(66 days)
Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They arc intended for use in the management of partial and full-thickness wounds.
The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Burns, (superficial)
Abrasions and lacerations
Incisions
Additionally Fenestrated dressings are intended for use in the management of surgically induced drainage sites such as:
G-tubes, J-tubes, Penrose drains, chest tubes, nephrotomy tubes, and sump drains.
The following indications for use are for Over-the-Counter Use:
Minor Burns
Minor cuts
Minor abrasions
Minor lacerations
Dermaphylyx Hydrophilic Foam Wound Dressings are sterile, and absorptive. Dermaphylyx Hydrophilic Foam Wound Dressing is composed of a hydrophilic polyurethane foam, The product provides absorptive qualitics to assist in the management of wound drainage.
This looks like a 510(k) premarket notification for a wound dressing, which typically doesn't involve the kind of performance studies with acceptance criteria, sample sizes, expert ground truth, and statistical analyses that are common for AI/ML-driven diagnostic devices.
The documents provided are for the Dermaphylyx Hydrophilic Foam Wound Dressing. This is a medical device, specifically a wound dressing, not a software or AI-driven diagnostic tool. Therefore, the concepts of acceptance criteria in terms of sensitivity, specificity, AUC, human reader improvement with AI assistance, standalone algorithm performance, or training/test set ground truth as commonly discussed for AI/ML devices do not apply here.
Instead, for a device like a wound dressing, the "acceptance criteria" and "study" would relate to its physical and biological properties, such as:
- Sterility: Demonstrated through microbiological testing.
- Biocompatibility: Demonstrated through ISO 10993 testing (cytotoxicity, irritation, sensitization).
- Absorptive capacity: Measured through specialized laboratory tests.
- Tensile strength/durability: Measured through mechanical testing.
- Adhesion (if applicable): Measured through peel strength tests.
- Shelf-life stability: Demonstrated through accelerated and real-time aging studies.
The provided documents focus on establishing substantial equivalence to predicate devices already on the market (Spyrofoam® Wound Dressings and Hydrasorb® Sterile Dressings). This is the primary regulatory pathway for many Class I and II medical devices that do not raise new questions of safety and effectiveness.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance, as they are not applicable to the Dermaphylyx Hydrophilic Foam Wound Dressing.
The "study" here is the substantial equivalence argument, which relies on comparing the device's characteristics and intended use to legally marketed predicate devices, not on clinical performance studies in the way you might expect for an AI diagnostic.
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FROM : Andrew M. Reed, PhD.
FAX ND. : 303 431 2242
AUG 12
510(k), K991920, Dermaphylyx Hydrophilic Foam Wound Dressing Dermaphylyx, Inc.
510(k) Summary
Dermaphylyx Hydrophilic Foam Wound Dressing Proprietary Name:
Common Name: Dressing
Classification: Unclassified
Dermaphylyx, Inc. Submitter's Details: 78-E, Olympia Avenue, Woburn, MA 01801-2057 Tel: (781) 933-4772 Fax: (781) 933-3933
Description:
Dermaphylyx Hydrophilic Foam Wound Dressings are sterile, and absorptive.
Dermaphylyx Hydrophilic Foam Wound Dressing is composed of a hydrophilic polyurethane foam, The product provides absorptive qualitics to assist in the management of wound drainage.
Dermaphylyx Hydrophilic Foam Dressings are intended for use in the management of partial and fullthickness wounds in both a professional and OTC environment. They may be used on the following wounds:
Venous stasis ulcers Diabetic ulcers Pressure sores Donor sites
Burns, (superficial). Abrasions and laccrations Incisions
Over the Counter applications include minor abrasions, minor lacerations, as well as minor burns.
Dermaphylyx Hydrophilic Foam Wound Dressings are substantially equivalent to Spyrofoam@Wound Dressings (Innovative Technologies US, Inc.), and Hydrasorb@ Sterile Dressings (ConvaTec/Calgon Vestal Laboratories).
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of a bird or eagle with three curved lines representing its wings or feathers. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106 West 75th Lane Arvada, Colorado 80005-5306
Re: K991920
Trade Name: Hydrophilic Foam Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: June 4, 1999 Received: June 7, 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 "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
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510(k), K991920, Dermaphylyx Hydrophilic Foam Wound Dressing Dermaphylyx, Inc.
Page 1 of 1
PRE-MARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
K991920 510(k) Number:
Dermaphylyx, Inc.
Dermaphylyx Hydrophilic Foam Wound Dressing Device Name:
Indications for Use:
Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They arc intended for use in the management of partial and full-thickness wounds.
The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers Diabetic ulcers Pressure sores Donor sites
Burns, (superficial) Abrasions and lacerations Incisions
Additionally Fenestrated dressings are intended for use in the management of surgically induced drainage sites such as:
G-tubes, J-tubes, Penrose drains, chest tubes, nephrotomy tubes, and sump drains.
The following indications for use are for Over-the-Counter Use: Minor Burns Minor cuts Minor abrasions Minor lacerations
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evatuation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
Division Sic eneral Restorative Devices Division of G 149192 510(k) Number
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.