When applied by a trained health care professional, the TZ Medical ARC™ device is indicated to assist in controlled compression hemostasis of the radial artery after a transradial procedure; the device is indicated to compress the radial artery access puncture site in order to achieve hemostasis and maintain patency of the radial artery (patent hemostasis).

Device Description

The TZ Medial ARC Adjustable Radial Cuff "ARC" compression device is used at the end of a Transradial catheterization procedures to provide hemostasis of the radial artery at the access site. The ridged brace designed radial compression device consisting of a rigid polycarbonate "C" shaped brace, a flexible strap containing a PVC backing, hook and loop fasteners, and two buckles which attach to the ends of the brace, a collapsible bubble fixed to an adjustable slider with an air fill tube and universal luer lock, as well as back pad opposite of the bubble for patient comfort. Each device also includes a standard 20cc male luer locking syringe.

The Cuff is positioned around the patient's wrist and secured in place by fastening and tightening the Back Hook and Strap Assembly. As the introducer sheath is removed from the patient's wrist, pressure is applied to the access site by inflating the compression bubble of the ARC device. The bubble is inflated when air is injected through a luer lock air injection port which assures the desired air volume/pressure remains in the compression bubble. The volume/pressure in the bubble can be titrated by the physician to meet the hemodynamic needs of the patient by increasing or decreasing the volume in the ARC device bubble.

The ARC devices is intended for a single use only with a Functional life is less than 24 hours. This device is individually packaged and sterilized by ethylene oxide gas.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ARC Adjustable Radial Cuff Compression Device." This document outlines the device's indications for use, its comparison to a predicate device (Terumo TR Band), and mentions performance testing conducted to verify conformity to applicable standards. However, it does not describe a study that involves an AI/ML device, nor does it contain information related to acceptance criteria or performance metrics such as those typically found in clinical trials for diagnostic or AI-assisted devices (e.g., sensitivity, specificity, AUC).

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a physical medical device (a vascular clamp/compression device). The "Performance Testing" section (M) refers to verification of conformity to external and internal standards (e.g., ISO standards for biological evaluation, risk management, sterilization, quality management, packaging). It also mentions Design Verification (DV) functional performance testing which included in-vitro engineering and bench testing on components.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets those criteria, as the provided text does not pertain to such a device or study.

If you have a different document or context related to an AI/ML medical device, please provide it, and I will do my best to answer your detailed questions.

Summary

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January 10, 2018

TZ Medical, Inc. John Lubisich President 17750 SW Upper Boones Ferry Rd #150 Portland, Oregon 97224

Re: K173563

Trade/Device Name: ARC Adjustable Radial Cuff Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: November 10, 2017 Received: November 17, 2017

Dear John Lubisich:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole G. Ibrahim -S

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) K173563

Device Name

ARC Adjustable Radial Cuff compression Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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A.) Submitter Name and Address:	TZ Medical, Inc.
	17750 SW Upper Boones Ferry Rd #150
	Portland, OR 97224
	Phone: 503-639-0282
	FAX: 503-639-0239

B.) Submitter's Establishment andRegistration Number:	TZ Medical Inc. 3027815
C.) Contact Person:	John LubisichManagement RepresentativeTEL: 503-639-0282FAX: 503-639-0239
D.) Date of Summary:
E.) Trade name/Date of Summary:
F.) Trade name/Proprietary:	ARC Adjustable Radial Cuff
G.) Common Name:	Cardiovascular, Vascular Clamp, CompressionDevice
H.) Classification Name:	Cardiovascular (Vascular Clamp) Surgical device

I.) Classification: CLASS II, per 21 CFR 870.4450

J.) Product Class/Panel: DXC, Cardiovascular

K.) Predicate Device:

Product	510K Number
Terumo Medical: TR Band Radial Compression Device	K152525

L.) Device Description:

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The ARC devices is intended for a single use only with a Functional life is less than 24 hours. This device is individually packaged and sterilized by ethylene oxide gas.

K173563

M.) Performance Testing:
- Performance testing was conducted to verify conformity to applicable external and internal standards. All a. testing meant acceptance criteria of the below listed Standards and test procedures.

Standard Designation	Standard Name
ISO 10993-1	Biological Evaluation of Medical Devices Part 1Evaluation and Testing
ISO 14971	Medical Devices- Applications of Risk Managementto medical devices
ISO 15223-1	Medical device- Symbols to be used with medicaldevice labels, labeling and information to besupplied- Part 1 general requirements
ISO 11135-1	Sterilization of Healthcare products- Ethylene OxideRequirements for Development, Validation andRoutine Control of Sterilization Process of MedicalDevices
ISO 13485	Medical devices- Quality management systems-Requirements for regulatory purposes.
ISO 11607-1	Requirements for materials, sterile barrier systemsand packaging systems
Internal Standards:	Included, but not limited to:Visual/AppearanceDimensionalFunctional Performance

N.) Non Clinical Data: Design Verification (DV) functional performance testing was completed to demonstrate that the ARC Adjustable Radial Cuff is substantially equivalent to the testing included in-vitro engineering and bench testing on components and finished devices which were representative of commercial device and including, but not limited to: Visual/Appearance, Dimensional, Nonclinical and Functional Performance.
O.) ARC Indication for Use: When applied by a trained health care professional, the TZ Medical ARC™ device is indicated to assist in controlled compression hemostasis of the radial artery after a transradial procedure; the device is indicated to compress the radial artery access puncture site in order to achieve hemostasis and maintain patency of the radial artery (patent hemostasis).
P.) Terumo Medical Predicate Indication for Use: The TR BAND® Radial Compression device is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Q.) Comparison to Predicate Devices: The substantial equivalence of the TZ Medical ARC Adjustable Radial Cuff is based on an equivalence in intended use, method of operation and action, materials, and relative indications and contraindications, meeting internal and external standards to the predicate device, Terumo Medical TR Band Radial Compression Device K152525.

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Item	Terumo TR Band™™	TZ Medical ARCTM	Comments
Manufacturer	Terumo Corporation	TZ Medical LLC	Equivalent
Intended Use	The TR BAND® RadialCompression Device is acompression device to assisthemostasis of the radial arteryafter a transradial procedure.	When applied by a trainedcare professional, the TZMedical ARC device isdesigned to assist incontrolled compressionhemostasis of the radialartery after a transradialprocedure, the device isdesigned to compress theradial artery access puncturesite in order to achievehemostasis and maintainpatency of the radial artery(patent hemostasis).	Equivalent
OperationalPrinciple	Operated manually,Pneumatic compression twoballoons are filled to applypressure to the access site	Operated manually, Pneumaticcompression a double stackedballoon is filled to applypressure to the access site.	Equivalent
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Equivalent
Packaging	Unit PouchShelf BoxShipping Carton	Unit PouchShelf BoxShipping Carton	Equivalent
Shelf Life	30 months	30 months	Equivalent
SingleUse/Disposable	Yes	Yes	Equivalent

R.) Conclusion: The TZ Medical ARC Adjustable Radial Cuff device, subject of this 510(k), is substantially equivalent in its intended use/indication for use, technical/principals of operation, materials and performance to the Terumo Medical Corporation TR Band (K152525).

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).