(182 days)
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.
The Duett Flowable Hemostat is comprised of a three-part procoagulant mixture of collagen, 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.
This response is based on the provided text, which is an FDA 510(k) notification for the Vascular Solutions Duett™ Flowable Hemostat. As such, the information is limited to what's typically included in such documents.
Acceptance Criteria and Study Details for Vascular Solutions Duett™ Flowable Hemostat
The provided document is a 510(k) submission and subsequent FDA letters for the Vascular Solutions Duett™ Flowable Hemostat. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than strictly meeting pre-defined acceptance criteria through extensive clinical studies specifically for the new device's efficacy. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test sets, expert-established ground truth, and comparative effectiveness studies is not explicitly present or applicable in the same way as it would be for a direct clinical trial validating new performance claims.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) based on substantial equivalence, specific numerical "acceptance criteria" for clinical performance are not stated in the document. Instead, the device's performance is affirmed through non-clinical testing and comparison to predicate devices for its intended use.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance |
|---|---|
| Ability to control bleeding from vascular access sites and percutaneous catheters (intended use). | "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." |
| Facilitate hemostasis reactions. | "The surface properties of the suspended collagen facilitate hemostasis reactions by triggering platelet adhesion and aggregation." |
| Enhance the surface-activated clotting cascade. | "The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin." |
| Suitability of physical properties (pH, viscosity, osmolarity, deliverability). | "The results of this battery of tests confirmed the suitability of the Duett Flowable Hemostat for its intended use." (Non-clinical testing) |
| Biocompatibility. | Confirmed by non-clinical testing. |
| Substantial equivalence to predicate devices (Syvek Patch and Hospal Tipstop). | "The Duett Flowable Hemostat is substantially equivalent to the Syvek Patch and the Hospal Tipstop." |
| Perform as intended. | "The testing performed confirms that the Duett Flowable will perform as intended." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not specified in the provided document for clinical performance. The document explicitly states: "No clinical evaluations of this product for this use have been conducted."
- Data Provenance: The document only refers to "non-clinical testing" conducted by the manufacturer, Vascular Solutions, Inc., located in Minneapolis, Minnesota, USA. It does not provide details on specific test sets or the origin of any data used for substantial equivalence other than the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. Since no clinical evaluations were conducted for this product's use, there was no expert-established ground truth for a clinical test set from this submission.
4. Adjudication method for the test set
- Not applicable/None specified. No clinical test set was described as being used for this 510(k) submission.
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 device is a flowable hemostat, not an AI-based diagnostic or imaging device. Therefore, MRMC studies and AI-assisted performance metrics are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical product for direct application, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing, the "ground truth" would be established by standard scientific measurement (e.g., measuring pH, viscosity, osmolarity, observing clotting in vitro according to established biological principles, and biocompatibility testing using recognized standards).
- For the substantial equivalence claim, the "ground truth" is essentially the established safety and effectiveness of the identified predicate devices (Syvek Patch Topical Hemostat and Hospal Tipstop Compression Dressing) for their respective indications.
8. The sample size for the training set
- Not applicable/Not specified. As there was no clinical evaluation conducted for this product's use, there is no mention of a "training set" in the context of clinical data for this 510(k) submission.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As there was no clinical evaluation conducted for this product's use, there is no mention of a "training set" or how its ground truth might be established.
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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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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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
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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: | UnclassifiedProduct Code, KMF |
| Manufacturer: | Vascular Solutions, Inc.2495 Xenium Lane NorthMinneapolis, Minnesota 55441 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah JensenV. P., Regulatory Affairs, Clinical Affairs, andQuality Systems(763) 656-4349 phone(763) 656-4252 fax |
| Performance Standards: | No performance standards have been developedunder 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
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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.
N/A