The ASAHI Precious guide catheter is intended for use in coronary artery 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. These devices are not intended for use in the cerebral vasculature. This Precious guide catheter consists of a tube, a proximal hub, and protector for the joint portion of the first 2 components. The surface of inner lumen of the shaft is coated with either PTFE or Sodium hyaluronate (depending upon the specific model number) to enhance lubricity. The outer surface of the product is coated with Silicone oil.

AI/ML Overview

The provided text does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance as it pertains to AI/ML software. This document is a 510(k) summary for a physical medical device (a guide catheter), not an AI/ML algorithm.

Therefore, many of the specific questions about AI/ML algorithm validation cannot be answered from this text.

Here's why and what can be extracted:

Acceptance Criteria/Reported Device Performance (Table): The document states that "mechanical and functional bench testing" was conducted and "demonstrates that the ASAHI Precious guide catheter performs as intended." However, it does not provide specific quantitative acceptance criteria or the numerical results of these tests (e.g., tensile strength, flexibility, lubricity thresholds, and measured values). It only broadly claims equivalence to predicate devices.
Sample size for the test set and data provenance: Not applicable. This is a physical device, not an AI/ML algorithm validated on a dataset. The testing refers to bench testing of the physical catheter.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on image interpretation) is not relevant here. The ground truth for a physical device is its physical and mechanical properties.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a physical catheter.
Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This is not an algorithm.
The type of ground truth used: For a physical device, the "ground truth" would be the expected physical and mechanical properties based on engineering specifications and industry standards. The document implies compliance through "bench testing" and "biocompatibility testing."
Sample size for the training set: Not applicable. This is not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) pertains to a physical medical device (a guide catheter) and describes its substantial equivalence to predicate devices based on material composition, dimensional specifications, biocompatibility, and mechanical/functional bench testing. It uses standard device clearance procedures and terminology, which are distinctly different from the validation requirements for AI/ML software.

The requested information about acceptance criteria, test sets, ground truth, expert involvement, and AI-specific studies (MRMC, standalone performance, training sets) is not present in the provided document because it addresses a different type of medical device submission.

Summary

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Kob1601

9.0 SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan
OFFICIALCORRESPONDENT	Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.1301 Dove Street, Suite 350Newport Beach, CA 92660Tel: (949) 756-8252FAX (949) 756-8165e-mail: yoshi@asahi-intecc.com	NOV 17 2006
TRADE NAME:	Precious
COMMON NAME:	Guide Catheter
CLASSIFICATIONNAME:	Percutaneous Catheter
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1250
PRODUCT CODE	DQY
PREDICATE DEVICE:	Boston Scientific MACH 1 (Various models) (K020028)Boston Scientific 6F MACH 1 (K010874)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATION FOR USE:

The ASAHI Precious guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, spuch as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

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TECHNICAL CHARACTERISTICS:

The ASAHI Precious guide catheter is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.

Performance Data:

All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains additional biocompatibility testing that was conducted on the actual device. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Precious guide catheter performs as intended.

SUMMARY/CONCLUSION:

The ASAHI Precious guide catheter catheteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.

Bench testing demonstrates that the device functions as intended.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 2006

Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO 1301 Dove Street, Suite 350 Newport Beach, CA 92660

Re: K061601

ASAHI Precious Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: October 2, 2006 Received: October 10, 2006

Dear Mr. Terai:

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 such 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. Yoshi Terai

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Wachner

Image /page/3/Picture/5 description: The image shows a signature. The signature appears to be a stylized combination of letters, possibly initials. The lines are fluid and connected, forming a unique design.

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 STATEMENT 2.0

510(k) Number (if known):

Device Name: Precious

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)

Durna R. Schiner

sion Sign-Off) Division of Cardiovascular Devices

510(k) Number_

Page

CONFIDENTIAL Asahi Intecc May 15, 2006

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).