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 (5Fr.) 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-tin 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.

The Heartrail™ III Guiding Catheter (5Fr.) is operated manually or by a manual process. During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing a guide wire and introducer within a vessel. Then the Heartrail™ III Guiding Catheter would be advanced over the guide wire. Next, the guide wire and Guiding Catheter would be advanced to the target vessel. The Heartrail™ III Guiding Catheter can then be used for injection of radiopaque media or for support and exchange of guide wires, catheters, and/or therapeutic agents.

AI/ML Overview

This document is a 510(k) summary for the Terumo Heartrail™ III Guiding Catheter (5Fr.). It describes a device that is substantially equivalent to a previously cleared device (K092372). This is a medical device submission, not a study evaluating an AI device or a novel medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable.

Here's an analysis based on the provided text, focusing on what is applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the Heartrail™ III Guiding Catheter (5Fr.) is a Special 510(k) based on substantial equivalence to a predicate device due to minor modifications (primarily a reduction in catheter outer diameter from 6Fr. to 5Fr. and additional tip shapes/lengths). Therefore, the "acceptance criteria" are not reported as strict performance metrics with thresholds in the typical sense of a novel device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through various nonclinical performance tests and biocompatibility assessments, ensuring the modified device performs as safely and effectively.

Acceptance Criteria Category (Implied by Substantial Equivalence and Testing)	Reported Device Performance (Summary of Test Results)
Nonclinical Performance (Bench Testing)	The performance of the Heartrail™ III Guiding Catheter (5Fr.) is substantially equivalent to the predicate device, as shown through bench testing on non-aged and aged devices for parameters such as: Surface, Tip configuration, Product dimensions, Force at break, Freedom from leakage, Radio detectability, Catheter burst/Leakage pressure, Flexibility/Catheter stiffness, Tip durability, Flow rate, Tip strength, Catheter inner surface friction, Torque control, Simulated use testing, Torque Strength, Flexibility and Kink Test, Catheter Bond Strength.
Biocompatibility (Blood Contacting Materials)	All blood contacting materials were tested per ISO 10993-1 and successfully passed: - Cytotoxicity: Non-cytotoxic - Sensitization: No evidence of causing delayed dermal contact sensitization - Acute Intracutaneous Reactivity: No evidence of significant irritation or toxicity - Acute Systemic Toxicity: No mortality or evidence of systemic toxicity - Hemolysis: Non-hemolytic - Pyrogenicity: Non-pyrogenic - InVivo Thromboresistance: Thromboresistant - Complement Activation: Not a complement system activator
Biocompatibility (Aged Device)	Limited screening tests demonstrated that aging (14 weeks at 60°C) does not affect biocompatibility: - Physicochemical Profile: Meets requirements - Cytotoxicity: Non-cytotoxic - Hemolysis: Non-hemolytic
Sterilization	Validated in accordance with ANSI/AAMI/ISO 11135-1, achieving a Sterility Assurance Level (SAL) of 10-6.

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

This document does not describe a clinical study with a "test set" in the context of an AI/algorithm evaluation. The "test set" here refers to the physical devices (non-aged and aged) that underwent bench testing and biocompatibility assessments. The exact number of units/samples for each specific test is not provided in this summary but would be detailed in the full test reports. The data provenance is from bench testing conducted by the manufacturer, Terumo Corporation, for a medical device.

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

Not applicable. This is a medical device submission, not a study involving human interpretation of data for ground truth establishment. Performance is evaluated against engineering specifications and established biological safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study requiring expert consensus for interpretation.

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

No, an MRMC comparative effectiveness study was not done. This submission pertains to a physical medical device, not a diagnostic algorithm requiring human interpretation.

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

Not applicable. This document is about a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by engineering specifications, recognized national and international standards for medical device performance (e.g., burst pressure, flow rate, bond strength), and biocompatibility standards (e.g., ISO 10993 series, ASTM F756). The device demonstrating substantial equivalence to a legally marketed predicate confirms its safety and effectiveness relative to those established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through engineering and materials science principles, not machine learning training.

