(479 days)
No
The document describes a negative pressure wound therapy dressing kit and film, which are passive components used with a pump. There is no mention of AI, ML, or any computational analysis of data for decision-making or control. The performance studies focus on physical properties and system compatibility.
Yes
The device is described as a Negative Pressure Wound Therapy (NPWT) system component, which is indicated for promoting wound healing by removing fluids, thereby treating various wound types. This falls under the definition of a therapeutic device.
No
Explanation: The device is a wound dressing kit used in Negative Pressure Wound Therapy (NPWT) systems to promote wound healing. It is not designed to diagnose diseases or conditions.
No
The device description explicitly states it is a sterile, single-use device containing physical components like foam wound filler sheets, a soft port, and transparent films. The performance studies also detail physical testing of these materials.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in conjunction with Negative Pressure Wound Therapy (NPWT) systems to promote wound healing by removing fluids. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details physical components like foam, ports, and films used for wound dressing and therapy. These are external devices applied to the body, not reagents or instruments used to examine specimens from the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a component of a Negative Pressure Wound Therapy system, which is a medical device used for wound treatment.
N/A
Intended Use / Indications for Use
RENASYS-F Foam dressing kits with Soft Port and RENASYS Films are intended to be used in conjunction with Smith & Nephew RENASYS 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 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
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The RENASYS-F XL Negative Pressure Wound Therapy (NPWT) Foam Dressing Kit with Soft Port is a sterile, single use device containing one extra-large polyurethane foam wound filler sheet (18.9in x 16.1in x 0.6in / 48cm x 41cm x 1.5cm), one soft port and six transparent films (12in x 8in / 30cm x 20cm).
The RENASYS XL Transparent Film Dressing is a sterile, single use device provided in a pack containing five transparent films (15in x 24in / 38cm x 60cm). The RENASYS XL Transparent Film Dressing are provided where additional film dressings may be needed to supplement other RENASYS dressing kits.
The RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port and RENASYS XL Transparent Film Dressing are intended to be used in conjunction with Smith & Nephew RENASYS Negative Pressure Wound Therapy (NPWT) systems and dressing kits.
These devices are compatible with the RENASYS TOUCH NPWT pump (cleared in K181822) and RENASYS GO NPWT pump (cleared in K152163).
The devices for which clearance is being sought are:
RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port Containing cleared components (soft-port and transparent film) and a larger sized foam sheet consisting of identical material to the foam sheets in the predicate device RENASYS XL Transparent Film Dressing
a larger sized transparent film of identical material to the film sheets in the predicate device
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
Not Found
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)
Verification activities were conducted which demonstrate the overall system performance of the RENASYS-F XL Foam Kit and RENASYS XL Film. The principal test methods used to demonstrate performance were simulated wound model tests.
- Wound model tests demonstrating performance of RENASYS-FXL Foam Kit and RENASYS XL Film when used with RENASYS GO and RENASYS TOUCH NPWT pumps at various pressures, minimum/maximum leak rates and use in combination with cleared RENASYS consumables
- Wound model testing demonstrating no change in performance between large and extra-large wound sizes
- Wound model tests demonstrating RENASYS GO and RENASYS TOUCH NPWT leak and blockage alarms are not impacted when used with RENASYS-F XL Foam Kit and RENASYS XL Film
- Physical testing on the XL Foam (tensile strength, elongation at break, loss on drying)
- Physical testing on the XL Transparent Film Dressing (Moisture Vapor permeability, Waterproofness, Adhesion to Steel, Tensile strength, Weight of Adhesive (g/m2), Weight of Base Film (g/m2), Extensibility, Permanent Set)
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.
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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 14, 2022
Smith & Nephew Medical Limited Steeve Lamvohee RA Director 101 Hessle Road Hull, Yorkshire HU3 2BN United Kingdom
Re: K202783
Trade/Device Name: Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 23, 2021 Received: September 27, 2021
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 (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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 website (https://www.fda.gov/medical-device-advice-advice-comprehensive-regulatorythe DICE assistance/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, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202783
Device Name
RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port RENASYS XL Transparent Film Dressing
Indications for Use (Describe)
RENASYS-F Foam dressing kits with Soft Port and RENASYS Films are intended to be used in conjunction with Smith & Nephew RENASYS 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 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) |
|---|---|
|| | 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
RENASYS™-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port RENASYS™ XL Transparent Film Dressing Traditional 510(k) Premarket Notification : K202783
510(k) Summary K202783
| 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 |
| Establishment | |
| Registration | |
| Number | 8043484 |
| Contact Name | Dr Steeve Lamvohee, Regulatory Affairs Director |
| Telephone Number | +44 7583 048727 |
| Date Prepared | 13th January 2022 |
| 21 CFR 807.92 (a)(2): Device Information | |
| Device Name | |
| (Trade/Proprietary | |
| Name) | RENASYS-F XL Negative Pressure Wound Therapy Foam |
| Dressing Kit with Soft Port | |
| RENASYS XL Transparent Film Dressing | |
| Common Name | Negative Pressure Wound Therapy foam kit |
| Negative Pressure Wound Therapy films | |
| Review Panel | General and 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: K142979 |
| Device Name: RENASYS-F Negative Pressure Wound Therapy | |
| Foam Dressing Kits with Soft Port | |
| 21 CFR 807.92 (a)(4): Device Description |
The RENASYS-F XL Negative Pressure Wound Therapy (NPWT) Foam Dressing Kit with Soft Port is a sterile, single use device containing one extra-large polyurethane foam wound filler sheet (18.9in x 16.1in x 0.6in / 48cm x 41cm x 1.5cm), one soft port and six transparent films (12in x 8in / 30cm x 20cm).
