The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation 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

When used with the RENASYS AB Abdominal Kit with Soft Port, the RENASYS EDGE pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Device Description

The RENASYS EDGE device is a software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump. The device is designed to provide Negative Pressure Wound Therapy at a range of pressure settings between 25-200mmHg to a closed environment over one or two wounds. The device removes exudate from the wound site(s) to a disposable container, which may promote wound healing via removal of fluids, including irrigation of body fluids, wound exudates and infectious materials.

RENASYS EDGE can be operated by either a mains power supply or internal battery. The RENASYS EDGE device is compatible with Smith & Nephew RENASYS Dressing Kits.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the RENASYS EDGE device, a negative pressure wound therapy (NPWT) system. Based on the document, here's an analysis of the acceptance criteria and the study performed:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in a quantitative manner as typically seen for diagnostic devices. Instead, it lists various verification activities conducted to demonstrate the overall system performance and substantial equivalence to a predicate device.

The "acceptance criteria" here are implicitly linked to compliance with relevant medical device standards and the successful completion of specific types of testing to ensure the device performs as intended and is safe and effective when compared to the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Electrical Safety (IEC 60601-1, IEC 60601-1-11)	Successful completion of electrical safety testing per IEC 60601-1 (general medical electrical equipment) and IEC 60601-1-11 (for home healthcare environment).
Electromagnetic Compatibility (EMC per IEC 60601-1-2)	Successful completion of EMC testing per IEC 60601-1-2.
Human Factors/Usability (IEC 62366, IEC 60601-1-6, FDA Guidance)	Successful completion of human factors testing per IEC 62366, IEC 60601-1-6, and applicable FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."
Bench-top Performance (including challenge conditions)	Successful completion of "simulated wound model tests" and other bench-top performance testing under various challenge conditions. This likely includes: - Exudate Management: Ability to remove fluids, wound exudate, and infectious materials. - Therapeutic Pressure Setting: Ability to maintain negative pressure within the 25-200mmHg range. - Alarm Functionality: Proper functioning of alarms to notify users of therapy loss. - Auto-restart Function: Effective re-initiation of therapy after pause.
Software Verification	Successful completion of software verification testing.
Substantial Equivalence	Demonstrated through evaluation of indications for use, principle of operation, materials, technology, product specifications, and energy requirements, alongside performance testing, software verification, EMC, and electrical safety testing.

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

The document explicitly states: "No clinical data were provided to support the demonstration of substantial equivalence."
Therefore, there is no sample size for a test set of patients, nor is there any provenance information such as country of origin or retrospective/prospective nature, as no human clinical studies were performed. The testing conducted was entirely non-clinical.

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. Since no clinical data was provided and no human test set was used, there were no experts establishing ground truth for a clinical test set. The validation was based on engineering and performance criteria against standards.

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

Not applicable, as no clinical test set requiring adjudication was used.

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. The RENASYS EDGE device is a physical medical device (NPWT pump), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to its evaluation.

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

Not applicable. This is not an algorithm-only device. The evaluation focused on the physical device's performance characteristics.

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

The "ground truth" for the non-clinical tests would have been the engineering specifications and established performance parameters defined by the manufacturer and relevant international medical device standards (e.g., specific negative pressure range, exudate removal rates, alarm trigger conditions, electrical safety limits, EMC limits). Compliance with these predefined technical criteria constituted the "ground truth."

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model that requires a training set.

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

Not applicable, as there was no training set for an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in a clear, sans-serif font, with "FDA" in a blue square.

November 22, 2022

Smith & Nephew Medical Limited Zoe Smith Regulatory Affairs Specialist 101 Hessle Road Hull, HU3 2BN United Kingdom

Re: K223041

Trade/Device Name: Renasys Edge (66803126) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 29, 2022 Received: September 29, 2022

Dear Zoe Smith:

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 Morabito, PhD 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) K223041

Device Name RENASYS EDGE

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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ditional 510/k) Premarket Notification - K223041

510(k) Summary (K223041)

