(30 days)
The RENASYS-G Gauze Dressing Kits with Soft Port are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the 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 and Grafts
The RENASYS Gauze Wound Dressing Kit with Soft Port consists of the following components:
- . Antimicrobial gauze wound filler
- Soft Port assembly
- Non-adherent wound contact layer ●
- RENASYS Transparent film ●
- . Saline bullet
- . No Sting Skin Prep
- . Wound ruler
The RENASYS-G Gauze kits are offered in four sizes: small, medium, large and extralarge. The components of the kit are individually packaged and sterilized and kitted in a non-sterile kit package. The kit is single use.
The Soft Port assembly attaches to an exudate canister to deliver negative pressure wound therapy to the wound. The qauze kits are designed specifically for use with the RENASYS negative pressure wound therapy devices and canisters.
This document is a 510(k) summary for the RENASYS-G Gauze Dressing Kits with Soft Port. It describes the device, compares it to a predicate device, and outlines the non-clinical tests performed to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the device's performance in terms of wound healing efficacy or similar outcomes. Instead, the study focuses on verifying the substantial equivalence of the modified device to its predicate. The "acceptance criteria" are implied by the successful completion of the verification tests, ensuring the modifications do not compromise the device's performance or safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintenance of package seal integrity during transit | Transit testing was conducted to assure the sterile barrier of the RENASYS Transparent Film remains intact in the flat configuration. |
| Individually packaged and sterilized components meet criteria for 24-month shelf life | Stability testing and simulated wound model testing on aged product has been conducted to assure acceptance criteria are met. |
| Device complies with applicable standards (e.g., ISO 10993 for biocompatibility) | All components comply with ISO 10993. The device complies with listed standards (EN ISO 13485:2003, EN 1041:2008 +A1, ISO 15223-1:2012, EN ISO 14971:2012, EN ISO 10993-1:2009, EN 62366:2008). |
| Indications for Use are substantially equivalent | Substantially equivalent (to predicate device). |
| Materials are substantially equivalent | Substantially equivalent (to predicate device). |
| Soft Port Assembly is substantially equivalent | Substantially equivalent (to predicate device). |
| Sterilization method is identical | Identical (to 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)
The document does not explicitly state the sample sizes for the "transit testing" or "stability testing" or provide details on the data provenance (country of origin, retrospective/prospective). These are non-clinical (bench) tests, not typically subject to the same patient data collection requirements.
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 information is not applicable. The tests performed are non-clinical bench tests (transit testing, stability testing), which do not involve expert interpretation or ground truth establishment in the way clinical studies with expert reviewers would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as there are no expert adjudications in these non-clinical bench tests.
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
There was no MRMC comparative effectiveness study. This document describes the substantial equivalence of a medical device (wound dressing kit), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical wound dressing kit, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Transit testing: The "ground truth" for package seal integrity would be based on validated physical testing methods and established criteria for package integrity.
- Stability testing: The "ground truth" for shelf life and performance specifications would be based on validated laboratory testing methods to assess material degradation, sterilization maintenance, and functional performance over time.
8. The sample size for the training set
This information is not applicable. The tests performed are non-clinical bench tests for device modifications, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an algorithm in this context.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image contains the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked, with the top one being the most prominent and each subsequent profile slightly offset and partially obscured by the one above. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2016
Smith & Nephew, Inc. Ms. Laura Revnolds Director, Regulatory Affairs 970 Lake Carillon Drive, Suite 300 St. Petersburg, FL 33716
Re: K162129
Trade/Device Name: RENASYS-G Gauze Dressing Kits with Soft Port Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: July 29, 2016 Received: August 1, 2016
Dear Ms. Reynolds:
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. 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.
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); good manufacturing practice requirements as set
{1}------------------------------------------------
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162129
Device Name RENASYS-G Gauze Dressing Kits with Soft Port
Indications for Use (Describe)
The RENASYS-G Gauze Dressing Kits with Soft Port are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the 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 ordiabetic) | |
| Partial-thickness burns | |
| Flaps and 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)
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}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of that, the text "smith&nephew" is written in orange.
Wound Management
Smith & Nephew, Inc. 970 Lake Carillon Drive Suite 300 St. Petersburg, FL 33716
Customer Care Center: 1 800 876-1261 www.smith-nephew.com
510(k) SUMMARY
General Information
| Submitter Name/ Address: | Smith & Nephew, Inc.970 Lake Carillon DriveSuite 300St Petersburg, FL 33716 |
|---|---|
| Establishment registration Number: | 3006760724 |
| Contact Person: | Laura ReynoldsDirector Regulatory Affairs |
| Phone Number: | (727) 686-8736 |
| Date Prepared: | August 30, 2016 |
Device Description
| Trade Name: | RENASYS™-G GauzeDressing Kit with Soft Port |
|---|---|
| Common or Usual Name: | Negative Pressure Wound TherapyPowered suction pump |
| Device Classification: | Powered suction pump; 21 CFR 878.4780Class II |
| Product Code: | OMP |
Predicate Device Information
| 510(k)# | Device | Clearance Date |
|---|---|---|
| K142979 | RENASYS EZ MAX NegativePressure Wound Therapy System andRENASYS Foam and Gauze NPWTWound Dressing Kits with Soft Port | Apr 29, 2015 |
{4}------------------------------------------------
Device Description
RENASYS Gauze NPWT Wound Dressing Kit with Soft Port
The RENASYS Gauze Wound Dressing Kit with Soft Port consists of the following components:
- . Antimicrobial gauze wound filler
- Soft Port assembly
- Non-adherent wound contact layer ●
- RENASYS Transparent film ●
- . Saline bullet
- . No Sting Skin Prep
- . Wound ruler
The RENASYS-G Gauze kits are offered in four sizes: small, medium, large and extralarge. The components of the kit are individually packaged and sterilized and kitted in a non-sterile kit package. The kit is single use.
