(71 days)
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
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.
This 510(k) submission for the Dermaphylyx Hydrocolloid Wound Dressing describes its intended use and claims substantial equivalence to an existing device (SpyroColloid® Wound Dressings). However, it does not provide any specific acceptance criteria or details of a study that proves the device meets such criteria.
The provided document is a 510(k) summary and the FDA's response letter. A 510(k) summary typically includes:
- A description of the device.
- Intended use.
- Comparison to a predicate device to establish substantial equivalence.
- A brief summary of any performance data if available, but it's not always required to be extensive for substantial equivalence claims.
In this specific document, the focus is on establishing equivalence to the predicate wound dressing based on material composition and intended use, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided text.
Here's how I would address your request based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| Implied Acceptance Criterion for 510(k): Substantial Equivalence to Predicate Device (SpyroColloid® Wound Dressings) in terms of: - Self-adhesive, semi-occlusive, absorptive hydrocolloid wound dressing. - Provides a barrier to exogenous water/dirt while maintaining breathability. - Intended for management of partial and full thickness wounds (venous stasis ulcers, diabetic ulcers, pressure sores, blisters, superficial burns, abrasions, lacerations, donor sites). - Over-the-counter use for abrasions, minor cuts, minor lacerations, minor burns, and blisters. | The device, Dermaphylyx Hydrocolloid Wound Dressing, is described as meeting these characteristics, aligning with the predicate device. The FDA's letter states: "We have reviewed your Section 510(k) notification... It is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. The document does not describe a clinical performance study with a test set.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The document does not describe a study involving expert assessment of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as a performance study generating ground truth data is not described in this document. The "ground truth" for a 510(k) for a simple device like this is typically the established performance and safety profile of the predicate device.
8. The sample size for the training set
- Not applicable. There is no training set described as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
{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 01801-2057Tel: (781) 933-4772Fax: (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/
N/A