← Product Code QSY · K213652 # Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) (K213652) _Cresilon, Inc. · QSY · Jun 28, 2023 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K213652 ## Device Facts - **Applicant:** Cresilon, Inc. - **Product Code:** QSY - **Decision Date:** Jun 28, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Cresilon Hemostatic Gel™ (CHG™) is a hemostatic gel for external use only. ## Device Story Cresilon Hemostatic Gel (CHG) is a sterile, viscous hemostatic gel composed of poly(N-acetyl-D-glucosamine, D-glucosamine), sodium alginate, and water. Supplied in single-use 5 mL pre-filled syringes. Applied topically by healthcare providers directly to bleeding wounds (minor cuts, lacerations, abrasions). Upon application, the gel adheres to the wound site, forming a mechanical barrier that stops bleeding and facilitates natural clot formation. Used in clinical settings; intended for prescription use. Benefits include rapid hemostasis for minor wounds. ## Clinical Evidence No human clinical data. Evidence consists of bench testing and in vivo animal efficacy testing. Animal study used a porcine skin laceration model to compare subject and predicate device performance; results confirmed the subject device functioned as intended with performance equivalent to the predicate. Biocompatibility testing (cytotoxicity, irritation, sensitization, pyrogenicity, systemic toxicity, hemolysis) performed per ISO 10993 and ASTM F756 standards; all tests passed. ## Technological Characteristics Composition: poly(N-acetyl-D-glucosamine, D-glucosamine), sodium alginate, water. Form factor: 5 mL pre-filled syringe. Mechanism: mechanical barrier. Sterilization: gamma radiation (10-6 SAL). Biocompatibility standards: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4, ASTM F756. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - Gel-E Flex ([K180152](/device/K180152.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 28, 2023 Cresilon, Inc. Hassaan Ahmad Vice President - Quality & Regulatory Affairs 87 35th Street. Suite 603/604 Brooklyn, New York 11232 Re: K213652/S003 Trade/Device Name: Cresilon Hemostatic Gel, CHG Regulatory Class: Unclassified Product Code: FRO Dated: September 1, 2022 Received: September 2, 2022 Dear Hassaan Ahmad: 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ 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, # David-Krause -S David Krause, Ph.D. Deputy Director OHT4. Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) To be assigned by FDA Device Name Cresilon Hemostatic Gel™ (CHGTM), Cresilon Hemostatic Gel™, CHGTM. Indications for Use (Describe) Cresilon Hemostatic Gel™ (CHGTM) is a hemostatic gel for external use only. Cresilon Hemostatic Gel™ (CHG™) is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary # 1. Submitter Information: | Sponsor and Application
Correspondent (US Agent): | Hassaan W. Ahmad
Vice President – Quality & Regulatory Affairs | |------------------------------------------------------|-------------------------------------------------------------------| | | 87 35th Street, Suite 603/604, | | | Brooklyn, NY 11232 | | Phone | 347 435 2226 x103 | | E-mail: | hassaan@cresilon.com | | Legal Manufacturer: | Cresilon, Inc. | | Phone: | 347 435 2226 x103 | | Contact Person: | Hassaan W. Ahmad | | E-mail: | hassaan@cresilon.com | | Date Prepared: | 18th Nov 2021 | | | | #### 2. Device Identification: | Device Trade Name: | | | |--------------------|--|--| |--------------------|--|--| | | CHG TM | |---------------------------|------------------------------------| | Product Code Description: | Dressing, Wound, Drug | | Device Classification: | Unclassified Device (pre-amendment | | Review Panel: | General & Plastic Surgery | | Product Code: | FRO | | Regulation Number | Not Applicable | #### 3. Predicate Device: Cresilon Hemostatic Gel™ (CHGTM) Cresilon Hemostatic Gel™ | Device Name | 510(k) Number | |----------------------------------------------------------------------------|---------------| | Gel-E Flex Manufactured by Gel-E, Inc. (Now registered
