(44 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the hemostatic foam and its ability to promote blood clotting, with no mention of AI or ML technologies.
Yes
The device is described as a hemostat used for temporary control of bleeding wounds and surface bleeding, which directly addresses a health condition.
No
The device is a hemostat, designed to control bleeding, not to diagnose a condition. It facilitates clot formation rather than providing diagnostic information.
No
The device description clearly states it is a "lyophilized gelatin foam pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride," which are physical components, not software.
Based on the provided information, the ThrombiGel thrombin/gelatin foam hemostat is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is applied topically to control bleeding from wounds and vascular access sites. This is a direct application to the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical foam pad with components that facilitate blood clotting at the site of application. It describes a physical barrier and enzymatic action on blood in situ, not a diagnostic test on a blood sample.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. The ThrombiGel device does not perform any such examination or provide diagnostic information.
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 percutaneous catheters or tubes.
Product codes (comma separated list FDA assigned to the subject device)
QSX, FRO
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, and a pair of wings at the top.
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.
2
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
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 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
Page 1 of __
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Kogosll Page 1/1
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 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 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. | |
| Intended Use: | The D-Stat Dry 3X3 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: | D-Stat Dry Hemostatic Bandage (K030836) |
| D-Stat Flowable Hemostat (K012293) | |
| Conclusions: | The ThrombiGel foam hemostat pad is substantially equivalent to the |
| currently marketed D-Stat Flowable hemostat and the D-Stat Dry | |
| hemostatic bandage based on a comparison of the indications for use | |
| and the technological characteristics of the device. |