The SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.

Device Description

The SheathLess Eaucath Coronary Guide Catheter is intended for use in coronary vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

The SheathLess Eaucath Coronary Guide Catheter consists of a "Catheter" and · "Dilator". The catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector. This product is being offered in two sizes: 6.5Fr and 7.5Fr.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device, the SheathLess Eaucath Coronary Guide Catheter. It describes non-clinical testing/performance data to establish substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested fields regarding acceptance criteria and a study design for an AI/ML device are not applicable to this document. The document focuses on demonstrating physical, mechanical, and biological properties of the catheter.

Here's an interpretation based on the provided text, while acknowledging the limitations for an AI/ML-centric request:

1. Table of acceptance criteria and the reported device performance

The document lists various non-clinical tests performed. While it doesn't explicitly state quantitative acceptance criteria in a table, the implied acceptance criterion for each test is that the device performs equivalently to or within acceptable ranges demonstrated by predicate devices. The "reported device performance" is summarized as the device "functions as intended, and is as safe and effective as its predicate."

Test/Assessment	Implied Acceptance Criterion (General)	Reported Device Performance (Summary)
Corrosion resistance	Comparable to predicate devices; no unacceptable corrosion	Device performs as intended
Force at break	Comparable to predicate devices; adequate mechanical strength	Device performs as intended
Liquid leakage under pressure test	No unacceptable leakage	Device performs as intended
Air leakage into hub assembly during aspiration	No unacceptable air leakage	Device performs as intended
Kinking short term test	Resists kinking under normal use	Device performs as intended
Coating integrity / Particulate Evaluation	Maintained coating integrity; minimal particulate generation	Device performs as intended
Radiopacity	Sufficiently radiopaque for visualization	Device performs as intended
Dimensional Verification	Meets specified dimensions	Device performs as intended
Cytotoxicity	Non-cytotoxic	Meets biocompatibility standards
Intracutaneous / Irritation	Non-irritating	Meets biocompatibility standards
Sensitization	Non-sensitizing	Meets biocompatibility standards
Systemic Toxicity	Non-systemically toxic	Meets biocompatibility standards
In Vitro Hemolysis	Non-hemolytic	Meets biocompatibility standards
In Vivo Thromboresistance	Resists thrombus formation in vivo	Meets biocompatibility standards
Plasma Recalcification Time Coagulation	No adverse effect on coagulation time	Meets biocompatibility standards
C3a Complement Activation	No significant C3a complement activation	Meets biocompatibility standards
SC5b-9 Complement Activation	No significant SC5b-9 complement activation	Meets biocompatibility standards
Pyrogen	Non-pyrogenic	Meets biocompatibility standards
Visual inspection (Package integrity)	No defects; package intact	Device performs as intended
Seal strength test (Package integrity)	Package seal integrity maintained	Device performs as intended
Ethylene oxide sterilization evaluation	Effective sterilization	Meets sterilization standards
EO residuals	EO residuals within acceptable limits	Meets sterilization standards
Endotoxin	Endotoxin levels within acceptable limits	Meets sterilization standards

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

The document does not specify sample sizes for individual non-clinical tests. It states that "Non clinical laboratory testing was performed." The data provenance would be from laboratory tests conducted by or for Asahi Intecc Co., Ltd. The document does not specify the country of origin of the data for these tests, but the applicant and some facilities are in Japan. These tests are inherently prospective as they are conducted for the purpose of this premarket notification.

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. This is a medical device (catheter) 510(k) submission, not an AI/ML device. Ground truth is not established by human experts in this context, but rather by standardized laboratory testing methods and measurements following established protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human expert evaluations, typically for AI/ML performance assessment. For physical device testing, results are objective measurements from laboratory equipment and methods.

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 medical device (catheter) 510(k) submission, not an AI/ML device. MRMC studies are used for evaluating diagnostic performance, often with AI assistance.

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

Not applicable. This is a medical device (catheter) 510(k) submission, not an AI/ML device. Standalone algorithm performance refers to the performance of an AI model without human intervention.

