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.

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

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 approved PTA Balloon Catheter family of products. 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 Chocolate PTA Balloon Catheter, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metric acceptance criteria in the way typically discussed for AI/ML devices.

The document is a regulatory submission for a medical device (a balloon catheter), and the "performance data" section focuses on bench testing to establish substantial equivalence to predicate devices, rather than meeting quantitative performance metrics against a defined standard.

Therefore, many of the requested sections (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, training set ground truth) are not applicable to this type of traditional medical device submission and its associated testing.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in a quantitative format. Instead, it lists the types of in vitro tests performed to demonstrate product safety and effectiveness for substantial equivalence. The "reported device performance" is implicitly summarized by the statement:

"Performance testing demonstrated that the devices reliably achieved the desired effect and are safe for the intended use."

The tests performed are:

Balloon Rated Burst Pressure
Balloon Inflation and Deflation
Balloon Fatigue / CS Fatigue
Catheter Diameter, Balloon Profile and Tip Configuration
Balloon Compliance
Trackability, Pushability
Kink Resistance
Device Interface Compatibility

There are no specified numerical acceptance thresholds or results provided for these tests in this summary. The goal was to show they "conformed to the requirements for its intended use" and were "substantially equivalent" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The performance data section refers to "bench testing" (in vitro tests), not clinical studies involving patient data or a test set in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by experts for a test set in this context. The "ground truth" for these tests would be the established performance specifications for the physical properties of the device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set was mentioned.

5. 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/ML algorithm that assists human readers.

6. 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.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the AI/ML sense. The "ground truth" for the listed in vitro tests would be the predefined engineering specifications and industry standards for medical device performance.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of traditional medical device bench testing.

9. How the ground truth for the training set was established

Not applicable. As above, no training set.

Summary

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K120677

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

MAR 1 5 2012

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:	December 28, 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)
	PTA Balloon Catheter Family (K101062, K103534, K111738)

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.

1. 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.

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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.

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 Diameter, Balloon Profile and Tip Configuration
. Balloon Compliance
Trackability, Pushability .
. Kink Resistance
Device Interface Compatibility .
Substantial Equivalence Comparison and Conclusion 6.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three distinct lines forming the body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

MAR 1 5 2012

William Sammons Intertek Testing Services NA, Inc. 2307 E Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K120677

Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: LIT, DQY Dated: March 5, 2012 Received: March 6, 2012

Dear Mr. Sammons:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premaint is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regarly manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderal Food Drug commerce prior to May 28, 1970, the enactivent and of the Federal Food, Drug, devices that have been reciassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval applicions of the Act . The and Cosmetic Act (Act) inal do not require the general controls provisions of the Act. The Act. The You may, meretore, market the device, secject to ween and registration, listing of
general controls provisions of the Act include requirements michranding and general controls provisions of the Act mercial valuations against mistranding and devices, good manufacturing placitics, idooming information related to contract liability. adulteration. Please note: CDKH does not evaluate information of misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
If your device is classified (see above) mio cinter eigs) in affecting your device can be
may be subject to additional controls. Existem as affecting your device EDA may may be subject to additional comrois. Existing films 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FD found in the Code of Federal Regulations, This 20, 11:00 Levice in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial equivalents with other requirements of the Act
that FDA has made a determination that your device complies with other r

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Page 2 - Mr. William Sammons

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 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,

Bramy
Direct

Bram/D. Zuckerman, M.D. Difector 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 (XXXXX):

Device Name: Chocolate PTA Balloon Catheter

Indications for Use:

The indication for use is the same for all members of the 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)

ivision Sign-Off) scular Devices Division of Cardioy 510(k) Number

12/28/2011

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).