(23 days)
The Thrombix 3X3 pad 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.
The Thrombix 3x3 hemostatic pad consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride in a non-woven gauze.
The provided text is a 510(k) summary for the Thrombix 3x3 hemostatic pad, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study. As such, it does not contain the detailed information typically found in an AI/medical device acceptance criteria study report.
Based on the information provided, here's what can be inferred and what is explicitly not mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in this context. The document describes a comparison to predicate devices, not specific acceptance criteria for performance in the way an AI algorithm would be evaluated. The core of this submission is substantial equivalence, not a set of performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The summary mentions "Tests conducted included assessment of the potlife of the pad after addition of up to 10 mls of saline." This refers to non-clinical bench testing, not a clinical test set with a defined sample size for evaluating performance in patients.
- Data Provenance: Not specified, but the testing described (potlife) would be laboratory-based (non-clinical).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There is no mention of expert-established ground truth because this is a non-clinical, non-AI device submission that relies on bench testing and comparison to predicates.
4. Adjudication Method for the Test Set
Not applicable. No expert-based adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a non-AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a non-AI medical device.
7. The Type of Ground Truth Used
Not applicable in the typical AI sense. For the non-clinical tests mentioned ("potlife of the pad"), the "ground truth" would be the measured physical/chemical properties or the observed behavior of the pad under test conditions, evaluated against internal specifications or standard laboratory practices, rather than expert consensus, pathology, or outcomes data in a clinical setting.
8. The Sample Size for the Training Set
Not applicable. This is a non-AI device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a non-AI device.
Summary of Device Information from Document:
- Device Name: Thrombix 3x3 hemostatic pad
- Description: A lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride in a non-woven gauze.
- Intended Use: Applied topically 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.
- Non-Clinical Testing: Assessment of the potlife of the pad after addition of up to 10 mLs of saline.
- Predicate Devices: D-Stat Dry 3x3 hemostatic pad (K040510) and ThrombiGel thrombin/gelatin foam hemostat (K050511).
- Conclusion: The device is substantially equivalent to the predicate devices based on indications for use and technological characteristics.
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February 10, 2023
Vascular Solutions, Inc. Linda Busklein Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K053054
Trade/Device Name: Thrombix 3x3 hemostatic pad 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 November 23, 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
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2005
Linda Busklein Senior Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K053054
Trade/Device Name: Thrombix 3x3 hemostatic pad Regulatory Class: Unclassified Product Code: FRO Dated: October 28, 2005 Received: November 4, 2005
Dear Ms. Busklein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the May 28, 1976, the enactment date of the Medical Device Amendments, or to connineroo price to 1125 2011 devices that have been require approval of a premarket approval application (PMA). and Cosmetic Plov (10) 110, 100 (10) 100 ) 100 ) 100 general controls provisions of the Act. The I ou may, dierely mains 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 may or subject to 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 or any reath 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- 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchner
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:
KUS3054
Device Name:
Thrombix 3x3 hemostatic pad
Indications for Use:
The Thrombix 3X3 pad 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) ﺬ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Harbare Buchm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of __
510(k) Number K053054
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NOV 2 3 2005
510(K) SUMMARY
| Common/Usual Name: | Topical Hemostatic |
|---|---|
| Product Trade Name: | Thrombix 3x3 hemostatic pad |
| 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) 656-4349 phone(763) 656-4250 fax |
| Performance Standards: | No performance standards have been developed undersection 514 for this device. |
| Device Description: | The Thrombix 3x3 hemostatic pad consists of a lyophilizedpad containing thrombin, sodium carboxymethylcellulose,and calcium chloride in a non-woven gauze. |
| Intended Use: | The Thrombix 3X3 pad is applied topically and is indicatedas a trauma dressing for temporary control of moderate toseverely bleeding wounds and for the control of surfacebleeding from vascular access sites and percutaneouscatheters or tubes. |
| Summary of Non-Clinical Testing: | Tests conducted included assessment of the potlife of thepad after addition of up to 10 mls of saline. |
| Predicate Devices: | D-Stat Dry 3x3 hemostatic pad (K040510)ThrombiGel thrombin/gelatin foam hemostat (K050511) |
| Conclusions: | The Thrombix 3x3 hemostatic pad is substantiallyequivalent to the currently marketed D-Stat Dry 3x3hemostatic pad and the ThrombiGel thrombin/gelatin foamhemostat, based on a comparison of the indications for useand the technological characteristics of the device. |
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N/A