(152 days)
No
The summary describes a hemostatic gel with a chemical composition and physical properties. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are based on biocompatibility, bench testing, and animal studies, not algorithmic performance.
No
The device is a hemostatic gel intended for controlling bleeding, which is a treatment for an acute condition, not a long-term therapeutic effect.
No
The device is a hemostatic gel used to control bleeding, not to diagnose a condition or disease. Its purpose is therapeutic (hemostatic), not diagnostic.
No
The device is a physical hemostatic gel supplied in a syringe, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary external use for controlling moderate to severe bleeding." This describes a therapeutic or interventional use, not a diagnostic one.
- Device Description: The description details a hemostatic gel applied externally to control bleeding. This is a physical intervention, not a test performed on a sample from the body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. TRAUMAGEL® is applied to the body to stop bleeding, which is a treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.
Product codes (comma separated list FDA assigned to the subject device)
QSY
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 irradiation to a sterility assurance level (SAL) of 10th. The hemostatic gel is viscous, opaque and tan in color.
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
Under the supervision of a healthcare professional
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)
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 testing demonstrated substantially equivalent performance between the device and the predicate.
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 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"
1
(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.
2
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
3
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)
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."
4
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
5
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.
6
| 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 for
use | TRAUMAGEL® is a
hemostatic gel
indicated for temporary
external use for
controlling moderate to
severe bleeding. | Under the supervision of a
healthcare professional
CELOX Gauze PRO/
CELOX PRO Hemostatic
Gauze/ OMNI-STAT Gauze/
OMNISTAT Hemostatic
Gauze for moderate to
severe external bleeding
wounds (Rx) is indicated for
temporary external treatment
for controlling moderate to
severe bleeding. | Indication for use of TRAUMAGEL® are
the same as that of primary predicate. |
| Rx/OTC | Rx | Rx | Same |
| Single Use | Yes | Yes | Same |
| Device Design | The hemostatic gel
consists of chitosan
granules suspended in a
sodium alginate gel and
is delivered via a
syringe applicator | The device consists of
chitosan hemostatic granules
(CELOX PRO 510(k) #
K093593) adhered onto a
base fabric (non-woven
gauze) using a hot melt
adhesive. | Similar with CELOX Gauze PRO.
TRAUMAGEL® is comprised of
chitosan granules suspended within a
sodium alginate gel, whereas Celox
adheres chitosan granules to a non-
woven gauze. |
| Packaged Size | 30 mL of hemostatic
gel in Syringe. | The CELOX Gauze PRO is
available in various sizes
ranging from 1" x 1" to 3" x
10ft. | N/A |
| Sterilization | Terminally sterilized
with gamma irradiation
SAL of 10-6. | Terminally sterilized with
gamma irradiation SAL of
10-6. | Same |
| Mechanism of
Action | When directly applied
to a source of bleeding,
the TRAUMAGEL®
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. | CELOX Gauze PRO
achieves the principle
intended action of
hemostasis by providing a
physical barrier to stop
bleeding. By applying the
CELOX Gauze PRO directly
onto a wound and together
with firm pressure the gel-
like plug on dressing's
surface creates a
physical barrier which
controls blood flow through
the dressing to stop bleeding
and reduce the risk of re-
bleeding | Same |
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 10993-1:2018 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.
| Biological
endpoint | Test Method | Purpose | Acceptance
criteria | Test
Result |
|--------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------|
| Physical and/or
Chemical
Information | ISO 10993-1:
Evaluation and
Testing within a
Risk Management
Process | To know regarding formulation,
manufacturing processes,
geometric and physical properties
and type of body contact and clinical
use that is used to determine whether
any additional biological or material
characterization testing is needed | N/A | N/A |
| Cytotoxicity | ISO 10993-5: Tests
for in vitro
Cytotoxicity | To verify cytotoxicity potential of the
subject device | Non-
cytotoxic | Pass |
| Sensitization | ISO 10993-10:
Tests for Skin
Sensitization | To verify sensitization potential of the
subject device | Non-
sensitizing | Pass |
| Irritation | ISO 10993-23:
Tests for Irritation. | To verify irritation potential of the
subject device | Non-
irritating | Pass |
| Material
Mediated
Pyrogenicity | ISO 10993-11:
Tests for Systemic
Toxicity | To verify the pyrogenicity potential of
the device. | Non-
pyrogenic | Pass |
| Acute Systemic
Toxicity | ISO 10993-11:
Tests for Systemic
Toxicity | Evaluation of the potential for
medical device materials to cause
adverse 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
8
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.