Catasyn Advanced Technology Wound Hydrogel

K172338 · Synedgen, Inc. · FRO · Feb 21, 2018 · SU

Device Facts

• Record ID: K172338
• Device Name: Catasyn Advanced Technology Wound Hydrogel
• Applicant: Synedgen, Inc.
• Product Code: FRO · SU
• Decision Date: Feb 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

Catasyn Advanced Technology Wound Hydrogel is a non-sterile, preserved hydrogel dressing. It is composed of hypromellose, arginine-derivatized chitosan, betaine, and methylparaben. The device is supplied in LDPE tubes of various sizes. It is applied topically to wounds to provide a moist environment, which supports the natural wound healing process. It is intended for both over-the-counter use by patients for minor skin injuries and prescription use by healthcare professionals for more complex wounds, including dermal ulcers, surgical incisions, and second-degree burns. The device functions as a physical barrier and moisture-retaining dressing.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (acute systemic toxicity). Hemolysis testing performed per ASTM 756-13. All results were non-reactive/non-toxic. Preservative effectiveness tested per USP 51.

Technological Characteristics

Hydrogel dressing composed of hypromellose, arginine-derivatized chitosan, betaine, and methylparaben. Supplied in LDPE tubes. Non-sterile, preserved formulation. Provides moist wound environment. Biocompatibility tested per ISO 10993; hemolysis tested per ASTM 756-13.

Indications for Use

Indicated for patients with minor skin irritations, cuts, lacerations, abrasions, and burns (OTC use). Indicated for patients with partial to full thickness dermal ulcers (pressure, venous stasis, arterial, diabetic), surgical wounds, and superficial/partial thickness burns (Rx use).

Predicate Devices

• Bionect Clear Hydrogel (K973725 RX) (K984264 OTC)

Reference Devices

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

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] 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.

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## Performance data:

| Biocompatibility Testing | |
|--------------------------|--|
| | |

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

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# Comparison of New and Predicate Devices

| | New Device (Catasyn Advanced<br>Technology Wound Hydrogel) | Predicate Device (Bionect Clear<br>Hydrogel) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Dermal wounds | Dermal wounds |
| OTC | Catasyn OTC is indicated for the<br>dressing and management of minor<br>burns, minor cuts, minor lacerations,<br>minor abrasions, and minor irritations<br>of the skin. | Bionect OTC is indicated for the<br>dressing and management of minor<br>burns; superficial cuts, lacerations, and<br>abrasions; and minor irritations of the<br>skin. |
| Indications for Rx | Catasyn RX may be used under the<br>direction of a health care professional<br>for the dressing and management of<br>partial to full thickness dermal ulcers<br>(pressure sores, venous stasis ulcers,<br>arterial ulcers, diabetic ulcers), surgical<br>wounds (post-operative incisions and<br>donor sites) and superficial and partial<br>thickness (second degree) burns. | Bionect may also be used under the care<br>of a health care professional for wounds<br>such as partial to full thickness dermal<br>ulcers (pressure ulcers, venous stasis<br>ulcers, arterial ulcers, diabetic ulcers),<br>surgical wounds (post-operative<br>incisions and donor sites), and 2nd degree<br>burns. |
| Sterile or<br>preservative | Non-sterile, preserved | Non-sterile, preserved |
| Composition | USP Purified water<br>Hypromellose<br>Chitosan derivatives (arginine<br>derivatized chitosan)<br>NF Methylparaben<br>Betaine | Purified water<br>Hyaluronic acid<br>Carbomer 980<br>Sorbitol<br>Sodium dehydroacetate<br>Methylparaben,<br>Propylparaben<br>Sodium hydroxide |
| Packaging | 0.07oz. (2mL), 0.85oz (25mL), or 3oz<br>(88.7mL) LDPE tubes | 100 gram LDPE tube |
| Shelf Life | Current real time aging studies support<br>9 months | Up to 24 months |
| Mode of action | Provides a moist wound environment<br>that is supportive to wound healing. | Provides a moist environment that is<br>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).