CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G by TRIREME MEDICAL INC

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 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 document describes the Chocolate PTA Balloon Catheter, a medical device. The 510(k) summary focuses on establishing substantial equivalence to predicate devices, primarily through bench testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Tests Performed)	Reported Device Performance
Balloon Rated Burst Pressure	Performed. Results support substantial equivalence.
Balloon Inflation and Deflation	Performed. Results support substantial equivalence.
Balloon Fatigue / CS Fatigue	Performed. Results support substantial equivalence.
Catheter Diameter, Balloon Profile and Tip Configuration	Performed. Results support substantial equivalence.
Balloon Compliance	Performed. Results support substantial equivalence.
Trackability, Pushability	Performed. Results support substantial equivalence.
Kink Resistance	Performed. Results support substantial equivalence.
Device Interface Compatibility	Performed. Results support substantial equivalence.

Study that proves the device meets the acceptance criteria:

The study conducted was a series of bench tests (in vitro tests) designed to evaluate the physical and mechanical properties of the Chocolate PTA Balloon Catheter. The purpose of these tests was to demonstrate that the device performs reliably and safely for its intended use, and that its performance is substantially equivalent to predicate devices.

Specific Information not available in the text:

The document broadly states that "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" and "Performance testing demonstrated that the devices reliably achieved the desired effect and are safe for the intended use." However, it does not provide specific quantitative acceptance criteria or detailed results for each individual test. For example, it doesn't state what the accepted range for balloon rated burst pressure was, or the actual burst pressures observed.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the sample size (number of devices) used for each individual bench test.
Data Provenance: The data is from bench testing (in vitro), meaning it was conducted in a laboratory setting, not on human subjects or patient data. The country of origin for the testing is not explicitly stated, but the submitter (TriReme Medical, Inc.) is located in Pleasanton, CA, USA, suggesting the testing likely occurred in the US or under US regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the evaluation was based on bench testing of physical device properties, not on interpretation of medical images or clinical outcomes that would require expert consensus for ground truth.

4. Adjudication method for the test set

This information is not applicable as the evaluation was based on bench testing, not on human interpretation or categorization of data requiring adjudication.

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

This information is not applicable. The device is a PTA Balloon Catheter, a physical medical device used for dilatation. It is not an AI-powered diagnostic or assistive technology that would involve human readers or an MRMC study.

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

This information is not applicable. The device is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used

The "ground truth" for this device's evaluation was based on engineering specifications and established performance standards for PTA balloon catheters, as determined by the design and intended use of the device. The bench tests measured objective physical properties against these predefined parameters.

8. The sample size for the training set

This information is not applicable. This is a traditional medical device (PTA balloon catheter), not a machine learning or AI-based device, so there is no concept of a "training set" in the context of its development or evaluation mentioned here.

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

This information is not applicable for the reasons stated above (no training set for this type of device).

Summary

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K12207o

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

AUG 15 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/QA/CAPhone: 925-931-1300 Ext 209Fax: 925-931-1361
Date Prepared:	July 12, 2012

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:	VascuTrak PTA Dilatation Catheter (K082343)PTA Balloon Catheter Family (K094019, K101062, K1K112281, K111738, K12067, and K121402)
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3. Intended Use

Device Description

Page 5-1

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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

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 seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

TriReme Medical, Inc. C/O Ms. Shiva Ardakani Vice President of Regulatory, Clinical and Quality 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566

Re: K122070

Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: July 12, 2012 Received: July 16, 2012

Dear Ms. 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 or mply with all the Act's requirements, including, but not limited to: registration and listing (21

AUG 15 2012

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Page 2 - Ms. Shiva Ardakani

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 (OS) 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 vours,

.A. Hillen

Gram 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 (XXXXX): K (22090

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)

Cug-thlelele

(Division Sign-Off) Division of Cardiovascular Devices

122070 510(k) Number_

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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).