SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)

K090254 · Convatec, A Division of E.R. Squibb & Sons, LLC · FRO · Sep 4, 2009 · SU

Device Facts

• Record ID: K090254
• Device Name: SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
• Applicant: Convatec, A Division of E.R. Squibb & Sons, LLC
• Product Code: FRO · SU
• Decision Date: Sep 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the supervision of a healthcare professional, the Silver Hydrofiber® Wound Dressing Reinforced with Nylon may be used for the management of: - Partial thickness (second degree) burns; - Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial and full thickness); - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; - Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; - Surgical wounds that heal by primary intention such as dermatological and surgical incisions (e.g., orthopedic and vascular) - Traumatic wounds - Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites - Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma - Management of painful wounds - Infected wounds

Device Story

Soft, sterile, non-woven flat wound dressing; composed of sodium carboxymethylcellulose hydrocolloid fibers; reinforced with nylon stitching; contains 1.2% ionic silver (approx. 12mg per 4x4 inch dressing). Functions as antimicrobial barrier; absorbs wound fluid; transforms into soft, cohesive gel; maintains moist environment; aids autolytic debridement. Used in clinical settings under healthcare professional supervision. Benefits include infection risk reduction, exudate management, comfort, and pain reduction during dressing changes. Subject device is identical to predicate in base fabric, with added nylon reinforcement.

Clinical Evidence

Evidence includes extensive clinical data from the predicate device (AQUACEL Ag) demonstrating safety and efficacy in various wound types. A single clinical study was conducted specifically for the reinforced dressing in partial thickness burns to confirm performance regarding flexibility.

Technological Characteristics

Non-woven flat dressing; sodium carboxymethylcellulose fibers; 1.2% ionic silver; nylon reinforcement stitching. Sterile. Standalone physical dressing.

Indications for Use

Indicated for management of partial thickness burns, diabetic foot ulcers, leg ulcers (venous, arterial, mixed), pressure ulcers, surgical wounds (primary/secondary intention), traumatic wounds, bleeding wounds, donor sites, oncology wounds with exudate, painful wounds, and infected wounds. For use under healthcare professional supervision.

Predicate Devices

• AQUACEL Ag Hydrofiber® Wound Dressing (K080383)

Submission Summary (Full Text)

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Premarket Notification - K090254

June 23, 2009

Response to FDA Request for Additional Information dated February 26, 2009

#### SECTION 5: 510(k) SUMMARY

## Silver Impregnated Hydrofiber® Dressing Reinforced with Nylon (Flat)

| Applicant: | ConvaTec Inc.<br>200 Headquarters Park Drive<br>Skillman, New Jersey 08558 | SEP - 4 2009 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Patricia Kearins<br>Manager, US Regulatory Affairs<br>908-904-2180<br>fax: [phone]<br>email: [e-mail]) | |
| Device: | Silver Hydrofiber® Dressing Reinforced with Nylon (Flat) | |
| Classification Name: | Dressing, Wound, Drug | |
| Device Class: | Unclassified | |
| Product Code: | FRO | |

Substantially Equivalent Device: AQUACEL Ag Hydrofiber® Wound Dressing - K080383

Silver Hydrofiber® Reinforced with Nylon Wound Dressings is a soft, sterile, non-woven flat dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose), that is reinforced with nylon stitching and that contain 1.2% ionic silver which allows for an average of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of nonviable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection.

Silver Hydrofiber® Reinforced with Nylon flat dressings are indicated for the management of wounds and can be used under the supervision of a healthcare professional for the management of: partial thickness (second degree) burns; diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; surgical wounds left to heal by secondary intention such as dehisced surgical incisions; surgical wounds that heal by primary intention such as dermatological and surgical incisions (e.g., orthopedic and vascular); traumatic wounds; wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;

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Premarket Notification – K090254

June 23, 2009

Response to FDA Request for Additional Information dated February 26, 2009

oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; management of painful wounds and infected wounds.

These indications are identical to those of the predicate device, K080383, AQUACEL® Ag Hydrofiber Dressing.

Extensive clinical testing, including controlled GCP studies, has been carried out with AQUACEL® Ag (the predicate). The results of these studies have consistently demosstated that the products are safe and effective dressings in the treatment of a wide range of wound types. The fluid handling and geling properties of AQUACEL® Ag have been shown to provide patient benefits in terms of exulate management, comfort, (comparative) pain reduction on dressing changes, control of peri-wound maceration, non-adherence and moist wound healing. See 510(k) #K080383 for details. Silver Fydrofiber® Dressing Reinforced with Nylon is essentially the same base fabric as AQUACEL® Ag, with the addition of Nylon stitching incorporated to reinforce the dressing.

In view of the breadth of evidence to support the clinical safety and performance of sodium carboxymethylcellulose fiber (in particular AQUACEL®) in a wide range of wounds, the well known and accepted antimicrobial profile of silver and the established clinical use of silver containing AQUACEL® Ag dressings, to or sher with clinical data relevant to this product extensive clinical investigations with Silver Fydrofiber® Dressings Reinforced with Nylon were not considered necessary to confirm the clinical safety and performance for all indications, however, a single study has been carried out in partial thickness burns, which is anticipated to be the major indication for this product due to the need for flexibility of a dressing as the wound dries out. This product due to the need tor tlexibility of a
clinical of K 00054 Clinical of K090254.

Based on the history of use of the predicate device and the above referenced clinical study, it is concluded that Silver Hydrofiber® Dressing Reinforced with Nylon is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

# SFP - 4 2009

ConvaTec, Inc. % Ms. Patricia Kearins Manager, Regulatory Affairs 200 Headquarters Park Drive Skillman. New Jersey 08558

Re: K090254

Trade/Device Name: Silver Impregnated Hydrofiker® Dressing Reinforced with Nylon

(Flat) Product Code: FRO Dated: August 19, 2009 Received: August 20, 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, listing 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 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.

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Page 2 - Ms. Patricia Kearins

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/cdrh/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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Response to FDA Request for Additional Information dated February 26, 2009

#### Section 4: Indications for Use Statement

#### 510(k) Number (if known): K090254

Device Name: Silver Impregnated Hydrofiber® Dressing Reinforced with Nylon (Flat)

#### Indications for Use:

Under the supervision of a healthcare professional, the Silver Hydrofiber® Wound Dressing Reinforced with Nylon may be used for the management of:

- Partial thickness (second degree) burns; .
- Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of . mixed etiology) and pressure ulcers/sores (partial and full thickness);
- Wounds as an effective barrier to bacterial penetration of the dressing as this may help . reduce infection;
- Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; .
- Surgical wounds that heal by primary intention such as dermatological and surgical . incisions (e.g., orthopedic and vascular)
- . Traumatic wounds
- Wounds that are prone to bleeding, such as wounds that have been mechanically or . surgically debrided and donor sites
- Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating t carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
- Management of painful wounds .
- . Infected wounds

Prescription Use X (21 CFR 801 Subpart D)

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 Kure

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090254