The Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band 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 and tubes.
The D-Stat Dry hemostatic bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride
- Adhesive bandage
The D-Stat Radial hemostatic band consists of the following components: - Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride in a non-woven gauze
- Application device consisting of an adjustable retention strap, collar and attached gauze pad
The D-Stat Dry hemostatic bandage and D-Stat Radial hemostatic band achieves their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by either the adhesive bandage or the retention band. The Iyophilized components (thrombin, CMC, and calcium chloride) establish an environment, in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
Here's an analysis of the provided text regarding the D-Stat Dry™ Hemostatic Bandage and D-Stat Radial™ Hemostatic Band, focusing on the acceptance criteria and study information:
Based on the provided FDA 510(k) summary (K030836), no specific acceptance criteria or details of a study proving the device meets acceptance criteria are documented in the traditional sense you might expect for an AI algorithm or a device with measurable performance metrics.
This document is a 510(k) premarket notification for a medical device that relies on substantial equivalence to predicate devices, rather than a de novo submission with extensive clinical trials establishing novel performance criteria. The device is a "hemostatic bandage/band," which operates based on physical properties and established biological mechanisms (thrombin) to assist with local hemostasis.
Let's break down the information based on your requested points:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not Explicitly Stated for this 510(k) Submission Not Explicitly Stated for this 510(k) Submission Implicitly, the device must achieve local hemostasis as intended, and be safe and effective when compared to predicate devices. Non-clinical testing confirmed suitability for intended use, and the device is deemed substantially equivalent to predicates that perform this function. Explanation: The 510(k) summary does not define quantitative acceptance criteria (e.g., "hemostasis achieved in X% of cases within Y minutes"). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The performance is "reported" as being suitable for its intended use based on non-clinical tests and the comparison to an existing product with a similar mechanism of action.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable/Not provided. The document states, "No clinical evaluations of this product for this use have been conducted."
- Data Provenance: Not applicable, as there were no clinical evaluations. "Non-Clinical Testing" was performed.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. There was no clinical test set that required expert-established ground truth.
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Adjudication Method for the Test Set:
- Not applicable. There was no clinical test set requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this device is a physical hemostatic product and not an AI-assisted diagnostic or therapeutic device involving human readers.
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Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Was standalone performance done? Not applicable in the context of an "algorithm only." This device is a physical product directly applied by a healthcare professional ("under the direction of a healthcare professional"). Its "standalone" performance would refer to its physical and biological function (clotting ability, mechanical properties) rather than an algorithm's output. The "Summary of Non-Clinical Testing" addresses this.
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Type of Ground Truth Used:
- For the non-clinical testing: The "ground truth" was established by "assessments of the physical properties of the lyophilized pad" and "the ability of the lyophilized components to achieve its intended use (clot blood) and biocompatibility assessments." This implies laboratory measurements, material science testing, and in vitro/in vivo biocompatibility studies using established scientific methods and standards. It relies on objective measurements of physical and biological characteristics.
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Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that sense.
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How the Ground Truth for the Training Set Was Established:
- Not applicable (see point 8).
In summary:
This FDA 510(k) document (K030836) pertains to a physical medical device (hemostatic bandage/band) that achieved market clearance through the "substantial equivalence" pathway. This pathway does not typically require the same type of detailed performance criteria and clinical study reporting as a novel device or an AI/software as a medical device (SaMD). The device's "performance" was demonstrated through non-clinical testing of its physical and biological properties and by showing it is similar enough to predicate devices that are already cleared for the same intended use. Clinical trials were explicitly stated as not having been conducted for this submission.
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February 10, 2023
Vascular Solutions, Inc. Deborah Jensen Vice President, Clinical and Quality Systems 907 South Lakewood AvenueBaltimore, Maryland 21224
Re: K030836
Trade/Device Name: Vascular Solutions D-Stat - Dry™ Hemostatic Bandage, D-Stat Radial™ Hemostatic Band 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 September 17, 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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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
ood and Drug Administras 200 Corporate Boulevard Rockville MD 20050
SEP 1 7 2003
Ms. Deborah Jensen Vice President, Clinical and Quality Systems Vascular Solutions. Inc. 6464 Sycamore Court Minneapolis. Minnesota 55369
Re: K030836
Trade/Device Name: Vascular Solutions D-Stat -- Dry™ Hemostatic Bandage and D-Stat Radial™ Hemostatic Band Regulatory Class: Unclassified Product Code: FRO Dated: June 20, 2003 Received: June 23, 2003
Dear Ms. Jensen:
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 - Ms. Deborah Jensen
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Marle N. Millenn
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
Vascular Solutions D-Stat-Dry™ Hemostatic Bandage and D-Device Name: Stat Radial™ Hemostatic band
Indications for Use:
The Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band 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 and tubes.
Mark N. Milkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030836
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SEP 1 7 2003
K030836
Page 1/2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Common/Usual Name: | Topical Hemostat |
|---|---|
| Product Trade Name: | D-Stat Dry™ Hemostatic BandageD-Stat Radial™ Hemostatic Band |
| Classification Name: | UnclassifiedProduct Code MHW |
| Manufacturer: | Vascular Solutions, Inc.2495 Xenium Lane NorthMinneapolis, Minnesota 55441 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah JensenVP Regulatory, Clinical and Quality Systems |
| Performance Standards: | No performance standards have been developedunder section 514 for this device. |
Device Description:
The D-Stat Dry hemostatic bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and . calcium chloride
- Adhesive bandage ●
The D-Stat Radial hemostatic band consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and . calcium chloride in a non-woven gauze
- Application device consisting of an adjustable retention strap, collar and attached ● gauze pad
The D-Stat Dry hemostatic bandage and D-Stat Radial hemostatic band achieves their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by either the adhesive bandage or the retention band. The Iyophilized components (thrombin, CMC, and calcium chloride) establish an environment, in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
Intended Use:
The Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band 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 and tubes.
Confidential
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K030836
Page 2/2
Summary of Non-Clinical Testing:
Testing conducted included assessments of the physical properties of the lyobhilized pad, the ability of the lyophilized components to achieve its intended use (clot blood) and biocompatibility assessments. The results of this battery of tests confirmed the suitability of the D-Stat Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band 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 D-Stat Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band is a subset of the intended use of the
- Vascular Solutions Inc., D-Stat Flowable Hemostat, K012293; product code ● MHW, unclassified.
- . TZ Medical Inc., EZ Band; product code MHW class I
- Gambro Healthcare, Hospal Tipstop, K982818 (cleared for market distribution on . October 21, 1998); product code KMF, Unclassified
Conclusions:
The D-Stat Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band is substantially equivalent to Vascular Solutions Inc., D-Stat Flowable Hemostat, TZ Medical Inc., EZ Band, and the Gambro Healthcare Hospal Tipstop. The testing performed confirms that the D-Stat Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band will perform as intended.
N/A