(30 days)
gel-e Flex+ gel OTC is indicated for the local management of bleeding wounds such as minor lacerations and minor abrasions.
gel-e Flex+ gel OTC is a laboratory tested non-irritating topical chitosan-based gel designed to rapidly (within 30 to 60 seconds) promote hemostasis when in contact with a bleeding wound. Gel-e Flex+ gel OTC is a clear, convenient, and easy to apply gel that can be used with commercially available gauze.
The provided text describes a 510(k) submission for the gel-e Flex+ gel OTC device, which is indicated for the local management of bleeding wounds such as minor lacerations and minor abrasions. The submission primarily focuses on establishing substantial equivalence to a predicate device (gel-e Flex+, K182811), rather than proving the device meets a specific set of acceptance criteria through a standalone clinical study with human data or an AI algorithm.
Therefore, many of the requested details regarding acceptance criteria, AI algorithm performance, multi-reader multi-case studies, and detailed ground truth establishment for large datasets are not applicable to this 510(k) summary. This submission relies heavily on comparisons to the predicate device and in vitro/in vivo (animal) studies to demonstrate performance and safety.
However, I can extract information related to the performance data provided and present it in a structured way that addresses the applicable questions.
Device Studied: gel-e Flex+ gel OTC (K192667)
Indication for Use: Local management of bleeding wounds such as minor lacerations and minor abrasions.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this 510(k) context refers to demonstrating that the modified device performs comparably to or as expected, given its intended use and the performance of the predicate device. It's not presented as a set of quantified thresholds for, for example, diagnostic accuracy of an AI algorithm.
| Acceptance Criteria Category (Implied by FDA Review) | Reported Device Performance (Summary from 510(k)) |
|---|---|
| Hemostasis Efficacy | In vivo preclinical studies in a controlled acute swine model of skin laceration showed that "gel-e Flex+ gel OTC functioned as intended and the control of bleeding observed was as expected." Both the predicate and subject devices operate by the same mechanism of action and use the same materials, implying similar efficacy. |
| Preservation Effectiveness | Established in accordance with USP <51> (Preservative Effectiveness Testing). The device met the acceptance criteria for 5 strains of microbial challenge organisms, demonstrating effective preservation for a period of 2 years. |
| Biocompatibility | Representative samples underwent testing per ISO 10993-1, covering cytotoxicity, irritation, sensitization, systemic toxicity, and pyrogenicity. The results demonstrate biocompatibility. |
| Bench Testing (Physical/Chemical Properties) | Representative samples underwent bench testing for pH and viscosity. The performance of gel-e Flex+ gel OTC was "substantially equivalent to the predicate device, gel-e Flex+." |
| Packaging Integrity | Packaging underwent testing including burst pressure and dye penetration testing. |
| Shelf-life and Use-life Stability | Shelf-life and use-life stability testing was conducted. Most notably, the "use life" (life after initially opening the product) was extended from 28 days for the predicate to 2 years for gel-e Flex+ gel OTC. This indicates that the device maintains its properties and effectiveness over this extended period. This was a key modification addressed in the submission, supported by the preservative effectiveness testing and other stability data. The device stability was demonstrated to support the 2-year use life claim. |
| Sterility Status | The device is "Not provided sterile." This is a change from the predicate which was terminally sterilized with gamma radiation. The acceptance for this change is implied by the FDA's acceptance of the 510(k) without requiring sterility for an OTC topical wound dressing. This is likely supported by the preservative effectiveness testing which addresses microbial load within the product. |
Study Details for Demonstrating Performance
Given that this is a 510(k) for a topical wound gel, not an AI/software device, the following points are addressed based on the provided information. Many questions are Not Applicable (N/A) in this context.
-
Sample size used for the test set and the data provenance:
- Animal Studies: Mentioned as "preclinical studies... in a controlled acute swine model of skin laceration." No specific number of animals ("sample size") is given. The data provenance is pre-clinical animal study.
- Preservative Effectiveness Testing: In accordance with USP <51>, which involves challenging the product with 5 specific microbial strains (e.g., S. aureus, P. aeruginosa, E. coli, C. albicans, A. brasiliensis). The "test set" here refers to the product samples subjected to microbial challenge. No specific sample size (N) of product units tested is provided, but it would align with standard laboratory testing protocols for USP<51>.
- Biocompatibility/Bench/Packaging/Stability: These involve laboratory testing on a sufficient number of representative device samples to meet the requirements of the standards (ISO 10993-1, internal stability protocols, etc.). Specific sample sizes (N) are not detailed in the summary but performed according to established protocols.
- Data Provenance: All data appears to be from laboratory and pre-clinical animal studies, likely conducted by or for the manufacturer. No indication of retrospective or prospective human clinical data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device is a wound gel, and the "ground truth" for its performance (hemostasis, stability, biocompatibility) is established through standardized laboratory tests and observation in animal models, not through expert human interpretation of images or clinical outcomes in the same way an AI diagnostic device would be evaluated. Results are objective measurements (e.g., pH, viscosity, time to hemostasis, microbial counts) or adherence to pass/fail criteria of specific standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for laboratory or animal efficacy studies.
