(86 days)
May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, venous stasis, and diabetic ulcers; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
Hydrogel
The provided document describes a 510(k) submission for the Woun'Dres® Collagen Hydrogel Wound Dressing, focusing on its biocompatibility and safety testing rather than an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific parameters cannot be fully addressed in the format provided in the prompt.
However, based on the document's content, here's a breakdown of the biocompatibility and safety testing results which serve as the "acceptance criteria" for this conventional medical device, alongside the "reported device performance."
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Acceptance Criteria) | Reported Device Performance (Result) |
|---|---|
| Biocompatibility & Safety | |
| Acute Dermal Toxicity Study (Not Considered Toxic) | Not Considered Toxic |
| Primary Skin Irritation Test (Is not considered a primary Irritant) | Is not considered a primary Irritant |
| Delayed Contact Sensitization Study (No evidence of causing delayed contact sensitization) | No evidence of causing delayed contact sensitization. |
| Cytotoxicity Agarose overlay (Nontoxic) | Nontoxic |
| Hemolysis Test (In Vitro) (Nonhemolytic) | Nonhemolytic |
| USP 23 <51> Anti-microbial Preservatives-Effectiveness (Meets USP 23 <51> Requirements) | Meets USP 23 <51> Requirements |
| Bioburden (Pass) | Pass |
| Drop Ship Test (No leakage or damage to tubes occurred) | No leakage or damage to tubes occurred. |
| Latex Gloves Product Compatibility (No changes imparted to Woun'Dres from the gloves and no change in strength of the gloves was observed) | No changes imparted to Woun'Dres from the gloves and no change in strength of the gloves was observed. |
Regarding the study that proves the device meets (these) acceptance criteria:
The document states: "The safety and preservative effectiveness of Woun'Dres® are substantiated by the sensitization, biotoxicological and challenge tests conducted on this device as listed below." The table above is the summary of these substantiating tests.
For the AI/ML specific requests (2-9), the document does not provide this information as it pertains to a traditional wound dressing, not an AI/ML medical device.
Therefore, I cannot provide details on:
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
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COLOPLASI
NOV 2 5 1998
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510(k) SUMMARY
1. DATE PREPARED
November 18, 1998
2. SUBMITTER Coloplast Corporation Skin Care Division 1940 Commerce Drive North Mankato, MN 56003
3. CONTACT PERSON
Harvey M. Arbit, Pharm.D., M.B.A. Vice President Research and Development
NAME OF THE MEDICAL DEVICE 4.
Classification Name: Dressing, Wound and Burn, Hydrogel Common/Usual Name: Collagen Hydrogel Wound Dressing
Proprietary Name: Woun'Dres®
5. DEVICE CLASSIFICATION Regulatory Class: 2
Product Code: MGQ SU (80)
STATEMENT OF SUBSTANTIAL EQUIVALENCE 6.
Woun'Dres® is substantially equivalent to Carrasyn Hydrogel Wound Dressing which obtained marketing approval under 510(k) K894541 and DuoDerm Hydroactive Gel which obtained marketing approval under 510(k) K925993. Carrasyn Hydrogel Wound Dressing was found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976.
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7. INDICATIONS FOR USE
May be used for superficial wounds and abrasions and minor bums. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, venous stasis, and diabetic ulcers; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
PHYSICAL DESCRIPTION 8. Hydrogel
9. BIOCOMPATIBILITY
The safety and preservative effectiveness of Woun'Dres® are substantiated by the sensitization, biotoxicological and challenge tests conducted on this device as listed below;
| Test | Results |
|---|---|
| Acute Dermal Toxicity Study | Not Considered Toxic |
| Primary Skin Irritation Test | Is not considered a primary Irritant |
| Delayed Contact Sensitization Study | No evidence of causing delayedcontact sensitization. |
| Cytotoxicity Agarose overlay | Nontoxic |
| Hemolysis Test (In Vitro) | Nonhemolytic |
| USP 23 <51> Anti-microbialPreservatives-Effectiveness | Meets USP 23 <51> Requirements |
| Bioburden | Pass |
| Drop Ship Test | No leakage or damage to tubesoccurred. |
| Latex Gloves Product Compatibility | No changes imparted to Woun'Dresfrom the gloves and no change instrength of the gloves was observed. |
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is in black and white.
NOV 2 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Harvey M. Arbit, Pharm.D., M.B.A. Coloplast Corporation 1940 Commerce Drive North Mankato, Minnesota 56003
Re: K983042 Trade Name: Woun'Dres® Collagen Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGO Dated: August 24, 1998 Received: August 31, 1998
Dear Dr. Arbit:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of 2. 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.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
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).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
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Page 2 - Dr. Harvey Arbit
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2000 0 100 10000
ﺎ ﮮ ۔ ﻧﺎ ﻠﮧ
11/10/20
510(k) Number: K983042
Device Name: Woun'Dres® Collagen Hydrogel Wound Dressing
Indications for Use:
May be used for superficial wounds and abrasions and ● minor burns. Use under the supervision of health care professionals for the local management of partial- and fullthickness wounds including pressure, venous stasis, and diabetic ulcers; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
(Pløase 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 V
Bode
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983042
N/A