(184 days)
Not Found
No
The device description focuses on the physical and chemical properties of the bandage and band components, and the mechanism of action is based on creating a physical barrier and enhancing the natural clotting cascade. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the local management and control of bleeding, which is a direct treatment of a medical condition.
No
The device is described as a hemostatic bandage and band intended for managing and controlling bleeding, which is a therapeutic function rather than a diagnostic one. It does not mention analyzing or interpreting any physiological data to determine a medical condition.
No
The device description clearly outlines physical components (lyophilized pad, adhesive bandage, application device, retention strap, collar, gauze pad) and their physical mechanisms of action (physical barrier, compression, enhancing clotting cascade). There is no mention of software as a component or its function.
Based on the provided information, this device 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 and tubes." This describes a therapeutic or procedural use on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device description details a physical bandage/band with lyophilized components (thrombin, CMC, calcium chloride) that work by creating a physical barrier and enhancing the natural clotting process at the site of bleeding. This is a direct intervention on the patient's body.
- Mechanism of Action: The mechanism of action involves creating a physical barrier and facilitating the natural clotting cascade in vivo (within the body). IVDs typically work by analyzing biological samples in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
In summary, the D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band are devices used to control bleeding directly on the patient's body, which falls under the category of therapeutic or procedural medical devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
QSX, FRO, MHW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access sites and percutaneous catheters and tubes
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
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.
Clinical Testing: No clinical evaluations of this product for this use have been conducted.
Key Metrics
Not Found
Predicate Device(s)
Vascular Solutions Inc., D-Stat Flowable Hemostat, K012293, TZ Medical Inc., EZ Band, Gambro Healthcare, Hospal Tipstop, K982818
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: 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 commonly used to indicate that a product or establishment is regulated by the FDA.
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
1
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.
2
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
3
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
4
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 Bandage |
| D-Stat Radial™ Hemostatic Band | |
| Classification Name: | Unclassified |
| Product Code MHW | |
| Manufacturer: | Vascular Solutions, Inc. |
| 2495 Xenium Lane North | |
| Minneapolis, Minnesota 55441 | |
| Establishment Registration: | 2134812 |
| Contact: | Deborah Jensen |
| VP Regulatory, Clinical and Quality Systems | |
| Performance Standards: | No performance standards have been developed |
| under 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
5
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.