(294 days)
Not Found
No
The summary describes a wound dressing and its components, focusing on material properties and biocompatibility testing. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is indicated for the management of various wounds, including burns, cuts, abrasions, diabetic ulcers, and pressure ulcers, which implies a therapeutic effect on the body.
No
The device is a wound dressing designed to absorb wound exudate and provide a moist environment for healing, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states two components: the hydrogel and the airless pump container, both of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of various types of wounds (burns, cuts, abrasions, ulcers). This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a wound dressing containing sodium alginate and other components designed to absorb exudate and promote healing. This aligns with a wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on biocompatibility and safety for wound application, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of 1st and 2nd degree burns, minor cuts and abrasions.
Under the care of a healthcare professional the Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of diabetic ulcers, foot ulcers, 1st and 2nd degree burns, pressure ulcers (stages I-IV), cuts and abrasions.
Product codes
FRO
Device Description
There are 2 components of the device. Phytacare® Alginate Hydrogel and the airless pump container. Phytacare® Alginate Hydrogel Wound Dressing contains sodium alginate, whose primary function is to absorb excess wound exudate, providing a moist wound environment to encourage natural healing. Phytacare Alginate hydrogel also contains moisturizers, thickeners and stabilizers, preservatives, and a fragrance. The Phytacare Alginate Hydrogel is packaged in 30 or 50 ml polypropylene airless pump containers.
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
Under the care of a healthcare professional
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
Standard biocompatibility tests including sensitization, cytotoxicity, acute systemic toxicity, and intracutaneous reactivity were performed on the Phytacare Alginate Hydrogel to establish device safety. The above tests and assays are typically performed for medical devices such as wound dressings. All tests were performed in accordance with Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North America Science Associates, Inc. (NAmSA). The studies indicated that Phytacare® Alginate Hydrogel is safe for its intended use.
Key Metrics
Not Found
Predicate Device(s)
K962218, K53450, K935096, K954738, K942270, K053538
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K053538 Page 1/2
510(k) Summary
General Information
Submitter Information:
OCT 1 0 2006
CuraPharm, Inc. 10054 Prospect Avenue, Suite F Santee, CA 92071, USA 619-449-7388 619-449-7453
Point of Contact: Thomas Hnat Date Summary was prepared: January 10, 2006
Device Name: Phytacare® Alginate Hydrogel, Wound Dressing Common Name: Hydrogel, Wound Dressing
Legally Marketed Devices to which Substantial Equivalence is Claimed: The Phytacare® Alginate Hydrogel, Wound Dressing is substantially equivalent to one or more of the following devices.
- K962218 CarraGauze® Carrasyn Hydrogel, Wound Dressing, Carrington ﺴﺮ Laboratories
- K53450 Curasol® Gel, Wound Dressing, Healthpoint Medical 2.
- Unknown TransiGel® Conformable Gel Dressing, Smith & Nephew United, Inc. 3.
-
- K935096 - Biolex Impregnated Wound Dressing, C.R. Bard, Inc.
- K954738 DermaGran® Hydrophyllic Wound Dressing, Derma Sciences 5.
- K942270 Saf-Gel®, Hydrating Dermal Wound Dressing with Alginate 6. ConvaTec
- K053538 Phytacare® Alginate Hydrogel Wound Dressing. PhytaTek 7. Laboratories
Description of Device: There are 2 components of the device. Phytacare® Alginate Hydrogel and the airless pump container. Phytacare® Alginate Hydrogel Wound Dressing contains sodium alginate, whose primary function is to absorb excess wound exudate, providing a moist wound environment to encourage natural healing. Phytacare Alginate hydrogel also contains moisturizers, thickeners and stabilizers, preservatives, and a fragrance. The Phytacare Alginate Hydrogel is packaged in 30 or 50 ml polypropylene airless pump containers.
Intended Use of the Device: Phytacare® Alginate Hydrogel Wound Dressing is an Alginate Hydrogel 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.
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K053538 Page 2/2
Technological Characteristics of the Device: Comparison to the Predicate Device: Phytacare Alginate Hydrogel Wound Dressing is similar in function, composition, and intended use to the predicate devices, all gel and gel-type wound dressings as described 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 natural healing.
Performance Data: Standard biocompatibility tests including sensitization, cytotoxicity, acute systemic toxicity, and intracutaneous reactivity were performed on the Phytacare Alginate Hydrogel to establish device safety. The above tests and assays are typically performed for medical devices such as wound dressings. All tests were performed in accordance with Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North America Science Associates, Inc. (NAmSA). The studies indicated that Phytacare® Alginate Hydrogel is safe for its intended use.
End of 510(k) Summary
V
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2006
CuraPharm, Inc. % Mr. Thomas Hnat President 10054 Prospect Avenue, Suite F Santee, California 92071
Re: K053538
Trade/Device Name: Phytacare Alginate Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 11, 2006 Received: August 15, 2006
Dear Mr. Hnat:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Thomas Hnat
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Rafanz Buchnd
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K023238
Device Name:
Phytacare Alginate Hydrogel Wound Dressing
Indications For Use:
The Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of 15 and 2nd degree burns, minor cuts and abrasions.
Under the care of a healthcare professional the Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of diabetic ulcers, foot ulcers, 1st and 2nd degree burns, pressure ulcers (stages I-IV), cuts and abrasions.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Evaluation (ODE)
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K053538