as Medcura, Inc) | K180152 | #### 4. Device Description Cresilon Hemostatic Gel™ (CHG™) is a hemostatic gel for external use only, indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions. CHG's hemostatic gel is comprised of poly(N-acetyl-D-glucosamine, D-glucosamine), sodium alginate, and water. CHG is supplied as individually pouched, sterile, pre-filled, single-use syringes. Each syringe is a single 5 mL hemostatic gel application. CHG is packaged in a box containing two (2) CHG applications. After removal from the pouch, the cap is unscrewed, and the syringe is primed, the hemostatic gel is topically applied directly to the source of bleeding via the syringe. {4}------------------------------------------------ # 5. Intended Use & Indications for Use Intended Use: Cresilon Hemostatic Gel™ (CHG™) is a hemostatic gel for external use only. Indications for Use: Cresilon Hemostatic Gel™ (CHG™) is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions. ## 6. Substantial Equivalence The subject device Cresilon Hemostatic Gel™ (CHG™) is substantially equivalent to the predicate device Gel-E Flex cleared under the 510(k) number, K180152. The intended use and the indications for use of the subject device are same as that of the predicate and the technological characteristics such as, device design, physical state, mechanism of action and application of the device of the subject device are substantially equivalent to that of the predicate device Gel-E Flex. Thus, CHG does not give rise to any new safety nor performance questions when compared with Gel-E Flex. | Table 2 – List of Predicate Devices | | | |-------------------------------------|-------------|---------------| | | Device Name | 510(k) Number | | Predicate | Gel-E Flex | K180152 | | | Device Name | 510(k) Number | |-----------|-------------|---------------| | Predicate | Gel-E Flex | K180152 | | Parameters | Subject Device | Predicate Device | Comments | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Cresilon Hemostatic GelTM
(CHGTM) | Gel-E Flex | N/A | | 510(k) number | N/A-To be assigned by FDA | K180152 | N/A | | Intended Use | Cresilon Hemostatic GelTM
(CHGTM) is a hemostatic gel
for External use only. | The device is a hemostatic
gel for External use only. | Same | | Indications for
use | Cresilon Hemostatic GelTM
(CHGTM) is indicated for the
local management of
bleeding wounds such as
minor cuts, minor
lacerations, and minor
abrasions | Gel-e Flex is indicated for
the local management of
bleeding wounds such as
minor cuts, minor
lacerations and minor
abrasions. | Same | | Part of the
body to be
interacted with | Injured or breached skin | Injured or breached skin | Same | | Single Use | Yes | Yes | Same | | Rx/OTC | Rx | OTC | Cresilon intends to market
CHGTM for prescription use (Rx).
As CHG is intended for use by
trained health care providers,
CHG is equivalent to the
predicate, as use error is
minimized | Table 3- Substantial Equivalence (Intended Use & Indications for Use) {5}------------------------------------------------ # Cresilon, Inc. # Traditional 510(k) Cresilon Hemostatic Gel™ (CHGTM) | Sr.No | Parameters | Subject device | Predicate Device | Comments | |-------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Name | Cresilon Hemostatic GelTM (CHGTM) | Gel-E Flex (Gel) | N/A | | 2. | 510(k) Number | N/A | K180152 | N/A | | 3. | Manufacturer | Cresilon Inc. | Gel-E, Inc. (Now registered with FDA as
Medcura, Inc.) | N/A | | 4. | Product Code | FRO | FRO | Same as predicate. | | 5. | Regulation Number | Unclassified | Unclassified | Same as predicate. | | 6. | Device Description | Cresilon Hemostatic GelTM (CHGTM) is
a gel, composed of poly(N-acetyl-D-
glucosamine, D-glucosamine)
(Chitosan), sodium alginate, and water. | Gel-e Flex is composed of a gel of
palmitoyl-N-acetylglucosamine (chitosan),
dissolved in 0.1M lactic acid in water. | Both products have chitosan.

Both products are delivered as viscous
gels from pre-filled syringes.

