(47 days)
The ThrombiGe1® thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds.and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
The ThrombiGel® thrombin/gelatin foam hemostat consists of a lyophilized absorbable gelatin sponge, USP containing thrombin, sodium carboxymethylcellulose (CMC), and calcium chloride.
The ThrombiGel® thrombin/gelatin foam hemostat is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding.
The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
The ThrombiGel® thrombin/gelatin foam hemostat is wetted before use with sterile water for injection or saline (not provided.) There are three versions of the pad which differ in their dimensions. The ThrombiGel® 10 thrombin/gelatin foam hemostat is approximately 10 cm³, the ThrombiGel® 40 thrombin/gelatin foam hemostat is approximately 40 cm² and the ThrombiGel® 100 thrombin/gelatin foam hemostat is approximately 100 cm . A desiccant is added to the package to maintain the moisture content.
This document is a 510(k) premarket notification for the ThrombiGel® thrombin/gelatin foam hemostat. The information provided outlines non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance metrics or presenting a study that proves it meets those criteria.
Therefore, the requested information elements cannot be fully populated as they pertain to clinical performance studies and specific acceptance thresholds, which are not detailed in this submission for this type of device and regulatory pathway.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance in the manner requested (e.g., sensitivity, specificity for diagnostic devices, or specific clinical endpoints for therapeutic devices). It lists physical and biocompatibility tests whose results confirmed the suitability of the device for its intended use, but not explicit numerical targets.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Properties | |
| Moisture Content Testing | Confirmed suitability for intended use |
| Thrombin Activity Testing | Confirmed suitability for intended use |
| Thrombin Activity Testing post 4 hours pot-life | Confirmed suitability for intended use |
| Wetting Time | Confirmed suitability for intended use |
| pH | Confirmed suitability for intended use |
| Biocompatibility | |
| MEM Elution | Biocompatible |
| Intracutaneous Injection Test | Biocompatible |
| Systemic Injection Test | Biocompatible |
| Rabbit Pyrogen Test | Biocompatible |
| Kligman Skin Sensitization | Biocompatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for non-clinical tests.
- Data Provenance: The tests are described as "Bench testing" and "biocompatibility assessment," implying laboratory-based testing, not human-related data. No country of origin for the data is mentioned, but the submitter is Minneapolis, Minnesota, USA. The tests are non-clinical and would be considered prospective for the purposes of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for diagnostic/clinical studies (e.g., expert reads, pathology) is not relevant for the non-clinical physical and biocompatibility testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are for reconciling differing expert opinions in clinical studies, which were not performed here.
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 is a medical device (hemostat), not an AI/diagnostic software. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by the standardized protocols and acceptance criteria of the respective physical and biocompatibility tests themselves (e.g., ISO standards, pharmacopeial methods).
8. The sample size for the training set
Not applicable. This submission describes non-clinical testing for a medical device's substantial equivalence, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. No training set for a machine learning model was involved.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
February 10, 2023
Vascular Solutions, Inc. c/o James Chapman Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K063860
Trade/Device Name: ThrombiGel® Thrombin/Gelatin Foam Hemostat Regulatory Class: Unclassified Product Code: QSX
Dear James Chapman:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 13, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSX.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, official design.