-
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:
- N/A. This is not an AI/software device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is not an AI/software device.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For Hemostasis: The "ground truth" was the observed time to hemostasis/bleeding control in a controlled acute swine model of skin laceration, compared to expected performance and the predicate device. This is an objective physiological outcome in an animal model.
- For Preservative Effectiveness: Meeting the quantitative acceptance criteria for reduction/maintenance of microbial challenge organisms as defined by USP <51>.
- For Biocompatibility: Adherence to the pass/fail criteria of ISO 10993-1 standards for various biological endpoints.
- For Bench Testing/Stability: Measured physical and chemical properties (e.g., pH, viscosity) falling within pre-defined specifications and maintaining stability over time.
-
The sample size for the training set:
- N/A. This refers to a manufactured medical device, not an AI model that requires a training set. The "training" in this context would be the R&D and formulation process to develop the gel, which is not quantified by a "training set size."
-
How the ground truth for the training set was established:
- N/A. See point 7.
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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: K192667 Trade/Device Name: gel-e Flex+ gel OTC 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 October 25, 2019. 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). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 25, 2019
gel-e, Inc. Elsa Abruzzo Head of Regulatory 387 Technology Dr., Suite 3110B College Park, Maryland 20742
Re: K192667
Trade/Device Name: gel-e Flex+ gel OTC Regulatory Class: Unclassified Product Code: FRO Dated: September 24, 2019 Received: September 25, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lixin Liu -S
For Cynthia J. Chang, 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
Enclosure
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Indications for Use
510(k) Number (if known) K192667
Device Name gel-e Flex+ gel OTC
Indications for Use (Describe)
gel-e Flex+ gel OTC is indicated for the local management of bleeding wounds such as minor lacerations and minor abrasions.
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+ GEL OTC 510(k) Summary
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 : | Sept 24, 2019 |
| D. Device Trade Name: | gel-eFlex+ gel OTC |
| 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: | gel-e's gel-e Flex+ (K182811) |
-
J. Intended Use:
Over-The-Counter Use (21 CFR 801 Subpart C): gel-e Flex+ gel OTC is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions. -
K. Device Description:
gel-e Flex+ gel OTC is a laboratory tested non-irritating topical chitosan-based gel designed to rapidly (within 30 to 60 seconds) promote hemostasis when in contact with a bleeding wound. Gel-e Flex+ gel OTC is a clear, convenient, and easy to apply gel that can be used with commercially available gauze. In vitro preservative effectiveness testing based on USP<51> has demonstrated that gel-e Flex+ gel OTC remains effectively preserved for a period of 2 years by meeting the acceptance criteria for 5 strains of microbial challenge organisms.
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L. Performance Data
Animal Studies
In vivo preclinical studies were conducted in a controlled acute swine model of skin lacteration to evaluate the performance of both the predicate device (gel-e Flex+: K182811) and the subject device. The swine model was selected based on published comparisons evaluating the effectiveness of hemostatic devices and agents. Both the predicate and subject devices operate by the same mechanism of action using the same materials. In all instances, the gel-e Flex+ gel OTC functioned as intended and the control of bleeding observed was as expected.
Preservative Effectiveness Testing
The preservative effectiveness of gel-e Flex+ gel OTC to prevent growth of microorganisms within the dressing has been established in accordance with the requirements of USP <51> (Preservative Effectiveness Testing).
Biocompatibility and Bench Testing
Representative samples of the device underwent testing including bench testing (pH, viscosity), biocompatibility testing per ISO 10993-1 (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity), packaging testing (burst pressure and dye penetration testing), shelf-life, and use-life stability testing. The performance of gel-e Flex+ gel OTC was substantially equivalent to the predicate device, gel-e Flex+.
M. Summary of Device Modification and Substantial Equivalence:
Gel-e has submitted information on modification of gel-Flex+ gel OTC relative to the predicate device. Those changes are: (1) non-sterile processing and (2) extension of use life (i.e. life after initially opening the product). Gel-e has also submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that gel-Flex+ gel OTC is substantially equivalent to the currently marketed predicate device, gel-e Flex+. gel-e Flex+ gel OTC has the same intended use/indication for use as the predicate device.
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| Gel-e Flex+ gel OTC | Predicate:Gel-e Flex+ (Gel)(K182811) | |
|---|---|---|
| Manufacturer | GEL-E, Inc. | GEL-E, Inc. |
| Classification | Unclassified | Same |
| Product Code | FRO | Same |
| Indications for Use | OTC: gel-e Flex+ gel OTC is indicated for the localmanagement of bleeding wounds such as minor cuts,minor lacerations and minor abrasions. | OTC: Same |
| Device Design | Viscous gel dispensed from a syringe that may beused with gauze, bandage or by itself | Same |
| Material | Gel-e Flex+ gel OTC is composed of a semi-transparent gel of palmitoyl-N-acetylglucomasine(chitosan) dissolved in 0.1M lactic acid in water | Same |
| Sizes | 5 mL and 10 mL syringe | Same |
| Weight | 10 g / 20 g | Same |
| Sterility | Not provided sterile | 10-6 SAL – Terminally sterilized with gamma radiation,for single patient use within 24 h. |
| Use Life | 2 years | 28 days |
| PerformanceStandards | pH, viscosity, biocompatibility, animal efficacy testingand preservative effectiveness testing | Same |
Comparison of gel-e Flex+ and Predicate Device
N/A