(91 days)
The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system.
The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and 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
RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems.
Based on the provided text, the document is a 510(k) summary from the FDA for a medical device called "RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port." This document does not describe an AI/ML device or its performance criteria. It pertains to a physical medical device used for negative pressure wound therapy.
Therefore, I cannot provide the requested information as the document does not contain details regarding acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets those criteria. The original text only mentions non-clinical tests (simulated wound model tests, human factors validation, biological evaluation) and explicitly states "No clinical performance data was necessary" for this particular device.
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February 18, 2025
Smith & Nephew Medical Ltd Ruby Uttley Senior Regulatory Affairs Specialist 101 Hessle Road Hull, East Riding of Yorkshire HU3 2BN United Kingdom
Re: K243576
Trade/Device Name: RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: November 19, 2024 Received: November 19, 2024
Dear Ruby Uttley:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about mediation-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,
Yu-chieh Chiu-S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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) K243576
Device Name
RENASYS™ Foam Wound Dressing Kits with AIRLOCK™ Technology and Soft Port RENASYS™ Gauze Wound Dressing Kits with AIRLOCK™ Technology and Soft Port
Indications for Use (Describe)
The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system.
The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and 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
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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510(k) Summary (K243576)
| 510(k) Summary21 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 |
| Establishment Registration Number | 8043484 |
| Contact Name | Ruby Uttley, Senior Regulatory Affairs Specialist |
| Telephone Number | +44 7740 531714 |
| Date Prepared | 12th Febuary 2025 |
| 21 CFR 807.92 (a)(2): Device Information | |
| Device Name (Trade/Proprietary Name) | RENASYSTM Foam Wound Dressing Kits with AIRLOCKTM Technology and Soft PortRENASYSTM Gauze Wound Dressing Kits with AIRLOCKTM Technology and Soft Port |
| Common Name | Negative Pressure Wound Therapy Powered Suction Pump |
| Review Panel | General & Plastic Surgery |
| Regulation Number | 21 CFR 878.4780 |
| Regulatory Class | Class II |
| Product Code | OMP |
| 21 CFR 807.92 (a)(3): Legally marketed device to which equivalence is claimed | 510(k) Number: K142979Device Name: RENASYS Foam and Gauze NPWT Wound Dressing Kits with Soft Port |
| 21 CFR 807.92 (a)(4): Device Description |
RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems.
21 CFR 807.92 (a)(5): Intended Use / Indications for Use
The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system.
The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.
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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 is the same as the predicate device in terms of its intended use, indications for use. The difference between the subject device and predicate device is the addition of RENASYS Film with AIRLOCK Technology and Retention Strips. The kit is considered substantially equivalent to the predicate device.
| Characteristics | Subject Device: RENASYSFoam and Gauze WoundDressing Kits withAIRLOCK Technology andSoft Port | Predicate Device:RENASYS Foam andGauze NPWT WoundDressing Kits with Soft Port |
|---|---|---|
| Intended Use | Same as predicate | Intended to create a closedenvironment over a wound toallow negative pressurewound therapy to evacuateexudate from the wound intoa collection canister |
| Indications for Use | Same as predicate | Chronic, Acute, Traumatic,Sub-Acute and dehiscedwounds, Ulcers (such aspressure or diabetic), Partial-thickness burns, Flaps andGrafts |
| Kit Components | RENASYS Film withAIRLOCK Technology andRetention Strips replace theRENASYS Transparent Film. | RENASYS Transparent Film,Foam or Gauze, User Manualand other components |
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| All other components are the | |
|---|---|
| same as the predicate device. | |
21 CFR 807.92 (b)(1): Brief discussion of nonclinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
Verification and validation activities conducted demonstrate the subject device continues to perform as intended by handling wound fluids and delivering negative pressure wound therapy. The principal test methods used to demonstrate performance were simulated wound model tests. Non-clinical performance testing was conducted for the determination of substantial equivalence:
- Simulated wound model testing demonstrated the subject device performed as intended ●
- Human Factors validation study demonstrated safe use by all test subjects ●
- Biological Evaluation demonstrated subject device is safe for intended use
21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
No clinical performance data was necessary.
21 CFR 807.92 (b)(3): Conclusions drawn
Based on the non-clinical performance testing provided in this submission, the subject device is substantially equivalent to the legally marketed predicate device (K142979) and there are no different questions of safety or effectiveness.
§ 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.