The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

Device Description

The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm. All materials are identical to GliderXtreme product. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices. The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

AI/ML Overview

The provided text describes the 510(k) summary for the TriReme Medical, Inc. Chocolate PTA Balloon Catheter. This device is an angioplasty catheter primarily relying on substantial equivalence to predicate devices, rather than a novel AI/ML algorithm requiring extensive clinical trials for performance validation. Therefore, many of the typical acceptance criteria and study components related to AI/ML device performance (like human reader studies, ground truth establishment, training sets) are not applicable in this context.

However, I can extract the relevant performance data and aspects that were used for FDA clearance in this traditional medical device submission.

Here's a breakdown based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (angioplasty catheter), performance is typically demonstrated through bench testing against established standards and comparison to predicate devices, rather than accuracy metrics seen in AI/ML. The provided document lists the tests performed, which serve as the "acceptance criteria" for demonstrating safety and effectiveness.

Acceptance Criteria (Bench Test Performed)	Reported Device Performance
Balloon Rated Burst Pressure	Assumed to meet specified pressure ratings; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Balloon Inflation and Deflation	Assumed to perform as intended; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Balloon Fatigue / CS Fatigue	Assumed to meet durability requirements; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Catheter Body Strength (Bond Strength)	Assumed to meet strength requirements; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Torsional Strength	Assumed to meet strength requirements; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Catheter Diameter, Balloon Profile & Tip Configuration	Assumed to meet specified dimensions and configurations; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Balloon Compliance	Assumed to meet specified compliance chart values; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Trackability, Pushability	Assumed to perform adequately; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Kink Resistance	Assumed to resist kinking during use; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Device Interface Compatibility	Assumed to be compatible with standard accessories; demonstration of "reliable achievement of desired effect" and "saf[ety] for its intended use." (Conclusion)
Overall Conclusion	"Performance testing demonstrated that the Chocolate Balloon Catheter reliably achieved the desired effect and is safe for its intended use. No new questions of safety or effectiveness were identified during device testing."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each bench test. The "test set" refers to the physical devices undergoing the described in vitro (bench) testing. The data provenance is from bench testing conducted by the manufacturer, TriReme Medical, Inc. There is no mention of human subject data or its origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. For a traditional medical device like a balloon catheter, "ground truth" is established through engineering specifications, material science, and established in vitro testing methodologies, not through expert consensus on medical images or clinical outcomes in the same way an AI device would.

4. Adjudication Method for the Test Set

Not applicable. Bench testing results are typically objectively measured against pre-defined engineering specifications, not subject to human adjudication methods like 2+1 or 3+1.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This type of study assesses how human performance improves with AI assistance and is not relevant for a standalone physical medical device like this balloon catheter.

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

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent in its design and manufacturing.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) for evaluating this device's performance would be:

Engineering Specifications and Industry Standards: Performance metrics (e.g., burst pressure, inflation/deflation times, material strength, dimensional tolerances) are compared against pre-defined engineering specifications for the device and relevant industry standards for angioplasty catheters.
Predicate Device Performance: A key aspect of this 510(k) submission is the demonstration of substantial equivalence to predicate devices, meaning its performance should be similar or better than those already cleared.

8. The Sample Size for the Training Set

Not applicable. There is no training set for a physical medical device. This term is used in the context of machine learning, where an algorithm learns from a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

K111738

DEC 1 4 2011

510(k) Summary [As required by 21 CFR 807.92(c)]

1. Submitter's Name / Contact Person

Submitter:	TriReme Medical, Inc.7060 Koll Center Parkway, Suite 300Pleasanton, CA 94566
Contact Person:	Shiva ArdakaniVP of RA/QAPhone: 925-931-1300 Ext 209Fax: 925-931-1361
Date Prepared:	April 8, 2011

General Information

Trade Name:	Chocolate PTA Balloon Catheter
Common/Usual Name:	Angioplasty Catheter
Classification Name:	Percutaneous Catheter (21 CFR 870.1250)
Product Code:	DQY / LIT
510(k) number:

Predicate Devices:	NanoCross PTA Dilatation Catheter (K090849)VascuTrak PTA Dilatation Catheter (K082343)GliderXtreme PTA Balloon Catheter (K101062)
--------------------	-------------------------------------------------------------------------------------------------------------------------------------------

3. Intended Use

The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

Device Description 4.

The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.

All materials are identical to GliderXtreme product. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is

{1}------------------------------------------------

used to inflate the balloon; the luer connector is compatible with standard inflation devices.

The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

1. Performance Data
  Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. The following in vitro tests were performed:
Balloon Rated Burst Pressure ●
Balloon Inflation and Deflation ●
Balloon Fatigue /CS Fatigue .
Catheter Body Strength (Bond Strength) .
. Torsional Strength
Catheter Diameter, Balloon Profile and Tip Configuration .
Balloon Compliance ●
. Trackability, Pushability
Kink Resistance .
Device Interface Compatibility .
1. Substantial Equivalence Comparison and Conclusion

All Chocolate PTA Balloon Catheters are substantially equivalent to the predicate devices in design, materials, packaging, fundamental scientific technology, manufacturing, sterilization and intended use. Performance testing demonstrated that the Chocolate Balloon Catheter reliably achieved the desired effect and is safe for its intended use. No new questions of safety or effectiveness were identified during device testing. Therefore, All Chocolate PTA Balloon Catheters are considered substantially equivalent to the predicate devices.

... ..........................................................................................................................................................................

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three curved lines representing its wings and body, and it is positioned above the words "USA".

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

Trireme Medical c/o Mr. Bhavesh Sheth 2307 E Aurora Rd., Unit B7 Twinsburg, OH 44087

DEC 1 4 2011

Re: K111738

Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY/LIT Dated: November 22, 2011 Received: November 29, 2011

Dear Mr. Sheth:

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

{3}------------------------------------------------

Page 2 - Mr. Bhavesh Sheth

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Wilhelm

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

{4}------------------------------------------------

Indications for Use

510(k) Number (XXXXX): 《[1] 738

Device Name: Chocolate PTA Balloon Catheter

Indications for Use:

The indication for use is same for all Chocolate PTA Balloon Catheter Family.

Prescription Use X (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)

.g. Willhemen

(Division Sign-Off) Division of Cardiovascular Devices

1111738 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).