(42 days)
Not Found
Not Found
No
The summary describes a traditional wound dressing with no mention of AI or ML technology.
Yes
The device is described as a foam wound dressing intended for the management of various partial and full-thickness wounds, including burns, ulcers, abrasions, and lacerations, which are therapeutic applications.
No
Explanation: The device is a wound dressing used for management of wounds, not for diagnosis. It absorbs and provides a moist environment.
No
The device description clearly describes a physical wound dressing made of foam and adhesive, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Dermallex Foam Wound Dressing is a topical dressing applied directly to wounds on the body. Its purpose is to manage wounds by providing absorption, breathability, and a moist environment. It does not involve testing samples taken from the body.
The device is a wound dressing, which falls under a different category of medical devices.
N/A
Intended Use / Indications for Use
Dermallex Foam Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of a variety of partial and full-thickness wounds.
The following indications are for Prescription Use or under the direction of a health care professional: Burns, (electrical and chemical) Venous stasis ulcers Abrasions and lacerations Diabetic ulcers Pressure sores Incisions Burns and abrasions associated with resurfacing procedures Donor sites such as dermabrasion, chemical, and laser resurfacing Skin Tears
The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
Dormaflex™ Foam Wound Dressings are sterile, self-adhesive, and absorptive.
Dennaflex provides moist wound environment characteristics and absorptive qualities of traditional therapies in a structure, which is both adhesive and conformable.
The wound contact surface of Dermallex is composed of a porous adhesive. A second layer consists of a microporous polyurethane foam. The product provides a barrier and dirt while maintaining breathability
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and OTC environment.
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)
Not Found
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.
Not Found
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
FROM : Andrew M. Reed, PhD.
: : 1
3/25/99
510(k) Dermaflex™ Wound Dressing Dermaphylyx, Inc. K990438
510(k) Summary
| Proprietary Name: | Dermaflex™ Foam Wound Dressing |
|---|---|
| ------------------- | -------------------------------- |
- Dressing Common Name:
- Unclassified Classification:
- Submitter's Details: Dermaphylyx, Inc. 78-E, Olympia Avenue, Woburn, MA 01801-2057 Tel: (781) 933-4772 Fax: (781) 933-3933
Description:
Dormaflex™ Foam Wound Dressings are sterile, self-adhesive, and absorptive.
Dennaflex provides moist wound environment characteristics and absorptive qualities of traditional therapies in a structure, which is both adhesive and conformable.
The wound contact surface of Dermallex is composed of a porous adhesive. A second layer consists of a microporous polyurethane foam. The product provides a barrier and dirt while maintaining breathability
Dermailex Foam Wound Dressings are intended for use in the management of partial and full- thickness wounds in both a professional and OTC environment. They may be used on the following wounds:
| Venous stasis ulcers | Burns, (electrical and chemical) |
|---|---|
| Diabetic ulcers | Abrasions and lacerations |
| Pressure sores | Incisions |
| Donor sites | Burns and abrasions associated with resurfacing procedures such as dermabrasion, chemical, and laser resurfacing |
| Skin Tears |
Over the Counter applications include abrasions, minor cuts, minor laccrations, and blisters. It may also be used on Poison Ivy and Sunburn.
Dermaflex Wound Dressings are substantially equivalent to Spyroflex®Wound Dressings (Innovative Technologies US. Inc.). and Flexzan Topical Wound Dressings (Dow Hickarn Pharmaceuticals. Inc.). These devices are self-adhesive wound dressings, which provide a degros of absorption and breathability. They are intended for use in the management of a wide variety of wounds.
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 resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 1999
Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106. West 75th Lane Arvada, Colorado 80005
Re: K990438
Trade Name:DermaflexTM Foam Wound Dressing Regulatory Class: Unclassifed Product Code: MGP Dated: February 8, 1999 Received: February 11, 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 (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.
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.
2
Page 2 -Andrew M. Reed, Ph.D.
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/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
3
510(k) Dermaflex™ Wound Dressing Dermaphylyx, Inc. K990438
Page 1 of 1
2011 - 11
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2 14 : 11 :
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PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K990438 |
|---|---|
| Dermaphylyx, Inc. |
| Device Name: | Dermaflex™ Foam Wound Dressing |
|---|---|
| -------------- | -------------------------------- |
Indications for Use:
Dermallex Foam Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of a variety of partial and full-thickness wounds.
The following indications are for Prescription Use or under the direction of a health care professional: Burns, (electrical and chemical) Venous stasis ulcers Abrasions and lacerations Diabetic ulcers Pressure sores Incisions Burns and abrasions associated with resurfacing procedures Donor sites such as dermabrasion, chemical, and laser resurfacing Skin Tears
The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters
(PLEASE 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
(Optional Format 1-7-96)
(Division Sign-Off)
Division of General Restorative Devices
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