The Precious Plus 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.

Device Description

The Precious plus 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 PTFE to enhance lubricity. The outer surface of the product is coated with Silicone oil.

AI/ML Overview

This document, a 510(k) Pre-Market Notification for the Precious Plus Guide Catheter, describes the device and its intended use, and argues for its substantial equivalence to predicate devices, but does not contain detailed acceptance criteria or a study proving that the device meets those criteria.

Therefore, many of your requested fields cannot be filled from the provided text.

Here is an attempt to answer as much as possible:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state specific acceptance criteria (e.g., minimum tensile strength, maximum friction coefficient) with corresponding reported values. It broadly states that "mechanical and functional bench testing that demonstrates that the Precious plus guide catheter performs as intended" and that "Bench testing demonstrates that the device functions as intended."

2. Sample sized 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 the sample size used for any test set or the provenance of any data (country of origin, retrospective/prospective). It only mentions "bench testing."

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 device is a physical medical instrument, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the way you describe.

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

Not applicable for this type of device and performance evaluation.

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 not an AI or diagnostic imaging device.

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

The "performance data" section states: "This 510(k) notice includes mechanical and functional bench testing that demonstrates that the Precious plus guide catheter performs as intended." This implies standalone testing of the device itself (without human-in-the-loop, as it's a catheter, not an AI algorithm) was conducted. However, no specific details of this testing are provided beyond this general statement.

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

For physical medical devices like this, "ground truth" typically refers to established engineering standards, material specifications, and functional requirements. For example, a "ground truth" might be that the catheter must withstand a certain pressure without leaking, or have a specific surface lubricity. The document implies compliance with these types of standards through "mechanical and functional bench testing," but does not explicitly detail them or how they were established.

8. The sample size for the training set

Not applicable. This is not an AI model requiring a training set.

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

Not applicable. This is not an AI model.

Summary of available information:

The document focuses on establishing substantial equivalence to predicate devices based on:

Identical indications for use.
Similar materials with a long history of biocompatibility.
Equivalence in dimensional specifications to predicate devices.
General statements about "mechanical and functional bench testing" demonstrating the device performs as intended.
Biocompatibility testing on the actual device.

The 510(k) process primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than comprehensive, detailed clinical studies with specific acceptance criteria and outcome measurements as might be seen for novel therapeutic drugs or AI diagnostic tools. For a Class II device like a guide catheter, bench testing and material equivalence are often central to the submission.

Summary

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510(K) SUMMARY 9.0

This 510(k) summary of safety and effectiveness information is being submitted in This STO(K) Summary of Streenents of SMDA 1990 and 21 CFR 807.92.

APPLICANT	Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan		SEP 17 2007
OFFICIALCORRESPONDENT	Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX (949) 756-8165e-mail: yoshi@asahi-intecc.com
TRADE NAME:	Precious Plus Guide Catheter
COMMON NAME:	Guide Catheter
CLASSIFICATIONNAME:	Percutaneous Catheter
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1250
PRODUCT CODE	DQY
PREDICATE DEVICE:	Asahi Precious Guide Catheter - K061601Guidant ACS Viking Guiding Catheter - K972484

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Precious plus 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. The Precious plus 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 PTFE to enhance lubricity. The outer surface of the product is coated with Silicone oil.

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INDICATION FOR USE:

TECHNICAL CHARACTERISTICS:

The Precious plus 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 Precious plus guide catheter performs as intended.

SUMMARY/CONCLUSION:

The Precious plus guide catheter characteristics 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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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. The symbol is stylized and modern, representing the department's mission related to health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2007

Asani Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705

Re: K072316

Precious Plus Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: August 7, 2007 Received: August 17, 2007

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,

R. bohner

A 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): __K 072316

Device Name: Precious Plus 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)

umer R. Vahnes
Sign-Off)
Cardiovascular Devices

510(k) Number_6 723 16

Page_( of of l

000015

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).