(154 days)
No
The device description and performance studies focus on the material properties and physical mechanism of action for controlling bleeding, with no mention of AI or ML.
Yes.
The device is intended for the local management of bleeding, a physiological condition, and its function involves direct contact with a wound to control bleeding, which is a therapeutic intervention.
No
The device is a topical bandage and gel intended for the local management of bleeding. It is not designed to diagnose any condition or disease.
No
The device description clearly outlines physical components (bandage, gel) made of specific materials (chitosan, cellulosic polymer, adhesive backing, lactic acid). The performance studies also involve bench testing of physical properties and in vivo studies on a physical device. This is not a software-only device.
Based on the provided information, the gel-e Flex device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local management of bleeding such as laceration and minor bleeding." This describes a topical application to a wound on the body, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a bandage and a gel applied directly to the wound site. This is consistent with a topical hemostatic device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the body.
- Providing information about a disease, condition, or physiological state.
- Using reagents or assays to detect specific substances.
- Being used in a laboratory setting.
The gel-e Flex is a medical device intended for direct application to a wound to control bleeding. This falls under the category of a topical hemostatic agent, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
gel-e Flex is indicated for the local management of bleeding such as laceration and minor bleeding.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
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.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hemcon Medical Technologies' Hemcon Bandage OTC Dressing (K072486)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Hemcon Medical Technologies' GuardaGel (K112215), gel-e's Gel-e Bandage (K172010)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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: 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
1
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.
2
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 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 : | 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 OTC
Dressing (K072486) |
| J. Reference Devices: | Hemcon Medical Technologies'
GuardaGel (K112215)
gel-e's
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.
5
- 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.
6
| 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 and | ||
| minor bleeding. | OTC: Same | ||
| Device Design | Single layer, non-woven pad attached to | ||
| skin-adhesive backing | Viscous gel dispensed from a sterile | ||
| syringe that may be used with gauze, | |||
| bandage, or by itself. | Equivalent | ||
| Single layer, non-woven pad attached | |||
| to skin-adhesive backing. | |||
| Reference Device GuardaGel | |||
| (K112215) is a Viscous gel dispensed | |||
| from a sterile syringe | |||
| Material | Gel-e Flex (Bandage) is composed of a | ||
| soft, sterile, non- woven palmitoyl-N- | |||
| acetylglucomasine (chitosan), a cellulosic | |||
| polymer, with a skin-adhesive backing | |||
| made of flexible woven cellulosic fabric | |||
| for simple application | Gel-e Flex (Gel) is composed of a semi- | ||
| transparent gel of palmitoyl-N- | |||
| acetylglucomasine (chitosan), the same | |||
| cellulosic polymer as the Gel-e Flex | |||
| (Bandage), dissolved in 0.1M lactic acid in | |||
| water. | Equivalent | ||
| The Hemcon Bandage OTC is a soft, | |||
| sterile, non-woven poly-N- | |||
| acetylglucosamine (chitosan), a | |||
| cellulosic biopolymer with a skin- | |||
| adhesive backing made of flexible | |||
| woven cellulosic fabric for simple | |||
| application. | |||
| Sizes | 19 mm x 76 mm (12 mm x 25 mm patch in | ||
| center) | 5 mL and 10 mL syringe | Equivalent | |
| 2.5 cm x 10 cm (2.5 cm x 2.5 cm patch | |||
| in center) | |||
| Weight | 0.4 g | 10 g / 20 g | Equivalent |
| 0.95 g | |||
| Sterility | 10-6 SAL - Terminally sterilized with | ||
| gamma radiation, for single use only | 10-6 SAL - Terminally sterilized with | ||
| gamma radiation, for single use only | Same | ||
| Performance | |||
| Standards | pH, moisture content, absorbency, | ||
| biocompatibility, and animal efficacy | |||
| testing | pH, viscosity, biocompatibility and animal | ||
| efficacy testing | Equivalent |