(195 days)
The Compeed® Psoriasis Dressing is indicated for use in the management of psoriasis and protection of psoriatic plaques.
The Compeed® Psoriasis Dressing is a non-sterile, hydrocolloid dressing marketed in Europe for the management of chronic plaque-type Psoriasis.
The provided text describes a 510(k) submission for the Compeed® Psoriasis Dressing. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, aspects of your request, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not applicable to this document.
The document's focus is on comparing the new device to a legally marketed predicate device (Compeed® Athletic Dressing K883588) to establish substantial equivalence.
Here's a breakdown of what is available based on the provided text, and where your requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a clinical study. The acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device.
- Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics that would typically come from a clinical trial. The comparison focuses on device composition, physical characteristics, and intended use as compared to the predicate.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not applicable. This document does not describe a clinical study with a test set of data.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts/Qualifications: Not applicable. Ground truth establishment for a clinical study is not described.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this document.
6. Standalone Performance:
- Standalone Performance: No, standalone (algorithm only without human-in-the-loop performance) was not done or reported. This device is a dressing, not an algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. Clinical ground truth (e.g., pathology, outcomes data) for a new clinical study is not described. The "ground truth" for this 510(k) is the existing characteristics and performance of the predicate device.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This document does not describe a machine learning model or a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable.
Summary derived from the document regarding substantial equivalence:
The Compeed® Psoriasis Dressing demonstrated substantial equivalence to the Compeed® Athletic Dressing (K883588). The comparison in Table 1 (provided in your input) highlights the similarities and differences.
Key points of equivalence and differences:
| Feature | Compeed® Psoriasis Dressing | Compeed® Athletic Dressing (Predicate K883588) | Equivalence Demonstrated |
|---|---|---|---|
| Composition | Carboxymethylcellulose, Petroleum hydrocarbon resin, copolymer, Dioctyl adipate, Polyurethane film, silicone paper | Carboxymethylcellulose, Petroleum hydrocarbon resin, copolymer, Dioctyl adipate, Polyurethane film, silicone paper | Yes |
| Function | Skinprotector | Skinprotector | Yes |
| Sterilization | Non-sterile | Non-sterile | Yes |
| Packaging | Hard plastic casing | Hard plastic casing | Yes |
| Intended Use | Non-sterile skin protector for use on chronic plaque-like psoriasis | Non-sterile, skin protector to prevent blisters and protect skin from friction that leads to calluses and corns | Yes (similar skin protection function, different target condition) |
| Shape | Triangular | Oval | No (different) |
| Sizes | One size | Small, medium, large | No (different) |
| Location of Device | Knees and elbows | Foot | No (different) |
The FDA's letter (K982493) confirms the "substantial equivalence" determination, allowing the device to be marketed, provided it adheres to general controls and specific labeling limitations (e.g., cannot be labeled for third-degree burns, accelerated wound healing, or as artificial skin). The changed indications (from blister/callus prevention to psoriasis management) and minor design changes (shape, size, target location) were deemed not to raise new questions of safety or effectiveness when compared to the predicate device.
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JAN 28 1999
510(k) Summary Compeed® Psoriasis Dressing
Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249 Date: 1/20/99
1. Contact Person
Ms. Sydney Lilly, (770) 281-8260
2. Name of the Medical Device
Classification name:
Common/usual name: PROPRIETARY name:
General Hospital and Personal Use Therapeutic Devices Skinprotector Compead® Psoriasis Dressing
3. Device Classification
Unclassified
4. Statement of Substantial Equivalence
The Compeed® Psoriasis Dressing is identical to the Compeed® Athletic Dressing manufactured by Coloplast A/S and approved for market under 510(k) K883588.
5. Intended Use
The Compeed® Psoriasis Dressing is indicated for use in the management of psoriasis and protection of psoriatic plaques.
6. Description of Device
The Compeed® Psoriasis Dressing is a non-sterile, hydrocolloid dressing marketed in Europe for the management of chronic plaque-type Psoriasis.
A comparison Matrix for the Compeed® Psoriasis Dressing versus the Compeed® Athletic Dressing is presented in Table 1.
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510(k) Summary Compeed® Psoriasis Dressing - Table 1 Comparison to Legally Marketed Device
| Compeed® PsoriasisDressing | Compeed® AthleticDressing K883588 | |
|---|---|---|
| Devicecomposition | Carboxymethylcellulose,Petroleum hydrocarbonresin, compolymer,Dioctyl adipate,Polyurethane film, silicone paper | Carboxymethylcellulose,Petroleum hydrocarbonresin, compolymer,Dioctyl adipate,Polyurethane film, silicone paper |
| Shape | triangular | oval |
| Sizes | one size | small, medium, large |
| Location ofdevice | Knees and elbows | Foot |
| Function ofdevice | Skinprotector | Skinprotector |
| Indication for use | Non-sterile skin protectorfor use on chronicplague-like psoriasis | Non-sterile, skin protectorto prevent blisters andprotect skin from frictionthat leads to calluses andcorns |
| Sterilization | Non-sterile | Non-sterile |
| Packaging | Hard plastic casing | Hard plastic casing |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Ms. M. Sydney Lilly Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062
Re: K982493 Trade Name: Compeed Psoriasis Dressing Regulatory Class: Unclassifed Product Code: MGP Dated: October 29, 1998 Received: November 2, 1998
Dear Ms. Lilly:
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.
- 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 - Ms. Sydney Lilly
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 toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrb/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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493 510(k) Number (if known):
Device Name: Compeed® Psoriasis Dressing
Indications for Use:
The Compeed® Psoriasis Dressing is indicated for use in the management of psoriasis and protection of psoriatic plaques.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division S al Restorative I
Prescription Use (Per 21 CFR 801.109 ાર
Over-The-Counter Use √
(Optional Format 1-2-96)
N/A