The Radial Artery Compression Tourniquet Device is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, haemodialysis, and in patients on anticoagulation therapy.

Device Description

The Radial Artery Compression Tourniquet devices consist of a plastic belt with an adjustable fastener on each end, two compression balloons, tubing and a unilateral valve. The plastic belt has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist and are made of clear plastic which allows the physician to view the access site during the haemostasis process. The inflation device introduces air through the unilateral valve filling two compression balloons (large and small) at the same time. The top small balloon is layered and internally connected to the bottom large balloon. The result of the balloon inflation is the haemostasis of the puncture site within the patient's wrist.

AI/ML Overview

The provided text describes the Radial Artery Compression Tourniquet and its substantial equivalence to predicate devices, but it does not contain the specific information requested in points 1 through 9 regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.

The document details the device's description, intended use, contraindications, warnings, and cautions. It also mentions "Tests Conducted," which include:

Biocompatibility: Assessed against ISO 10993 Biological Evaluation of Medical Devices - Part 10 for Irritation and Sensitization and Part 5 Tests for Cytotoxicity. It states that the device "has been shown to meet the acceptance criteria, and did not raises additional safety and effectiveness concerns."
Performance: A "side-by-side comparison of the predicate TR Band®, Terumo Corporation, K070423 performance of the balloon’s maintenance of internal pressure was performed with the Lepu’s device." The conclusion is that "The balloon profile performance characteristics of both devices are very similar when factoring the balloon size and volume inflation difference and do not impose any additional safety or performance issues."

However, this information is for a physical medical device (a tourniquet) and not for an AI/algorithm-based device. Therefore, the requested details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth for training was established are not present in the provided text.

Based on the provided text, the answer to the specific questions regarding acceptance criteria and a study proving the device meets those criteria for an AI/algorithm would be:

Table of acceptance criteria and reported device performance: Not applicable for an AI/algorithm performance study. The document mentions biocompatibility acceptance criteria (meeting ISO 10993 standards) and performance comparison of balloon pressure maintenance to a predicate device, concluding similarity.
Sample size for the test set and data provenance: No test set information for an AI/algorithm is provided.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for an AI/algorithm.
Adjudication method: Not applicable for an AI/algorithm.
Multi reader multi case (MRMC) comparative effectiveness study: No MRMC study is mentioned.
Standalone performance: No standalone (algorithm only) performance is mentioned.
Type of ground truth used: Not applicable for an AI/algorithm. For the physical device, the "ground truth" for biocompatibility was meeting ISO standards, and for performance, it was comparable balloon pressure maintenance to a marketed predicate.
Sample size for the training set: No training set information for an AI/algorithm is provided.
How the ground truth for the training set was established: Not applicable for an AI/algorithm.

Summary

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Section 5: 510k) Summary

The Summary of Safety and Effectiveness on the Radial Artery Compression Tourniquet reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tequire alterations of the conclusions or recommendations set forth.

