The ASAHI PTCA Guide Wire, Fielder FC J is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

Device Description

The Asahi PTCA Guide Wire, Fielder FC J is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made soft and easily bendable with the vessel curve, and is provided in a pre-shaped J configuration. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire and dimethylpolysiloxane (silicone oil - not contacting blood) is applied to gape space in spring-coil in the tip part. The proximal section of this guide wire is coated with PTFE.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Asahi PTCA Guide Wire, Fielder FC J:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria (based on predicate device equivalence and intended use):	Reported Performance:
- Device is substantially equivalent to predicate devices (Asahi PTCA Guide Wire, Fielder - K052022; Asahi PTCA Guide Wire, Fielder FC- K063819) regarding material, dimensional specifications, and design.	"The ASAHI PTCA Guide Wire. Fielder FC J is of the same materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for the intended use."
- Performs as intended for facilitating the placement of balloon dilatation catheters during PTCA and PTA.	"This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI PTCA Guide Wire, Fielder FC J performs as intended.""Bench testing demonstrates that the device functions as intended."
- Not to be used in cerebral blood vessels.	This is an indication for use, implying that its performance outside this scope is not claimed or tested for.
- Meets safety standards (implied by 510(k) clearance).	FDA's clearance of the 510(k) submission implies that the device meets safety requirements for its intended use.

Explanation: The document does not explicitly list quantitative acceptance criteria or specific performance metrics with target values (e.g., minimum tensile strength of X N, maximum friction of Y mN). Instead, it relies on the concept of substantial equivalence to predicate devices. The "acceptance criteria" are therefore implicitly tied to demonstrating that the new device is as safe and effective as the previously cleared predicate devices for the same indication. The reported performance confirms this equivalence and that the device functions as intended through bench testing.

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

Sample Size for Test Set: Not specified. The document only mentions "mechanical and functional bench testing." It does not provide details on the number of wires tested or the specific tests conducted.
Data Provenance: Not specified. The testing described is "bench testing," which implies laboratory testing. There is no mention of clinical data or data from a specific country or population. It's a pre-market submission for a medical device, so the data would have been generated by the manufacturer (Asahi Intecc Co., Ltd., Japan). The study is not a retrospective or prospective clinical study but rather bench-top engineering testing.

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

This information is not applicable to this submission. The device is a physical medical instrument (guide wire), and the testing described is mechanical and functional bench testing. "Ground truth" in this context would typically refer to objective measurements of the device's physical properties or performance in a controlled environment, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. As the testing is mechanical and functional bench testing, there would be no need for expert adjudication in the way it's used for AI/diagnostic studies (e.g., resolving discrepancies in expert interpretations). The results would be objective measurements against predefined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. The submission describes mechanical and functional bench testing, not a clinical trial involving human readers or cases.

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

Not applicable. This device is a physical guide wire, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" would be objective engineering measurements and specifications. For example, measurements of tensile strength, torque transmission, coating integrity, lubricity, radiopacity, and dimensions would be compared against predefined internal specifications or industry standards. There is no mention of expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model or algorithm that requires a training set.

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

Not applicable. As there is no training set for an AI model, this question is not relevant to this medical device submission.

Summary

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9.0 510(K) SUMMARY

K072705

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 463-0024JapanOCT 23 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:	Asahi PTCA Guide Wire, Fielder FC J
COMMON NAME:	Guide Wire
CLASSIFICATIONNAME:	Catheter Guide Wire
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330
PRODUCT CODE	DQX
PRIMARYPREDICATE DEVICE:	Asahi PTCA Guide Wire, Fielder - K052022Asahi PTCA Guide Wire, Fielder FC- K063819

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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K072705

INDICATION FOR USE:

TECHNICAL CHARACTERISTICS:

The ASAHI PTCA Guide Wire. Fielder FC J is of the same materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for the intended use.

Performance Data:

This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI PTCA Guide Wire, Fielder FC J performs as intended.

SUMMARY/CONCLUSION:

The ASAHI PTCA Guide Wire, Fielder FC J 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2007

Asahi 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: K072705

ASAHI PTCA Guide Wire, Fielder FC J Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DOX Dated: September 10, 2007 Received: September 24, 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.

M. G. Helvenner

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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2.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K072705

Device Name: ASAHI PTCA Guide Wire, Fielder FC J

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)

W.g. Hillebrand

Division of Čardiovascular Devices

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510(k) Number_K072709

000015

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.