(586 days)
Cresilon Hemostatic Gel™ (CHG™) 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.
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.
The provided document is a 510(k) premarket notification from the FDA, specifically concerning the Cresilon Hemostatic Gel (CHG) device. It outlines the device's characteristics, intended use, and a comparison to a predicate device (Gel-E Flex) to demonstrate substantial equivalence.
However, the document does not contain information about:
- A "study that proves the device meets the acceptance criteria" in the context of an AI/machine learning device.
- "Acceptance criteria" as typically defined for the performance metrics of an AI/machine learning model (e.g., sensitivity, specificity, AUC).
- Details on a test set (sample size, provenance), expert ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, standalone algorithm performance, or training set details.
This document pertains to a medical device (a hemostatic gel), not an AI/machine learning product. Therefore, the requested information points (1-9) are largely irrelevant to the content of this FDA 510(k) submission. Medical devices like this gel are typically evaluated based on biocompatibility, performance bench testing (e.g., in vivo animal efficacy), sterilization, and shelf-life, as detailed in the "Non-clinical Testing" section.
Based on the provided text, it is not possible to answer the questions about AI/ML device acceptance criteria and study details. The document is for a physical medical device (hemostatic gel), not a software or AI-powered diagnostic/therapeutic tool.
If the request implies searching for acceptance criteria and study data within the context of a traditional medical device rather than an AI/ML device, then the relevant information from the document would be as follows:
Acceptance Criteria and Device Performance (for a Traditional Medical Device):
The "acceptance criteria" for this traditional medical device are primarily related to its safety and functional performance as observed in non-clinical (biocompatibility and animal efficacy) testing, demonstrating it is "as safe, as effective, and performs as well as the predicate device."
| Acceptance Criteria (Biological Endpoint/Test Result) | Reported Device Performance (Test Result) |
|---|---|
| Non-cytotoxic | Pass |
| Non-irritating and non-sensitizing | Pass |
| Non-pyrogenic | Pass |
| Non-toxic (Acute Systemic Toxicity) | Pass |
| Non-hemolytic | Pass |
| Functional as intended (In vivo animal efficacy) | Functioned as intended; performance as expected |
Details of the Study (Non-Clinical Testing for a Traditional Medical Device):
The document describes non-clinical testing, but not in the format of an AI/ML study.
- A table of acceptance criteria and the reported device performance: See table above.
- Sample size used for the test set and the data provenance:
- Biocompatibility Testing: Not specified as a "test set" in terms of number of samples, but tests were performed on "representative samples." Data provenance is not explicitly stated beyond being conducted per ISO 10993-1:2009.
- In Vivo Animal Efficacy Testing: Conducted in a "porcine model of skin laceration." The number of animals or specific "sample size" is not provided. Data provenance is implied to be from this specific animal model, likely controlled lab conditions. "Retrospective or prospective" is not applicable in the AI/ML sense but would generally be a prospective animal study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance in animal models is typically objective (e.g., cessation of bleeding, lack of adverse reactions) or determined by veterinary professionals, not "experts" in the context of radiological interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used:
- Biocompatibility: Compliant with ISO 10993-1:2009 standards for biological endpoints (cytotoxicity, irritation, sensitization, pyrogenicity, acute systemic toxicity, hemolysis).
- In Vivo Animal Efficacy: Demonstrated functional performance (hemostatic effect) in a porcine laceration model. The "ground truth" is whether the device stopped bleeding as intended.
- The sample size for the training set: Not applicable, as this is not an AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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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
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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
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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) |
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510(k) Summary
1. Submitter Information:
| Sponsor and ApplicationCorrespondent (US Agent): | Hassaan W. AhmadVice 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 registeredas 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.
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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 gelfor External use only. | The device is a hemostaticgel for External use only. | Same |
| Indications foruse | Cresilon Hemostatic GelTM(CHGTM) is indicated for thelocal management ofbleeding wounds such asminor cuts, minorlacerations, and minorabrasions | Gel-e Flex is indicated forthe local management ofbleeding wounds such asminor cuts, minorlacerations and minorabrasions. | Same |
| Part of thebody to beinteracted with | Injured or breached skin | Injured or breached skin | Same |
| Single Use | Yes | Yes | Same |
| Rx/OTC | Rx | OTC | Cresilon intends to marketCHGTM for prescription use (Rx).As CHG is intended for use bytrained health care providers,CHG is equivalent to thepredicate, as use error isminimized |
Table 3- Substantial Equivalence (Intended Use & Indications for Use)
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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 asMedcura, 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) isa gel, composed of poly(N-acetyl-D-glucosamine, D-glucosamine)(Chitosan), sodium alginate, and water. | Gel-e Flex is composed of a gel ofpalmitoyl-N-acetylglucosamine (chitosan),dissolved in 0.1M lactic acid in water. | Both products have chitosan.Both products are delivered as viscousgels from pre-filled syringes.The animal efficacy testing data andthe biocompatibility testing data donot raise additional questions aboutsafety or efficacy of the subjectdevice. |
| 7. | DeviceDesign/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 withgamma radiation | 10-6 SAL – Terminally sterilized withgamma radiation | Same as predicate |
| 10. | Mechanism of Action | When directly applied to a source ofbleeding, the hemostatic gel rapidlyadheres to the wound site. Thehemostatic gel forms a mechanicalbarrier that stops the flow of bleedingand allows the body to create a naturalclot. | 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) | ||
|---|---|---|
| ------------------------------------------------------------------ | -- | -- |
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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 TestingSeal Strength TestingDye Penetration Testing | Burst Pressure TestingDye Penetration testing | Similar |
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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.
| Biologicalendpoint | Test Method | Purpose | Acceptancecriteria | Test Result |
|---|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | To verify Cytotoxicity potential ofthe subject device | Non-cytotoxic | Pass |
| IrritationandSensitization | ISO 10993-10 | To verify irritation andsensitization potential of thesubject device | Non-irritatingand non-sensitizing | Pass |
| Pyrogenicity | ISO 10993-11 | To verify the pyrogenicity of thedevice. | Non-pyrogenic | Pass |
| AcuteSystemicToxicity | ISO 10993-11: | Evaluation of the potential formedical device materials to causeadverse systemic reactions. | Non-toxic | Pass |
| Hemolysis | ASTM F756, ISO10993-4 | To verify the hemolytic property ofthe 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.
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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.
N/A