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

Not applicable, as there is no "training set" for this device.

Summary

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K113335
Page 1 of 7

Image /page/0/Picture/1 description: The image shows the logo for Terumo. The logo consists of a circle with a T inside of it, followed by the word "TERUMO" in all capital letters. There is a small circle in the upper right corner of the word "TERUMO".

TERUMO CORPORA Head Office 44-1. 2-chome. Hatagava. Telephone: 81-3-3374-8111 Facs

JUL 16 2012

Terumo Medical Corporation 950 Elkton Blvd, Elkton, MD 21921 Telephone: 410-392-7213 Facsimile: 410-398-6079

510(K) SUMMARY - HEARTRAIL™ III GUIDING CATHETER (5FR.)

1) Submitter Information

Owner/Operator

Terumo Corporation, Tokyo, Japan 44-1, 2-chome Hatagaya Shibuya-ku Tokyo 151-0072 Japan Registration No: 801 002 6

Manufacturing Facility and Sterilization Facility Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya Shizuoka 418-0015 Japan Registration No: 968 183 4

Distributor

Terumo Medical Corporation, Somerset, NJ 2101 Cottontail Lane Somerset, NJ 08873 Registration No: 224 344 1

Submitter's Name: Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist

Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 Phone: (410) 392-7213 Fax: (410) 398-6079 Email: mark.unterreiner@terumomedical.com

Date Prepared:

January 30, 2012

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2) Device Name

Proprietary Name:	Heartrail™ III Guiding Catheter
Common Name:	Guiding Catheter
Classification Name:	Catheter, Intravascular, Diagnostic

3) Predicate Device

The predicate device is the Terumo Heartrail™ III Guiding Catheter cleared under K092372. The differences between the devices do not raise any new issues of safety or effectiveness.

4) Description

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Terumo Corporation Special 510(k) - Heartrail™ III Guiding Catheter (5Fr.) Section II. 510(k) Summary

5) 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 the prooutic 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.

This is the same intended use as the unmodified device the Heartrail™ III Guiding Catheter cleared under K092372.

6) Design / Materials/ Specifications

The Heartrail TM III Guiding Catheter (5Fr.) in this submission uses similar materials as the Heartrail™ III Guiding Catheter cleared under K092372. Differences in materials between the devices do not raise any new issues of safety and effectiveness.

Part	Raw material
Soft tip*	Polyester elastomer containing tungsten
Inner layer*	Polytetrafluoroethylene
Braid	Stainless steel
Outer layer*	Polyester elastomer containingtungsten**
Strain relief	Polyester elastomer
Hub*	Nylon 12

Blood contacting material

** Some parts of outer layer may not contain tungsten.

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Terumo Corporation Special 510(k) – Heartrail™ III Guiding Catheter (5Fr.)

Section II. 510(k) Summary

	Summary of Comparative Information Between the Modified
	Device and the Predicate Device
	Before Device Modification	After Device Modification
	Cleared Under K092372
Trade name	Heartrail™ III Guiding Catheter(6Fr.)	Heartrail™ III Guiding Catheter(5Fr.)
Tip Shape/Material	AMPLATZ LEFT/SHORT AMPLATZ/AMPLATZ RIGHT/BYPASS/--IKARI LEFT/IKARI RIGHT/TIGER-MODIFIED/--INTERNAL MAMMARY/JUDKINS LEFT/JUDKINS RIGHT/MULTIPURPOSE	AMPLATZ LEFT/SHORT AMPLATZ/AMPLATZ RIGHT/BYPASS/BACKUP LEFT/BACKUP LEFT-MODIFIED/IKARI LEFT/IKARI RIGHT/TIGER-MODIFIED/IKARI FEMORAL LEFT/IKARI FEMORAL RIGHT/INTERNAL MAMMARY/JUDKINS LEFT/JUDKINS RIGHT/MULTIPURPOSE
	Polyester elastomercontaining tungsten	Polyester elastomercontaining tungsten
Catheter O.D.	6Fr.	5Fr.
Usable length	100 cm	100 cm, 110cm
Maximum Injection Pressure	700 psi	700 psi

