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

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

Device Description

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

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called Cutinova Hydro. It describes a modification to an already cleared wound dressing and aims to demonstrate substantial equivalence to the predicate device.

Regarding acceptance criteria and study information, the document unfortunately does not contain the detailed information you've requested for typical AI/ML device studies. This is because:

It's a modification of a physical wound dressing, not an AI/ML device. The "device" in this context is a physical product (a polyurethane dressing), not a software algorithm. Therefore, the types of studies and acceptance criteria (e.g., sensitivity, specificity, F1 score) associated with AI/ML performance metrics are not applicable here.
The regulatory submission is for substantial equivalence (510(k)). This type of submission focuses on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, rather than proving novel performance against specific clinical acceptance criteria in the way an innovative AI device would.

However, I can extract the relevant information presented in the provided text as it pertains to the safety and performance of this physical device:

Summary of Safety and Effectiveness for Cutinova® hydro - K984595

This submission is for a modification to an existing wound dressing, Cutinova hydro. The modification involves changing the material used for the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and adding a small amount of an antioxidant (alpha-tocopherol) to improve thermal stability.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: No negative effects (in accordance with ISO 10993)	Biological tests in accordance with ISO 10993 showed no negative effects for the modified Cutinova hydro.
Performance Characteristics: Comparable to currently marketed product	Performance characteristics were comparable to the currently marketed product.
Thermal Stability: Improved (due to added alpha-tocopherol)	Alpha-tocopherol was added to improve the thermal stability of the product.
Indications for Use: No change from predicate device	The modification does not affect the indications for use.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document only states "Biological tests were done" and "Performance characteristics were also comparable."
Data Provenance: Not specified. The study types (biological tests, performance characteristic comparisons) suggest laboratory-based testing rather than clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This is not an AI/ML device, and the evaluation relies on standardized biological and performance testing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable. (See #3)

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

Ground Truth for Biocompatibility: Compliance with ISO 10993 standards and established toxicology/biocompatibility protocols.
Ground Truth for Performance Characteristics: Comparative measurements against the established performance of the predicate device (the original Cutinova hydro) using standardized material testing methods.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set" for the modification of a physical wound dressing; rather, it would be R&D and manufacturing process optimization.

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

Not applicable. (See #8)

Conclusion from the document:

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

Important Note on Indications for Use based on FDA Letter (March 19, 2007 - Correction Letter):

While the submission states the modification does not affect the indications for use, the FDA's corrected letter imposes specific labeling limitations:

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

The 510(k) submission document itself (Page 4 & 5) lists the intended indications:

Management of surface, moderately to highly exudating wounds such as:
- Leg ulcers
- Pressure ulcers (Stage I-IV, though the FDA approval slip on page 4 just says 'Pressure ulcers')
- Second-degree burns.

Summary

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04:46PM JOBST CHAR FEB 15 "99

984595

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Summary of Safety and Effectiveness for Cutinova® hydro - K984595

This 510(k) is being submitted for a modification to Cutinova hydro that was originally cleared for sale in the U.S. in 1991 (K905688)

Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova hydro. Performance characteristics were also comparable to the currently marketed product. In addition, a very small amount of to 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 hydro is substantially equivalent to the current legally marketed Cutinova hydro.

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 design of three human profiles facing right, arranged in a staggered formation. The profiles are connected by a flowing line that forms the shape of a wing or a stylized representation of movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top half of the design.

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: K984595 Trade Name: Cutinova Hydro 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 We have reviewed your Section 910(ts) premation with the device is substantially equivalent to device referenced above and have decembined the sessate commerce prior to May 28, 1976,
legally marketed predicate devices marketed in interstate daying that have been legally marketed predical Device Amendments or to devices that have been
the enactment date of the Medical Device Americal Food. Drug, and Cosme the enactment date of the Medical Device Finalisms of the Federal Food, Drug, and Cosmetic Act
reclassified in accordance with the provisions of the Federal (DMAA) . You may, reclassified in accordance with the proval (PMA). You may, therefore,
(Act) that do not require approval of a premarket approval (PMA). The general (Act) that do not require approval or a premisions of the Act. The general
market the device, subject to the general controls provisions of the Active market the device, subject to the general controls for annual registration, listing of
controls provisions of the Act including requirements for any provinst mishranding a controls provisions of the Act fileting requirements of the most of the 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 Eederal 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 A. Milliman

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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K984595

Device name: Cutinova hydro

Indications For Use:

510(k) Number:

Over the Counter

Cutinova hydro may be used under the direction of a health care professional for the management of surface, moderately to highly exudating wounds such as: Leg ulcers Pressure 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) Prescription Use OR Over The Counter Use (Per 21 CFR 801.109)

(Division Sigh-Off) Division of General Restorative Device KSB4595 510(k) Number .

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Page 1 of 1

510(k) Number (if known): _

Device name: Cutinova hydro

Indications For Use:

Cutinova hydro is indicated for the management of surface, moderately to highly secreting wounds such as:

Leg ulcers Stage I-IV pressure 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

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984595

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

N/A