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) 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.

AI/ML Overview

The provided text describes the gel-e Flex device, specifically focusing on its preclinical studies and performance data to demonstrate substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity for an AI-powered diagnostic).

However, I can extract the information related to the performance studies conducted for this medical device and present it in a similar structure as requested, interpreting "acceptance criteria" as the performance aspects evaluated for substantial equivalence.

Here's an analysis of the provided text based on the request:

1. Table of "Acceptance Criteria" (Interpreted as Performance Aspects for Substantial Equivalence) and Reported Device Performance

"Acceptance Criteria" / Performance Aspect	Reported Device Performance
Mechanism of Action (Hemostasis)	The gel-e Flex in both bandage and gel form "functioned as intended and the control of bleeding observed was as expected." Both the predicate and subject device operate by the same mechanism of action using the same core material, chitosan. This implies effective hemostasis.
Bench Testing (Bandage: pH, Moisture Content, Absorbency)	Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific values not provided)
Bench Testing (Gel: pH, Viscosity)	Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific values not provided)
Biocompatibility (per ISO 10993-1: Cytotoxicity, Irritation, Systemic Toxicity, Pyrogenicity)	Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific results not provided, but passing these tests is implied by equivalence)
Packaging Testing (Burst Pressure, Dye Penetration)	Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific results not provided)
Sterilization Validation Testing	Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific results not provided)
Shelf-Life Stability Testing	Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific results not provided)

2. Sample size used for the test set and the data provenance

Test Set Description: "In vivo preclinical studies were conducted in a controlled acute swine model of minor bleeding via skin laceration."
Sample Size: Not specified (e.g., number of swine, number of lacerations).
Data Provenance: Animal model (swine), preclinical study. The country of origin is not specified, but the applicant's address is College Park, MD, USA. Given it's a preclinical study, it's considered prospective in terms of data collection for this specific study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a hemostatic agent, not a diagnostic device requiring expert interpretation of images or data to establish ground truth or diagnosis. The "ground truth" for its performance is the direct observation of bleeding control in the animal model.

4. Adjudication method for the test set

Not applicable. As above, this is not a diagnostic study requiring expert adjudication.

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

Not applicable. This is not an AI-powered diagnostic or assistive technology for human readers. It is a medical device for topical bleeding control.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the effectiveness of the device in controlling bleeding was the direct observation of hemostasis in the acute swine model of minor bleeding via skin laceration.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device requiring a training set. The term "training set" is not relevant to the described preclinical and bench testing.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this device.

Summary of what the study did prove:

The study described was a preclinical in vivo study in swine combined with various bench tests, biocompatibility tests, packaging tests, and stability tests. The primary goal was to demonstrate that the gel-e Flex device (both bandage and gel configurations) is substantially equivalent to the predicate device, Hemcon Bandage OTC, in its ability to control minor bleeding and meet relevant safety and performance standards. The critical finding was that in all instances, the gel-e Flex "functioned as intended and the control of bleeding observed was as expected," and its performance was "statistically equivalent" to the predicate device across all tested parameters.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

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, Julie.Morabito@fda.hhs.gov.

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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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.387 Technology Dr., Suite 3110BCollege Park, MD 20742
B. Contact Person:	Matthew Dowling, PhDChief Scientific OfficerPhone: (301) 405-3585Fax: (301) 314-9592
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'Hemcon Bandage OTCDressing (K072486)
J. Reference Devices:	Hemcon Medical Technologies'GuardaGel (K112215)gel-e'sGel-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 (Gel):

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:Hemcon Bandage OTC(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 andminor bleeding.		OTC: Same
Device Design	Single layer, non-woven pad attached toskin-adhesive backing	Viscous gel dispensed from a sterilesyringe that may be used with gauze,bandage, or by itself.	EquivalentSingle layer, non-woven pad attachedto skin-adhesive backing.Reference Device GuardaGel(K112215) is a Viscous gel dispensedfrom a sterile syringe
Material	Gel-e Flex (Bandage) is composed of asoft, sterile, non- woven palmitoyl-N-acetylglucomasine (chitosan), a cellulosicpolymer, with a skin-adhesive backingmade of flexible woven cellulosic fabricfor simple application	Gel-e Flex (Gel) is composed of a semi-transparent gel of palmitoyl-N-acetylglucomasine (chitosan), the samecellulosic polymer as the Gel-e Flex(Bandage), dissolved in 0.1M lactic acid inwater.	EquivalentThe Hemcon Bandage OTC is a soft,sterile, non-woven poly-N-acetylglucosamine (chitosan), acellulosic biopolymer with a skin-adhesive backing made of flexiblewoven cellulosic fabric for simpleapplication.
Sizes	19 mm x 76 mm (12 mm x 25 mm patch incenter)	5 mL and 10 mL syringe	Equivalent2.5 cm x 10 cm (2.5 cm x 2.5 cm patchin center)
Weight	0.4 g	10 g / 20 g	Equivalent0.95 g
Sterility	10-6 SAL - Terminally sterilized withgamma radiation, for single use only	10-6 SAL - Terminally sterilized withgamma radiation, for single use only	Same
PerformanceStandards	pH, moisture content, absorbency,biocompatibility, and animal efficacytesting	pH, viscosity, biocompatibility and animalefficacy testing	Equivalent

Comparison of gel-e Flex and Predicate Device

Regulation Number and Section

N/A