(71 days)
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Not Found
No
The summary describes a traditional wound dressing made of calcium alginate fibers and does not mention any AI or ML components or functionalities.
Yes
The device is a wound dressing intended to manage various wounds and help control minor bleeding, which are therapeutic functions.
No
Explanation: The device is a wound dressing used for managing wounds and controlling minor bleeding, not for diagnosing medical conditions.
No
The device description clearly states it is a physical wound dressing made of calcium alginate fibers, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that Dermaphylyx Calcium Alginate Wound Dressings are applied directly to wounds to absorb exudate and promote healing. They are physical dressings, not tests performed on samples.
- Intended Use: The intended use is for the management of various types of wounds, which is a therapeutic application, not a diagnostic one.
Therefore, the Dermaphylyx Calcium Alginate Wound Dressings are a medical device used for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dermaphylyx Calcium Alginate Wound Dressings 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 Diabctic ulcers Pressure ulcers Ancrial ulcers
Superficial burns Abrasions and laccrations Donor sites Postoperative wounds
The following Indications are for Over-the-Counter Usc:
Abrasions Minor Burns Minor Cuts Minor Laccrations
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
Dermaphylyx Calcium Alginate Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of calcium alginate fibers fabricated into a felt or rope configuration.
Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a gel/fiber mat which provides an environment conducive to moist wound healing. The formation of the gel/fiber mat facilitates trauma free removal from the wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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.
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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
K991608
510(k) Dermaphylyx Calcium Alginate Wound Dressing Dermaphylyx, Inc.
510(k) Summary
Dermaphylyx Calcium Alginate Wound Dressing Proprietary Name: Common Name: Dressing Classification: Unclassified Submitter's Details: Dermaphylvx, Inc. 78-E, Olympia Avenue, Woburn, MA 01801-2057 Tel: (781) 933-4772 Fax: (781) 933-3933
Description:
Dermaphylyx Calcium Alginate Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of calcium alginate fibers fabricated into a felt or rope configuration.
Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a gel/fiber mat which provides an environment conducive to moist wound healing. The formation of the gel/fiber mat facilitates trauma free removal from the wound.
Dermaphylyx Calcium Alginate 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 Calcium Alginate 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.
Dermaphylyx Calcium Alginate Wound Dressings are substantially equivalent to Innovative Technologies Calcium AlginateWound Dressings (Innovative Technologies Group, Ltd.) and Kaltostat® Calcium Alginate Wound Dressings (Calgon Vestal Laboratories). These devices are absorptive Calcium Alginate Wound Dressings, manufactured from calcium alginate fibers. 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 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 an abstract image of a bird-like figure with three lines representing the body and wings.
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: K991608 Trade Name: Calcium Alginate Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: May 7, 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.
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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) K991608, Dermaphylyx Calcium Alginate Wound Dressing 城市场 Dermaphylyx, Inc.
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K991608 Dermaphylyx, Inc. |
|---|---|
| Device Name: | Dermaphylyx Calcium Alginate Wound Dressing |
Indications for Use:
Dermaphylyx Calcium Alginate Wound Dressings 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 Diabctic ulcers Pressure ulcers Ancrial ulcers
Superficial burns Abrasions and laccrations Donor sites Postoperative wounds
The following Indications are for Over-the-Counter Usc:
Abrasions Minor Burns Minor Cuts Minor Laccrations
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991608 |
| Prescription Use | X | OR | Over-the-Counter Use | X |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Formal 1-2-96)