(71 days)
Not Found
Not Found
No
The document describes a passive wound dressing and contains no mention of AI, ML, or related technologies.
No.
The device is a wound dressing designed to absorb exudate and control minor bleeding, which supports healing but does not actively provide therapeutic treatment to alter the body's function or structure in a way that would classify it as a therapeutic device.
No
The device description and intended use clearly state that it is a wound dressing intended for the management of various wounds by absorbing exudate and controlling bleeding, which are therapeutic and wound care functions, not diagnostic ones.
No
The device description clearly states it is a physical wound dressing made of absorbent fibers, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Dermaphylyx Absorbent Fiber Wound Dressings: This device is a wound dressing applied directly to the wound on the body. Its function is to absorb wound exudate, help control bleeding, and create a moist wound healing environment. It does not perform any tests on samples taken from the body.
The description clearly indicates it's a topical wound care product, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound,
The following Indications are for Prescription Use or under the direction of a health care professional:
Venous ulcers
Diabetic ulcers
Pressure ulcers
Arterial ulcers
Superficial burns
Abrasions and lacerations
Donor sites
Incisions
The following Indications are for Over-the-Counter Use:
Abrasions
Minor Burns
Minor Cuts
Minor Lacerations
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of Absorbent fibers fabricated into a felt or rope configuration.
Dermaphylyx Absorbent Fiber Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a fiber mat which provides an environment conducive to moist wound healing. The fiber mat facilitates traums free removal from the wound.
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
§ 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.
0
JUL 20 1999
991609
510(k) Dermaphylyx Absorbent Fiber Wound Dressing K991609. Dermaphylyx, Inc.
510(k) Summary
| Proprietary Name: | Dermaphylyx Absorbent Fiber 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:
Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of Absorbent fibers fabricated into a felt or rope configuration.
Dermaphylyx Absorbent Fiber Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a fiber mat which provides an environment conducive to moist wound healing. The fiber mat facilitates traums free removal from the wound.
Dermaphylyx Absorbent Fiber 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 ulcers | Superficial burns |
|---|---|
| Diabetic ulcers | Abrasions and lacerations |
| Pressure ulcers | Donor sites |
| Arterial ulcers | Incisions |
Dermaphylyx Absorbent Fiber Wound Dressings may also be used to control minor bleeding.
Over the Counter applications include abrasions, minor lacerations, as well as minor burns and the control of minor bleeding by application of pressure to the wound.
Dermaphylyx Absorbent Fiber Wound Dressings are substantially equivalent to Aquace!™ Hydrofiber™ Wound Dressings (Convated), and Kaltostat@ Wound Dressings (Calgon Vestal Laboratories). These devices are absorptive Wound Dressings, manufactured from Absorbent fibers. They are intended for use in the management of a wide variety of wounds.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles embedded within the eagle's body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1999
Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106 West 75th Lane Arvada, Colorado 80005-5306
Re: K991609 Trade Name: Absorbent Fiber Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: May 6, 1999 Received: May 10, 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 (QS) 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.
2
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
3
510(k) Dermaphylyx Absorbent Fiber Wound Dressing K991609, Dermaphylyx, Inc.
991609
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K991609 |
|---|---|
| Dermanh |
aphylyx, Inc.
Device Name:
Dermaphylyx Absorbent Fiber Wound Dressing
Indications for Use:
Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound,
The following Indications are for Prescription Use or under the direction of a health care professional:
Venous ulcers Diabetic ulcers Pressure ulcers Arterial ulcers
Superficial burns Abrasions and lacerations Donor sites Incisions
The following Indications are for Over-the-Counter Use:
Abrasions Minor Burns Minor Cuts Minor Lacerations
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evelustion (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
२०
Tóledo
(Division Sign-Off) Division of General Re 510(k) Number