gel-e Flex

K180152 · Gel-E, Inc. · QSY · Jun 22, 2018 · SU

Device Facts

• Record ID: K180152
• Device Name: gel-e Flex
• Applicant: Gel-E, Inc.
• Product Code: QSY · SU
• Decision Date: Jun 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

gel-e Flex is indicated for the local management of bleeding such as lacerations and minor bleeding.

Device Story

gel-e Flex is a non-invasive topical hemostatic device available as a bandage or gel. The bandage consists of a sterile, lyophilized palmitoyl-N-acetylglucomasine (chitosan) pad on an adhesive backing; the gel consists of the same chitosan polymer dissolved in 0.1M lactic acid. Both configurations are intended for OTC use to control minor bleeding by adhering to the wound site. The device is applied topically by the patient or caregiver. The chitosan material acts as a hemostatic agent upon contact with the wound. The device is terminally sterilized via gamma radiation for single-use. It provides a physical barrier and chemical interaction to facilitate hemostasis, aiding in the management of minor injuries.

Clinical Evidence

No human clinical data. Evidence consists of in vivo preclinical studies in a controlled acute swine skin laceration model comparing gel-e Flex (bandage and gel) to the Hemcon Bandage OTC. Results showed the subject device functioned as intended with bleeding control comparable to the predicate. Bench testing included biocompatibility (ISO 10993-1: cytotoxicity, irritation, systemic toxicity, pyrogenicity), packaging integrity (burst pressure, dye penetration), sterilization validation, and shelf-life stability.

Technological Characteristics

Materials: Palmitoyl-N-acetylglucomasine (chitosan) and cellulosic polymer. Form factors: Bandage (non-woven pad with adhesive backing) and Gel (0.1M lactic acid solution). Sterilization: Gamma radiation (10^-6 SAL). Connectivity: None. Software: None.

Indications for Use

Indicated for local management of minor bleeding and lacerations in patients requiring topical hemostasis.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Hemcon Bandage OTC Dressing (K072486)

Reference Devices

• GuardaGel (K112215)
• Gel-e Bandage (K172010)

Submission Summary (Full Text)

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April 21, 2023

gel-e, Inc. Elsa Abruzzo Head of Regulatory 387 Technology Dr., Suite 3110B College Park, Maryland 20742

Re: K180152 Trade/Device Name: gel-e Flex Regulatory Class: Unclassified Product Code: QSY

Dear Elsa Abruzzo:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 22, 2018. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, [e-mail].

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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June 22, 2018

gel-e, Inc. Elsa Abruzzo Head of Regulatory 387 Technology Dr., Suite 3110B College Park, Maryland 20742

Re: K180152 Trade/Device Name: gel-e Flex Regulatory Class: Unclassified Product Code: FRO Dated: February 14, 2018 Received: February 16, 2018

Dear Elsa Abruzzo:

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 (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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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 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

- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K180152

Device Name gel-e Flex

Indications for Use (Describe)

gel-e Flex is indicated for the local management of bleeding such as laceration and minor bleeding.

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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### GEL-E FLEX 510(k) Summary K180152

### 510(k) Summary

| A. Name and Address of Applicant: | gel-e, Inc.<br>387 Technology Dr., Suite 3110B<br>College Park, MD 20742 |
|-----------------------------------|--------------------------------------------------------------------------------------------------|
| B. Contact Person: | Matthew Dowling, PhD<br>Chief Scientific Officer<br>Phone: [phone]<br>Fax: [phone] |
| C. Date of Submission : | Jan 17, 2018 |
| D. Device Trade Name: | gel-e Flex |
| E. Device Common Name: | Dressing, Wound, Drug |
| F. Device Classification: | Unclassified Device (pre-amendment) |
| G. Classification Name: | Unclassified |
| H. Product Code: | FRO |
| I. Predicate Device: | Hemcon Medical Technologies'<br>Hemcon Bandage OTC<br>Dressing (K072486) |
| J. Reference Devices: | Hemcon Medical Technologies'<br>GuardaGel (K112215)<br>gel-e's<br>Gel-e Bandage (K172010) |

### K. Intended Use:

Over-The-Counter Use (21 CFR 801 Subpart C): gel-e Flex is indicated for the local management of bleeding such as lacerations and minor bleeding.

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- L. Device Description:
The gel-e Flex (Bandage):

The gel-e Flex (Bandage) is a non-invasive topical bandage intended to control minor bleeding when in contact with a wound by adhering to the site of injury. Gel-e Flex (Bandage) is composed of a soft, sterile, lyophilized, palmitoyl- Nacetylglucomasine (chitosan), a cellulosic polymer woven fabric pad, attached to a soft adhesive backing.

