(72 days)
Not Found
Not Found
No
The summary describes a physical wound dressing and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device is a wound dressing intended for management of wounds and not for providing therapy or treatment of diseases.
No
The device is described as a wound dressing, used for the management of various wounds, not for diagnosing conditions.
No
The device description clearly states it is a physical wound dressing composed of adhesive and polyurethane film, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe the device as a wound dressing for managing various types of wounds. This is a topical application for wound care, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details the physical composition of the wound dressing (adhesive, polyurethane film). This aligns with a medical device for external use, not an IVD which typically involves reagents, instruments, and analysis of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic and protective covering for wounds.
N/A
Intended Use / Indications for Use
Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. 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:
Dermal Ulcers
Donor Sites
Incisions
Superficial Burns
Abrasions and lacerations
IV Catheter Sites
The following Indications are for Over-the-Counter Use:
Abrasions
Minor Burns
Minor Cuts
Minor Lacerations
Blisters
As a Cover for gauze and gel bandages.
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive.
The wound coulact surface is composed of a norous adhesive. A second layer consists of a polyurethane film that allows for moisture vapor and gas exchange and is impermeable to bacteria, water 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
Prescription Use or under the direction of a health care professional; Over-the-Counter Use
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
MAY 2 7 1999
510(k) Dermaphylyx Film Wound Dressing Dermaphylyx, Inc.
510(k) Summary
| Proprietary Name: | Dermaphylyx Film Wound Dressing |
|---|---|
| ------------------- | --------------------------------- |
Dressing Common Name:
Unclassified Classification:
Dermaphylyx, Inc. Submitter's Details: 78-E, Olympia Avenue, Woburn, MA 01801-2057 Tel: (781) 933-4772 Fax: (781) 933-3933
Description:
tion:
Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive.
The wound coulact surface is composed of a norous adhesive. A second layer consists of a polyurethane
s and and controlled and success were water and dirt while maintaining b The wound coulace surface is composed of a porous adminst . I soccally and the maintaining breathability.
Dermaphylyx Film Wound Dressings are intended for use in the management of partial and full-Demaphylyx Film Wound Dressings are intended for use intended for use management of the following wounds.
| Dermal Ulcers | Superficial Burns |
|---|---|
| Donor Sites | Abrasions and lacerations |
| Incisions | IV Catheter Sites |
Over the Counter applications include abrasions, minor cuts, minor lacerations, as well as minor burns and blisters.
Dermaphylyx Film Wound Dressings are substantially equivalent to SpyroFilm® (a.k.a.).
These de and the may of the support of the supplive Technologies U.S. Inc.). These de Dermaphylyx Film Wound Dressings (Innovative Technologics US, Inc.). These devices are
SpyroDerm®) and Mitrasher™ Would Dressings (Innovative Technologics US, Inc.). They are SpyroDerm®) and Mitrasher™ Wound Dressings, which provide a degree breathability. They are intended for
self-adhesive polyurethane film wound dressmass which provide a degree 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 a stylized image of three human figures, possibly representing a family, with their arms raised in a gesture of support or unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1999
Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106 West 75th Lane Arvada, Colorado 80005
Re: K990875 Trade Name: Film Wound Dressing Regulatory Class: Unclassifed Product Code: MGP Dated: March 12, 1999 Received: March 16, 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 3. as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. ধ:
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.
f your device is classified (see above) into either class II (Special Controls) or class III
n Firsting and the consisted by the controls. Existing major f your device is classified (see above) into enchaadditional controls. Existing major (Premarket Approval) if may be subject to such additions of Federal Regulations (CFR).
regulations affecting your device can be found in the Code of Federal Regulance regulations affecting your device can tic todas and course compliation assumes compliance
Title 21, Parts 800 to 895. A substantialiy equivalent disable Houses General GMP Title 21, Parts 800 to 873. A substantially equivel Devices: General GMP
with the Good Manufacturing Practices (GMP) for Medical Devices attactions, the Food with the Good Manufacturing Fractices (OMP inspections, the Food and regulation (21 CFK Part 820) allu that, through persons. Failure to comply with the GMP
Drug Administration (FDA) will verify such assumptions. Failure to complish further Drug Administration (ITDA) will verify back eddition, FDA may publish further regulation may result in regulatory action. In accirco. Pressent Please note: this response announcements concerning your device in the reason was the Electronic Product to your premarket notification submission for devices under the Electronic Product
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) This letter will anow you to begin maikening your also would be of your device to a
premarket notification. The FDA finding of substantial equivalence and thus, ne premarket notification. The PDA miding of backers. 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 If you desire specific advice for your actives), please contact the Office of
and additionally 809.10 for in vitto diagnostic devices), please contaction and and additionally 607.10 for in 1122 and Compliance at (301) 594-4775. Additionally 1991-1991 Compliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliance at anymor commended advertising of your device, prease soled, "Misbranding by reference to premarket Also, please note the regulation entition, "reading on your responsibilities under the notification (21 CFK 807.97). Other general 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) Dermaphylyx Film Wound Dressing Dermaphylyx, Inc.
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510(k) Number:
K Dermaphylyx, Inc.
Device Name:
Dermaphylyx Film Wound Dressings
990875
Indications for Use:
Dermaphylyx Film Wound Dressings are self-adhesive and semi-occlusive. 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:
Dermal Ulcers Donor Sites Incisions
Superficial Burns Abrasions and lacerations IV Catheter Sites
The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters
As a Cover for gauze and gel bandages.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
(Division Sige-Off)
Division of General Restorative Devices
510(k) Number K990875
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