(294 days)
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.
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.
The provided information is for K053538 Phytacare Alginate Hydrogel Wound Dressing, and it explicitly states that the device is a wound dressing. While the request asks about acceptance criteria and studies proving the device meets them, the provided text describes biocompatibility tests for safety rather than performance acceptance criteria as might be expected for an AI/CADe device.
Therefore, the following information is based on what is available in the text, highlighting that the "acceptance criteria" and "device performance" in this context refer to safety rather than diagnostic accuracy or efficiency for an AI system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 10993) | Reported Device Performance (Safety) |
|---|---|
| Cytotoxicity (absence of toxic effects on cells) | Indicated as safe |
| Sensitization (absence of allergic/sensitizing reactions) | Indicated as safe |
| Acute Systemic Toxicity (absence of toxic effects after single exposure) | Indicated as safe |
| Intracutaneous Reactivity (absence of local irritation after intracutaneous injection) | Indicated as safe |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Standard biocompatibility tests... were performed," but does not provide details on the number of samples or subjects used in these tests.
- Data Provenance: The tests were performed in accordance with ISO 10993 by North America Science Associates, Inc. (NAMSA). The country of origin of the data is not explicitly stated, but NAMSA is a US-based company with global operations. The tests are retrospective in the sense that they were conducted for the purpose of demonstrating the device's safety prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of biocompatibility testing. The "ground truth" for these tests would be established through laboratory analyses and observations according to standardized protocols and expert interpretation of those results (e.g., cell viability, animal reactions), rather than consensus among medical experts on images or clinical data.
4. Adjudication Method for the Test Set
This question is not applicable to biocompatibility testing. The results of the tests (e.g., cell viability, observed animal responses) are interpreted against established criteria outlined in ISO 10993, rather than through an adjudication process like 2+1 or 3+1 used for clinical diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable as the device is a wound dressing, not an AI/CADe system. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a wound dressing, not an AI/CADe system.
7. The Type of Ground Truth Used
The ground truth used for these tests was based on biological responses and observations (e.g., cell death, inflammatory reactions, systemic toxicity) evaluated against predefined criteria outlined in the ISO 10993 standard. This is a form of laboratory/biological data rather than expert consensus, pathology reports, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This question is not applicable. Biocompatibility testing does not involve training sets in the way AI/Machine Learning models do.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the reasons stated above.
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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
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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
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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
N/A