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

Cutinova foam may be used under the direction of a health care professional for the management of moderately to highly exudating wounds surrounded by sensitive skin, such as: Pressure ulcers Leg ulcers Diabetic ulcers Second degree burns

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) submission for a modification to an existing wound dressing, Cutinova foam. The submission focuses on demonstrating substantial equivalence to the predicate device, not on proving new efficacy or performance standards through extensive clinical studies. Therefore, many of the requested categories for a typical medical device study are not applicable or explicitly mentioned in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Study for Cutinova foam - K984599

Category	Description of Acceptance Criteria (if stated)	Reported Device Performance / Study Findings
Substantial Equivalence	The modified device must be substantially equivalent to the legally marketed predicate device (Cutinova foam cleared in 1992, K922681) in terms of safety and effectiveness, and must not affect the indications for use.	The modified Cutinova foam demonstrated "no negative effects" in biological tests conducted in accordance with ISO 10993. "Performance characteristics were also comparable to the currently marketed product."
Material Change Impact	The change from an aromatic diisocyanate to an aliphatic diisocyanate for urethane material should not negatively impact safety or performance, and should not affect indications for use.	Biological tests (ISO 10993) showed "no negative effects" for the modified foam. Performance characteristics were "comparable" to the predicate. Addition of a "very small amount of α Tocopherol" was to improve thermal stability.
Biocompatibility	The device should not cause adverse biological reactions.	Biological tests were done in accordance with ISO 10993 and showed "no negative effects."
Performance Characteristics	Performance characteristics should be equivalent to the predicate device.	Performance characteristics were "comparable" to the currently marketed product.
Thermal Stability	(Implicit) The device should maintain its stability.	A very small amount of α Tocopherol was added to improve the thermal stability of the product.

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of human subjects or clinical data for performance comparison. The biological tests were conducted in accordance with ISO 10993, which are standardized laboratory tests. No information is provided regarding the specific number of samples or data provenance for these biological or performance characteristics tests beyond the standard ex vivo or in vitro nature implied by ISO 10993.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The study described is not a diagnostic or clinical study requiring expert ground truth in the traditional sense. The "ground truth" for the substantial equivalence claim relies on standardized biological testing and comparative performance evaluations against a predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set with adjudicated outcomes is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/imaging device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth used for demonstrating substantial equivalence was based on:
- Biological testing results: Conformance to ISO 10993 standards for biocompatibility.
- Comparative performance characteristics: Evaluation against the predicate device's established performance.
- Safety information from international databases: Used as supporting evidence.
The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training data" for the device's design would effectively be the knowledge and experience used to develop the predicate device and the understanding of material science.
How the ground truth for the training set was established:
Not applicable. As there's no training set mentioned for an AI/machine learning device, this question is not relevant to the provided text.

Summary

{0}------------------------------------------------

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)

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

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.

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:

This device may not be labeled for use on third degree burns.
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

{2}------------------------------------------------

Page 2 - Mr. Angelo Pereira

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.

{3}------------------------------------------------

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

{4}------------------------------------------------

984599

Page 1 of 1

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 -

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '9', '8', '4', '5', and '9', and ends with another '9'. The characters are written in a dark ink, contrasting with the white background.

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

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

r . La

Regulation Number and Section

N/A