Vasc Band hemostat (Vasc Band) is a compression device that applies mechanical pressure to achieve hemostasis of vascular access sites. Vasc Band consists of an adjustable retention strap, inflatable compression balloon, inflation tube, and an inflation valve. A 22 ml inflation syringe is also included with the device. Vasc Band is available in five band lengths: 21 cm, 27 cm, 29 cm, and 37 cm.

AI/ML Overview

The provided text is a 510(k) Summary for the Vasc Band hemostat. While it discusses the device's substantial equivalence to predicate devices and mentions "bench tests to provide evidence," it does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria in the way a clinical study or detailed performance report would.

The document is a regulatory submission, primarily focused on establishing substantial equivalence to legally marketed predicate devices, rather than providing an in-depth scientific study report with specific performance metrics against pre-defined acceptance thresholds.

Here's what can be extracted and what information is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in a quantitative manner for specific performance metrics.	"Results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness." (Page 4)
(Implicitly: Device functionality as a compression device for hemostasis)	"Vasc Band is substantially equivalent to the specified predicate devices based on comparison of the device functionality, technological characteristics, and indications for use." (Page 4)
(Implicitly: Balloon pressure and band size)	"The device design has been verified through balloon pressure and band size tests." (Page 4)

2. Sample size used for the test set and the data provenance

Sample size: Not specified. The document mentions "bench tests" but does not detail how many units were tested or how many measurements were taken.
Data provenance: Not specified beyond "bench tests." It's typically ex-vivo or in-vitro for bench tests, but this isn't stated. Country of origin of the data is not mentioned. Whether retrospective or prospective is not applicable to bench tests as described here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "bench tests" would likely involve engineering or quality control personnel evaluating physical properties, not clinical experts establishing ground truth in a diagnostic sense.

4. Adjudication method for the test set

This is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpreting ambiguous results, which is not described for these bench tests.

5. 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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical hemostat and not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The Vasc Band hemostat is a physical medical device, not an algorithm.

7. The type of ground truth used

For the "bench tests," the "ground truth" would be the engineering specifications and performance standards for physical properties like balloon pressure and band size. This is implicitly "engineering specifications" or "physical measurements" rather than expert consensus, pathology, or outcomes data, as those apply to diagnostic or treatment efficacy studies.

8. The sample size for the training set

This is not applicable. The device is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this type of device.

In summary: The provided document is a regulatory submission for a physical medical device. It attests to the device's substantial equivalence to predicates based on "bench tests" verifying device design (balloon pressure and band size). It does not provide the detailed scientific study data, specific acceptance criteria values, or expert review processes that would be typical for validating diagnostic algorithms or complex clinical interventions. The focus is on demonstrating that the new device is fundamentally similar in function and safety to already-approved devices, rather than proving novel effectiveness through a comprehensive, quantitative clinical or AI performance study against acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other, with flowing lines extending from the heads.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 23, 2014

Lepu Medical Technology (Beijing) Co., Ltd. c/o Ms. Erin Badali Sr. Regulatory Operations Associate Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K142359

Trade/Device Name: Vasc Band Hemostat Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 26, 2014 Received: August 27, 2014

Dear Ms. Badali.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilleman

for

for
Bram D. Zuckerman, M.D.
Director Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K142359

Device Name: Vasc Band hemostat

Indications for Use:

The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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2 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: August 22, 2014

510(k) Number: _________

Submitter's Name / Contact Person

Manufacturer Lepu Medical Technology (Beijing) Co., Ltd. No. 37 Chaogian Road Beijing, Changping District, CH 102200 Establishment Registration # 3008002401

Regulatory Correspondent

Erin Badali Sr. Regulatory Operations Associate Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 Tel: 763-656-4300 Fax: 763-656-4253

General Information

Trade Name	Vasc Band
Common / Usual Name	hemostat
Classification Name	870.4450, DXC – Clamp, vascular, Class II
Predicate Device(s)	K111837 - Radial Artery Compression Tourniquet, Lepu Medical
	K081740 - HemoBand, Hemoband Corporation

Device Description

Intended Use / Indications

The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.

Technological Characteristics

Vasc Band has the same intended use as the predicate devices and the same indications for use statement as HemoBand. Vasc Band has the same materials of construction as the predicate Radial Artery Compression Tourniquet and is similar in design as both devices are sterile compression bands that use an inflatable balloon to apply pressure at an access site to achieve hemostasis. Vasc Band is available in a wider range of lengths than the predicate devices.

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Substantial Equivalence and Summary of Studies

Technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence of Vasc Band substantial equivalence. Vasc Band is substantially equivalent to the specified predicate devices based on comparison of the device functionality, technological characteristics, and indications for use. The device design has been verified through balloon pressure and band size tests.

Results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness. Therefore, Vasc Band is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).