(47 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a gelatin sponge with thrombin, not on any computational or learning algorithms.
Yes.
The device is indicated for temporary control of bleeding, which is a medical treatment.
No
This device is a hemostat, designed to control bleeding by forming a physical barrier and aiding in blood clot formation; it does not diagnose medical conditions.
No
The device description clearly outlines a physical product composed of a lyophilized absorbable gelatin sponge containing various chemical components. It is applied topically and functions as a physical barrier and through chemical reactions, indicating it is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for topical application to control bleeding from wounds and vascular access sites. This is a direct therapeutic application to the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a physical hemostat that works by creating a barrier and facilitating clot formation in situ on the bleeding site. It does not describe a test kit, reagent, or instrument used to analyze a biological sample.
- Performance Studies: The performance studies focus on physical properties and biocompatibility, which are relevant for a topically applied medical device, not for an IVD which would typically involve analytical performance characteristics like sensitivity, specificity, etc.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
QSX, FRO
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.
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.
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
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)
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. 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.
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 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
1
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
2
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
3
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 |
4
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 Court |
| Minneapolis, 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
5
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
6
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.