MODIFICATION OF CUTINOVA THIN DRESSING by BEIERSDORF-JOBT, INC.

Cutinova thin is a dressing indicated for the management of surface wounds with low to moderate exudate, such as: Minor burns Abrasions Cutinova thin may also be used under the direction of a health care professional for partial thickness wounds such as: Second degree burns Leg ulcers Pressure ulcers Post-op wounds Donor sites

Device Description

Cutinova thin is a polyurethane dressing that is indicated for the management of wounds with low to moderate exudate. 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 is a 510(k) summary for a medical device modification, specifically for the Cutinova® thin wound dressing. It details regulatory information and a brief summary of testing, but it does not contain the specific information requested in the prompt regarding acceptance criteria and a detailed study's results.

Here's an analysis based on the provided text, Highlighting the information that is not present:

1. Table of acceptance criteria and the reported device performance:

Not present in the document. The document states "Performance characteristics were also comparable to the currently marketed product," but it does not define these characteristics, their acceptance criteria, or the specific quantitative results achieved.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not present in the document. The document mentions "Biological tests were done in accordance with ISO 10993" and "Performance characteristics were comparable," but it does not specify the sample sizes used for these tests, the type of study (retrospective or prospective), or the data's origin.

3. 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 / Not present. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnoses). The described tests are biological and performance characteristic tests for a wound dressing, which do not involve human expert consensus for ground truth as would be seen in diagnostic device studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not present. Similar to point 3, adjudication methods are for expert consensus on subjective assessments. The tests described are laboratory-based biological and performance tests.

5. 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 device is a wound dressing, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a wound dressing, not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Implied by the tests, but not explicitly stated as 'ground truth'. For biological tests (ISO 10993), the ground truth generally refers to established biological safety standards or predetermined acceptable ranges for various biological responses (e.g., cytotoxicity, sensitization, irritation). For performance characteristics, the "ground truth" would be the established performance metrics of the predicate device. However, the document doesn't detail how these were specifically established.

8. The sample size for the training set:

Not applicable / Not present. Training sets are relevant for machine learning/AI models. This document describes a physical medical device.

9. How the ground truth for the training set was established:

Not applicable. As above, training sets and ground truth establishment for them are not relevant to this type of device.

In summary, the provided K984593 510(k) summary focuses on demonstrating substantial equivalence through:

Biological testing: "Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova thin." (This implies a comparison against safety standards).
Performance characteristics comparison: "Performance characteristics were also comparable to the currently marketed product." (This implies a comparison against the predicate device's performance).
Material change justification: The primary change is a material alteration (aromatic to aliphatic diisocyanate) and the addition of a small amount of Vitamin E for thermal stability, which the submission argues does not affect the indications for use or safety/effectiveness.

The document does not provide the detailed study results, specific acceptance criteria values, or sample sizes common in a detailed study report for a diagnostic or AI-powered device. Its purpose is to demonstrate substantial equivalence to a predicate device for regulatory clearance, not to publish a comprehensive scientific study.

Summary

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K984593

Summary of Safety and Effectiveness for Cutinova® thin - K984593

This 510(k) is being submitted for a modification to Cutinova thin that was originally cleared for sale in the U.S. in 1994 (K944581)

Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova thin. 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 thin is substantially equivalent to the current legally marketed Cutinova thin.

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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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 a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.

Public Health Service

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: K984593 Trade Name: Cutinova Thin 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.

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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.

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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 (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 McMillan

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

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K984593

Page 1 of 1

...

510(k) Number:

K984593

Device name: Cutinova thin

Indications For Use:

Over-the-Counter

Cutinova thin is a dressing indicated for the management of surface wounds with low to moderate exudate, such as:

Minor burns Abrasions

Cutinova thin may also be used under the direction of a health care professional for partial thickness wounds such as:

Second degree burns Leg ulcers Pressure ulcers Post-op wounds Donor sites

(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 X

(Division Sidn-Off Division of General Restorative De 198454 510(k) Number

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Page 1 of 1

8984593 510(k) Number.

Device name: Cutinova thin

Indications For Use:

Cutinova thin is indicated for the management of surface wounds with low to moderate exudate, such as: First and second degree burns Follow-up management of abrasions and donor sites Partial thickness wounds Leg ulcers Stage I & II pressure ulcers Post-operative wounds

Prescription

(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. Colly 8

Regulation Number and Section

N/A