(68 days)
Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns.
The following indications for use are for Prescription and Over-the-Counter Use:
Dermaphylyx Skin Protectors are intended for the prevention of:
- Blisters .
- Friction Burns .
Dermaphylyx Skin Protectors are non-sterile, self-adhesive, flexible, and absorptive.
Dermaphylyx Skin Protectors act as an extra layer of skin protection. They are intended to be used in the prevention of blisters and friction burns.
The skin contact surface of Dermaphylyx Skin Protectors is composed of a porous pressure sensitive adhesive. A second layer consists of a polyurethane foam. The product provides a barrier to exogenous water and dirt while maintaining breathability
The provided text describes a 510(k) premarket notification for the "Dermaphylyx Skin Protector." This document primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a clinical study with detailed acceptance criteria and performance data as typically found for complex medical devices or AI algorithms.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they are not typically part of a 510(k) submission for a simple, unclassified device like a skin protector.
Based on the provided information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for a skin protector, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is not quantified with specific metrics in the way an AI algorithm's performance would be (e.g., sensitivity, specificity).
| Acceptance Criteria (Implicit from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device acts as an extra layer of skin. | Dermaphylyx Skin Protectors act like an extra layer of skin. |
| Intended Use Equivalence: Prevention of blisters. | Intended for the prevention of: - Blisters. |
| Intended Use Equivalence: Prevention of friction burns. | Intended for the prevention of: - Friction Burns. |
| Material/Composition Equivalence (implied): Composed of similar materials with similar properties. | Skin contact surface: porous pressure sensitive adhesive. Second layer: polyurethane foam. (This implies it's consistent with typical skin protectors). |
2. Sample size used for the test set and the data provenance
- Not applicable. This document does not describe a clinical study with a test set of human subjects or data in the context of device performance testing for an AI algorithm. A 510(k) for a simple device like this typically relies on material characterization, biocompatibility, and functional testing, not a "test set" in the sense of evaluating diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth establishment by experts is not described as part of this 510(k) submission.
4. Adjudication method for the test set
- Not applicable. Adjudication is not described.
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
- No. This is not a diagnostic device or AI algorithm, so an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, so standalone performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's acceptance is its substantial equivalence to a legally marketed predicate device (Spyroflex® Skin Protectors, Innovative Technologies US, Inc.), as determined by the FDA based on shared indications for use, technological characteristics (implied similarity in function and composition), and safety. There isn't a "ground truth" derived from patient outcomes or expert consensus in the typical sense of evaluating a diagnostic or AI device.
8. The sample size for the training set
- Not applicable. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
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SEP | 4 |999
510(k) Dermaphylyx Skin Protectors Dermaphylyx, Inc.
510(k) Summary
| Proprietary Name: | Dermaphylyx Skin Protector |
|---|---|
| Common Name: | Skin Protector |
| Classification: | Unclassified |
| Submitter's Details: | Dermaphylyx, Inc.78-E, Olympia Avenue,Woburn, MA 01801-2057 |
Tel: (781) 933-4772 Fax: (781) 933-3933
Description:
Dermaphylyx Skin Protectors are non-sterile, self-adhesive, flexible, and absorptive.
Dermaphylyx Skin Protectors act as an extra layer of skin protection. They are intended to be used in the prevention of blisters and friction burns.
The skin contact surface of Dermaphylyx Skin Protectors is composed of a porous pressure sensitive adhesive. A second layer consists of a polyurethane foam. The product provides a barrier to exogenous water and dirt while maintaining breathability
Dermaphylyx Skin Protectors are intended for the prevention of:
- Blisters .
- Friction Burns .
Dermaphylyx Skin Protectors are substantially equivalent to Spyroflex® Skin Protectors (Innovative Technologies US, Inc.). They are intended for both prescription and over-the-counter use.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1999
Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106, West 75th Lane Arvada, Colorado 80005
Re: K992302
Trade Name: Dermaphylyx Skin Protector Regulatory Class: Unclassified Product Code: MGP Dated: July 2, 1999 Received: July 8, 1999
Dear Dr. Reed:
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 (Act). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2 -- Andrew M. Reed, Ph.D.
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 ي ڪري واري "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
-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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510(k) Dermaphylyx Skin Protectors Dermaphylyx, Inc.
Page 1 of 1
ي سمي موجود و
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510(k) Number:
K992802 Dermaphylyx, Inc.
Dermaphylyx Skin Protectors Device Name:
Indications for Use:
Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns.
The following indications for use are for Prescription and Over-the-Counter Use:
Dermaphylyx Skin Protectors are intended for the prevention of:
- Blisters .
- Friction Burns .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992302 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
N/A