The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.

Device Description

The Heartrail III Guiding Catheter is a three-layer construction comprised of a stainless steel mesh sandwiched between a layer of polytetrafluoroethylene and a layer of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyester elastomer containing tungsten. This tip is permanently welded to the catheter shaft. Depending on the product code, the tip is either straight or curved into a specific shape.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device called the "Heartrail™ III Guiding Catheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional study with acceptance criteria and performance metrics in the way a new, novel device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, training set sample size, detailed ground truth establishment) are not applicable in this context because the manufacturer is not conducting a de novo clinical trial or an AI/software performance study.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to predicate devices across several key attributes. The "reported device performance" is then framed in relation to these predicates, primarily through bench testing.

Acceptance Criterion (Implicit for 510(k))	Reported Device Performance (as stated in submission)
Intended Use Equivalence: The device's intended clinical application must be the same as the predicate.	The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures to deliver radiopaque media, guide wires, catheters, and therapeutic agents. This is stated to be substantially equivalent to the predicate devices.
Technological Characteristics Equivalence: Design, materials, and principle of operation should be similar, and any differences should not raise new questions of safety or effectiveness.	The Heartrail™ III Guiding Catheter utilizes a three-layer construction (stainless steel mesh, PTFE, polyester elastomer with tungsten), a "soft-tip", and similar materials to the predicate devices (Radifocus® Optitorque™ Angiographic Catheter K082736 and Boston Scientific Mach 1 Catheter K981788). Differences in materials are explicitly stated not to raise new issues of safety and effectiveness. The principle of operation is manual, similar to predicates.
Performance Equivalence: The device must perform as safely and effectively as the predicate, typically demonstrated through non-clinical testing.	Bench Testing: "The performance of the Heartrail III Guiding Catheter is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing." Specific quantitative results for individual performance parameters (e.g., maximum injection pressure, catheter length, available sizes) are listed: - Available Sizes: 6 Fr. - Catheter Length: 100 cm - Maximum Injection Pressure: 700 psi. These specifications implicitly meet the performance of equivalent predicate devices. Biocompatibility: Materials are biocompatible, tested according to ISO-10993, for limited contact (<24 hrs). Sterilization: Validated to a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135-1. Manufacturing Controls: Include visual, functional, dimensional, and sterility tests.

Study Details (Not applicable for this 510(k) submission)

As this is a 510(k) for a guiding catheter (a physical medical device, not an AI/software product or a drug), the detailed "study" elements you requested are not relevant or provided in this type of regulatory document.

Sample size used for the test set and the data provenance: Not applicable. Performance demonstrated through bench testing and comparison to predicates. No patient data test sets mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench testing, not expert-adjudicated test sets, was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/software device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical properties, the "ground truth" is defined by established engineering and biological standards (e.g., maximum injection pressure, biocompatibility standards, sterilization efficacy). For clinical relevance, it's the demonstrated safe and effective use of the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/software device.
How the ground truth for the training set was established: Not applicable.

In summary: The K092372 submission for the Heartrail™ III Guiding Catheter demonstrates that the device meets its "acceptance criteria" by proving its substantial equivalence to existing, legally marketed predicate devices through a combination of similar intended use, design, materials, principle of operation, and successful bench testing for physical and biological performance (e.g., maximum pressure, biocompatibility, sterilization). The document does not describe a clinical study in the traditional sense with patient data, expert reviews, or AI performance metrics.

Summary

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K692372

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SECTION II. 510(K) SUMMARY

A. Device Name

Proprietary Name:	HeartrailTM III Guiding Catheter
Classification Name:	Diagnostic Intravascular Catheter
Common Name:	Guiding Catheter

B. Intended Use

The Heartrail III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.

C. Device Description

D. Principle Of Operation / Technology

The Heartrail III Guiding Catheter is operated manually or by a manual process.

E. Design / Materials

The Heartrail III Guiding Catheter in this submission uses similar materials as the predicate devices. Differences in materials between the devices do not raise any new issues of safety and effectiveness.

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F. Specifications

Available Sizes	6 Fr.
Catheter Length	100 cm
Maximum InjectionPressure	700 psi.

G. Performance

The performance of the Heartrail III Guiding Catheter is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing.

H. Additional Safety Information

Manufacturing controls include visual, functional, dimensional and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".

The catheter is classified as Externally Communicating Devices, Circulating Blood, limited Contact (<24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible.

Sterilization conditions have been validated in accordance with ANSI/AAMI/ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10-6.

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H. Substantial Equivalence

The Heartrail III Guiding Catheter submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, and materials to the
Radifocus® Optitorque™ Angiographic Catheter K082736. It was also found to be substantially equivalent2 in intended use, design, principle of operation / technology, materials, and performance to the Boston Scientific Mach 1 Catheter which was cleared under K981788. Differences between the devices do not raise any issues of safety or effectiveness.

I. Submitter Information

Prepared By:	Mr. Mark UnterreinerSr. Regulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921Phone: (410) 392-7213Fax: (410) 398-6079Email: mark.unterreiner@terumomedical.com
Date Prepared:	July 29, 2009

2 A statement of substantially equivalence to another product is required by 21CFR807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seg. (1977)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The seal is simple and monochromatic.

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

Terumo Medical Corporation c/o Mr. Mark Job 1394 25th St. NW Buffalo, MN 55313

Re: K092372

Trade/Device Name: Heartrail™ III Guiding Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: August 27, 2009 Received: August 28, 2009

Dear Mr. Job:

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.

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 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.

SEP 1 1 2009

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Page 2 - Mr. Mark Job

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/CDRHQffices/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.htm1.

Sincerely vours.

vuna R. vchmer

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): ___ K o 9 2 3 7 Z __________________________________________________________________________________________________________________________________

Heartrail™ III Guiding Catheter Device Name:

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oma R. Veline

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K092372

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).