(152 days)
TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.
TRAUMAGEL® is a single-use, hemostatic gel indicated for temporary external use only. The subject device is supplied as an individually pouched 30 mL hemostatic gel syringe, containing chitosan [poly (N-acetyl-D-glucosamine, D-glucosamine)] granules suspended in a sodium alginate hydrogel and is enclosed in a protective pouch. Each syringe is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic gel is viscous, opaque and tan in color.
The provided document is a 510(k) summary for the TRAUMAGEL® Hemostatic Gel. It primarily focuses on demonstrating substantial equivalence to a predicate device (CELOX Gauze Pro) based on design, technological characteristics, and non-clinical testing.
The document does not include the information requested regarding a study that proves the device meets specific acceptance criteria related to a human-in-the-loop or standalone AI/software performance. This is because TRAUMAGEL® is a medical device (hemostatic gel), not an AI or software-based medical device. Therefore, the questions about sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, AI assistance, training data, etc., are not applicable to this product and its regulatory submission.
The "Acceptance Criteria" described in the document relate to biocompatibility testing and performance bench testing for a physical medical device, not a software algorithm.
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance (for biocompatibility testing):
| Biological endpoint | Acceptance criteria | Test Result |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | Pass |
| Sensitization | Non-sensitizing | Pass |
| Irritation | Non-irritating | Pass |
| Material Mediated Pyrogenicity | Non-pyrogenic | Pass |
| Acute Systemic Toxicity | Non-toxic | Pass |
(Note: "Physical and/or Chemical Information" acceptance criteria is listed as N/A, as it's for information gathering, not a Pass/Fail test.)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for each non-clinical test, but implied to be sufficient for the required ISO standards.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory and animal studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a diagnostic AI/software device requiring human expert annotation of images/data for ground truth. The "ground truth" for the non-clinical tests is established by the standardized test methods (e.g., ISO standards for biocompatibility) and direct measurement of physical or biological responses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for non-clinical device testing.
5. 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; this device is a physical hemostatic product, not an AI/software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is not a software algorithm.
7. The type of ground truth used:
- For biocompatibility: Adherence to ISO standards and observed biological responses.
- For performance bench testing: Physical and chemical properties measured against predefined specifications.
- For non-clinical animal studies: Direct observation of hemostatic performance in a porcine model. The document states: "testing demonstrated substantially equivalent performance between the device and the predicate."
8. The sample size for the training set:
- Not applicable; there is no AI/machine learning training set for this product.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image shows 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" followed by the words "U.S. Food & Drug Administration".
August 14, 2024
Cresilon, Inc. Hassaan Ahmad Vice President - Quality & Regulatory Affairs 86 34th Street Suite D603/D604 Brooklyn, New York 11232
Re: K240713
Trade/Device Name: TRAUMAGEL® Hemostatic Gel Regulatory Class: Unclassified Product Code: QSY Dated: July 11, 2024 Received: July 11, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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) K240713
Device Name TRAUMAGEL®
Indications for Use (Describe)
TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Submitter Information
| Sponsor and Application | Hassaan W. Ahmad |
|---|---|
| Correspondent (US Agent): | Vice President – Quality & Regulatory Affairs |
| 86 34th Street, Suite D603/D604, | |
| Brooklyn, NY 11232 | |
| Phone | +1 347 269 1407 |
| E-mail: | hassaan@cresilon.com |
| Legal Manufacturer: | Cresilon, Inc. |
|---|---|
| Phone: | +1 347 269 1407 |
| Contact Person: | Hassaan W. Ahmad |
| E-mail: | hassaan@cresilon.com |
| Date Prepared: | 14-Aug-2024 |
Device Identification:
| Device Trade Name: |
|---|
| Common Name: |
| Device Class: |
| Review Panel: |
| Product Code: |
| Regulation Number |
TRAUMAGEL®
Hemostatic wound dressing without thrombin or other biologics Unclassified General & Plastic Surgery QSY Not Applicable
Predicate Device:
CELOX Gauze Pro (K113560)
Device Description
TRAUMAGEL® is a single-use, hemostatic gel indicated for temporary external use only. The subject device is supplied as an individually pouched 30 mL hemostatic gel syringe, containing chitosan [poly (N-acetyl-D-glucosamine, D-glucosamine)] granules suspended in a sodium alginate hydrogel and is enclosed in a protective pouch. Each syringe is terminally sterilized with gamma
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irradiation to a sterility assurance level (SAL) of 10th. The hemostatic gel is viscous, opaque and tan in color.
Indications for Use
TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.
Substantial Equivalence
The subject device TRAUMAGEL® is substantially equivalent to the predicate device CELOX Gauze PRO cleared under the 510(k) number, K113560. By evaluating the various technological characteristics along with its performance data, it is clear that the subject device is substantially equivalent to the predicate in terms of its design and technological characteristics. The subject device does not give rise to any new safety or performance questions when compared with its predicate CELOX Gauze PRO.
