(65 days)
Not Found
No
The device description focuses on the chemical and physical properties of the patch and its interaction with the blood clotting cascade. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used to control surface bleeding by aiding in hemostasis, which is treating a physiological condition.
No
The device description clearly states its purpose is to control surface bleeding by aiding hemostasis, not to diagnose a medical condition.
No
The device description clearly states it is a "lyophilized patch containing bovine derived thrombin," which is a physical, biological component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Thrombix™ Patch Function: The Thrombix™ Patch is applied topically to control surface bleeding. It works by creating a physical barrier and facilitating the natural clotting process at the site of bleeding. It does not analyze a sample taken from the body to provide diagnostic information.
- Intended Use: The intended use clearly states it's an "adjunct to manual compression" for "control of surface bleeding." This is a therapeutic/hemostatic function, not a diagnostic one.
- Device Description: The description details the components and how they work to promote clotting on the surface. There is no mention of analyzing a biological sample.
Therefore, the Thrombix™ Patch is a topical hemostatic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Thrombix™ Patch is applied topically and is indicated as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Product codes
QSX, FRO
Device Description
The Thrombix " Patch thrombin hemostasis patch consists of a lyophilized patch containing bovine derived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride.
The Thrombix" Patch 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
vascular access sites and percutaneous catheters or tubes
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
Non-Clinical Testing included assessment of the physical properties of the Thrombix™ Patch and its ability to achieve its intended use. Bench testing of the physical properties of the Thrombix™ Patch confirmed the suitability of the device for its intended use. The following physical tests were performed:
- Moisture Content Testing
- Thrombin Activity Testing post 4 hours pot-life
- Wetting Time .
- pH .
A biocompatibility assessment of the device was also performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the following testing:
- MEM Elution
- Intracutaneous Injection Test
- Systemic Injection Test
- Kligman Skin Sensitization .
The results of the tests confirmed the suitability of the device for its intended use.
No human clinical testing was required for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left, there is the Department of Health & Human Services 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. c/o James Chapman Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K072117
Trade/Device Name: Thrombix™ Patch, Thrombin Hemostasis Patch Regulatory Class: Unclassified Product Code: QSX
Dear James Chapman:
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 October 5, 2007. 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. % Mr. James Chapman Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
OCT 5 - 2007
Re: K072117
Trade/Device Name: Thrombix" Patch, Thrombin Hemostasis Patch Regulatory Class: Unclassified Product Code: FRO Dated: July 30, 2007 Received: August 01, 2007
Dear Mr. Chapman:
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 set 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 - Mr. James Chapman
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" (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson 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: | K072.117 |
|---|---|
| ---------------- | ---------- |
Device Name:
Thrombix™ Patch thrombin hemostasis patch
Indications for Use:
The Thrombix™ Patch is applied topically and is indicated as an adjunct to manual compression and is indicated 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office off
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072117
4
OCT 5 * 2007 510(k) Summary (As required by 21 CFR 807.92(c))
510(k) Number: K072(17 Page 1 of 3
Date Prepared: July 30, 2007
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore Court |
| Minneapolis, MN 55369 |
Establishment Registration: 2134812
| Contact Person: | James Chapman |
|---|---|
| Regulatory Affairs Associate | |
| Phone: (763) 656-4380 | |
| Fax: (763) 656-4253 |
Device Information
| Trade Name: | Thrombix™ Patch, Thrombin Hemostasis Patch |
|---|---|
| Common Name: | Topical hemostat |
| Classification Name: | Unclassified |
| Product Code: | FRO |
| Regulation: | Not Applicable |
Predicate Device(s)
The predicate devices are the currently marketed D-Stat® Dry Topical Hemostat (K030836) and D-Stat® Dry 3x3 (K040510).
Device Description
The Thrombix " Patch thrombin hemostasis patch consists of a lyophilized patch containing bovine derived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride.
The Thrombix" Patch 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.
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Image /page/5/Picture/0 description: The image contains handwritten text that appears to be a combination of letters and numbers. The text reads 'K072117'. The characters are written in a casual, slightly slanted style, and the overall impression is that of a handwritten code or identifier.
Vascular Solutions, Inc. Thrombix™ Patch Thrombin Hemostasis Patch 510(k) Summary Page 2 of 3
The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
Intended Use/Indications for Use
The Thrombix" Patch is applied topically and is indicated as an adjunct to manual compression for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Summary of Non-Clinical Testing
The Non-Clinical Testing included assessment of the physical properties of the Thrombix™ Patch and its ability to achieve its intended use. Bench testing of the physical properties of the Thrombix™ Patch confirmed the suitability of the device for its intended use. The following physical tests were performed:
- Moisture Content Testing ● Thrombin Activity Testing post 4 hours pot-life
- Wetting Time .
- pH .
A biocompatibility assessment of the device was also performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the following testing:
- . MEM Elution
- . Intracutaneous Injection Test
- . Systemic Injection Test
- Kligman Skin Sensitization .
The results of the tests confirmed the suitability of the device for its intended use.
6
Vascular Solutions, Inc. Thrombix™ Patch Thrombin Hemostasis Patch 510(k) Summary Page 3 of 3
Summary of Clinical Testing
No human clinical testing was required for this device.
Statement of Equivalence
The Thrombix" Patch is substantially equivalent to the currently marketed D-Stat® Dry and D-Stat® Dry 3x3 hemostatic bandages based on a comparison of the indications for use and the technological characteristics of the device.
Conclusion
The Thrombix" Patch is substantially equivalent to the currently marketed D-Stat® Dry and D-Stat® Dry 3x3 hemostatic bandages based on the technological characteristics and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.