(203 days)
No
The device description and performance studies focus on the material properties and biological effects of a hydrogel wound dressing, with no mention of AI or ML.
Yes.
The device is indicated for the dressing and management of various wounds, including burns, cuts, lacerations, abrasions, dermal ulcers, and surgical wounds, which are therapeutic uses.
No
Explanation: This device is a hydrogel dressing used for wound management, creating a moist environment for healing. It does not perform any diagnostic functions like detecting, characterizing, or monitoring a disease or condition. Its purpose is therapeutic, not diagnostic.
No
The device is described as a hydrogel dressing supplied in tubes, indicating it is a physical substance and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin" (OTC) and for the "dressing and management of partial to full thickness dermal ulcers, surgical wounds, and superficial and partial thickness (second degree) burns" (RX). These are all applications for treating external wounds and skin conditions.
- Device Description: The device is described as a "clear, colorless hydrogel" that "provides a moist wound environment." This aligns with the function of a topical wound dressing.
- Lack of In Vitro Diagnostic Characteristics: There is no mention of the device being used to test samples taken from the human body (like blood, urine, tissue, etc.) to provide information about a person's health status, diagnose a disease, or monitor treatment.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological specimens. This device is applied in vivo (on the body) to treat wounds.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D) - under the direction of a health care 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
- Cytotoxicity Direct Contact: Cytotoxicity was evaluated using ISO-10993-5. Result: Non-toxic.
- Maximization Test For Delayed Type Hypersensitivity: Delayed-type hypersensitivity was evaluated according to ISO 10993-10:2010. Result: No Sensitization reaction was observed in any of the test animals.
- Dermal Irritation: Dermal irritation was evaluated according to ISO 10993-10:2010. Result: 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. Result: 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. Result: The corrected hemolytic index was 0% for extraction and direct contact. The test article is considered non-hemolytic.
Preservation:
- Catasyn was tested for its 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.
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.
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.
K143444, K143527, K160192, K041342
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym stacked above the words "U.S. FOOD & DRUG" and the word "ADMINISTRATION" below that.
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.
1
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
2
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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3
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 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.
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.
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.
4
Performance data:
| Biocompatibility Testing | |
|---|---|
| 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. |
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.
5
Comparison of New and Predicate Devices
| | New Device (Catasyn Advanced
Technology Wound Hydrogel) | Predicate Device (Bionect Clear
Hydrogel) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Dermal wounds | Dermal wounds |
| OTC | Catasyn OTC is indicated for the
dressing and management of minor
burns, minor cuts, minor lacerations,
minor abrasions, and minor irritations
of the skin. | Bionect OTC is indicated for the
dressing and management of minor
burns; superficial cuts, lacerations, and
abrasions; and minor irritations of the
skin. |
| Indications for Rx | 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. | Bionect may also be used under the care
of a health care professional for wounds
such as partial to full thickness dermal
ulcers (pressure ulcers, venous stasis
ulcers, arterial ulcers, diabetic ulcers),
surgical wounds (post-operative
incisions and donor sites), and 2nd degree
burns. |
| Sterile or
preservative | Non-sterile, preserved | Non-sterile, preserved |
| Composition | USP Purified water
Hypromellose
Chitosan derivatives (arginine
derivatized chitosan)
NF Methylparaben
Betaine | Purified water
Hyaluronic acid
Carbomer 980
Sorbitol
Sodium dehydroacetate
Methylparaben,
Propylparaben
Sodium 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 support
9 months | Up to 24 months |
| Mode of action | Provides a moist wound environment
that is supportive to wound healing. | Provides a moist environment that is
supportive 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).