(16 days)
Not Found
No
The device description and performance studies focus on the physical components and hemostatic properties of the band, with no mention of AI or ML.
Yes
The device is indicated for the control of surface bleeding, which is a therapeutic action.
No
The device is described as an hemostatic band used for controlling surface bleeding, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components such as a gauze pad, release tab, retainer pad, polycarbonate retainer, copolymer retention strap, foam pads, and an adhesive bandage. It also contains biological/chemical components like thrombin, sodium carboxymethylcellulose, and calcium chloride. This is a physical medical device, not a software-only one.
Based on the provided information, the D-Stat Rad-Band is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes. This is a direct application to the patient's body to control bleeding, not for testing samples in vitro (outside the body).
- Device Description: The device is a topical hemostatic band with a gauze pad containing hemostatic agents. This is a physical device applied externally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely therapeutic (controlling bleeding).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The D-Stat Rad-Band does not fit this description.
N/A
Intended Use / Indications for Use
The D-Stat Rad-Band is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Product codes (comma separated list FDA assigned to the subject device)
QSX, FRO
Device Description
The D-Stat Rad-Band consists of a gauze pad secured to a release tab and retainer pad on a polycarbonate retainer at the end of an adjustable copolymer retention strap. Two foam pads included on the strap can be adjusted (or removed) for patient comfort. The D-Stat Rad-Band has a lyophilized non-woven gauze pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride to facilitate hemostasis. By pulling the release tab between the gauze pad and the retainer after hemostasis is achieved, the retention strap/retainer can be removed from the patient, leaving the gauze pad behind on the access site. The D-Stat Rad-Band includes an adhesive bandage.
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)
The D-Stat Rad-Band is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
February 10, 2023
Vascular Solutions, Inc. c/o Lisa Gallatin Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K092612
Trade/Device Name: D-Stat® Rad-band Regulatory Class: Unclassified Product Code: QSX
Dear Lisa Gallatin:
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 11, 2009. 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
SEP 1 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Vascular Solutions, Inc. % Ms. Lisa Gallatin Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K092612
Trade Name: D-Stat® Rad-Band Product Code: FRO Dated: August 25, 2009 Received: August 26, 2009
Dear Ms. Gallatin:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Lisa Gallatin
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Milburn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K092612
Device Name: D-Stat® Rad-Band
Indications for Use:
D-Stat® Rad-Band: The D-Stat Rad-Band is applied topically and is indicated 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1 (Posted November 13, 2003)
Daniel Krone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092612
4
SEP 1 1 2009
Vascular Solutions, Inc.
K092612
page 1 of 1
Special 510(k) Premarket D-Stat® Rad-Band
3 510(k) Summary
Date Prepared: September 9, 2009
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Lisa Gallatin, RAC Senior Regulatory Affairs Associate Tel: 763.656.4399 (direct); Fax: 763.656.4253 Email: Igallatin@vascularsolutions.com
General Information
D-Stat® Rad-Band Trade Name Common Name Topical Hemostat Classification Name Unclassified K050133. D-Stat® Radial Hemostatic Band (Vascular Solutions, Inc.) Predicate Device K073264, D-Stat® Dry Clear Hemostatic Bandage (Vascular Solutions, Inc.)
Device Description
The D-Stat Rad-Band consists of a gauze pad secured to a release tab and retainer pad on a polycarbonate retainer at the end of an adjustable copolymer retention strap. Two foam pads included on the strap can be adjusted (or removed) for patient comfort. The D-Stat Rad-Band has a lyophilized non-woven gauze pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride to facilitate hemostasis. By pulling the release tab between the gauze pad and the retainer after hemostasis is achieved, the retention strap/retainer can be removed from the patient, leaving the gauze pad behind on the access site. The D-Stat Rad-Band includes an adhesive bandage.
Intended Use / Indications
The D-Stat Rad-Band is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Substantial Equivalence and Summary of Studies
The D-Stat Rad-Band is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions.
Confidential
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