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Terumo Corporation Special 510(k) - Heartrail™ III Guiding Catheter (5Fr.) Section II. 510(k) Summary

7) Nonclinical Performance Testing

The performance of the Heartrail™ III Guiding Catheter (5Fr.) is substantially equivalent to the performance of the predicate device. The equivalence was shown through bench testing. The following testing was performed on non-aged and aged devices:

Surface
Tip configuration
Product dimensions(O.D. ,effective length)
Force at break(1.shaft 2.hub)
Freedom from leakage
Radio detectability
Catheter burst /Leakage pressure
Flexibility / Catheter stiffness (1.shaft 2.distal)
Tip durability
Flow rate
Tip strength
Catheter inner surface friction
Torque control
Simulated use testing
Torque Strength
Flexibility and Kink Test
Catheter Bond Strength (1.soft tip 2.shaft)

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8) Additional Safety Information

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-I, "Biological Evaluation of Medical Devices Part-1:15maluation and Testing within a risk management process.".

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. The Heartrail™ III Guiding Cathoter successfully passed all of the following biocompatibility tests:

Biocompatibility Testing on the Heartrail III Guiding Catheter(non-aged, sterile)
Test	Test Method	Result
Cytotoxicity	ISO 10993-5	Non-cytotoxic
Sensitization - NaCl andCSO Extract	ISO 10993-10	No evidence of causing delayed dermalcontact sensitization.
Acute IntracutaneousReactivity - NaCl andCSO Extract	ISO 10993- 10	No evidence of significant irritation ortoxicity.
Acute Systemic Toxicity -NaCl and CSO Extract	ISO 10993-11	No mortality or evidence of systemictoxicity.
Hemolysis	ASTM F756	Non-hemolytic.
Pyrogen Study	ISO 10993-11	Non-pyrogenic.
InVivo Thromboresistance	ISO10993-4	Thromboresistant
Complement ActivationTesting C3a	ISO10993-4	Not a complement system activator
Complement ActivationTesting Sc5b-9	ISO10993-4	Not a complement system activator

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Limited screening tests were conducted on the accelerated-aged', sterile device to demonstrate that aging does not affect the device's biocompatibility. The results are summarized in the table below.

Test	Test Method	Result
Physicochemical Profile	USP	Meets requirements
Cytotoxicity	ISO 10993-5	Non-cytotoxic
Hemolysis	ASTM F756	Non-hemolytic.

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.

9) Substantial Equivalence

The Heartrail™ III Guiding Catheter (5Fr.) submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Heartrail™ III Guiding Catheter which was cleared under K092372. Differences between the devices do not raise any issues of safety or effectiveness.

1 (14 weeks at 60°C) Ref: Sterilization Science, Accelerated Aging of Packaging: Considerations, Suggestions, and Use In Expiration Date Verification. MD&DI, March 1988, pp.34-39

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JUL 16 2012

Terumo Medical, Corp. c/o Mr. Mark Unterreiner Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921

Re: K113335

Trade Name: Heartrail III Guiding Catheter (5Fr) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: DOO Dated: June 28, 2012 Received: June 29, 2012

Dear Mr. Unterreiner:

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. Ilsting 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.

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Page 2 - Mr. Mark Unterreiner

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 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" (21 CFR 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,

. A. Hillen

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

Enclosures

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Indications for Use

KII3335 510(k) Number (if known): _

Heartrail™ III Guiding Catheter (5Fr) Device Name:

Indications For Use:

Prescription Use (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)

CmA Stillwell

on Sign-Off) Division of Cardiovascular Devices

118335 510(k) Number

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).