(330 days)
No
The device description and performance studies focus on the material properties and physical function of the bandage and gel for wound care and bleeding control. There is no mention of AI or ML in the text.
Yes.
The device is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions, and it controls minor bleeding when in contact with a wound. This aligns with the definition of a therapeutic device designed to treat or prevent disease or injury.
No
The device is a topical bandage and gel intended for the local management and control of bleeding wounds and to act as a bacterial barrier. It does not analyze patient data or provide a diagnosis of a condition.
No
The device description clearly outlines physical components (bandage, gel) made of specific materials (chitosan, cellulosic polymer, adhesive backing) and describes their physical properties and mechanisms of action (adhering to the wound, forming a barrier). There is no mention of software as a component or function of the device.
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 cuts, minor lacerations and minor abrasions." This describes a topical treatment applied directly to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "non-invasive topical bandage" and a "topically applied gel." These are external applications, not devices used to analyze biological samples.
- Mechanism of Action: The device works by "adhering to the site of injury" and providing a "barrier to bacterial penetration." This is a physical and protective mechanism, not a diagnostic process.
- Performance Studies: The performance studies focus on hemostasis (stopping bleeding), antibacterial barrier properties, and biocompatibility. These are all related to the device's function as a wound dressing, not its ability to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
gel-e Flex+ is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO, QSY
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. Based on in vitro testing, the gel-e Flex+ (Bandage) provides an effective barner to bacterial penetration for up to 48 hours. Gel-e Flex+ (Bandage) is composed of a soft, sterile, lyophilized, palmitoyl-N-acetylglucomasine (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. In vitro testing based on USP has demonstrated the gel-e Flex+ (Gel) remains effectively preserved for up to 28 days after opening the container.
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
Not Found
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)
Animal Studies
In vivo preclinical studies were conducted in a controlled acute swine model of skin laceration to evaluate the chitosan materials of both the predicate device (Hemcon Bandage PRO OTC: K150916) and the gel-e Flex+ in both the bandage and the gel configurations. 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 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.
Antibacterial Barrier (Bandage)
Antibacterial barrier testing on gel-e Flex+ (Bandage) for end of shelf life efficacy was conducted against 8 bacteria. Three (3) species of gram-negative (Acinetobacter baumannii. Shigella bovdii. Pseudomonas Aeruginosa) and 5 species of gram-positive bacteria (Enterococcus faecalis, Moraxella catarrhalis, Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Streptococcus pyogenes) were used. These species are clinically relevant. The results demonstrate that gel-e Flex+ (Bandage) is an effective barrier to bacterial penetration.
Antibacterial Properties (Bandage and Gel)
Antibacterial effectiveness testing on gel-e Flex+ (Bandage) for end of shelf life efficacy was conducted using the AATCC Test Method 100-2004 "Antibacterial Finishes on Textiles - Assessment of." The results show a log reduction of 4.0 or greater achieved on all of the organisms tested.
Organisms Included in Antibacterial Testing
- A. baumannii
- E. faecalis
- M. catarrhalis
- S. boydii
- Staphylococcus aureus MRSA
- Staphylococcus epidermis
- Streptococcus pneumoniae
- Streptococcus pyogenes
Based on the results of AATCC 100 testing, gel-e Flex+ (bandage) prevents the growth of bacteria within the dressing.
The preservative effectiveness of gel-e Flex+ (Gel) to prevent growth of microorganisms within the dressing has been established in accordance with the requirements of USP (Antimicrobial Effectiveness Testing).
Biocompatibility and Bench Testing
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, sensitization, systemic toxicity, 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.
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.
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 Cygnus Regulatory 387 Technology Dr, Ste 3110B College Park, Maryland 20742
Re: K182811 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 August 29, 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
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
August 29, 2019
gel-e. Inc. % Elsa Abruzzo Head of Regulatory Cygnus Regulatory 387 Technology Dr. Suite 3110B College Park, MD 20742
Re: K182811
Trade/Device Name: gel-e Flex+ Regulatory Class: Unclassified Product Code: FRO Dated: July 31, 2019 Received: August 2, 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
2
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 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 medical devices and radiation-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,
Anjana Jain -S
for Cynthia 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 Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K182811
Device Name gel-e Flex+
Indications for Use (Describe)
gel-e Flex+ is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
GEL-E FLEX+ 510(k) Summary K182811
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 : | Aug 1, 2019 |
| 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: | Primary: Hemcon Medical Technologies'
Hemcon Bandage PRO OTC
Dressing (K150916) |
| J. Reference Device: | gel-e's
gel-e Flex (K180152) |
K. Intended Use:
Over-The-Counter Use (21 CFR 801 Subpart C): gel-e Flex+ (Bandage) is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions.
gel-e Flex+ (Gel) is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions.
