(71 days)
Not Found
Not Found
No
The 510(k) summary describes a standard hydrocolloid wound dressing and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as descriptions of training or test sets typically associated with AI/ML development.
Yes
The device, a wound dressing, is intended for managing various wounds, which makes it a therapeutic device designed to aid in the healing process.
No
The provided text describes Dermaphylyx Hydrocolloid Wound Dressings as products for managing wounds (e.g., ulcers, burns, abrasions) by providing a barrier and absorption. Their intended use is for treatment and protection, not for diagnosing conditions or diseases.
No
The device description clearly states it is a wound dressing composed of physical materials (hydrocolloid adhesive, polyurethane film/foam), indicating it is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that Dermaphylyx Hydrocolloid Wound Dressings are applied directly to wounds on the body. They manage wounds, not analyze biological samples.
- The description focuses on wound management. The indications for use and device description detail how the dressing interacts with the wound and the surrounding skin (self-adhesive, semi-occlusive, absorptive, barrier to water and dirt). This is consistent with a wound care device, not a diagnostic test.
- There is no mention of analyzing biological samples. The text does not describe any process of collecting or testing blood, urine, tissue, or any other bodily fluid or substance.
Therefore, Dermaphylyx Hydrocolloid Wound Dressings fall under the category of wound care devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Dermaphylyx Hydrocolloid 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:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Blisters
Superficial burns
Abrasions and lacerations
Donor sites
The following Indications are for Over-the-Counter Use:
Abrasions
Minor Burns
Minor Cuts
Minor Lacerations
Blisters
Product codes (comma separated list FDA assigned to the subject device)
MGP
Device Description
Dermaphylyx Hydrocolloid Wound Dressings are sclf-adhesive, semi-occlusive and absorptive.
The wound contact surface is composed of a hydrocolloid adhesive. A second layer consists of a polyurcthane film/foam. The product provides a barrier to exogenous 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
Not Found
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
510(k) Dermaphylyx Hydrocolloid Wound Dressing Dermaphylyx, Inc.
K 990891
510(k) Summary
| Proprietary Name: | Dermaphylyx Hydrocolloid Wound Dressing |
|---|---|
| Common Name: | Dressing |
| Classification: | Unclassified |
| Submitter's Details: | Dermaphylyx, Inc. |
| 78-E, Olympia Avenue, | |
| Woburn, MA 01801-2057 | |
| Tel: (781) 933-4772 | |
| Fax: (781) 933-3933 |
Description:
- T
Dermaphylyx Hydrocolloid Wound Dressings are sclf-adhesive, semi-occlusive and absorptive.
The wound contact surface is composed of a hydrocolloid adhesive. A second layer consists of a polyurcthane film/foam. The product provides a barrier to exogenous water and dirt while maintaining breathability.
Dermaphylyx Hydrocolloid Wound Dressings are intended for use in the management of partial and fitle thickness wounds in both a professional and OTC environment. They may be used on the following wounds:
Venous stasis ulcers Diabetic ulcers Pressure sores Blisters
Superficial burns Abrasions and lacerations Donor sites
Over the Counter applications include abrasions, minor cuts, minor lacerations, as well as minor burns and blisters.
Dermaplylyx Hydrocolloid Wound Dressings are substantially equivalent to SpyroColloid® Wound Dressings (Innovative Technologies US, Inc.). These devices are sclf-adhesive polyurethane Hydrocolloid Wound Dressings, which provide a degree 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 and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1993
Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106 West 75th Lane Arvada, Colorado 80005-5306
Re: K990891 Trade Name: Hydrocolloid Wound Dressing Regulatory Class: Unclassifed Product Code: MGP Dated: March 12, 1999 Received: March 17, 1999
Dear Dr. Reed:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your section 970(x) notificants. It is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, use stated in the cherosule) to actions al 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 (the Act). " Tou may, unerelore, masseric 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 గా 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, I he general controls provisions of the 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
n major If your device is classified (see above) mo such additional controls. Existing major (Premarket Approval) it may be subject to such attincolde of Federal Regulations (CFR),
regulations affecting your device can be found in the Code of Federal Regulations (CFR regulations affecting your device can be found in the Courses on and many and and and and Title 21, Parts 800 to 895. A substaintially courrely and Devices: General GMP
with the Good Manufacturing Practices (GMP) for Medical Devices: the Food with the Good Manufacturing Fractices (GMP) Prochic GMP inspections, the Food and
regulation (21 CFR Part 820) and that, through periodic GMP inspections, the G regulation (21 CFR Part 820) and that, through periodic Crim Interprocemply with the GMP
Drug Administration (FDA) will verify such assumptions. Failure to comply with the GM Drug Administration (FDA) Will Venty Such assuming a FDA may publish further regulation may result in regulatory action. In addition Please note: this response
announcements concerning your device in the Federal Register Please note: this response announcements concerning your device in the received any obligation you might have
to your premarket notification submission for for accesses under the Flectronic Product to your premarket notifications subthsslor for devices under the Llectronic Product
under sections 531 through 542 of the Art for devices under the Llectronic Product
or sect under sections 551 tiffough 5 the Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k)
The states and and and and and security as for hetartial courvalence of your device to This letter will allow you to begin matketing your activelence of your device to a
premarket notification. The FDA finaling of substitation for vour device and thus, per premarket notification. The FDA miding of substantial equilation 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
Press and the support of the liness of admines), plansa contact the Office of If you desire specific advice for your uevice on varies), please contact the Office of
and additionally 809.10 for in vitro successions of the forcessions on the promotion an and additionally 809.10 for in villy diagnolice are contributions on the promotion and Compliance at (301) 594-4595. Additionally, 161 questions of Compliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliance to premarket advertising of your device, piease connect the over reserved to preference to premarket.
Also, please note the regulation entitled, "Misformation on your responsibilities Also, please note the regulation onlines, "Information on your responsibilities under the notification" (21 CFR 807.97). Online of Small Manufacturers Assistance at its toll-free
Act may be obtained from the Division of Small Manufacturers Assistance at its toll-f Act may be obtained from also =443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Dermaphylyx Hydrocolloid Wound Dressing Dermaphylyx, Inc.
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510(k) Number:
વ્વવહિવા K Dermaphylyx, Inc.
Dermaphylyx Hydrocolloid Wound Dressing Device Name:
Indications for Use:
Dermaphylyx Hydrocolloid 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:
Venous stasis ulcers Diabetic ulcers Pressure sores Blisters
Superficial burns Abrasions and laccrations Donor sites
The following Indications are for Over-the-Counter Use:
Abrasions 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_ A (Per 21 CFR 801.109)
OR Over-The-Counter Use X
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices:
510(k) Number K94089/