THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT by VASCULAR SOLUTIONS, INC.

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.

Device Description

The ThrombiGel foam hemostat consists of a lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. The ThrombiGel foam hemostat works in the same manner as the D-Stat Dry 3x3 hemostatic Pad and the D-Stat Flowable Hemostat. It 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the ThrombiGel™ thrombin/gelatin foam hemostat. However, it does not contain the specific details of acceptance criteria or a study that directly proves the device meets such criteria in the format requested.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the given documents. The 510(k) summary (page 4) states: "No performance standards have been developed under section 514 for this device." and "Testing included assessment of the physical properties of the lyophilized pad and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use." This is a high-level summary and does not contain specific acceptance criteria or quantitative performance reports.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions "Summary of Non-Clinical Testing" but does not detail sample sizes, study design (retrospective/prospective), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The device is a topical hemostat, and the testing described is non-clinical. The concept of "experts establishing ground truth for a test set" usually applies to diagnostic devices or AI algorithms that rely on human interpretation, which is not the case here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. As mentioned above, the testing is non-clinical and thus adjudication methods as typically understood for clinical or diagnostic studies are not applicable.

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

This information is not applicable/not provided. The ThrombiGel device is a physical hemostat, not an AI-assisted diagnostic tool. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. This device is a physical medical device, not an algorithm, so "standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated beyond "results of the tests confirmed the suitability of the device for its intended use." Given the nature of a hemostat, the "ground truth" would likely involve objective measurements of hemostasis (e.g., time to hemostasis, blood loss, re-bleeding rates in an animal model or in vitro setting), but these specifics are missing.

8. The sample size for the training set

This is not applicable/not provided. The ThrombiGel device is a physical hemostat and does not involve a "training set" in the context of an AI/ML algorithm.

9. How the ground truth for the training set was established

This is not applicable/not provided. As above, the concept of a training set and its ground truth is not relevant to this type of device submission.

Summary of what the document does provide:

Device Name: ThrombiGel™ thrombin/gelatin foam hemostat
Intended Use/Indications for Use: Applied topically 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.
Device Description: A lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. It works by creating a physical barrier with manual compression and facilitating a natural blood clot through thrombin's action.
Predicate Devices: D-Stat Dry Hemostatic Bandage (K030836) and D-Stat Flowable Hemostat (K012293).
Conclusion for Substantial Equivalence: The ThrombiGel foam hemostat pad is substantially equivalent to the predicate devices based on a comparison of indications for use and technological characteristics.
Testing: "Testing included assessment of the physical properties of the lyophilized pad and its ability to achieve its intended use. The results of the tests confirmed the suitability of the device for its intended use." (However, no details of these tests are provided).

In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than providing detailed acceptance criteria and a study report with quantitative performance data typically seen for novel device approvals or AI-enabled technologies.

Summary

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February 10, 2023

Vascular Solutions, Inc. Linda Busklein Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K050511

Trade/Device Name: ThrombiGel™ thrombin/gelatin foam hemostat Regulatory Class: Unclassified Product Code: QSX

Dear Linda Busklein:

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 April 14, 2005. 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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2005

Ms. Linda Busklein Senior Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K050511

Trade/Device Name: ThrombiGel™ thrombin/gelatin foam hemostat Regulatory Class: Unclassified Product Code: FRO Dated: February 28, 2005 Received: March 1, 2005

Dear Ms. Busklein:

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 docs 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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Linda Busklein

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 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) 276-0120 . 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting 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

K050511

510(k) Number:

K050511

Device Name:

ThrombiGel™ thrombin/gelatin foam hemostat

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carlin Archer

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APR 1 4 2005

510(K) SUMMARY

Common/Usual Name:	Topical Hemostat
Product Trade Name:	ThrombiGel thrombin/gelatin foam hemostat
Classification Name:	Unclassified, product code FRO
Manufacturer:	Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369
Establishment Registration:	2134812
Contact:	Linda BuskleinSr. Regulatory Affairs Associate(763) 656-4217 phone, (763) 656-4250 fax
Performance Standards:	No performance standards have been developed under section 514 forthis device.
Device Description:	The ThrombiGel foam hemostat consists of a lyophilized gelatin foampad containing thrombin, sodium carboxymethylcellulose, and calciumchloride.The ThrombiGel foam hemostat works in the same manner as the D-Stat Dry 3x3 hemostatic Pad and the D-Stat Flowable Hemostat. It isapplied directly over the source of bleeding, creating a physical barrierto blood flow through the application of adjunctive manualcompression. The lyophilized components (thrombin, CMC, andcalcium chloride) establish an environment in which a natural bloodclot can build and form a physical barrier to bleeding. The thrombinfacilitates hemostasis by enhancing the surface-activated clottingcascade through enzymatic cleavage and conversion of fibrinogen tofibrin.
Intended Use:	The D-Stat Dry 3X3 is applied topically and is indicated as a traumadressing for temporary control of moderate to severely bleedingwounds and for the control of surface bleeding from vascular accesssites and percutaneous catheters or tubes.
Summary of Non-ClinicalTesting:	Testing included assessment of the physical properties of thelyophilized pad and its ability to achieve its intended use. The resultsof the tests confirmed the suitability of the device for its intended use.
Predicate Devices:	D-Stat Dry Hemostatic Bandage (K030836)D-Stat Flowable Hemostat (K012293)
Conclusions:	The ThrombiGel foam hemostat pad is substantially equivalent to thecurrently marketed D-Stat Flowable hemostat and the D-Stat Dryhemostatic bandage based on a comparison of the indications for useand the technological characteristics of the device.

Regulation Number and Section

N/A