The Soft Port assembly attaches to an exudate canister to deliver negative pressure wound therapy to the wound. The qauze kits are designed specifically for use with the RENASYS negative pressure wound therapy devices and canisters.
Indications for Use
The RENASYS-G Gauze Wound Dressing Kit with Soft Port is intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the 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 and grafts.
{5}------------------------------------------------
Comparison between Subject and Predicate Devices
RENASYS-G Gauze Dressing Kit with Soft Port
| Subject Device: | Predicate Device: | |
|---|---|---|
| 510(k)# K142979 | ||
| Trade Name: | RENASYS-G GauzeDressing Kit with Soft Port | RENASYS EZ MAX NPWTand RENASYS Foam andGauze Dressing Kits withSoft Port |
| Indications for Use: | Substantially equivalent | Substantially equivalent |
| Materials: | Substantially equivalent | Substantially equivalent |
| Soft Port Assembly: | Substantially equivalent | Substantially equivalent |
| Single-use orReusable: | Single-use | Single-use |
| Method ofSterilization: | Identical | Identical |
| Biocompatibility: | All components comply withISO 10993 | All components comply withISO 10993 |
| Packaging: | Individually packaged andsterilized components arekitted into Tyvek pouch.RENASYS Transparent Filmlies flat in slightly largerouter Tyvek pouch. | Individually packaged andsterilized components arekitted into Tyvek pouch.RENASYS Transparent Filmis folded prior to placing inpouch. |
| Kit Shelf-life | 24 months | 9 months |
| Kit configuration | Identical | RENASYS G - GauzeDressing Kits with Soft Port,Small, Medium, Large, X-large |
| Product Codes: | ||
| Renasys-G GauzeDressing Kit withSoft Port-Small | 66020933 | 66800933 |
| RENASYS-GGauze Dressing Kitwith Soft Port-Medium | 66020934 | 66800934 |
| RENASYS-GGauze Dressing Kit | ||
| Subject Device: | Predicate Device: | |
| Trade Name: | RENASYS-G GauzeDressing Kit with Soft Port | 510(k)# K142979RENASYS EZ MAX NPWTand RENASYS Foam andGauze Dressing Kits withSoft Port |
| with Soft Port-Large | 66020935 | 66800935 |
| RENASYS-GGauze Dressing Kitwith Soft Port-ExtraLarge | 66020936 | 66800936 |
{6}------------------------------------------------
Table of Modifications
| Modification | Reason For Change | Verification TestingPerformed |
|---|---|---|
| The sterile RENASYSTransparent Film iscurrently folded prior tobeing placed in the outerpackaging of the kit. Themodification is to placethe transparent film flat,not folded, into the outerpackaging of the kit.This changenecessitates increasingthe size of the outer | During routine transittesting, Smith & Nephewidentified breaches in theseal of the primarypackaging of theTransparent Filmspecifically in area of thepouch where it is folded. | Transit testing wasconducted to assure thesterile barrier of theRENASYS TransparentFilm remains intact inthe flat configuration |
| Product codesreferenced in thepredicate 510(k)(K142979) have beenchanged | There have been nochanges to the kit contents,the product code changeswere due to internalbusiness decision. | NA |
| Extend shelf life from 9months to 24 months | Shelf life extension | Stability testing andsimulated wound modeltesting on aged producthas been conducted toassure acceptancecriteria are met. |
{7}------------------------------------------------
Non-Clinical Tests (Bench)
RENASYS-G Gauze Dressing Kit with Soft Port
Testing has been conducted to verify the modifications to the RENASYS-G Gauze Dressing Kits with Soft Port meet design specifications and demonstrate substantial equivalence to the predicate device.
- Verification that the change of the configuration of the Renasys Transparent Film in the outer pouch maintains package seal integrity during transit.
- Verification that individually packaged and sterilized components within the kit . meet criteria for 24 month shelf life, including meeting performance specifications.
Standards
The device complies with the following standards:
EN ISO 13485:2003 Quality Management Systems - Medical Devices - System requirements for regulatory purposes
EN 1041:2008 +A1 Information Supplied by Manufacturers with Medical Devices
ISO 15223-1:2012 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied.
EN ISO 14971:2012 Medical Devices — Application of Risk Management to Medical Devices
EN ISO 10993-1:2009 Biological evaluation of medical devices-Evaluation and testing with a risk management process
EN 62366:2008: Medical devices - Application of usability engineering to medical devices
Conclusion
In establishing substantial equivalence to the currently marketed predicate device, Smith & Nephew, Inc. evaluated the indications for use, materials, technology and product specifications of the device. Verification testing has been successfully completed to demonstrate that the subject device RENASYS-G Gauze Dressing kits with Soft Port are substantially equivalent to the predicate device for the intended use.
§ 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.