(28 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 applied topically to control surface bleeding, which is a therapeutic intervention.
No
Explanation: The device is indicated for the control of surface bleeding, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly outlines physical components including a lyophilized pad, adjustable retention strap, retainer, and attached pads. This indicates a hardware-based medical device, not a software-only one.
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 "control of surface bleeding from vascular access sites and percutaneous catheters or tubes." This is a therapeutic/hemostatic function applied directly to the patient's body.
- Device Description: The device is a topical hemostatic band containing thrombin and other components. It is applied externally to control bleeding.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.
Therefore, the D-Stat Radial Hemostatic Band is a medical device used for hemostasis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The D-Stat Radial Hemostatic 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)
FRO, QSX
Device Description
The D-Stat Radial Hemostatic Band consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride secured to a application device consisting of an adjustable retention strap, retainer, and attached pads. After hemostasis has been achieved, the lyophilized pad may be removed from the application device, covered with a provided adhesive bandage, and left in place for up to 24 hours.
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)
Tests conducted included assessment of the ability to separate the lyophilized pad from the retainer and a biocompatibility assessment of new materials.
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.
Vascular Solutions D-Stat Radial Hemostatic Band (K030836), Vascular Solutions D-Stat Dry Hemostatic Bandage (K030836)
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
Image /page/0/Picture/0 description: The image shows 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 a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
February 10, 2023
Vascular Solutions, Inc. Linda Busklein Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K050133
Trade/Device Name: D-Stat Dry Radial Hemostatic Band Regulatory Class: Unclassified Product Code: QSX
Dear Linda Busklein:
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 February 18, 2005. 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
FEB 1 8 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Busklein Senior Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K050133
K050133
Trade/Device Name: D-Stat Dry Radial Hemostatic Band Regulatory Class: Unclassified Product Code: FRO Dated: January 20, 2005 Received: January 21, 2005
Dear Ms. Busklein:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 5 ro(x) premainted in the may be needed in interstate referenced anove and nave decimined the arrived medicate devices marketed in interstate for use stated in the enclosure for regary mancess promote and one of the Local Drug commerce prior to May 20, 1970, the chance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisel opplication (PMA devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provinces of the Act. This and Cosmetic Act (Act) that do not require uppro rar e seneral controls provisions of the Act. The You may, meretore, market the device, sayler to me of annual registration. Ifsting of
general controls provisions of the Act include requirements mightending and general controls provisions of the received.
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 If your device is classified (see above) mis enning regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such additional controlis. Existing may be found in the Code of Poderal Regeral Register in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualles of a substance or alle other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decemmation that your avres by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing ( 2 l
ess statutes act s requirements, including, but not limited to: registration and listin comply with all the Act s requirements, mename manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the clectron CTR Part 807), labeling (21 CTK Part 601), god at if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000), 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Linda Busklein
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legal This letter will allow you to begin nakting your article appreace of your device of your device to a legally premarket notification. The PDA Inding of substantial equivalence 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
rs the latest of the may on 10, 276, 0115 - Alama dessa note the regulation If you desire specific advice for your ac vice on our noomig nogram note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the r contact the Office of Complance at (210) 216 on (21CFR Part 807.97). You may obtain " Misbranding by relefence to prehance notificancer the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638, other general information on your responsion and at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance arovicdrh/industry/support/index.html.
Sincerely yours.
Miriam C. Provost
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:
Device Name:
Vascular Solutions D-Stat Dry Radial Hemostatic Band
Indications for Use:
The D-Stat Radial Hemostatic Band is applied topically and is indicated for the control The D-Stat Radial Hemootate Band 10 appentaneous catheters of tubes.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of __________
510(k) Number K050133
4
K050133
page 1/1
FEB | 8 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Common/Usual Name: | Topical Hemostatic |
|---|---|
| Product Trade Name: | D-Stat® Radial Hemostatic Band |
| Classification Name: | Unclassified, Product Code FRO |
| Manufacturer: | Vascular Solutions, Inc. |
| 6464 Sycamore Court | |
| Minneapolis, Minnesota 55369 | |
| Establishment Registration: | 2134812 |
| Contact: | Linda Busklein |
| Sr. Regulatory Affairs Associate | |
| (763) 656-4349 phone | |
| (763) 656-4250 fax | |
| Performance Standards: | No performance standards have been developed under section |
| 514 for this device. | |
| Device Description: | The D-Stat Radial Hemostatic Band consists of a lyophilized pad |
| containing thrombin, sodium carboxymethylcellulose, and | |
| calcium chloride secured to a application device consisting of an | |
| adjustable retention strap, retainer, and attached pads. | |
| After | |
| hemostasis has been achieved, the lyophilized pad may be | |
| removed from the application device, covered with a provided | |
| adhesive bandage, and left in place for up to 24 hours. | |
| Intended Use: | The D-Stat Radial Hemostatic Band is applied topically and is |
| indicated for the control of surface bleeding from vascular | |
| access sites and percutaneous catheters or tubes. | |
| Summary of Non-Clinical Testing: | Tests conducted included assessment of the ability to separate |
| the lyophilized pad from the retainer and a biocompatibility | |
| assessment of new materials. | |
| Predicate Devices: | Vascular Solutions D-Stat Radial Hemostatic Band (K030836) |
| Vascular Solutions D-Stat Dry Hemostatic Bandage (K030836) | |
| Conclusions: | The D-Stat Radial Hemostatic Band is substantially equivalent to |
| the currently marketed D-Stat Radial Hemostatic Band and the | |
| D-Stat Dry Hemostatic Bandage, based on a comparison of the | |
| indications for use and the technological characteristics of the | |
| device. |