(30 days)
Not Found
No
The 510(k) summary describes a negative pressure wound therapy dressing kit and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical components and their function in delivering negative pressure.
Yes
Explanation: The device, as part of a Negative Pressure Wound Therapy (NPWT) system, is indicated to "promote wound healing" and is used for various wound types, aligning with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a wound dressing kit used in conjunction with negative pressure wound therapy systems to promote wound healing by removing fluids. It does not diagnose medical conditions.
No
The device description explicitly lists physical components such as antimicrobial gauze, soft port assembly, film, saline bullet, skin prep, and wound ruler. These are all hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "negative pressure wound therapy" to promote wound healing by removing fluids. This is a therapeutic application, not a diagnostic one.
- Device Description: The components are materials used for wound dressing and applying negative pressure. There are no components described that would be used to analyze biological samples (like blood, urine, tissue) to diagnose a condition.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analyzing samples, or providing information for diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (on the body) for therapeutic wound treatment.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
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.
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)
Non-Clinical Tests (Bench)
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.
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.
Not Found
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/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)
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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 Drive
Suite 300
St Petersburg, FL 33716 |
|------------------------------------|-----------------------------------------------------------------------------------------|
| Establishment registration Number: | 3006760724 |
| Contact Person: | Laura Reynolds
Director Regulatory Affairs |
| Phone Number: | (727) 686-8736 |
| Date Prepared: | August 30, 2016 |
Device Description
| Trade Name: | RENASYS™-G Gauze
Dressing Kit with Soft Port |
|------------------------|---------------------------------------------------------|
| Common or Usual Name: | Negative Pressure Wound Therapy
Powered suction pump |
| Device Classification: | Powered suction pump; 21 CFR 878.4780
Class II |
| Product Code: | OMP |
Predicate Device Information
| 510(k)# | Device | Clearance Date |
|---|---|---|
| K142979 | RENASYS EZ MAX Negative | |
| Pressure Wound Therapy System and | ||
| RENASYS Foam and Gauze NPWT | ||
| Wound 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 Gauze | |
| Dressing Kit with Soft Port | RENASYS EZ MAX NPWT | |
| and RENASYS Foam and | ||
| Gauze Dressing Kits with | ||
| Soft Port | ||
| Indications for Use: | Substantially equivalent | Substantially equivalent |
| Materials: | Substantially equivalent | Substantially equivalent |
| Soft Port Assembly: | Substantially equivalent | Substantially equivalent |
| Single-use or | ||
| Reusable: | Single-use | Single-use |
| Method of | ||
| Sterilization: | Identical | Identical |
| Biocompatibility: | All components comply with | |
| ISO 10993 | All components comply with | |
| ISO 10993 | ||
| Packaging: | Individually packaged and | |
| sterilized components are | ||
| kitted into Tyvek pouch. | ||
| RENASYS Transparent Film | ||
| lies flat in slightly larger | ||
| outer Tyvek pouch. | Individually packaged and | |
| sterilized components are | ||
| kitted into Tyvek pouch. | ||
| RENASYS Transparent Film | ||
| is folded prior to placing in | ||
| pouch. | ||
| Kit Shelf-life | 24 months | 9 months |
| Kit configuration | Identical | RENASYS G - Gauze |
| Dressing Kits with Soft Port, | ||
| Small, Medium, Large, X- | ||
| large | ||
| Product Codes: | ||
| Renasys-G Gauze | ||
| Dressing Kit with | ||
| Soft Port-Small | 66020933 | 66800933 |
| RENASYS-G | ||
| Gauze Dressing Kit | ||
| with Soft Port- | ||
| Medium | 66020934 | 66800934 |
| RENASYS-G | ||
| Gauze Dressing Kit | ||
| Subject Device: | Predicate Device: | |
| Trade Name: | RENASYS-G Gauze | |
| Dressing Kit with Soft Port | 510(k)# K142979 | |
| RENASYS EZ MAX NPWT | ||
| and RENASYS Foam and | ||
| Gauze Dressing Kits with | ||
| Soft Port | ||
| with Soft Port- | ||
| Large | 66020935 | 66800935 |
| RENASYS-G | ||
| Gauze Dressing Kit | ||
| with Soft Port-Extra | ||
| Large | 66020936 | 66800936 |
6
Table of Modifications
| Modification | Reason For Change | Verification Testing
Performed |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| The sterile RENASYS
Transparent Film is
currently folded prior to
being placed in the outer
packaging of the kit. The
modification is to place
the transparent film flat,
not folded, into the outer
packaging of the kit.
This change
necessitates increasing
the size of the outer | During routine transit
testing, Smith & Nephew
identified breaches in the
seal of the primary
packaging of the
Transparent Film
specifically in area of the
pouch where it is folded. | Transit testing was
conducted to assure the
sterile barrier of the
RENASYS Transparent
Film remains intact in
the flat configuration |
| Product codes
referenced in the
predicate 510(k)
(K142979) have been
changed | There have been no
changes to the kit contents,
the product code changes
were due to internal
business decision. | NA |
| Extend shelf life from 9
months to 24 months | Shelf life extension | Stability testing and
simulated wound model
testing on aged product
has been conducted to
assure acceptance
criteria 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.