(41 days)
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.
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.
This document is a 510(k) summary for the ThrombiGel™ thrombin/gelatin foam hemostat. It provides information about the device, its intended use, and a comparison to a predicate device, but it does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.
Therefore, I cannot provide the specific information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies directly from the provided text.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The document states: "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 doesn't provide specific acceptance criteria or quantitative performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "confirmed the suitability of the device for its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the document. The "Summary of Non-Clinical Testing" mentions "assessment of the physical properties of the lyophilized pad and its ability to achieve its intended use," but it does not specify sample sizes or data provenance. The testing appears to be non-clinical, likely bench testing.
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 present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the document.
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 present in the document. The device is a hemostat, not an AI-based diagnostic tool, so an MRMC study related to AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not present in the document. The device is a physical product (thrombin/gelatin foam hemostat), not an algorithm or software. Standalone performance as an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in the document. For a hemostat, "ground truth" would likely involve standardized bleeding models (in vitro or in vivo animal studies) where the cessation of bleeding is objectively measured. The document only vaguely refers to "assessment of the physical properties... and its ability to achieve its intended use."
8. The sample size for the training set:
This information is not present in the document. The device is a physical medical device, not a machine learning model, so the concept of a "training set" in the context of AI is not applicable.
9. How the ground truth for the training set was established:
This information is not present in the document, as the concept of a "training set" and "ground truth" for a training set is not applicable to this type of device.
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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
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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
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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
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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
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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 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 thrombin/gelatin foam hemostat consists of alyophilized gelatin foam pad containing thrombin, sodiumcarboxymethylcellulose, and calcium chloride.The ThrombiGel is applied directly over the source of bleeding,creating a physical barrier to blood flow through the application ofadjunctive manual compression. The lyophilized components(thrombin, CMC, and calcium chloride) establish an environment inwhich a natural blood clot can build and form a physical barrier tobleeding. The thrombin facilitates hemostasis by enhancing thesurface activated clotting cascade through enzymatic cleavage andconversion of fibrinogen to fibrin. |
| Intended Use: | The ThrombiGel 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: | ThrombiGel thrombin/gelatin foam hemostat (K050511) |
| Conclusions: | The ThrombiGel foam hemostat pad is substantially equivalent to thecurrently marketed ThrombiGel foam hemostat based on acomparison of the indications for use and the technologicalcharacteristics of the device. |
N/A