(182 days)
Not Found
No
The device description focuses on the chemical and physical properties of the hemostatic agent and delivery tools, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a hemostat used for local management and control of bleeding, which is a treatment for a physiological condition.
No
The device is a hemostat, intended for the local management and control of bleeding. It is not described as being used to diagnose a condition or disease.
No
The device description explicitly states it is comprised of a three-part procoagulant mixture and includes delivery tools and mixing accessories, indicating it is a physical medical device, not software-only.
Based on the provided information, the Vascular Solutions Duett™ Flowable Hemostat is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local management and control of bleeding from vascular access sites and percutaneous catheters." This describes a direct therapeutic action on the patient's body to stop bleeding.
- Device Description: The description details a "three-part procoagulant mixture of collagen, thrombin and a buffered diluent" that works by creating a "physical barrier to blood flow" and enhancing the natural clotting process. This is a description of a topical hemostatic agent applied directly to the bleeding site.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information about a patient's health status. IVDs are used to diagnose, monitor, or screen for diseases or conditions.
The device is a therapeutic device used to control bleeding, not a diagnostic device used to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Vascular Solutions Duett Flowable Hemostat is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters.
Product codes
FRO, QSX
Device Description
The Duett Flowable Hemostat is comprised of a three-part procoagulant mixture The Duett I lowagen, thrombin and a buffered diluent. The Duett Flowable Hemostat achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow and establishes an environment in which a natural blood clot can build and form a physical barrier to bleeding. The surface properties of the suspended collagen facilitate hemostasis reactions by triggering platelet adhesion and aggregation. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. The device also contains several delivery tools and mixing accessories. The device is sterilized with ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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
No clinical evaluations of this product for this use have been conducted.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 10, 2023
Vascular Solutions, Inc. Deborah Jensen Vice President, Regulatory, Clinical and Quality Systems 2495 Xenium Lane North Minneapolis, Minnesota 55441-3625
Re: K012293
Trade/Device Name: Vascular Solutions Duett™ Flowable Hemostat Regulatory Class: Unclassified Product Code: QSX
Dear Deborah Jensen:
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 January 18, 2002 and the correction letter dated July 11, 2003. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2003
Ms. Deborah Jensen Vice President, Clinical and Quality Systems Vascular Solutions 2495 Xenium Lane North Minneapolis, Minnesota 55441-3625
Re: K012293
Trade/Device Name: Vascular Solutions Duett Flowable Hemostat Regulatory Class: Unclassified Product Code: FRO Dated: October 30, 2001 Received: October 31, 2001
Dear Ms. Jensen:
This letter corrects our substantially equivalent letter of January 18, 2002 regarding the Duett Flowable Hemostat, which was mistakenly classified as a Class I Compression Dressing with product code MHW. As this device contains a biological component, it is unclassified with product code FRO.
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 (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.
In addition, we have determined that your product contains the following component subject to regulation as a biologic:
Thrombin vial (5,000 units)
Our substantially equivalent determination does not apply to the biologic component of your product. For information on applicable Agency requirements for marketing this product, we suggest you contact:
Director Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike Rockville, Maryland 20852-1148
2
Page 2 - Ms. Deborah Jensen
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Miriam C. Provost
For Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number:
k o 12393
Device Name:
Vascular Solutions Duett™ Flowable Hemostat
Indications for Use:
The Vascular Solutions Duett Flowable Hemostat is intended for use under the direction The Vascular Soludons Ducti I lowlocal management and control of bleeding from of a ficalcheare professioneous catheters and tubes.
2
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_ko12293
4
JAN 1 8 2002
KO12293
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Common/Usual Name: | Topical Hemostat |
|---|---|
| Product Trade Name: | Duett™ Flowable Hemostat |
| Classification Name: | Unclassified |
| Product Code, KMF | |
| Manufacturer: | Vascular Solutions, Inc. |
| 2495 Xenium Lane North | |
| Minneapolis, Minnesota 55441 | |
| Establishment Registration: | 2134812 |
| Contact: | Deborah Jensen |
| V. P., Regulatory Affairs, Clinical Affairs, and | |
| Quality Systems | |
| (763) 656-4349 phone | |
| (763) 656-4252 fax | |
| Performance Standards: | No performance standards have been developed |
| under section 514 for this device. |
Device Description:
The Duett Flowable Hemostat is comprised of a three-part procoagulant mixture The Duett I lowagen, thrombin and a buffered diluent. The Duett Flowable Hemostat achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow and establishes an environment in which a natural blood clot can build and form a physical barrier to bleeding. The surface properties of the suspended collagen facilitate hemostasis reactions by triggering platelet adhesion and aggregation. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. The device also contains several delivery tools and mixing accessories. The device is sterilized with ethylene oxide.
Intended Use:
The Vascular Solutions Duett Flowable Hemostat is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters.
Summary of Non-Clinical Testing:
Testing conducted included assessments of the physical properties of the procoagulant (pH viscosity, osmolarity, and deliverability), the ability of the procoagulant to achieve
5
its intended use (clot blood) and biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Duett Flowable Hemostat for its intended use.
Summary of Clinical Testing:
No clinical evaluations of this product for this use have been conducted.
Predicate Devices:
The intended use of the Duett Flowable Hemostat is a subset of the intended use of the Syvek Patch Topical Hemostat(K984177) and is similar to that of the Hospal Tipstop Compression Dressing (K982818). These three products use slightly different technologies to control the bleeding associated with vascular access sites.
Conclusions:
The Duett Flowable Hemostat is substantially equivalent to the Syvek Patch and the Hospal Tipstop. The testing performed confirms that the Duett Flowable will perform as intended.