The RadAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, brachial, dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in patients on anticoagulation therapy.

Device Description

The RadAR™ Vascular Compression Devices consist of a strap with a housing with controls for device securement and adjustment, and a compression pad. The product is designed to reduce blood flow in the subject blood vessel compressed by the pad, while allowing blood flow in other vessels in the arm or the leg to promote hemostasis at the vascular puncture site. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow into the compressed blood vessel during puncture site hemostasis. This device is not life supporting or life sustaining. The product is provided individually packaged. It is a sterile, single use device.

AI/ML Overview

This FDA 510(k) summary for the RadAR™ Vascular Compression Devices (K142122) explicitly states that no new testing was deemed required, and no performance testing or clinical evaluations were submitted for this 510(k).

The basis for the device's acceptance is its substantial equivalence to previously cleared predicate devices, specifically:

The RadAR™ Vascular Compression Devices cleared under 510(k) K092503 (itself).
The HemoBand® manufactured by Innovations for Access, Inc. (K081740).

Therefore, based on the provided document, I cannot provide the requested information regarding:

A table of acceptance criteria and the reported device performance: No new performance data was presented.
Sample size used for the test set and the data provenance: No new test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set was used.
Adjudication method for the test set: Not applicable as no new test set was used.
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 a physical medical device, not an AI/software device involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable as no new testing was performed for this submission.
The sample size for the training set: Not applicable as no new testing was performed for this submission.
How the ground truth for the training set was established: Not applicable as no new testing was performed for this submission.

The document indicates that the current 510(k) submission (K142122) is primarily to revise the indications for use for the RadAR™ Vascular Compression Devices. The manufacturer leveraged information and testing from the previous clearance (K092503) for the same device to support the substantial equivalence claim for the expanded indications.

Conclusion stated in the document:
"Previous testing on the submitted RadAR™ Vascular Compression Device has demonstrated that this device is as safe and as effective as the predicate devices."

This means the acceptance criteria and performance data for this device are implicitly tied to the previous 510(k) clearances and the performance characteristics of the predicate devices. The current submission did not involve new studies to generate new performance data.

Summary

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

December 4, 2014

Advanced Vascular Dynamics Mr. Matthew Semler President 4252 SE International Way, Suite F Milwaukie, Oregon 97222

Re: K142122

Trade/Device Name: Radar Vascular Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: October 1, 2014 Received: October 2, 2014

Dear Mr. Semler:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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. Hillebrenner

for

Bram D. Zuckerman, M.D. 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): K142122

Device Name: RadAR™ Vascular Compression Assist Devices

Indications for Use:

Prescription Use __ X

Over-The-Counter Use __

(Part 21 CFR 801 Subpart D)

AND/OR

(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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510(k) Summary

Submitter's name:	Advanced Vascular Dynamics
	4252 SE International Way, Ste. F
	Milwaukie, OR 97222

Contact name and address:	Matthew Semler, President
	4252 SE International Way, Ste. F
	Milwaukie, OR 97222
	(503-223-2333 ext. 382)

Date summary prepared: 14 November 2014

Device name:

Proprietary name:	RadAR™ Vascular Compression Devices
Common or usual name:	Vascular compression device
Classification name:	Vascular clamp (870.4450), Vascular clamp (74 DXC)

Legally marketed device for substantial equivalence comparison:

The predicate devices for this submission are the RadAR™ Vascular Compression Devices submitted by Advanced Vascular Dynamics and cleared for marketing under 510(k) K092503, and the HemoBand®, manufactured by Innovations for Access, Inc. (K081740).

Description of the device:

Intended use of the device:

The RadAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, brachial, dorsalis or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in patients on anticoagulation therapy.

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Technological characteristics:

The device features of the RadAR™ Vascular Compression Devices and the HemoBand® Device are similar. They are adjustable straps that are applied around an arm or a leg, to apply pressure to a restricted area. There are some design variations, but the means of applying external compression for the purpose of reducing blood flow in the subject blood vessel remains substantially equivalent, in that a device is pressed against a portion of the limb.

Testing conducted:

Since this submission applies to the RadARTM Vascular Compression Devices to revise the indications for use, no additional testing has been deemed to be required. As its own predicate device, the device, production, and sterilization testing reported in K092503, apply. Although no new testing was performed, testing on the predicate device has been leveraged to demonstrate that the submitted device is appropriate for the new indications for use. No further testing has been deemed necessary.

Performance Testing:

Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).

Conclusion:

Previous testing on the submitted RadAR™ Vascular Compression Device has demonstrated that this device is as safe and as effective as 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).