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

For this type of device, "ground truth" for the non-clinical tests would be established by:

Standardized measurements: Ensuring dimensions meet specifications, force at break values, etc.
Established laboratory protocols: For biocompatibility (e.g., ISO standards for cytotoxicity, sensitization), sterility (e.g., EO residuals), and material properties.
Comparison to predicate devices: Implicitly, the performance of the predicate devices in these tests sets a comparative "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a training set would be used in this context.

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

Not applicable. There is no AI/ML model for which a training set ground truth would be established in this context.

Summary

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K132556

OCT 2 4 2013

Premarket Notification SheathLess Eaucath Coronary Guide Catheter

ASAHI INTECC CO.,LTD.

1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel.+81-52-768-1211 Fax.+81-52-768-1221 Branch office : Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore,Beijing Research Facilities and Factories : Osaka, Seto. Thailand, Hanoi

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

SheathLess Eaucath Coronary Guide Catheter

510(k) _____

APPLICANT

Asahi Intecc Co., Ltd. 1703 Wakita-cho, Moriyama-ku Nagoya, Aichi 463-0024 Japan

Owner/Operator Number: 3003775027

OFFICIAL Correspondent

Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705 Tel: (949) 756-8252 FAX (949) 756-8165 e-mail: yoshi.terai@asahi-intecc.com

SheathLess Eaucath Coronary Guide Catheter

Trade Name:

Common Name: Guide Catheter

Class 2 per 21 CFR §870.1250 DEVICE

Classification:

CLASSIFICATION Catheter, Percutaneous NAME:

PRODUCT CODE DQY

PREDICATE DEVICES:

K021256 6F Launcher Guide Catheter (Medtronic Vascular) K022764 7F Launcher Guide Catheter (Medtronic Vascular) K023402 8F Launcher Guide Catheter (Medtronic Vascular) K972484 ACS Viking Catheter (Guidant Corp.) K091188 ASAHI ZenyteEX Guiding Catheter (ASAHI Intecc Co., Ltd. K092372 Heartrail III Guiding Catheter (Terumo Medical Corp.)

K051601 Pinnacle Destination (Terumo Medical Corp.)
Date Prepared: July 25, 2013

Asahi Intecc Co., Ltd

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INTENDED USE:

DESCRIPTION:

Comparison Table With Predicate Devices:

Comparisons of the SheathLess Eaucath Coronary Guide Catheter and predicate devices show that the technological characteristics of the SheathLess Eaucath such as intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the current marketed predicate devices.

Non Clinical Testing / Performance Data:

Non clinical laboratory testing was performed on the SheathLess Eaucath Coronary Guide Catheter to determine substantial equivalence. The following testing/assessments were performed:

Performance test/evaluation summary:

Corrosion resistance .
. Force at break
Liquid leakage under pressure test .
. Air leakage into hub assembly during aspiration
. Kinking short term test
. Coating integrity / Particulate Evaluation
. Radiopacity
Dimensional Verification .

Biocompatibility:

Cytotoxicity .
Intracutaneous / Irritation .
Sensitization .
Systemic Toxicity .

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Premarket Notification SheathLess Eaucath Coronary Guide Catheter

. In Vitro Hemolysis
. In Vivo Thromboresistance
Plasma Recalcification Time Coagulation .
. C3a Complement Activation
. SC5b-9 Complement Activation
Pyrogen .

Package integrity:

. Visual inspection
. Seal strength test

Sterilization:

Ethylene oxide sterilization evaluation .
EO residuals .
Endotoxin .

CONCLUSION:

The SheathLess Eaucath Coronary Guide Catheter has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and is as safe and effective as its predicate.

Therefore, the SheathLess Eaucath Coronary Guide Catheter is substantially equivalent to the predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with a modern, abstract design, consisting of three curved lines. The text is written in a bold, sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 24, 2013 -

Asahi Intecc Co., Ltd. C/O Semih Oktay CardioMed LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K132556

Trade/Device Name: SheathLess Eaucath Coronary Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 23, 2013 Received: August 26, 2013

Dear Semih Oktay:

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.

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Page 2- Semih Oktay

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. Zillicherm

for 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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Premarket Notification SheathLess Eaucath Coronary Guide Catheter

Indications for Use

510(k) Number (if known):	K132556
Device Name:	SheathLess Eaucath Coronary Guide Catheter
Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Lillehemann

Page 1 of 1

Asahi Intecc Co., Ltd

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).