(182 days)
The RENASYS™ - F/-AB Abdominal Wound Dressing Kit 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.
This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
The RENASYS™ -FIAB Abdominal Dressing Kit consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polvurethane organ protection layer, six transparent film drapes and a suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.
The RENASYS- FIAB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and EZ PLUS negative pressure wound therapy pumps and canister kits, which have been previously cleared under 510(k) numbers K082426, K091470 and K102001.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic or AI-powered device would.
The document is a 510(k) summary for a medical device called the RENASYS™ -F/AB Abdominal Dressing Kit. It primarily focuses on demonstrating substantial equivalence to a predicate device and includes details about:
- Biocompatibility testing: This confirms the materials used are safe for contact with the body. The table lists various tests (Cytotoxicity, Irritation, Sensitization, Implantation, Sub-acute Toxicity, Genotoxicity) completed for each kit component. These are safety standards, not performance criteria in the sense of accuracy, sensitivity, or specificity.
- Design verification testing: The document states this was conducted "to demonstrate the device meets the performance specifications, delivers negative pressure wound therapy to the wound and removes exudates." However, it does not provide:
- A table of actual "performance specifications" or acceptance criteria.
- Specific results from this design verification testing.
- Details on the sample size, data provenance, ground truth establishment, or expert involvement for this testing.
- Any information about a comparative effectiveness study (MRMC) or a standalone (algorithm only) study.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth, or study types as they are typically described for devices with measurable diagnostic or analytical performance claims.
The document concludes that the device "has successfully undergone testing to demonstrate that the device is substantially equivalent to the predicate device and effective for the intended use." This is the general statement required for a 510(k) clearance, indicating that it meets the regulatory bar for market entry, but not detailing specific performance metrics.
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lofz
We are smith&nephew
Wound Management Smith & Nephew. Inc. 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716 T 727 392-1261 F 727 392-6914 or 727 392-0797 Customer Care Center: 1 800 876-1261 www.smith-nephew.com
510(k) Summary RENASYS™ -F/AB Abdominal Dressing Kit 510(k) # K100787
SEP 1 7 2010
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- Submitter: Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
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- Contact: Laura D. Reynolds, RAC Regulatory Affairs Manager 727-329-7702
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- Date Prepared: September 14, 2010
- RENASYS™ -F/AB Abdominal Dressing Kit 4. Device Name: Abdominal Dressing Kit Common Name: Classification Name: Mesh, Surgical, Polymeric, 21 CFR 878.3300 Product Classification/Code: Class II, FTL
5. Predicate Device Information:
V.A.C.® Abdominal Dressing KCI USA. Inc. 510(k) # K022011
ം. Device Description:
The RENASYS™ -FIAB Abdominal Dressing Kit consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polvurethane organ protection layer, six transparent film drapes and a suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.
The RENASYS- FIAB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and EZ PLUS negative pressure wound therapy pumps and canister kits, which have been previously cleared under 510(k) numbers K082426, K091470 and K102001.
7. Intended Use:
The RENASYS- F/AB Abdominal Dressing Kit 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.
This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
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K100787
2 of 2
We are smith&nephew
Summary of Non-Clinical Testing 8.
The following biocompatibility testing for all kit components has been successfully completed per applicable parts of ISO 10993:
| Kit Component | Tests Completed |
|---|---|
| Foam | Cytotoxicity |
| Irritation | |
| Sensitization | |
| Organ Protection Layer | Cytotoxicity |
| Irritation | |
| Sensitization | |
| Implantation | |
| Sub-acute Toxicity | |
| Genotoxicity | |
| Transparent Film Drape | Cytotoxicity |
| Irritation | |
| Sensitization | |
| Suction Port Assembly | Cytotoxicity |
| Irritation | |
| Sensitization | |
| Sub-acute Toxicity | |
| Genotoxicity |
Design verification testing has been conducted to demonstrate the device meets the performance specifications, delivers negative pressure wound therapy to the wound and removes exudates.
Conclusions Drawn ு.
The RENASYS-F/AB Abdominal Dressing Kit has successfully undergone testing to demonstrate that the device is substantially equivalent to the predicate device and effective for the intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Smith and Nephew % Ms. Laura Reynolds, RAC Regulatory Affairs Manager 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716
SEP 1 7 2010
Re: K100787
Trade/Device Name: Renasys™ F/-AB Abdominal Wound Dressing Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 31, 2010 Received: September 1, 2010
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. Iisting 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
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Page 2 - Ms. Laura Reynolds, RAC
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/medicaldevices/resourcesforyou/industry/default.htm.
Sincerely yours,
fal D.St
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: RENASYS™ F/- AB Abdominal Wound Dressing Kit
SEP 1 7 2010
Indications for Use:
- ,
The RENASYS™ - F/-AB Abdominal Wound Dressing Kit 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.
This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sigh-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K106787 |
|---|---|
| --------------- | --------- |
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.