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| Parameters | Subject device | Substantial Equivalence (Technological Characteristics)Predicate Device | Comments |
|---|---|---|---|
| Name | TRAUMAGEL® | Celox Gauze Pro | N/A |
| 510(k) Number | K240713 | K113560 | N/A |
| Manufacturer | Cresilon Inc. | MedTrade Products, Ltd. | N/A |
| Product Code | QSY | QSY | Same |
| Device Class | Unclassified | Unclassified | Same |
| Intended/Indications foruse | TRAUMAGEL® is ahemostatic gelindicated for temporaryexternal use forcontrolling moderate tosevere bleeding. | Under the supervision of ahealthcare professionalCELOX Gauze PRO/CELOX PRO HemostaticGauze/ OMNI-STAT Gauze/OMNISTAT HemostaticGauze for moderate tosevere external bleedingwounds (Rx) is indicated fortemporary external treatmentfor controlling moderate tosevere bleeding. | Indication for use of TRAUMAGEL® arethe same as that of primary predicate. |
| Rx/OTC | Rx | Rx | Same |
| Single Use | Yes | Yes | Same |
| Device Design | The hemostatic gelconsists of chitosangranules suspended in asodium alginate gel andis delivered via asyringe applicator | The device consists ofchitosan hemostatic granules(CELOX PRO 510(k) #K093593) adhered onto abase fabric (non-wovengauze) using a hot meltadhesive. | Similar with CELOX Gauze PRO.TRAUMAGEL® is comprised ofchitosan granules suspended within asodium alginate gel, whereas Celoxadheres chitosan granules to a non-woven gauze. |
| Packaged Size | 30 mL of hemostaticgel in Syringe. | The CELOX Gauze PRO isavailable in various sizesranging from 1" x 1" to 3" x10ft. | N/A |
| Sterilization | Terminally sterilizedwith gamma irradiationSAL of 10-6. | Terminally sterilized withgamma irradiation SAL of10-6. | Same |
| Mechanism ofAction | When directly appliedto a source of bleeding,the TRAUMAGEL®hemostatic gel rapidlyadheres to the woundsite. The hemostatic gelforms a mechanicalbarrier that stops theflow of bleeding andallows the body tocreate a natural clot. | CELOX Gauze PROachieves the principleintended action ofhemostasis by providing aphysical barrier to stopbleeding. By applying theCELOX Gauze PRO directlyonto a wound and togetherwith firm pressure the gel-like plug on dressing'ssurface creates aphysical barrier whichcontrols blood flow throughthe dressing to stop bleedingand reduce the risk of re-bleeding | Same |
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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 10993-1:2018 under the section "Surface devices used on breached or compromised surface with limited contact duration (≤24 hours)". 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 | TestResult |
|---|---|---|---|---|
| Physical and/orChemicalInformation | ISO 10993-1:Evaluation andTesting within aRisk ManagementProcess | To know regarding formulation,manufacturing processes,geometric and physical propertiesand type of body contact and clinicaluse that is used to determine whetherany additional biological or materialcharacterization testing is needed | N/A | N/A |
| Cytotoxicity | ISO 10993-5: Testsfor in vitroCytotoxicity | To verify cytotoxicity potential of thesubject device | Non-cytotoxic | Pass |
| Sensitization | ISO 10993-10:Tests for SkinSensitization | To verify sensitization potential of thesubject device | Non-sensitizing | Pass |
| Irritation | ISO 10993-23:Tests for Irritation. | To verify irritation potential of thesubject device | Non-irritating | Pass |
| MaterialMediatedPyrogenicity | ISO 10993-11:Tests for SystemicToxicity | To verify the pyrogenicity potential ofthe device. | Non-pyrogenic | Pass |
| Acute SystemicToxicity | ISO 10993-11:Tests for SystemicToxicity | Evaluation of the potential formedical device materials to causeadverse systemic reactions. | Non-toxic | 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 pH, rheology, safety and performance testing and other tests as applicable to the subject device.
c) Non-Clinical Animal Studies
In vivo animal performance testing was conducted in a porcine femoral arteriotomy model to evaluate both the predicate device and TRAUMAGEL®. The porcine model was used due to the vast similarities between pigs and humans when it comes traumatic injuries. Both the predicate and subject devices operate by the same mechanism of action. This
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testing demonstrated substantially equivalent performance between the device and the predicate.
6.1 Sterilization and Shelf Life:
TRAUMAGEL® is terminally sterilized using gamma irradiation to a Sterility Assurance Level (SAL) of 10-6.
The proposed shelf-life of the product is 12 months in the current submission.
6.2 Conclusion:
The intended use and the indications for use of the subject device, TRAUMAGEL®, are the same as that of the primary predicate. The technological characteristics of the subject device are the same as that of the predicate device CELOX Gauze PRO. Through the evaluation of the technological characteristics along with its performance and nonclinical test data, also using an additional predicate, Cresilon concludes that the subject device does not give rise to any new safety or performance concerns when compared to its primary predicate CELOX Gauze PRO.
The conclusions drawn above demonstrate that the proposed device is as safe, effective and performs as well as the legally marketed predicate device.
N/A