(41 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the hemostat and its ability to promote blood clotting, with no mention of AI or ML technologies.
No
The device is described as a hemostat for controlling bleeding, which is a treatment for an acute condition rather than a long-term therapeutic intervention.
No
The ThrombiGel is described as a hemostat used for temporary control of bleeding wounds by creating a physical barrier and facilitating clot formation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a lyophilized gelatin foam pad containing various chemical components, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is applied topically to control bleeding from wounds and access sites. This is a direct application to the body for a therapeutic purpose (hemostasis).
- Device Description: The description details a physical hemostat that works by creating a barrier and facilitating the natural clotting process at the site of bleeding. It does not involve analyzing samples of blood, tissue, or other bodily fluids in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays to detect specific substances in a sample.
Therefore, the ThrombiGel thrombin/gelatin foam hemostat is a topical hemostatic device, not an In Vitro Diagnostic device.
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 percularedus and 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 gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride.
The ThrombiGel 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.
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)
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.
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). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is commonly used to indicate that a product or establishment is regulated by the FDA.
February 10, 2023
Vascular Solutions, Inc. Linda Busklein Senior Associate, Regulatory Affairs 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K053644
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 February 9, 2006. 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
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized caduceus symbol, which features a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 9 2006
Ms. Linda Busklein Senior Associate, Regulatory Affairs Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K053644
Trade/Device Name: ThrombiGel™ thrombin/gelatin foam hemostat Regulatory Class: Unclassified Product Code: FRO Dated: December 28, 2005 Received: December 30, 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 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 sct forth in the quality systems (QS) 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 - Ms. Busklein
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" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrn
Mark N. Melkerson Acting 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 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 percularedus and or tubes.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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).
Sadare Buchur
Division Six. 22
Divi and Neu
Page 1 of
510(k) Number K053644
4
2006 FEB 9
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 Court | |
| Minneapolis, Minnesota 55369 | |
| Establishment Registration: | 2134812 |
| Contact: | Linda Busklein |
| Sr. Regulatory Affairs Associate | |
| (763) 656-4217 phone, (763) 656-4250 fax | |
| Performance Standards: | No performance standards have been developed under section 514 for |
| this device. | |
| Device Description: | The ThrombiGel thrombin/gelatin foam hemostat consists of a |
| lyophilized gelatin foam pad containing thrombin, sodium | |
| carboxymethylcellulose, and calcium chloride. | |
| The ThrombiGel 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. | |
| Intended Use: | The ThrombiGel 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 |
| 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. | |
| Predicate Devices: | ThrombiGel thrombin/gelatin foam hemostat (K050511) |
| Conclusions: | The ThrombiGel foam hemostat pad is substantially equivalent to the |
| currently marketed ThrombiGel foam hemostat based on a | |
| comparison of the indications for use and the technological | |
| characteristics of the device. |