includingirrigation and body fluids, wound exudatesand infectious materials.	The ActiV.A.C., InfoVAC., V.A.C. ATS,V.A.C. Freedom, V.A.C. Via, and V.A.C.Simplicity Negative Pressure Wound TherapySystems are integrated wound managementsystems for use in acute, extended and homecare settings.When used on open wounds, they are Intendedto create an environment that - promoteswound healing by secondary or tertiary(delayed primary) intention by preparing thewound bed for closure, reducing edema,promoting granulation tissue formation andperfusion, and by removing exudate andinfectious material.When used on closed surgical incisions, theyare also intended to manage the environment ofsurgical incisions that continue to drainfollowing sutured or -stapled closure bymaintaining a closed environment andremoving exudates via the application ofnegative pressure wound therapy	Yes - The subject device contains thesame indications as the predicatedevice for open wounds.Closed wounds are not listedindications for the subject device.These have different compatibleNPWT systems (manufacturerspecific).
Indications of Use(IndicatedWound Type)	Appropriate wound types include: chronic,acute, traumatic, sub-acute and dehiscedwounds, ulcers (such as pressure or diabetic),partial-thickness burns, flaps and grafts.	Open wound types include chronic, acute,traumatic, *subacute and dehisced wounds,partial-thickness burns, ulcers (such asdiabetic, pressure or venous Insufficiency),flaps and grafts. .	Yes - The Indicated wound types forthe subject device are the same as thepredicate device except for thepredicate device specifically statingVenous insufficiency ulcers, this is notincluded for the subject device to keepalignment with the compatibleRENASYS devices
Contraindications	The use of NPWT and the RENASYS SoftPort is contraindicated in the presence of:• Untreated osteomyelitis• Exposed arteries, veins, organs ornerves• Necrotic tissue with eschar present• Malignancy in wound (with exceptionof palliative are to enhance quality oflife)• Non-enteric and unexplored fistulas• Exposed Anastomotic sites	• Do not place foam dressings of theV.A.C. Therapy System directly incontact with exposed blood vessels,anastomotic sites, organs or nervesNOTE: Refer to Warnings section foradditional information concerning Bleeding.• V.A.C. Therapy is contraindicated forpatients with:• Malignancy in the wound• Untreated osteomyelitisNOTE: Refer to Warnings section forOsteomyelitis information.• Non-enteric and unexplored fistulas• Necrotic tissue with eschar presentNOTE: After debridement of necrotic tissueand complete removal of eschar, V.A.C.Therapy may be used	Yes - The subject device contains thesame contraindications as thepredicate device for open wounds
Sterility	Sterilised by Gamma Irradiation	Sterilised by Gamma Irradiation	Yes, same
Packaging	Polyethylene inner and Aluminum foil outerpouch	Polyethylene inner and Aluminum foil outerpouch	Yes, same
Materials	PVA Foam, moistened with water	PVA Foam, moistened with water	Yes, same
Status	Rx Only	Rx Only	Yes - both the subject device andpredicate device are prescription only
Environment of Use	Clinical and Home Environments	Clinical and Home Environments	Yes - both the subject device andpredicate device are available for usein clinical and home environments, inline with the respective NPWT system

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RENASYS™-WF White Foam NPWT Dressing
Traditional 510(k) Premarket Notification

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RENASYS™-WF White Foam NPWT Dressing
Traditional 510(k) Premarket Notification

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RENASYS™-WF White Foam NPWT Dressing Traditional 510(k) Premarket Notification

21 CFR 807.92 (b)(1): Brief discussion of nonclinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence

Wound model testing in challenge conditions using compatible components
Comparative wound model testing between the subject and predicate device
Testing in accordance with the relevant parts of ISO 10993 ●

21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence

No clinical study conducted or submitted as part of this submission.

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

Testing indicates that the subject device performs as intended and on an equivalence basis with the predicate device.

The subject device is substantially equivalent to the predicate device with respect to safety and effectiveness.

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.