od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. % Mr. James Chapman Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
FEB 1 3 2007
Re: K063860
Trade/Device Name: ThrombiGel® thrombin/gelatin foam hemostat Regulatory Class: Unclassified Product Code: FRO Dated: December 26, 2006 Received: December 28, 2006
Dear Mr. Chapman:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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Page 2 - Mr. James Chapman
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Molkerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
Device Name:
ThrombiGel® thrombin/gelatin foam hemostat
Indications for Use:
The ThrombiGe1® thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds.and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
| Prescription Use | X | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | 1063860 |
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510(k) Summary (As required by 21 CFR 807.92(c))
FEB 1 3 2007
Kol 2860 510(k) Number: Page 1 of 3
Date Prepared: December 26, 2006
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore CourtMinneapolis, MN 55369 |
Establishment Registration 2134812
| Contact Person: | James Chapman |
|---|---|
| Regulatory Affairs Associate | |
| Phone: | (763) 656-4380 |
| Fax: | (763) 656-4253 |
Device Information
| Trade Name: | ThrombiGel® thrombin/gelatin foam hemostat |
|---|---|
| Common Name: | Topical hemostat |
| Classification Name: | Unclassified |
| Product Code: | FRO |
| Regulation: | Not Applicable |
Predicate Device(s)
The predicate device is the currently marketed Thrombin/gelatin foam hemostat (K053644, K050511).
Device Description
The ThrombiGel® thrombin/gelatin foam hemostat consists of a lyophilized absorbable gelatin sponge, USP containing thrombin, sodium carboxymethylcellulose (CMC), and calcium chloride.
The ThrombiGel® thrombin/gelatin foam hemostat is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding.
Vascular Solutions, Inc. ThrombiGel® thrombin/gelatin foam hemostat 510(k) Pre-market Notification December 26, 2006
Section 5-2
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ThrombiGel® thrombin/gelatin foam hemostat 510(k) Summary Page 2 of 3
The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. Vascular Solutions, Inc.
The ThrombiGel® thrombin/gelatin foam hemostat is wetted before use with sterile water for injection or saline (not provided.) There are three versions of the pad which differ in their dimensions. The ThrombiGel® 10 thrombin/gelatin foam hemostat is approximately 10 cm³, the ThrombiGel® 40 thrombin/gelatin foam hemostat is approximately 40 cm² and the ThrombiGel® 100 thrombin/gelatin foam hemostat is approximately 100 cm . A desiccant is added to the package to maintain the moisture content.
Intended Use/Indications for Use
The ThrombiGel® thrombin/gelatin foam hemostat is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Summary of Non-Clinical Testing
Testing included assessment of the physical properties of the ThrombiGel® thrombin/gelatin foam hemostat utilizing the Vascular Solutions Inc. manufactured absorbable gelatin sponge, USP and its ability to achieve its intended use. Bench testing of the physical properties of the ThrombiGel® thrombin/gelatin foam hemostat confirmed the suitability of the device for its intended use. The following physical tests were performed;
Moisture Content Testing Thrombin Activity Testing Thrombin Activity Testing post 4 hours pot-life Wetting Time pH
A biocompatibility assessment was also performed. The purpose of the biocompatibility testing was to demonstrate that samples of Thrombin/gelatin foam hemostat utilizing Vascular Solutions, Inc. manufactured absorbable gelatin sponge, USP and Vascular Solutions, Inc. absorbable gelatin sponge, USP alone were biocompatible on the basis of the following testing:
MEM Elution Intracutaneous Injection Test Systemic Injection Test Rabbit Pyrogen Test Kligman Skin Sensitization
Vascular Solutions, Inc. ThrombiGel® thrombin/gelatin foam hemostat 510(k) Pre-market Notification December 26, 2006
Section 5-3
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Vascular Solutions, Inc. ThrombiGel® thrombin/gelatin foam hemostat 510(k) Summary Page 3 of 3
The results of the tests confirmed the suitability of the device for its intended use.
Summary of Clinical Testing
No human clinical testing was required for this device.
Statement of Equivalence
The ThrombiGel® thrombin/gelatin foam hemostat is substantially equivalent to the currently marketed ThrombiGe1® thrombin/gelatin foam hemostat based on a comparison of the indications for use and the technological characteristics of the device.
Conclusion
The ThrombiGel® thrombin/gelatin foam hemostat utilizing an absorbable gelatin sponge, USP manufactured by Vascular Solutions, Inc. is substantially equivalent to the currently marketed ThrombiGel® thrombin/gelatin foam hemostat based on the technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.
N/A