(65 days)
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.
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.
This document is a 510(k) summary for the Thrombix™ Patch, a thrombin hemostasis patch. It describes the device, its intended use, and comparative studies with predicate devices.
Here's an analysis based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for performance. Instead, it describes internal quality control tests and biocompatibility assessments. The "reported device performance" is essentially that the device was found suitable for its intended use based on these tests, and substantially equivalent to predicate devices.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Moisture Content within specified limits | Confirmed suitability |
| Thrombin Activity post 4 hours pot-life | Confirmed suitability |
| Wetting Time within specified limits | Confirmed suitability |
| pH within specified limits | Confirmed suitability |
| Biocompatibility (MEM Elution, Intrac. Inj. Test, Systemic Inj. Test, Kligman Skin Sensitization) | Biocompatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses bench testing for physical properties and biocompatibility.
- Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for internal quality control. No "test set" in the context of clinical data for performance assessment.
- Data Provenance: The tests are likely performed by Vascular Solutions, Inc. or their contracted labs. The country of origin of this internal testing data is not specified, but the company is based in Minneapolis, MN, USA. The data is retrospective in the sense that it was generated prior to submission for clearance.
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)
Not applicable. The document describes bench testing and biocompatibility assessments, not a study where expert ground truth was established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is relevant for studies involving human interpretation or clinical outcomes, which were not conducted for this submission (as stated in Section 6).
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
Not applicable. This is a medical device for hemostasis, not an AI-assisted diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is geared towards AI/software as a medical device. The Thrombix™ Patch is a physical hemostatic device. The "standalone" performance refers to the device's intrinsic function as a hemostat, which was assessed through the non-clinical bench testing. No human-in-the-loop performance study was conducted or required.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was established by standardized laboratory test methods and scientific principles for assessing physical properties (e.g., moisture content measurement, pH measurement, thrombin activity assay) and established biocompatibility testing protocols (e.g., MEM Elution, Intracutaneous Injection Test). There was no clinical ground truth (like pathology or outcomes data) used as no human clinical testing was required.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning model. There is no "training set" for this device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there's no ground truth to establish for it.
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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
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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
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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
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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 CourtMinneapolis, 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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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.
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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.
N/A