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. Based on in vitro testing, the gel-e Flex+ (Bandage) provides an effective barner to bacterial penetration for up to 48 hours. Gel-e Flex+ (Bandage) is composed of a soft, sterile, lyophilized, palmitoyl-N-acetylglucomasine (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. In vitro testing based on USP has demonstrated the gel-e Flex+ (Gel) remains effectively preserved for up to 28 days after opening the container.
M. Performance Data
Animal Studies
In vivo preclinical studies were conducted in a controlled acute swine model of skin laceration to evaluate the chitosan materials of both the predicate device (Hemcon Bandage PRO OTC: K150916) and the gel-e Flex+ in both the bandage and the gel configurations. 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 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.
Antibacterial Barrier (Bandage)
Antibacterial barrier testing on gel-e Flex+ (Bandage) for end of shelf life efficacy was conducted against 8 bacteria. Three (3) species of gram-negative (Acinetobacter baumannii. Shigella bovdii. Pseudomonas Aeruginosa) and 5 species of gram-positive bacteria (Enterococcus faecalis, Moraxella catarrhalis, Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Streptococcus pyogenes) were used. These species are clinically relevant. The results demonstrate that gel-e Flex+ (Bandage) is an effective barrier to bacterial penetration.
Antibacterial Properties (Bandage and Gel)
Antibacterial effectiveness testing on gel-e Flex+ (Bandage) for end of shelf life efficacy was conducted using the AATCC Test Method 100-2004 "Antibacterial Finishes on Textiles - Assessment of." The results show a log reduction of 4.0 or greater achieved on all of the organisms tested.
6
Organisms Included in Antibacterial Testing
- A. baumannii
- E. faecalis
- M. catarrhalis
- S. boydii
- Staphylococcus aureus MRSA
- Staphylococcus epidermis
- Streptococcus pneumoniae
- Streptococcus pyogenes
Based on the results of AATCC 100 testing, gel-e Flex+ (bandage) prevents the growth of bacteria within the dressing.
The preservative effectiveness of gel-e Flex+ (Gel) to prevent growth of microorganisms within the dressing has been established in accordance with the requirements of USP (Antimicrobial Effectiveness Testing).
Biocompatibility and Bench Testing
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, sensitization, systemic toxicity, 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 gel-Flex+ is substantially equivalent to the currently marketed predicate device, Hemcon Medical Technologies' Hemcon Bandage PRO OTC. gel-e Flex+ has essentially the same intended use/indication for use as the predicate device.
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| Comparison of gel-e Flex+ and Predicate Device | |||||
|---|---|---|---|---|---|
| Gel-e Flex+ | Primary Predicate: | Reference Predicate | |||
| Gel-e Flex + (Bandage) | Gel-e Flex+ (Gel) | Hemcon Bandage | |||
| PRO OTC | |||||
| (K150916) | Gel-e Flex | ||||
| (Bandage) | Gel-e Flex | ||||
| (Gel) | |||||
| Manufacturer | GEL-E, Inc. | Hemcon Medical | |||
| Technologies | GEL-E, Inc. | ||||
| Classification | Unclassified | Same | Unclassified | ||
| Product Code | FRO | Same | FRO | ||
| Indications for Use | OTC: gel-e Flex+ (Bandage) | ||||
| is indicated for the local | |||||
| management of bleeding | |||||
| wounds such as minor cuts, | |||||
| minor lacerations and minor | |||||
| abrasions. | OTC: gel-e Flex+ (Gel) | ||||
| is indicated for the local | |||||
| management of bleeding | |||||
| wounds such as minor | |||||
| cuts, minor lacerations | |||||
| and minor abrasions. | OTC: Same | OTC: gel-e Flex is | |||
| indicated for the local | |||||
| management of bleeding | |||||
| such as laceration and | |||||
| minor bleeding | |||||
| Device Design | Single layer, non-woven | ||||
| pad attached to skin- | |||||
| adhesive backing | Viscous gel | ||||
| dispensed from a | |||||
| sterile syringe that | |||||
| may used with | |||||
| gauze, bandage or | |||||
| by itself | Equivalent |
Single layer, non-
woven pad attached to
skin-adhesive backing
Reference device gel-e
Flex (Gel) (K180152)
is a viscous gel
dispensed from a sterile
syringe | Same | Same |
| 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
PRO 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. | Same | Same |
| 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) | Same | Same |
| Weight | 0.4 g | 10 g / 20 g | 0.95 g | Same | Same |
| Sterility | 10-6 SAL - Terminally
sterilized with gamma
radiation, for single use
only | 10-6 SAL - Terminally
sterilized with gamma
radiation, for single
patient use within 24 h. | 10-6 SAL - Terminally
sterilized with gamma
radiation, for single use
only | Same | Same |
| Performance
Standards | pH, moisture content,
absorbency,
biocompatibility, animal
efficacy testing and
antibacterial testing | pH, viscosity,
biocompatibility, animal
efficacy testing and
antibacterial testing | Same | Same | Same |