(153 days)
Not Found
No
The device description and performance studies focus on the material properties and equivalence to a predicate device, with no mention of AI or ML.
No
The device, Topkin® foil and adhesive, is described as a temporary coverage for non-infected skin defects. While it covers wounds and may contribute to the healing process, its primary function is temporary mechanical protection rather than active therapeutic intervention (e.g., drug delivery, stimulation, or biological modification of the wound environment). It is compared to a "wound dressing," which typically falls under wound management rather than active therapy.
No
The device, Topkin® foil, is described as a synthetic, polymeric, transparent foil for temporary coverage of non-infected skin defects. Its function is to cover wounds, not to diagnose them.
No
The device description clearly states it is a "synthetic, polymeric, transparent foil" and an "adhesive," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary coverage of non-infected skin defects, such as superficial wounds." This describes a physical barrier applied to the body for wound management.
- Device Description: The device is a "synthetic, polymeric, transparent foil" and an "adhesive" used for fixation. These are materials applied externally to the skin.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are specifically designed to perform tests in vitro (outside the body) on specimens derived from the human body. This device is applied in vivo (on the body) for wound coverage.
N/A
Intended Use / Indications for Use
For temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.
Product codes (comma separated list FDA assigned to the subject device)
QSZ, FRO
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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.
2
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
a
Enclosure
3
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)
OR
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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Image /page/4/Picture/0 description: The image shows a logo with the word "BIOMET" on the top right and the word "MERCK" below it. There is a black square to the left of "BIOMET". A partial circle is on the left side of the logo, starting below the black square and ending below the word "MERCK".
Joint Replacement
Trauma
Spine
Biomet Merck GmbH
OCT 3 0 2003
Cement
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.
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
5
Image /page/5/Picture/0 description: The image shows a document with the words "Joint Replacement", "Cement", "Trauma", and "Spine" written on it. The document also contains the text "Biomet Merck GmbH" and the number "- 2 -". There is also a handwritten number "K031684" and the word "MERCK" written on the document. The page number "2/3" is also handwritten on the document.
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.
6
Image /page/6/Picture/0 description: The image shows the word "MERCK" in bold, black letters. Below the word "MERCK" is a black line with the words "Joint Replacement", "Cement", "Trauma", and "Spine" written above it. There is also some handwritten text that says "K031684 page 3/3".
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