MODIFICATION OF CUTINOVA FOAM DRESSING

K984599 · Beiersdorf-Jobt, Inc. · FRO · Mar 1, 1999 · SU

Device Facts

• Record ID: K984599
• Device Name: MODIFICATION OF CUTINOVA FOAM DRESSING
• Applicant: Beiersdorf-Jobt, Inc.
• Product Code: FRO · SU
• Decision Date: Mar 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

Cutinova foam is indicated for the management of surface, moderately to highly secreting wounds surrounded by sensitive skin, such as: Stage I-IV pressure ulcers Leg ulcers Diabetic ulcers First and second degree burns

Device Story

Cutinova foam is a polyurethane wound dressing designed for managing moderately to highly exudating wounds on sensitive skin. The device functions as a passive dressing to cover and protect wound sites. It is applied topically by healthcare professionals or patients (for OTC use) to the wound area. The dressing material consists of polyurethane modified with an aliphatic diisocyanate (replacing aromatic diisocyanate) and contains alpha-tocopherol for thermal stability. It provides a protective barrier for various ulcer types and burns. The device does not accelerate healing, treat, or cure wounds, nor is it intended as a long-term or permanent dressing.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through biological testing in accordance with ISO 10993 and comparative performance bench testing.

Technological Characteristics

Polyurethane foam dressing; material modified from aromatic diisocyanate to aliphatic diisocyanate; contains alpha-tocopherol additive for thermal stability. Passive wound dressing form factor.

Indications for Use

Indicated for management of surface, moderately to highly secreting wounds surrounded by sensitive skin, including Stage I-IV pressure ulcers, leg ulcers, diabetic ulcers, and first and second degree burns.

Predicate Devices

• Cutinova foam (K922681)

Submission Summary (Full Text)

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FEB 12 '99 04:48PM JOBST CHAR

3/1/59

K984599

#### Summary of Safety and Effectiveness for Cutinova® foam - K984599

This 510(k) is being submitted for a modification to Cutinova foam that was originally cleared for sale in the U.S. in 1992 (K922681)

Cutinova foam is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds surrounded by sensitive skin. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.

Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova foam. Performance characteristics were also comparable to the currently marketed product. In addition, a very small amount of & Tocopherol was added to improve the thermal stability of the product.

Based on safety information in international data bases, biological testing and performance characteristics, it can be concluded that the modified Cutinova foam is substantially equivalent to the current legally marketed Cutinova foam.

Dated: February 9, 1999

Prepared by: Angelo Pereira Manager, Regulatory Affairs Beiersdorf-Jobst Inc. 5825 Carnegie Boulevard Charlotte, N.C. 28209

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Mr. Angelo Pereira Beiersdorf-Jobst, Inc. 5825 Carnegie Boulevard Charlotte, North Carolina 28209-4633

Re: K984599 Trade Name: Cutinova Foam Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 23, 1998 Received: December 28, 1998

Dear Mr. Pereira:

This letter corrects our substantially equivalent letter of March 1, 1999.

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 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 (PMA). You may, therefore . market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:

1. This device may not be labeled for use on third degree burns.

2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.

3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

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Page 2 - Mr. Angelo Pereira

4. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 3 - Mr. Angelo Pereira

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Wilkerson

Mark Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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984599

Page 1 of 1

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510(k) Number (if known):

Device name: Cutinova foam

Indications For Use:

.. ...

Cutinova foam is indicated for the management of surface, moderately to highly secreting wounds surrounded by sensitive skin, such as:

Stage I-IV pressure ulcers Leg ulcers Diabetic ulcers First and second degree burns

#### (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over The Counter Use

P. De Leon

(Division Sign-Off) Division of General Restorative Devices ] _ G 510(k) Number -

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Page 1 of 1

### 510(k) Number:

#### KABASAD

Device name: Cutinova foam

Over-the-Counter Indications For Use:

Cutinova foam may be used under the direction of a health care professional for the Cumitova roam may of used under and the exudating wounds surrounded by sensitive skin, such as:

Pressure ulcers Leg ulcers Diabetic ulcers Second degree burns

# (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number .

Prescription Use (Per 21 CFR 801.109)

OR Over The Counter Use

X

(Division Sign-Off)
Division of General Restorative Devices LISSE

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