(30 days)
Not Found
No
The summary describes a topical gel for wound care and does not mention any AI or ML components.
Yes.
This device is designed to rapidly promote hemostasis in bleeding wounds, which is a therapeutic action aimed at treating a medical condition (bleeding).
No
Explanation: The device is designed for the local management of bleeding wounds to promote hemostasis. It is not used to diagnose a medical condition or disease.
No
The device description clearly states it is a "topical chitosan-based gel," indicating a physical substance applied to a wound, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local management of bleeding wounds such as minor lacerations and minor abrasions." This describes a topical treatment applied directly to a wound on the body.
- Device Description: The description details a "topical chitosan-based gel" designed to promote hemostasis when in contact with a bleeding wound. This is a physical interaction with the wound itself, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any such specimens.
The device is a topical hemostatic agent for wound care, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
gel-e Flex+ gel OTC is indicated for the local management of bleeding wounds such as minor lacerations and minor abrasions.
Product codes
QSY, FRO
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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
Animal Studies: In vivo preclinical studies were conducted in a controlled acute swine model of skin laceration 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 (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+.
Key Metrics
Not Found
Predicate Device(s)
gel-e Flex+ (K182811)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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: 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
2
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 3110B
College Park, MD 20742 |
|------------------------------------|--------------------------------------------------------------------------------------------------|
| B. Contact Person: | Matthew Dowling, PhD
Chief Scientific Officer
Phone: (301) 405-3585
Fax: (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 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 (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 local
management of bleeding wounds such as minor cuts,
minor lacerations and minor abrasions. | OTC: Same |
| Device Design | Viscous gel dispensed from a syringe that may be
used 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 |
| Performance
Standards | pH, viscosity, biocompatibility, animal efficacy testing
and preservative effectiveness testing | Same |