The animal efficacy testing data and
the biocompatibility testing data do
not raise additional questions about
safety or efficacy of the subject
device. | | 7. | Device
Design/Technology | Viscous Gel in Pre-Filled Syringe | Viscous Gel in Pre-Filled Syringe | Same as predicate | | 8. | Volume | 5 mL syringe | 5 mL or 10 mL syringes. | Same as predicate | | 9. | Sterilization | 10-6 SAL – Terminally sterilized with
gamma radiation | 10-6 SAL – Terminally sterilized with
gamma radiation | Same as predicate | | 10. | Mechanism of Action | When directly applied to a source of
bleeding, the hemostatic gel rapidly
adheres to the wound site. The
hemostatic gel forms a mechanical
barrier that stops the flow of bleeding
and allows the body to create a natural
clot. | Same as subject device | Same as Predicate | | 11. | Bench Testing | Bench testing: pH, ViscosityAnimal efficacy testing | Bench testing: pH, viscosityAnimal efficacy testing | Same as predicate. | | 12. | Biocompatibility | Cytotoxicity | Cytotoxicity | Similar | | Table 4- Substantial Equivalence (Technological Characteristics) | | | |------------------------------------------------------------------|--|--| |------------------------------------------------------------------|--|--| {6}------------------------------------------------ # Traditional 510(k) Cresilon Hemostatic Gel™ (CHGTM) Cresilon, Inc. | Sr.No | Parameters | Subject device | Predicate Device | Comments | |-------|------------|--------------------------------------------------------------------|---------------------------------------------------|----------| | | | Sensitization | Sensitization | | | | | Irritation/ | Irritation | | | | | Pyrogenicity | Pyrogenicity | | | | | Systemic Toxicity | Systemic toxicity | | | | | Hemolysis | | | | 13. | Packaging | Bubble Testing
Seal Strength Testing
Dye Penetration Testing | Burst Pressure Testing
Dye Penetration testing | Similar | {7}------------------------------------------------ # Traditional 510(k) Cresilon Hemostatic Gel™ (CHGTM) # 7. Non-clinical Testing: The Subject Device has been evaluated through a series of nonclinical studies to determine whether the device meets the acceptance criteria for its intended applications. All the nonclinical tests conducted on the device are summarized below. # a) Biocompatibility Testing Biocompatibility tests have been performed per the requirements of ISO 10993-1:2009, under the section "Surface devices used on breached or compromised surface with limited contact duration (≤24 hrs) ". The subject device complies with all the tests conducted and complies to the following standards identified in the below table. | Biological
endpoint | Test Method | Purpose | Acceptance
criteria | Test Result | |------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------|-------------| | Cytotoxicity | ISO 10993-5 | To verify Cytotoxicity potential of
the subject device | Non-
cytotoxic | Pass | | Irritation
and
Sensitization | ISO 10993-10 | To verify irritation and
sensitization potential of the
subject device | Non-irritating
and non-
sensitizing | Pass | | Pyrogenicity | ISO 10993-11 | To verify the pyrogenicity of the
device. | Non-
pyrogenic | Pass | | Acute
Systemic
Toxicity | ISO 10993-11: | Evaluation of the potential for
medical device materials to cause
adverse systemic reactions. | Non-toxic | Pass | | Hemolysis | ASTM F756, ISO
10993-4 | To verify the hemolytic property of
the device. | Non-
hemolytic | Pass | Table 5 – Summary of Biocompatibility Testing performed # b) Performance Bench Testing As a part of design verification studies, representative samples of the device underwent testing including packaging validation testing (Bubble Testing, Seal Strength Testing, Dye Penetration Testing and Removal Torque Testing) and in vivo animal efficacy testing. In vivo animal efficacy testing was conducted in a porcine model of skin laceration to evaluate both the predicate device and Cresilon Hemostatic Gel™ (CHGTM). The porcine model was used due to the vast similarities between pigs and humans when it comes to dermal wound lacerations. Both the predicate and subject devices operate by the same mechanism of action. In all instances, Cresilon Hemostatic GelTM (CHGTM) functioned as intended, device performance was as expected. # 8. Sterilization and Shelf Life: Cresilon Hemostatic Gel™ (CHG™) is terminally sterilized using gamma irradiation to a Sterility Assurance Level (SAL) of 10-6. Cresilon Hemostatic Gel™ (CHG™) is subjected to shelf-life testing to evaluate the shelflife of the product for in vivo efficacy, container closure integrity, and deployment force. {8}------------------------------------------------ ## 9. Conclusion: The intended use and the indications for use of the subject device, Cresilon Hemostatic Gel™, are the same as that of the predicate. The technological characteristics such as device design, physical state, mechanism of action, and application of the subject device are the same as that of the predicate device Gel-E Flex. The nonclinical test data further demonstrates that the subject device is as safe, as effective, and performs as well as the predicate device. Based on the comparison above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K213652](https://fda.innolitics.com/device/K213652) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com