Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

Catasyn RX may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites) and superficial and partial thickness (second degree) burns.

Device Description

Catasyn is a clear, colorless hydrogel that is composed of hypromellose, arginine derivatized chitosan, betaine, and methylparaben to form a hydrogel dressing. The device is a non-sterile, preserved hydrogel. The gel is supplied in 0.07oz. (2mL), 0.85oz (25mL), or 3oz (88.7mL) tubes.

Catasyn is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called "Catasyn Advanced Technology Wound Hydrogel." The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The document does not describe a study that proves the device meets specific acceptance criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Instead, it presents performance data related to the physical and biological properties of the wound hydrogel itself, to show its safety and function compared to a predicate device.

Therefore, I cannot fulfill your request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document is for a non-AI/ML medical device.

To directly answer your prompt, based only on the provided document, the following points are relevant, but not in the context of an AI/ML device:

A table of acceptance criteria and the reported device performance:

While not "acceptance criteria" in the sense of an AI/ML model's performance metrics (like sensitivity, specificity, AUC), the document presents a table of Biocompatibility Testing with descriptions of the tests (the "criteria" for safety) and their results (the "performance"):

Test	Description	Result
Cytotoxicity Direct Contact	Cytotoxicity was evaluated using ISO-10993-5, Biological evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity.	Non-toxic
Maximization Test For Delayed Type Hypersensitivity	Delayed-type hypersensitivity was evaluated according to ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for Irritation and skin sensitization.	No Sensitization reaction was observed in any of the test animals
Dermal Irritation	Dermal irritation was evaluated according to ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.	No erythema or edema was observed. The Primary Irritation Index for the test article was 0.
Acute Systemic Toxicity	Acute systemic toxicity was tested according to ISO 10993-11, Biological Evaluation of Medical Devices – Tests for Systemic Toxicity.	No Biological reactivity was observed at any time point
Hemolysis extraction method and direct contact	Hemolysis was tested according to ASTM 756-13 for both extraction and direct contact methods.	The corrected hemolytic index was 0% for extraction and direct contact. The test article is considered non-hemolytic.

Additionally, preservation effectiveness and shelf-life data are presented:

Preservation: Meets USP 51 Category 2 challenge (immediately following production and at 6-month shelf life).
Shelf Life: Meets specifications after 9 months of real-time aging (on a 36-month study).

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
For the biocompatibility tests (e.g., Cytotoxicity, Maximization Test, Dermal Irritation, Acute Systemic Toxicity, Hemolysis), the document does not specify the sample sizes of cells, animals, or human subjects used. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These are standard in vitro or in vivo (animal) lab tests, not clinical studies on human patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is not an AI/ML device requiring expert adjudication for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" here refers to established biological and chemical safety standards (e.g., ISO 10993 series, ASTM 756-13, USP 51) and laboratory test results demonstrating the absence of toxicity, irritation, sensitization, or hemolytic reactions.
The sample size for the training set:
Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established:
Not applicable.

In summary, the provided document is a 510(k) submission for a traditional wound care product (hydrogel) and thus does not contain the information typically required for evaluating an AI/ML medical device.

Summary

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February 21, 2018

Synedgen, Inc Shenda Baker President and Chief Operating Officer 1420 N. Claremont Blvd., Suite 105D Claremont, California 91711

Re: K172338

Trade/Device Name: Catasyn Advanced Technology Wound Hydrogel Regulatory Class: Unclassified Product Code: FRO Dated: January 15, 2018 Received: January 19, 2018

Dear Shenda Baker:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172338

Device Name

Catasyn Advanced Technology Wound Hydrogel

Indications for Use (Describe)

Catasyn OTC is indicated for the dressing and management of minor cuts, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), surgical wounds (postoperative incisions and donor sites) and superficial and partial thickness (second degree) burns.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K172338

Synedgen, Inc.

Catasyn Advanced Technology Wound Hydrogel

Submitter:

Synedgen, Inc. 1420 North Claremont Blvd. Suite 105D Claremont, CA 91711 Phone: 909-447-6858 909-447-6801 Fax: Contact Person: Shenda Baker Date Prepared: February 15, 2018

Device:

Name of Device: Catasyn Advanced Technology Wound Hydrogel

Common or Usual name: Hydrogel Wound Dressing

Classification: Unclassified

Product Code: FRO

Primary Predicate Device:

Bionect Clear Hydrogel (K973725 RX) (K984264 OTC) (FRO) This predicate has not been subject to a design-related recall.