The RENASYS XL Transparent Film Dressing is a sterile, single use device provided in a pack containing five transparent films (15in x 24in / 38cm x 60cm). The RENASYS XL Transparent Film Dressing are provided where additional film dressings may be needed to supplement other RENASYS dressing kits.
The RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port and RENASYS XL Transparent Film Dressing are intended to be used in conjunction with
4
ENASYS™-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port RENASYS™ XL Transparent Film Dressing Traditional 510(k) Premarket Notification : K202783
Smith & Nephew RENASYS Negative Pressure Wound Therapy (NPWT) systems and dressing kits.
These devices are compatible with the RENASYS TOUCH NPWT pump (cleared in K181822) and RENASYS GO NPWT pump (cleared in K152163).
The devices for which clearance is being sought are:
RENASYS-F XL Negative Pressure Wound Therapy Foam Dressing Kit with Soft Port Containing cleared components (soft-port and transparent film) and a larger sized foam sheet consisting of identical material to the foam sheets in the predicate device RENASYS XL Transparent Film Dressing
a larger sized transparent film of identical material to the film sheets in the predicate device
21 CFR 807.92 (a)(5): Intended Use / Indications for Use
RENASYS-F Foam dressing kits with Soft Port and RENASYS Films are intended to be used in conjunction with Smith & Nephew RENASYS 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 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
21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices
The subject device and predicate device have identical indications for use, similar technological characteristics and the same principles of operation. The minor technological difference in the dimensions of the foam and transparent film does not raise any new or different questions of safety and effectiveness compared to the predicate device. The changes made to the Soft Port from the predicate device specifically relate to the release handles and the controlled leak pathway, and do not impact the safety or effectiveness.
The subject device and the predicate device are based on the following same technological elements:
- · The devices are single patients use, supplied sterile and disposable
- · The devices have the similar design and utilise the same materials of construction
5
NASYS™-F XL Neqative Pressure Wound Therapy Foam Dressing Kit with Soft Port RENASYS™ XL Transparent Film Dressing Traditional 510(k) Premarket Notification : K202783
- · The devices are connected to a negative pressure pump via the RENASYS Soft Port
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-F XL Foam Kit and RENASYS XL Film. The principal test methods used to demonstrate performance were simulated wound model tests.
- Wound model tests demonstrating performance of RENASYS-FXL Foam Kit and RENASYS XL Film when used with RENASYS GO and RENASYS TOUCH NPWT pumps at various pressures, minimum/maximum leak rates and use in combination with cleared RENASYS consumables
- · Wound model testing demonstrating no change in performance between large and extra-large wound sizes
- · Wound model tests demonstrating RENASYS GO and RENASYS TOUCH NPWT leak and blockage alarms are not impacted when used with RENASYS-F XL Foam Kit and RENASYS XL Film
- · Physical testing on the XL Foam (tensile strength, elongation at break, loss on drying)
- · Physical testing on the XL Transparent Film Dressing (Moisture Vapor permeability, Waterproofness, Adhesion to Steel, Tensile strength, Weight of Adhesive (g/m2), Weight of Base Film (g/m2), Extensibility, Permanent Set)
RENASYS-F XL Foam Kit and RENASYS XL Film meets the biocompatibility requirements of:
- · 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. The biological endpoints for the subject devices are in line with the requirements of ISO 10993 with consideration to: Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Systemic toxicity (acute, sub-acute and sub-chronic) and Implantation
- · Evaluation and risk assessment of bacterial endotoxin contamination in accordance with ANSI/AAMI ST72:2019
21 CFR 807.92 (b)(3): Conclusions drawn
Based on the test results and the additional supporting information provided in this submission, S+N believe the subject device is substantially equivalent to the legally marketed predicate device. To the extent that where there are differences between the subject device and the predicate device, these differences do not raise new or different questions of safety or effectiveness.