(23 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a hemostatic pad, with no mention of AI or ML.
No.
The device is a hemostatic pad used for temporary control of bleeding from wounds and vascular access sites, which is a short-term, acute care application, not a therapeutic treatment for a disease or condition.
No
The device is described as a "trauma dressing" for "temporary control of moderate to severely bleeding wounds," which indicates a therapeutic rather than diagnostic function. It is used to stop bleeding, not to identify or measure a medical condition.
No
The device description clearly states it is a "lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride in a non-woven gauze," indicating a physical, hardware-based medical device.
Based on the provided information, the Thrombix 3X3 pad is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is applied topically to control bleeding wounds and surface bleeding from vascular access sites. This is a direct application to the body for therapeutic purposes.
- Device Description: The description details a pad containing substances that interact with blood in situ (on the body) to promote clotting.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Thrombix 3X3 pad does not perform this function.
Therefore, the Thrombix 3X3 pad is a hemostatic device used for topical application, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
QSX, FRO
Device Description
The Thrombix 3x3 hemostatic pad consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride in a non-woven gauze.
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)
Tests conducted included assessment of the potlife of the pad after addition of up to 10 mls of saline.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
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
1
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.
2
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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page 1/1
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 Court | |
| Minneapolis, Minnesota 55369 | |
| Establishment Registration: | 2134812 |
| Contact: | Linda Busklein |
| Sr. Regulatory Affairs Associate | |
| (763) 656-4349 phone | |
| (763) 656-4250 fax | |
| Performance Standards: | No performance standards have been developed under |
| section 514 for this device. | |
| Device Description: | The Thrombix 3x3 hemostatic pad consists of a lyophilized |
| pad containing thrombin, sodium carboxymethylcellulose, | |
| and calcium chloride in a non-woven gauze. | |
| Intended 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. | |
| Summary of Non-Clinical Testing: | Tests conducted included 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) |
| ThrombiGel thrombin/gelatin foam hemostat (K050511) | |
| Conclusions: | The Thrombix 3x3 hemostatic pad is substantially |
| equivalent to the currently marketed D-Stat Dry 3x3 | |
| hemostatic pad and the ThrombiGel thrombin/gelatin foam | |
| hemostat, based on a comparison of the indications for use | |
| and the technological characteristics of the device. |
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