The gel-e Flex (Gel):

The gel-e Flex (Gel) is a topically applied gel intended to control minor bleeding when in contact with a wound. Gel-e Flex (Gel) is composed of a semitransparent gel of palmitoyl-N-acetylglucomasine (chitosan), the same cellulosic polymer as the Gel-e Flex (Bandage), dissolved in 0.1M lactic acid in water. The lactic acid is present to improve the solubility of chitosan.

#### M. Performance Data

In vivo preclinical studies were conducted in a controlled acute swine model of minor bleeding via skin laceration to evaluate the chitosan materials of both the predicate device (Hemcon Bandage OTC: K072486) and the gel-e Flex in both the bandage and gel configurations. The swine model was selected based on published comparisons evaluating the effectiveness of hemostatic devices and agents. Both the predicate and subject device operate by the same mechanism of action using the same core material, chitosan. In all instances, the gel-e Flex in both the bandage and gel form functioned as intended and the control of bleeding observed was as expected.

Representative samples of the device, both in bandage and gel configurations, underwent testing including bench testing (bandage: pH, moisture content, absorbency; gel: pH, viscosity), biocompatibility testing per ISO 10993-1 (cytotoxicity, irritation, systemic toxicity, pyrogenicity, pyrogenicity), packaging testing (burst pressure and dye penetration testing), sterilization validation testing, and shelf-life stability testing. The performance of gel-e Flex was statistically equivalent to the predicate device, Hemcon Bandage OTC.

- N. Summary of Substantial Equivalence:
Gel-e has submitted information on indication for use, design and principle of operation, biocompatibility, and performance characteristics to establish that the gel-e Flex is substantially equivalent to the currently marketed predicate device the Hemcon Medical Technologies' Hemcon Bandage OTC Dressing (K072486). gel-e Flex has essentially the same intended use/indication for use and technological characteristics as the predicate device.

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| Gel-e Flex | | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bandage (REF #GF001) | Gel (REF #GF002) | Primary Predicate:<br>Hemcon Bandage OTC<br>(K072486) |
| Manufacturer | GEL-E, Inc. | GEL-E, Inc. | Hemcon Medical Technologies |
| Classification | Unclassified | | Same |
| Product Code | FRO | | Same |
| Indications for Use | OTC: gel-e Flex is indicated for the local management of bleeding such as laceration and<br>minor bleeding. | | OTC: Same |
| Device Design | Single layer, non-woven pad attached to<br>skin-adhesive backing | Viscous gel dispensed from a sterile<br>syringe that may be used with gauze,<br>bandage, or by itself. | Equivalent<br>Single layer, non-woven pad attached<br>to skin-adhesive backing.<br>Reference Device GuardaGel<br>(K112215) is a Viscous gel dispensed<br>from a sterile syringe |
| Material | Gel-e Flex (Bandage) is composed of a<br>soft, sterile, non- woven palmitoyl-N-<br>acetylglucomasine (chitosan), a cellulosic<br>polymer, with a skin-adhesive backing<br>made of flexible woven cellulosic fabric<br>for simple application | Gel-e Flex (Gel) is composed of a semi-<br>transparent gel of palmitoyl-N-<br>acetylglucomasine (chitosan), the same<br>cellulosic polymer as the Gel-e Flex<br>(Bandage), dissolved in 0.1M lactic acid in<br>water. | Equivalent<br>The Hemcon Bandage OTC is a soft,<br>sterile, non-woven poly-N-<br>acetylglucosamine (chitosan), a<br>cellulosic biopolymer with a skin-<br>adhesive backing made of flexible<br>woven cellulosic fabric for simple<br>application. |
| Sizes | 19 mm x 76 mm (12 mm x 25 mm patch in<br>center) | 5 mL and 10 mL syringe | Equivalent<br>2.5 cm x 10 cm (2.5 cm x 2.5 cm patch<br>in center) |
| Weight | 0.4 g | 10 g / 20 g | Equivalent<br>0.95 g |
| Sterility | 10-6 SAL - Terminally sterilized with<br>gamma radiation, for single use only | 10-6 SAL - Terminally sterilized with<br>gamma radiation, for single use only | Same |
| Performance<br>Standards | pH, moisture content, absorbency,<br>biocompatibility, and animal efficacy<br>testing | pH, viscosity, biocompatibility and animal<br>efficacy testing | Equivalent |

# Comparison of gel-e Flex and Predicate Device