(162 days)
Not Found
Not Found
No
The device description focuses on the physical components and chemical composition of a wound dressing, with no mention of AI or ML capabilities.
Yes
The device is intended for the management and healing of various wounds such as diabetic ulcers, burns, and pressure ulcers, which are therapeutic purposes.
No
Explanation: The device is described as a wound dressing intended to absorb exudate and provide a moist environment for healing, not to diagnose medical conditions.
No
The device description clearly states it is a wound dressing composed of a cotton gauze pad and an alginate hydrogel, which are physical components, 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 this is a "wound dressing" intended for direct application to wounds on the body. It absorbs exudate and provides a moist environment for healing.
- Intended Use: The intended uses listed are for managing various types of wounds, which are external conditions, not internal biological samples.
The device is a topical wound care product, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
phytacare™ Alginate Hydrogel Wound Dressing is an alginate hydrogel wound dressing that is indicated for the management of diabetic ulcers, foot ulcers, 1st and 2nd degree burns, pressure ulcers stages I-IV, cuts, and abrasions. This intended use is shared by the predicate devices.
For the management of: Diabetic Ulcers, Foot Ulcers, 1st and 2nd Degree Burns, Pressure Ulcers Stages I-IV, Cuts, and Abrasions.
Product codes (comma separated list FDA assigned to the subject device)
MGQ
Device Description
phytacare™ Alginate Hydrogel Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide a moist environment for the management of moderately exuding, partial to full thickness wounds.
There are 2 components of the phytacare™ Alginate Hydrogel Wound Dressing: a standard 12-ply cotton gauze pad and the phytacare™ Alginate Hydrogel. The primary function of the alginate component of the phytacare™ Alginate Hydrogel Wound Dressing is to absorb excess wound exudate, providing a moist wound environment to encourage healing. The phytacare™ Alginate Hydrogel also contains common humectants and moisturizers, thickeners and stabilizers, anti-oxidants, preservatives, and a fragrance.
The dressing is packaged in a foil laminate pouch.
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)
Non-clinical tests: Standard biocompatibility tests were performed on the phytacare™ Alginate Hydrogel to establish device safety. All the test and assay results were negative, which indicates that phytacare™ Alginate Hydrogel Wound Dressing can be expected to perform safely in clinical situations. The above tests and assays are typically performed for medical devices such as wound dressings.
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.
CarraGauze® - Carrasyn® Hydrogel Wound Dressing, Carrington 1. Laboratories
Curasol™ Gel Wound Dressing, Healthpoint Medical 2.
DermaGran™ Hydrophilic Wound Dressing, Derma Sciences 3.
TransiGel™ Conformable Gel Dressing, Smith & Nephew United, Inc. 4.
Biolex™ Impregnated Wound Dressing, C.R. Bard, Inc. 5.
Saf-Gel®, Hydrating Dermal Wound Dressing with Alginate, ConvaTec 6.
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
JUN 26 1998
510(k) Summary
General Information (a)
Submitter Information: (1)
PhytaTek Laboratories, Inc. 210 Grant St. (Suite 1) Pittsburgh, PA 15219 (412) 392-1533 (412) 391-8113 (fax)
Point of Contact: Mr. Mark G. Lombardo Date Summary was prepared: 6 January 1998
- Device Name: phytacare™ Alginate Hydrogel Wound Dressing (2) Common Name: Hydrogel Wound Dressing
Legally Marketed Devices to which Substantial Equivalence is Claimed: (3) phytacare™ Alginate Hydrogel Wound Dressing is substantially equivalent to one or more of the following legally marketed devices:
CarraGauze® - Carrasyn® Hydrogel Wound Dressing, Carrington 1. Laboratories
- Curasol™ Gel Wound Dressing, Healthpoint Medical 2.
- DermaGran™ Hydrophilic Wound Dressing, Derma Sciences 3.
- TransiGel™ Conformable Gel Dressing, Smith & Nephew United, Inc. 4.
- Biolex™ Impregnated Wound Dressing, C.R. Bard, Inc. న.
- Saf-Gel®, Hydrating Dermal Wound Dressing with Alginate, ConvaTec 6.
Description of Device: phytacare™ Alginate Hydrogel Wound Dressings are highly (4) conformable, sterile, primary wound dressings intended to provide a moist environment for the management of moderately exuding, partial to full thickness wounds.
There are 2 components of the phytacare™ Alginate Hydrogel Wound Dressing: a standard 12-ply cotton gauze pad and the phytacare™ Alginate Hydrogel. The primary function of the alginate component of the phytacare™ Alginate Hydrogel Wound Dressing is to absorb excess wound exudate, providing a moist wound environment to encourage
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6/1/98
1
healing. The phytacare™ Alginate Hydrogel also contains common humectants and moisturizers, thickeners and stabilizers, anti-oxidants, preservatives, and a fragrance.
The dressing is packaged in a foil laminate pouch.
Intended Use of the Device: phytacare™ Alginate Hydrogel Wound Dressing is an (2) alginate hydrogel wound dressing that is indicated for the management of diabetic ulcers, foot ulcers, 1st and 2nd degree burns, pressure ulcers stages I-IV, cuts, and abrasions. This intended use is shared by the predicate devices.
Technological Characteristics of the Device; Comparison to the Predicate (6) Device: phytacare™ Alginate Hydrogel Wound Dressing is similar in function, composition, and intended use to the predicate devices, all gel-type wound dressings, as described in (a)(3) above. phytacare™ Alginate Hydrogel Wound Dressing also contains sodium alginate. whose primary function is to absorb excess wound exudate, providing a moist wound environment to encourage healing.
Performance Data (b)
(1) Non-clinical tests: Standard biocompatibility tests were performed on the phytacare™ Alginate Hydrogel to establish device safety. All the test and assay results were negative, which indicates that phytacare™ Alginate Hydrogel Wound Dressing can be expected to perform safely in clinical situations. The above tests and assays are typically performed for medical devices such as wound dressings.
End of 510(k) Summary.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
JUN 26 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Phytatek Laboratories, Inc. c/o King and Spalding 1730 Pennsylvania Avenue, N.W. Washington, D.C. 20006-4706
Attention: Ms. Elizabeth S. Crockett
Re: K980132 Regulatory Class: Unclassified Product Code: MGQ Dated: April 23, 1998 Received: April 23, 1998
Dear Ms. Crockett:
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
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- This device may not be labeled as a treatment or a cure for any type of wound.
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
3
Page Two - Ms. Elizabeth S. Crockett
registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.
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
4
510(k) Number (if known): phytacare™ Alginate Hydrogel Wound Dressing Device Name:
Indications For Use:
For the management of: Diabetic Ulcers, Foot Ulcers, 1st and 2nd Degree Burns, Pressure Ulcers Stages I-IV, Cuts, and Abrasions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f
(
D
restorative le es
K0002132
D
restorative-de-es
5. Jik, Number K9880132
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)