Topkin® foil is a synthetic, polymeric, transparent foil for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.

Topkin® adhesive is made from the same ingredients like the Topkin® foil plus Titanium dioxide and is used for the fixation of Topkin® foil on healthy skin. The fixation is mediated by cohesive forces between the Topkin® foil, the Topkin® adhesive and the healthy skin.

Material used:
Topkin® foil: Lactide-caprolactone copolymers
Topkin® Adhesive: 99 % Oligocaprolactone-co-lactide and 1 % Titanium dioxide

AI/ML Overview

The provided documents are a 510(k) premarket notification and subsequent administrative update for the Topkin® Wound Dressing. These documents primarily focus on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative sense as might be expected for novel AI/diagnostic devices.

Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth for a performance study is not present in these documents. The submission relies on demonstrating similarity to an already approved device (Bioderm® thin film wound dressing) rather than independent performance validation against predefined criteria.

However, I can extract the information that is present and explain why other requested details are missing.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantitative performance metrics for Topkin®, but rather implied by "substantial equivalence" to the predicate device. The performance of the predicate device (Bioderm®) sets the de-facto "acceptance criteria" through comparison.
Reported Device Performance: The document states: "The effectiveness and substantial equivalence of Topkin® was determined by comparing relevant data. The results showed that Topkin® is at least equal to Bioderm® and thus fulfilled its intended use." And "The non-clinical performance data comparing Topkin® with the predicate device Bioderm® confirm that in all relevant properties Topkin® is at least as good as Bioderm and that both wound dressings are substantially equivalent in their indication and effect on the wound healing process and pain relief."

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent to Bioderm® in intended use	Topkin®'s intended use is identical to Bioderm®.
Equivalent to Bioderm® in transparency	Both wound dressings are transparent.
Equivalent to Bioderm® in water vapor and oxygen permeability	Both wound dressings are permeable to water vapor and oxygen, leading to a favorable healing climate.
Effectiveness at least equal to Bioderm®	"The results showed that Topkin® is at least equal to Bioderm® and thus fulfilled its intended use."
All relevant properties at least as good as Bioderm®	"The non-clinical performance data comparing Topkin® with the predicate device Bioderm® confirm that in all relevant properties Topkin® is at least as good as Bioderm."
Substantially equivalent to Bioderm® in indication and effect on wound healing process and pain relief	"Both wound dressings are substantially equivalent in their indication and effect on the wound healing process and pain relief." Topkin® is "safe and effective for use in the above mentioned indications" and "substantially equivalent to Bioderm® in terms of indication and intended use."
Biocompatibility	Topkin® foil has been tested experimentally and is considered biocompatible. Topkin® adhesive underwent toxicological assessment and is deemed suitable.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The submission refers to "non-clinical performance data" and "relevant data" but does not give specific numbers of cases or subjects used in any comparative testing.
Data Provenance: Not specified. It's unclear if this "relevant data" refers to in-house testing, literature review, or specific clinical trials. Given the 510(k) summary format for substantial equivalence, formal clinical trials (especially with large sample sizes) are often not required if bench testing and materials characterization are sufficient to show equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable/Not mentioned. The submission focuses on material properties and equivalence to a predicate, not on a diagnostic task requiring expert-established ground truth.
Qualifications of Experts: Not applicable/Not mentioned.

4. Adjudication method for the test set

Adjudication method: Not applicable/Not mentioned. This type of adjudication is relevant for studies involving human interpretation or subjective assessments, which is not the primary focus here.

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

MRMC Study: No, an MRMC study was not done. The device is a wound dressing, not an AI-assisted diagnostic tool.
Effect size of human readers improving with AI: Not applicable, as this is not an AI device.

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

Standalone Performance: Not applicable. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not explicitly defined in terms of a "ground truth" for a performance study. Instead, the comparison is based on scientific concepts, physical/performance characteristics (e.g., transparency, permeability, degradation profile, biocompatibility, toxicological assessment), and the intended use of the predicate device (Bioderm®). The "truth" here is essentially the established properties and safety profile of the predicate device and the new device demonstrating similar characteristics.

8. The sample size for the training set

Sample Size: Not applicable/Not mentioned. This is not an AI/machine learning device that requires a "training set."

