(124 days)
The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is applied topically for temporary control of moderate to severely bleeding wounds and for the local management of surface bleeding from vascular access sites and percutaneous tubes and catheters.
Each Thrombi-Paste Thrombin/gelatin powder paste hemostat includes the following components; A 10 mL syringe with attached mixing luer filled with 550mg of powdered absorbable gelatin sponge, USP (manufactured by Vascular Solutions, Inc. (VSI)), A vial of Bovine-derived Thrombin (5,000 IU, supplied to VSI by King Pharmaceuticals, U.S. license # 977), A diluent vial (5 mL, Supplied to VSI by Chesapeake Biological Laboratories, U.S. registration # 1123903), Mixing accessories (10 mL syringe and needleless, non-coring vial access device) and Applicator tips (1 - small bore tip, 1 - large bore tip). The pouch containing the syringe with gelatin powder also contains a desiccant packet to maintain low moisture levels.
The provided text is a 510(k) summary for the Thrombi-Paste® Thrombin/gelatin powder paste hemostat. It states that no human clinical testing was required for this device, which means there is no study that proves the device meets specific acceptance criteria based on human performance. The summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format for the performance of the device in comparison to its intended use (hemostasis). Instead, it lists non-clinical tests performed to confirm the suitability of the device, implying that the device met the internal criteria for these tests.
| Acceptance Criteria (Implied by testing) | Reported Device Performance (Summary) |
|---|---|
| pH in acceptable range | Confirmed suitability |
| Thrombin Activity in acceptable range | Confirmed suitability |
| Pot-life in acceptable duration | Confirmed suitability |
| Delivery Force within limits | Confirmed suitability |
| Tip Kink Resistance | Confirmed suitability |
| Hemostatic Suspension Mass | Confirmed suitability |
| Wetting / Mixing Time within limits | Confirmed suitability |
| Biocompatibility | Confirmed suitability |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for each non-clinical test (e.g., how many syringes were tested for delivery force). The data provenance is internal, as "Vascular Solutions, Inc." manufactured the absorbable gelatin sponge and sourced other components. The tests are non-clinical (bench testing) and do not involve human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for non-clinical bench testing is established by engineering specifications and objective measurements, not by human experts interpreting results in the way clinical studies require.
4. Adjudication method for the test set
Not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies where expert consensus is needed to determine outcomes or classifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. The document explicitly states, "No human clinical testing was required for this device."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical product (hemostat), not an algorithm or AI-based diagnostic tool. Performance is assessed through physical and chemical properties and basic functional tests, not by an algorithm.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" would be established by the defined specifications and measurement standards for each physical and chemical property being tested (e.g., a specific pH value range is acceptable). This is based on scientific and engineering principles rather than a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set.
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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: K070938
Trade/Device Name: Thrombi-Paste® Thrombin/gelatin powder paste hemostat 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 August 6, 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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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2007
Vascular Solutions, Inc. % Mr. James Chapman Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K070938
Trade/Device Name: Thrombi-Paste® Thrombin/gelatin powder paste hemostat Regulatory Class: Unclassified Product Code: FRO Dated: June 29, 2007 Received: July 2, 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.
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Page 2 - Mr. James Chapman
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) 276-0115. 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. Milburn
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:
Device Name:
Thrombi-Paste® Thrombin/gelatin powder paste hemostat
Indications for Use:
The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is applied topically for temporary control of moderate to severely bleeding wounds and for the local management of surface bleeding from vascular access sites and percutaneous tubes and catheters.
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 of Device Evaluation (ODE)
Mark A. Wilson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070938
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K070938 Page 1 of 3
510(k) Summary (As required by 21 CFR 807.92(c))
AUG -6 2007
510(k) Number: Page 1 of 3
April 2, 2007 Date Prepared:
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore CourtMinneapolis, MN 55369 |
Establishment Registration 2134812
| Contact Person: | James ChapmanRegulatory Affairs AssociatePhone: (763) 656-4380Fax: (763) 656-4253 |
|---|---|
| ----------------- | ----------------------------------------------------------------------------------------------- |
Device Information
| Trade Name: | Thrombi-Paste® Thrombin/gelatin powder paste hemostat |
|---|---|
| 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® Flowable hemostat (K012293) and ThrombiGel® Thrombin/gelatin foam hemostat (K.063860).
Device Description
Each Thrombi-Paste Thrombin/gelatin powder paste hemostat includes the following components;
A 10 mL syringe with attached mixing luer filled with 550mg of powdered absorbable gelatin sponge, USP (manufactured by Vascular Solutions, Inc. (VSI)),
A vial of Bovine-derived Thrombin (5,000 IU, supplied to VSI by King Pharmaceuticals, U.S. license # 977),
A diluent vial (5 mL, Supplied to VSI by Chesapeake Biological Laboratories, U.S. registration # 1123903),
Vascular Solutions, Inc. Thrombi-Paste® Thrombin/gelatin powder paste hemostat 510(k) Pre-market Notification April 2, 2007
Section 5-2
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K0709336
Vascular Solutions, Inc. Thrombi-Paste® Thrombin/gelatin powder paste hemostat 510(k) Summary Page 2 of 3
Mixing accessories (10 mL syringe and needleless, non-coring vial access device) and
Applicator tips (1 - small bore tip, 1 - large bore tip).
The pouch containing the syringe with gelatin powder also contains a desiccant packet to maintain low moisture levels.
Intended Use/Indications for Use
The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is applied topically for the temporary control of moderate to severely bleeding wounds or, the local management 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 Thrombi-Paste® Thrombin/gelatin powder paste hemostat and its ability to achieve its intended use. Bench testing of the physical properties of the Thrombin/gelatin powder paste hemostat confirmed the suitability of the device for its intended use. The following physical tests were performed;
pH Testing Thrombin Activity Testing Pot-life Testing Delivery Force Tip Kink Testing Hemostatic Suspension Mass Wetting / Mixing Time Biocompatibility
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Vascular Solutions, Inc. Thrombi-Paste® Thrombin/gelatin powder paste hemostat 510(k) Summary Page 3 of 3
Summary of Clinical Testing
No human clinical testing was required for this device.
Statement of Equivalence
The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is substantially equivalent to the currently marketed D-Stat® Flowable hemostat and ThrombiGel® Thrombin/gelatin foam hemostat based on a comparison of the indications for use and the technological characteristics of the device.
Conclusion
The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is substantially equivalent to the currently marketed D-Stat® Flowable hemostat and ThrombiGel® Thrombin/gelatin foam hemostat based on the technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.
N/A