21 CFR 807.92 (a)(1): Submitter's Information
510(k) OwnerName	Smith & Nephew Medical Ltd
Address	101 Hessle Road, Hull, HU3 2BN, United Kingdom
EstablishmentRegistrationNumber	8043484
Contact Name	Zoe Smith
Telephone Number	+447583672659
Date Prepared	November 21st 2022
21 CFR 807.92 (a)(2): Device Information
Device Name(Trade/ProprietaryName)	RENASYS EDGE
Common Name	Negative pressure wound therapy system
Review Panel	General and Plastic Surgery
RegulationNumber	21 CFR 878.4783
Regulatory Class	Class II
Product Code	OMP
21 CFR 807.92(a)(3): Legallymarketed device towhich equivalenceis claimed	510(k) Number: K181822Device Name: RENASYS TOUCH
	21 CFR 807.92 (a)(4): Device Description

RENASYS EDGE can be operated by either a mains power supply or internal battery. The RENASYS EDGE device is compatible with Smith & Nephew RENASYS Dressing Kits.

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

The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials. Appropriate wound types include:

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FNASYS® FDG Traditional 510(k) Premarket Notification – K223041

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 RENASYS EDGE device is the next generation in the existing RENASYS family. While there are minor technological differences between the RENASYS EDGE device and predicate device, they have the same requirements and capability with respect to exudate management, therapeutic pressure setting, and operating principles. There minor differences between the devices are to enhance the user experience and do not raise any new or different questions of safety and effectiveness.

	Predicate Device (K181822)	Subject Device (K223041)	Comparison
Trade Name:	RENASYS TOUCH	RENASYS EDGE
Intended Use:	Same as subject device	Per intended use section	Same, aside from minorformatting change
Mode of Action	Negative Pressure Wound Therapy	Negative Pressure Wound Therapy	Same
Device Operation	Software	Software	Same
User Interface	Utilizes a touch screen and tactile buttons	Utilizes tactile buttons with soft keyfunction	Different, but with noimpact to therapy
Single-use orReusable:	Reusable pump unit, Disposable canister	Reusable pump unit, Disposable canister	Same
Method ofSterilization:	Non-Sterile	Non-Sterile	Same
O-Ring	Incorporates O-ring on the device	Incorporates O-ring on the canistersallowing for a new O-ring with eachtherapy	Similar
Battery type	Lithium Ion	Lithium Ion	Same
Negative Pressure	25-200mmHg	25-200mmHg	Same
Therapy Mode	Continuous & Intermittent	Continuous & Intermittent	Same
Alarms	Device utilizes alarms to notify the user ofany loss of therapy	Device utilizes alarms to notify the user ofany loss of therapy	Same
Auto Restart	N/A	Incorporates an auto-restart function to re-initiate therapy if the device has been lefton pause for more than 1 hour	Different, with thesubject device providingan enhanced userexperience
WirelessTechnology	Utilizes wireless data (3G) to enabledevice tracking	Incorporates wireless technology to allowfor Bluetooth connectivity	Different, but with noimpact to therapy
Configurations	300ml & 800ml canisters available	300ml & 800ml canisters available	Same
Accessories
Carry Bag	Carry bag for use with device and 300mlCanister	Carry bag for use with device and 300mlCanister	Same
Carry Strap	Carry strap fixes to carry strap mounts	Carry strap fixes to carry handle	Similar

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raditional 510(k) Premarket Notification – K223041

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

Verification activities were conducted which demonstrate the overall system performance of the RENASYS EDGE device. The principal test methods used to demonstrate performance were simulated wound model tests.

Electrical safety per IEC 60601-1 and IEC 60601-1-11 (home use) ●
EMC per IEC 60601-1-2
Human factors per IEC 62366, IEC 60601-1-6 and applicable guidelines listed in FDA ● Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices (FDA 2011-D0469)
Bench top performance testing including challenge conditions ●

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

No clinical data were provided to support the demonstration of substantial equivalence.

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

In establishing substantial equivalence to the predicate device, Smith & Nephew Medical Ltd evaluated the indications for use, principle of operation, materials, technology, product specifications and energy requirements of the device. Performance testing, software verification testing, electromagnetic compatibility testing and electrical safety testing has been completed to demonstrate that the RENASYS EDGE device is substantially equivalent to the predicate device for the intended use.

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.