AQUACEL AG SURGICAL

K091034 · Convatec · FRO · Dec 16, 2009 · SU

Device Facts

Record IDK091034
Device NameAQUACEL AG SURGICAL
ApplicantConvatec
Product CodeFRO · SU
Decision DateDec 16, 2009
DecisionSESE
Submission TypeTraditional
Device ClassClass U
AttributesTherapeutic

Intended Use

AQUACEL® Ag Surgical may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.

Device Story

AQUACEL® Ag Surgical is a sterile, one-piece post-operative dressing. It consists of an inner non-woven pad made of hydrocolloid fibers (Hydrofiber® technology) containing ionic silver, held by two layers of skin-friendly hydrocolloid adhesive and an outer polyurethane film. The pad is stitchbonded with nylon and elastane yarn to provide extensibility and shape retention during limb movement. The dressing functions as a waterproof, bacterial, and viral barrier. It absorbs wound fluids to form a soft gel, maintaining a moist environment to support healing. Used in clinical settings under healthcare professional supervision, the dressing is applied to surgical incisions to manage drainage and reduce infection risk. The design facilitates ease of application and removal, potentially reducing the frequency of dressing changes compared to standard dressings.

Clinical Evidence

No new clinical trials were conducted for this submission. Evidence relies on literature reviews and clinical data provided in previous 510(k) submissions (K080383) for Hydrofiber®-based products. Literature suggests that Hydrofiber® dressings are safe and effective for managing surgical incisions healing by primary intent and result in fewer dressing changes compared to standard dressings.

Technological Characteristics

Non-woven pad composed of hydrocolloid fibers (Hydrofiber® technology) with ionic silver; adhesive layers of hydrocolloid; outer layer of polyurethane film; stitchbonded with nylon and elastane yarn for extensibility. Sterile, waterproof, bacterial/viral barrier. No electronic components or software.

Indications for Use

Indicated for management of wounds healing by primary intent, including traumatic and elective post-operative wounds/incisions, in patients requiring wound care under the supervision of a healthcare professional.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K091034 page 1 of 2 Premarket Notification 510(k) K091034 Response to FDA Request for Additional Information 4 October 16, 2009 ## Section 5: 510(K) Summary | Device: | AQUACEL® Ag Surgical | |----------------------|---------------------------------------------------------------------------------------------------------------------------------| | Applicant: | ConvaTec Inc. | | Contact: | Patricia Kearins<br>Manager, US Regulatory Affairs<br>908-904-2180<br>fax: 908-904-2235<br>email: patricia.kearins@convatec.com | | Date: | October 16, 2009 | | Trade Name: | AQUACEL® Ag Surgical | | Classification Name: | Dressing, Wound, Drug | | Device Class: | Unclassified | | Product Code: | FRO | | Predicate Devices: | AQUACEL® Ag Hydrofiber® Dressing, K080383<br>DuoDERM® Extra Thin Dressing, K891696<br>(currently Class 1, 510(k) exempt) | AQUACEL® Ag Surgical Dressing with Silver is a one piece post-operative dressing comprised of an inner (wound contact) non-woven pad which is held in place by two layers of skin-friendly hydrocolloid adhesive and an outer top layer of polyurethane film. The nonskin moraly if your over of and innic silver sitems and ionic silver stitchbonded with nylon and elastane yarn for dressing extensibility (so the ressing will stretch and be eiastane yairi for drossing oxiension (after limb movement the dressing will return to its original shape and size without the application of any additional force to the skin). The one-piece dressing design provides ease of application and removal and provides a waterproof, bacterial, and viral barrier covering to the wound. The benefits provided by this waterproof, at the clinical need for improved management of surgical wounds which have wound drainage and are at risk of infection. AQUACEL® Ag Surgical combines the absorbency/retention properties of AQUACEL® Ag AQUACEL Ag Surgical combines the absorbonomics of DuoDERM® Extra Thin adhesive. Page 99 {1}------------------------------------------------ K091034 page 2 of 2 Premarket Notification 510(k) K091034 Response to FDA Request for Additional Information October 16, 2009 AQUACEL® Ag Surgical dressing is a soft, sterile, non-woven pad composed of hydrocolloid fibers. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment and supports the body's healing process. AQUACEL® Ag Surgical dressing is available under the supervision of a healthcare professional and is indicated for the management of wounds healing by primary intent (e.g., traumatic and elective post-operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection. Since AQUACEL® Ag Surgical dressing is based on the AQUACEL® Ag Hydrofiber" technology, the safety and effectiveness of AQUACEL® Ag Surgical has been demonstrated by the lite and clinical data provided in previous 510(k)s (i.e., K080383). In summary, a careful and thorough review of the literature suggests that Hydrofiber® dressings have been used safely and effectively in clinical trials for the management of-surgical incisions healing with primary intent. All the studies which have been reviewed suggest that, compared to a standard dressing, using a dressing with AQUACEL® leads to less dressing changes. Thus we believe that, similar to previously cleared Hydrofiber"-based products (reference K080383), AQUACEL® Ag Surgical can be used safely and effectively for the management wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 ConvaTec Inc. % Ms. Patricia Kearins Manager, US Regulatory Affairs 200 Headquarters Park Drive Skillman, New Jersey 08558 DEC 1 6 2009 Re: K091034 Trade/Device Name: Aquacel® Ag Surgical Regulatory Class: Unclassified Product Code: FRO Dated: December 02, 2009 Received: December 03, 2009 Dear Ms. Kearins: 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. 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 {3}------------------------------------------------ Page 2 - Ms. Patricia Kearins 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/ucm1 1 5809.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/cdrl/mdr/ 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/cdrh/industry/support/index.html. Sincerely yours. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Premarket Notification 510(k) K091034 Response to FDA Request for Additional Information October 16, 2009 ## Section 4: Indications For Use Statement 510(k) Number: K091034 Device Name: AQUACEL® Ag Surgical Under the supervision of a healthcare professional: AQUACEL® Ag Surgical may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Keane (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091034 . ••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
Innolitics
510(k) Summary
Decision Summary
Classification Order
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