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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December 16, 2022

Biomet Merck GmbH Thomas Kiewitt Managing Director Atles Widalmi 12 Ried Bei Kerzers, 3216 Switzerland

Re: K031684

Trade/Device Name: Topkin® Wound Dressing Regulatory Class: Unclassified Product Code: QSZ

Dear Thomas Kiewitt:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 30, 2003. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

Dr. Thomas Kiewitt Managing Director Biomet Merck GmbH Atles Widalmi 12 Ried Bei Kerzers Switzcrland 3216

Re: K031684

Trade/Device Name: Topkin® Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 17, 2003 Received: September 22, 2003

Dear Dr. Kicwitt:

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 such 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.

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Page 2 - Dr. Thomas Kiewitt

This letter will allow you to begin 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

fed Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number K031684

Device Name: Topkin® wound dressing

Indications for Use:

For temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031684

ను

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Joint Replacement

Trauma

Spine

Biomet Merck GmbH

OCT 3 0 2003

Cement

K031684

page
1/3

510(k) Summary of Safety and Effectiveness

(according to document 807.92: Content and format of a 510 (k))

(1)

Submitters name: Biomet Merck GmbH Submitters address: Altes Widalmi 12, 3216 Ried bei Kerzers, Switzerland Contact person: Dr. Thomas Kiewitt/ Dr. Adelheid Liebendörfer Date: 28 th of May 2003

(2) Name of the device: Topkin®, wound dressing

(3) Legally market device to which the submitter claims equivalence:

Bioderm® thin film wound dressing, FDA no .: K982939

(4) Description of Topkin®:

Topkin® foil is a synthetic, polymeric, transparent foil for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.

Material used:

Topkin® foil:

Lactide-caprolactone copolymers

Topkin® Adhesive:

99 % Oligocaprolactone-co-lactide and 1 % Titanium dioxide

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Scientific concepts, significant physical and performance characteristics:

To avoid resp. minimize regular painful wound dressing changes this concept of a degradable wound dressing which can remain on the wound (Topkin®) resp. healthy skin (Topkin® adhesive) has been developped. It consists of the degradable copolymer Topkin® foil and the Topkin® adhesive. Due to the degradability of the material the dressing needs to be changed rarely or not at all during the healing process. Under normal conditions the wound covering is degraded within approximately 4 weeks.

The Topkin® foil degrades physically. When it comes into the body it is physiologically metabolized.

Hydrolytic degradation of the polymers liberates 6-hydroxycaproic acid and D,L-Lactic acid. Llactate is degraded in the Cori-Cycle (lactid acid cycle) to glucose.

D-Lactide is metabolized in two different ways: it can be excreted renally or breathed out as CO2.

6-Hydroxycapronacid is metabolized via ß-oxidation to Acetyl-CoA units and then is metabolized in the Citrate-Cycle.

Polylactides are extensively documented polymers which on account of their physical, chemical as well as biological properties have already proved effective in various medical applications.

Topkin® foil has been tested experimentally and is considered to be biocompatible. Topkin® adhesive as well underwent toxicological assessment and too is deemed to be suitable for the described application.

(5) Statement of the intended use of the device:

Topkin® is indicated for temporary coverage of non-infected skin defects, such as superficial wounds under sterile conditions.

Topkin® adhesive is made from the same constituents plus Titanium dioxide to make it visible. It has been developed to fix Topkin® on healthy skin.

(6)

Summary of the technological characteristics of the new device in comparison to those of the predicate device

The intended use of Topkin® is identical to the legally marketed device Bioderm®. Both wound dressings are transparent and are permeable to water vapor and oxygen therefore leading to a favourable healing climate in and around the wound.

The effectiveness and substantial equivalence of Topkin® was determined by comparing relevant data. The results showed that Topkin® is at least equal to Bioderm® and thus fulfilled its intended use.

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3 -

Biomet Merck GmbH

The non-clinical performance data comparing Topkin® with the predicate device Bioderm® confirm that in all relevant properties Topkin® is at least as good as Bioderm and that both wound dressings are substantially equivalent in their indication and effect on the wound healing process and pain relief.

In summary, Topkin® is safe and effective for use in the above mentioned indications. Topkin® is substantially equivalent to Bioderm® in terms of indication and intended use.

Ried bei Kerzers

5/28/03

ihi-h

Dr. Thomas Kiewitt

Regulation Number and Section

N/A