THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT

K050511 · Vascular Solutions, Inc. · QSX · Apr 14, 2005 · SU

Device Facts

• Record ID: K050511
• Device Name: THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
• Applicant: Vascular Solutions, Inc.
• Product Code: QSX · SU
• Decision Date: Apr 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

ThrombiGel is a topical hemostatic device consisting of a lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. It is applied directly over bleeding sources by clinicians. The device functions by creating a physical barrier to blood flow, supplemented by manual compression. Thrombin facilitates hemostasis by enzymatically converting fibrinogen to fibrin, enhancing the natural clotting cascade. The device is intended for use in clinical settings for trauma wounds and vascular access sites to achieve hemostasis and reduce bleeding time.

Clinical Evidence

Bench testing only. Assessment of physical properties of the lyophilized pad and its ability to achieve hemostasis confirmed suitability for intended use.

Technological Characteristics

Lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. Operates via physical barrier formation and enzymatic clotting cascade activation. Topical application with manual compression.

Indications for Use

Indicated for patients requiring temporary control of moderate to severe bleeding wounds or surface bleeding from vascular access sites and percutaneous catheters or tubes.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• D-Stat Dry Hemostatic Bandage (K030836)
• D-Stat Flowable Hemostat (K012293)

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] . 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 [phone] or [phone] 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:

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.

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.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Linda Busklein<br>Sr. Regulatory Affairs Associate<br>[phone] phone, [phone] fax |
| Performance Standards: | No performance standards have been developed under section 514 for<br>this device. |
| Device Description: | The ThrombiGel foam hemostat consists of a lyophilized gelatin foam<br>pad containing thrombin, sodium carboxymethylcellulose, and calcium<br>chloride.<br>The ThrombiGel foam hemostat works in the same manner as the D-<br>Stat Dry 3x3 hemostatic Pad and the D-Stat Flowable Hemostat. It is<br>applied directly over the source of bleeding, creating a physical barrier<br>to blood flow through the application of adjunctive manual<br>compression. The lyophilized components (thrombin, CMC, and<br>calcium chloride) establish an environment in which a natural blood<br>clot can build and form a physical barrier to bleeding. The thrombin<br>facilitates hemostasis by enhancing the surface-activated clotting<br>cascade through enzymatic cleavage and conversion of fibrinogen to<br>fibrin. |
| Intended Use: | The D-Stat Dry 3X3 is applied topically and is indicated as a trauma<br>dressing for temporary control of moderate to severely bleeding<br>wounds and for the control of surface bleeding from vascular access<br>sites and percutaneous catheters or tubes. |
| Summary of Non-Clinical<br>Testing: | Testing included assessment of the physical properties of the<br>lyophilized pad and its ability to achieve its intended use. The results<br>of the tests confirmed the suitability of the device for its intended use. |
| Predicate Devices: | D-Stat Dry Hemostatic Bandage (K030836)<br>D-Stat Flowable Hemostat (K012293) |
| Conclusions: | The ThrombiGel foam hemostat pad is substantially equivalent to the<br>currently marketed D-Stat Flowable hemostat and the D-Stat Dry<br>hemostatic bandage based on a comparison of the indications for use<br>and the technological characteristics of the device. |