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Applicant:	Lepu Medical Technology (Beijing) Co., Ltd.
	No. 37 Chaoqian Road
	Changping District, Beijing 102200
	P.R. ChinaSEP 27 2011
Telephone:	+86-10-80120641
Date:	June 27, 2011
Name:	Radial Artery Compression Tourniquet
Common Name:	Vascular Compression Device
Classification Name:	Vascular Clamp
Classification:	870.4550
Product Code:	DXC
Predicate:	TR Band®, Terumo Corporation, K070423 and RadAR™ VascularCompression Devices, Advanced Vascular Dynamics Division, K092503with market clearance dates of March 28, 2007 and November 19, 2009respectively.
Description:	The Radial Artery Compression Tourniquet devices consist of a plastic beltwith an adjustable fastener on each end, two compression balloons, tubingand a unilateral valve. The plastic belt has a support plate over the twocompression balloons to assure that the balloons and belt conform to thecontour of the wrist and are made of clear plastic which allows thephysician to view the access site during the haemostasis process. Theinflation device introduces air through the unilateral valve filling twocompression balloons (large and small) at the same time. The top smallballoon is layered and internally connected to the bottom large balloon.The result of the balloon inflation is the haemostasis of the puncture sitewithin the patient's wrist.
Intended Use	The Radial Artery Compression Tourniquet Device is a compression deviceto assist haemostasis following a catheterization or other puncture into ablood vessel in a patient's arm, including radial artery catheterization,arterial or venous line removal, haemodialysis, and in patients onanticoagulation therapy.
Contraindications	• Patients hypersensitive to the materials of compression device.• Patients with infection or other serious skin diseases at the site ofpuncture.• Patients with an abnormal Allen test or radial pulse, or insufficient dualarterial supply.• Not intended for femoral artery compression.
Warning	• Patients should not be left unattended while the Radial ArteryCompression Tourniquet is in use.• Ensure correct alignment of the Radial Artery Compression Tourniquetprior to use.• Do not inject air into any port other than the air injection port of thisdevice.• Do not leave Radial Artery Compression Tourniquet on forinappropriately long periods of time as tissue damage may occur.• Arterial pulse distal to the compression site should be monitored toensure the artery is not completely occluded as arterial damage and/orthrombosis could occur.
Caution	• Ensure correct placement of Radial Artery Compression Tourniquet.• Federal (USA) law restricts this device to sale by or on the order of aphysician.• The product is intended for single use only.• Do not reuse or re-sterilize.• Do not use if package opened or damaged.• Over inflation of balloon > 20 ml as balloon damage could occurcompromising the performance of the Radial Artery CompressionTourniquet.• The diameter of the wrist at the site of puncture is too large or toosmall, which exceeds the allowable range of compression device.
SubstantialEquivalencyInformation	The information provided in this submission, comparing intended use,principle of operation and overall technological characteristics, the RadialArtery Compression Tourniquet Devices is substantially equivalent toexisting legally marketed devices and the operational differences betweenthe predicate device RadAR™ Vascular Compression Devices and theRadial Artery Compression Tourniquet Devices does not present asignificant effect in the therapeutic outcome.
Tests Conducted	Biocompatibility: The Radial Artery Compression Tourniquet was assessedagainst the standard ISO 10993 Biological Evaluation of Medical Devices- Part 10 for Irritation and Sensitization and Part 5 Tests for Cytotoxicity,has been shown to meet the acceptance criteria, and did not raisesadditional safety and effectiveness concerns.Performance: A side-by-side comparison of the predicate TR Band®,Terumo Corporation, K070423 performance of the balloon's maintenanceof internal pressure was performed with the Lepu's device. The balloonprofile performance characteristics of both devices are very similar whenfactoring the balloon size and volume inflation difference and do notimpose any additional safety or performance issues.
TechnologicalCharacteristics	The device features of the Lepu LPY20 models Radial Artery CompressionTourniquet and the predicate devices are very similar. All three productshave an adjustable strap and apply pressure to the puncture site in thepatient's arm. There are some design variations, but these do not affect thesubstantial equivalence of the Lepu LPY20 Radial Artery CompressionTourniquet Devices.

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Section 5: 510k) Summary

The Summary of Safety and Effectiveness on the Radial Artery Compression Tourniquet reflects data available and represented at the time the submission was prepared, but caution should be execised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

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

2011 SEP 27

Lepu Medical Technology (Beijing) Co., Ltd. c/o Mr. Arthur S. Goddard FDA Regulatory and Quality Systems Consultant 1531 Felton Road South Euclid. OH 44121-2722

Re: K111837

Trade/Device Name: Radial Artery Compression Tourniquet Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: June 27, 2017 Received: June 29, 2011

Dear Mr. Goddard:

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. Ifsting 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

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Page 2 - Mr. Arthur S. Goddard

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 dotermination 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 électronic 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm135809.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/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 Small Manufacturers, International and Consumer Assistance 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,

Dr. D. Zukerman, M.D.

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

Enclosure

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(11/837 510(k) Number (if known): _

Device Name: Radial Artery Compression Tourniquet

Indications for Use:

The Radial Artery Compression Tourniquet is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

510(k) Number

Over-The-Counter Use (Optional Format 1-2-96)

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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).