The Chocolate™ XD PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.

Device Description

The Chocolate XD PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire.

AI/ML Overview

The provided document is a 510(k) summary for the TriReme Medical Chocolate XD PTCA Balloon Catheter. This document does not contain information on the acceptance criteria, study design, or results for an AI/ML powered device. It describes a medical device, a balloon catheter, and its equivalence to a predicate device, based on standard performance testing for devices of this type, not for an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device from this document.

The document discusses standard device performance testing for a physical medical catheter, such as:

Dimensional Verification
Balloon Preparation, Deployment & Retraction
Flexibility & Kink
Balloon Rated Burst Pressure (RBP)
Rate Burst Pressure in Stent
Balloon Fatigue
Balloon Fatigue in Stent
Balloon Compliance
Balloon Inflation and Deflation
Catheter Bond Strength
Tip Pull Test
Torque Strength
Radiopacity
Particulate Evaluation
Biocompatibility Testing

These are physical and material property tests to ensure the catheter functions safely and effectively, not diagnostic performance metrics for an AI system.

Summary

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

June 23, 2016

TriReme Medical, LLC Shiva Ardakani Sr. VP of RA/QA and Compliance 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566

Re: K153682

Trade/Device Name: Chocolate XD PTCA Balloon Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 19, 2016 Received: May 24, 2016

Dear Shiva Ardakani,

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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 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,

Kenneth J. Cavanaugh -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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3. Indications for Use

510(k) Number (XXXXX): K153682

Device Name: Chocolate XD™ PTCA Balloon Catheter

Indications for Use:

Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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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and

4. 510(k) Summary

Submitter's Name / Contact Person

Submitter:	TriReme Medical, LLC
	7060 Koll Center Parkway, Suite 300
	Pleasanton, CA 94566 U.S.A.
Contact Person:	Shiva Ardakani
	Senior VP of Regulatory / Quality & Compliance
	Phone: (925) 931-1300
	Fax: (925) 931-1361
Date Prepared:	December 17, 2015
General Information
Trade Name:	Chocolate™ XD PTCA Balloon Catheter
Common / Usual Name:	PTCA catheter
Product Code:	LOX
Classification Name:	Percutaneous transluminal coronary angioplasty (PTCA) catheter[21 CFR 870.5100(a)]
Predicate Device:	Chocolate PTCA Balloon Catheter (TriReme Medical) - ( K133632 K150292)

Device Description

Intended Use / Indications

The Chocolate™ XD PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including In-Stent Restenosis.

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Technological Characteristics/Performance Testing/Substantial Equivalence

The subject device has classification information, indication for use, fundamental design features, mechanism of action, materials, and principle of operation identical to the predicate device. The device specifications are all similar and within the range of the predicate devices. Testing requirements for this device was based upon the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010).

Dimensional Verification .
Balloon Preparation, Deployment & Retraction
Flexibility & Kink
Balloon Rated Burst Pressure (RBP)
Rate Burst Pressure in Stent
Balloon Fatigue ●
Balloon Fatigue in Stent
Balloon Compliance
Balloon Inflation and Deflation
Catheter Bond Strength
. Tip Pull Test
Torque Strength ●
. Radiopacity
Particulate Evaluation ●
Biocompatibility Testing ●

Conclusion:

No new questions of safety or effectiveness were identified during device testing; therefore, the Chocolate XD PTCA Balloon Catheter is considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.