D-STAT RADIAL HEMOSTATIC BAND by VASCULAR SOLUTIONS, INC.

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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for the D-Stat Dry Radial Hemostatic Band. It details the regulatory classification, device description, intended use, and a summary of non-clinical testing. However, it does not contain specific acceptance criteria or a study that proves the device meets such criteria in a quantitative or statistical manner typically expected for medical device performance studies (e.g., sensitivity, specificity, accuracy, or clinical endpoints for 510(k) devices that are usually compared to a predicate device's established performance).

The "study" mentioned here is a Summary of Non-Clinical Testing, which is a basic assessment of the device's functional integrity.

Here's the breakdown based on the information provided:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Ability to separate the lyophilized pad from the retainer	Demonstrated (Implied by conclusion of substantial equivalence based on non-clinical testing).
Biocompatibility of new materials	Demonstrated (Implied by conclusion of substantial equivalence based on non-clinical testing).

Note: The document states "No performance standards have been developed under section 514 for this device." This means there aren't pre-defined, standardized numerical benchmarks the device must meet for efficacy or safety. The 510(k) pathway relies on demonstrating substantial equivalence to a legally marketed predicate device.

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The summary only mentions "Tests conducted included assessment of the ability to separate the lyophilized pad from the retainer and a biocompatibility assessment of new materials." This is qualitative testing, not a statistical sample size for clinical or diagnostic performance.
- Data Provenance: Not specified, but generally, non-clinical tests would be performed in a laboratory setting by the manufacturer (Vascular Solutions, Inc.).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is for hemostasis, and the "tests" described are non-clinical, functional and biocompatibility assessments. "Ground truth" in the diagnostic or clinical sense (e.g., for image interpretation) is not established by experts for these types of tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process is described for these non-clinical tests.
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 is not an AI/diagnostic device; therefore, no MRMC study, human readers, or AI assistance is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests described, the "ground truth" would be established by standard engineering and chemical testing methodologies and specifications, not expert consensus, pathology, or outcomes data. For example, the separation force of the pad from the retainer would be compared against an internal engineering specification. Biocompatibility would be assessed against ISO standards (e.g., ISO 10993 series).
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied.

In summary, the provided document details a 510(k) submission for a medical device that controls bleeding. The "study" mentioned is a brief summary of non-clinical tests to assess functional aspects and biocompatibility, not a clinical trial or a diagnostic performance study. The device's clearance is based on substantial equivalence to predicate devices, focusing on indications for use and technological characteristics rather than meeting specific quantitative performance criteria through a detailed clinical study.

Summary

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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

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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.

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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

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Indications for Use Statement

K050133

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

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K050133
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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 CourtMinneapolis, Minnesota 55369
Establishment Registration:	2134812
Contact:	Linda BuskleinSr. Regulatory Affairs Associate(763) 656-4349 phone(763) 656-4250 fax
Performance Standards:	No performance standards have been developed under section514 for this device.
Device Description:	The D-Stat Radial Hemostatic Band consists of a lyophilized padcontaining thrombin, sodium carboxymethylcellulose, andcalcium chloride secured to a application device consisting of anadjustable retention strap, retainer, and attached pads.Afterhemostasis has been achieved, the lyophilized pad may beremoved from the application device, covered with a providedadhesive bandage, and left in place for up to 24 hours.
Intended Use:	The D-Stat Radial Hemostatic Band is applied topically and isindicated for the control of surface bleeding from vascularaccess sites and percutaneous catheters or tubes.
Summary of Non-Clinical Testing:	Tests conducted included assessment of the ability to separatethe lyophilized pad from the retainer and a biocompatibilityassessment 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 tothe currently marketed D-Stat Radial Hemostatic Band and theD-Stat Dry Hemostatic Bandage, based on a comparison of theindications for use and the technological characteristics of thedevice.

Regulation Number and Section

N/A