(586 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical mechanism of action of a hemostatic gel, with no mention of AI or ML technologies.
Yes
The device is a hemostatic gel for external use indicated for the local management of bleeding wounds, which describes a therapeutic function.
No
This device is a hemostatic gel intended for the local management of bleeding wounds, which is a therapeutic function, not a diagnostic one. It is used to stop bleeding, not to identify or monitor a medical condition.
No
The device is a physical gel supplied in syringes, not a software program.
Based on the provided information, Cresilon Hemostatic Gel™ (CHG™) is not an In Vitro Diagnostic (IVD) device.
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 is a therapeutic application, not a diagnostic one.
- Mechanism of Action: The device is a hemostatic gel applied topically to stop bleeding. This is a physical or chemical interaction with the wound itself, not an analysis of a sample taken from the body.
- Device Description: The description details the composition and application method, which are consistent with a topical hemostatic agent.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Cresilon Hemostatic Gel™ does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Injured or breached skin
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)
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: Cytotoxicity; Test Method: ISO 10993-5; Purpose: To verify Cytotoxicity potential of the subject device; Acceptance criteria: Non-cytotoxic; Test Result: Pass
Biological endpoint: Irritation and Sensitization; Test Method: ISO 10993-10; Purpose: To verify irritation and sensitization potential of the subject device; Acceptance criteria: Non-irritating and non-sensitizing; Test Result: Pass
Biological endpoint: Pyrogenicity; Test Method: ISO 10993-11; Purpose: To verify the pyrogenicity of the device.; Acceptance criteria: Non-pyrogenic; Test Result: Pass
Biological endpoint: Acute Systemic Toxicity; Test Method: ISO 10993-11:; Purpose: Evaluation of the potential for medical device materials to cause adverse systemic reactions.; Acceptance criteria: Non-toxic; Test Result: Pass
Biological endpoint: Hemolysis; Test Method: ASTM F756, ISO 10993-4; Purpose: To verify the hemolytic property of the device.; Acceptance criteria: Non-hemolytic; Test Result: Pass
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.
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.
Not Found
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 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) |
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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.