Reference Predicate Devices:

SynePure (K143444) (KMF) IPM Wound Gel Bio/ IPM Derm Gel Bio 1 (K143527) (FRO) Atteris Antimicrobial Skin and Wound Cleanser (K160192) (FRO) MimyX Cream (K041342) (MGQ)

Device Description:

Catasyn is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing.

Indications for use:

Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

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Performance data:

Biocompatibility Testing

Test	Description	Result
Cytotoxicity Direct Contact	Cytotoxicity was evaluatedusing ISO-10993-5, Biologicalevaluation of Medical Devices-Part 5: Tests for In VitroCytotoxicity.	Non-toxic
Maximization Test For Delayed Type Hypersensitivity	Delayed-type hypersensitivitywas evaluated according to ISO10993-10:2010, Biologicalevaluation of medical devices -Part 10: Tests for Irritation andskin sensitization.	No Sensitization reaction wasobserved in any of the testanimals
Dermal Irritation	Dermal irritation was evaluatedaccording to ISO 10993-10:2010, Biological evaluationof medical devices – Part 10:Tests for irritation and skinsensitization.	No erythema or edema (wasobserved. The Primary IrritationIndex for the test article was 0.
Acute Systemic Toxicity	Acute systemic toxicity wastested according to ISO 10993-11, Biological Evaluation ofMedical Devices – Tests forSystemic Toxicity.	No Biological reactivity wasobserved at any time point
Hemolysis extraction methodand direct contact	Hemolysis was tested accordingto ASTM 756-13 for bothextraction and direct contactmethods.	The corrected hemolytic indexwas 0% for extraction and directcontact. The test article isconsidered non-hemolytic.

Preservation

Catasyn was tested for it preservative effectiveness and meets the category 2 challenge by USP 51 immediately following production and at the 6-month shelf life test point. The product will continue to be challenged at 12,18, 24, 30, and 36 months testing.

Shelf life

The first study of stability incorporated three lots of the device including each tube type and is schedule for 36 months. The current data for real time aging of the samples indicate the product meets its specification after 9 months.

Comparison with predicate:

The candidate device, Catasyn, has the same intended use and substantially equivalent technological characteristics as the predicate device, Bionect Clear Hydrogel. Both the predicate and candidate device contain aqueous based viscous, highly hydrated, and lubricating gels. The gels are composed primarily of water with the addition of thickeners and moisturizers. Both gels are supplied non-sterile and contain preservatives to extend shelf life. Like the predicate device, Catasyn provides a moist environment for wound healing of skin wounds and burns.

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Comparison of New and Predicate Devices

	New Device (Catasyn AdvancedTechnology Wound Hydrogel)	Predicate Device (Bionect ClearHydrogel)
Intended Use	Dermal wounds	Dermal wounds
OTC	Catasyn OTC is indicated for thedressing and management of minorburns, minor cuts, minor lacerations,minor abrasions, and minor irritationsof the skin.	Bionect OTC is indicated for thedressing and management of minorburns; superficial cuts, lacerations, andabrasions; and minor irritations of theskin.
Indications for Rx	Catasyn RX may be used under thedirection of a health care professionalfor the dressing and management ofpartial to full thickness dermal ulcers(pressure sores, venous stasis ulcers,arterial ulcers, diabetic ulcers), surgicalwounds (post-operative incisions anddonor sites) and superficial and partialthickness (second degree) burns.	Bionect may also be used under the careof a health care professional for woundssuch as partial to full thickness dermalulcers (pressure ulcers, venous stasisulcers, arterial ulcers, diabetic ulcers),surgical wounds (post-operativeincisions and donor sites), and 2nd degreeburns.
Sterile orpreservative	Non-sterile, preserved	Non-sterile, preserved
Composition	USP Purified waterHypromelloseChitosan derivatives (argininederivatized chitosan)NF MethylparabenBetaine	Purified waterHyaluronic acidCarbomer 980SorbitolSodium dehydroacetateMethylparaben,PropylparabenSodium hydroxide
Packaging	0.07oz. (2mL), 0.85oz (25mL), or 3oz(88.7mL) LDPE tubes	100 gram LDPE tube
Shelf Life	Current real time aging studies support9 months	Up to 24 months
Mode of action	Provides a moist wound environmentthat is supportive to wound healing.	Provides a moist environment that issupportive to wound healing.

Conclusions:

Based on the Indications for Use and the data presented in this submission, Catasyn Advanced Technology Wound Hydrogel is substantially equivalent to the predicate device (K973725).

Regulation Number and Section

N/A