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 is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 180 cm and 300 cm length. 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 flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Asahi PTCA Guide Wire Fielder. It states that "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Fielder met the acceptance criteria and performed equivalent to the predicate devices." However, it does not provide a table of acceptance criteria or specific reported device performance metrics. It also does not detail the methodology of the study or the provenance of data, only that testing was conducted.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a summary of what can be extracted and what cannot:

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

Cannot be provided. The text states that "bench and biocompatibility testing...met the acceptance criteria and performed equivalent to the predicate devices" but does not explicitly list the criteria or the specific device performance results.

2. Sample sized used for the test set and the data provenance

Cannot be provided. The text mentions "bench and biocompatibility testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Cannot be provided. There is no mention of expert involvement in establishing ground truth for any testing described.

4. Adjudication method for the test set

Cannot be provided. There is no mention of an adjudication method.

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

Cannot be provided. The device is a PTCA Guide Wire, not an AI or imaging device that would typically involve human reader studies.

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

Cannot be provided. The device is a medical instrument, not an algorithm.

7. The type of ground truth used

Cannot be explicitly stated based on the text. For "bench and biocompatibility testing," ground truth would typically be established through standardized methods, specifications, and laboratory measurements. However, the text does not detail how the acceptance criteria for these tests were set or what constitutes "ground truth" for them.

8. The sample size for the training set

Not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

Not applicable. As above, there is no "training set" for a physical device.

Summary of available information:

Study Type: Bench and biocompatibility testing.
Conclusion: The device "met the acceptance criteria and performed equivalent to the predicate devices." This implies the study aimed to demonstrate substantial equivalence through these tests.
Predicate Devices: JoWire Neo's PTCA Guide Wire (K022762) and JoWire Asahi PTCA Guide Wire (K031277).
No new safety or effectiveness issues were raised during the testing.

Summary

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K052022
p. 1 of 2

Asahi Intecc Co., Ltd. July 2005

AUG 25 2005

Asahi PTCA Guide Wire Fielder Special 510(k)

510(k) Summary of Safety and Effectiveness

Date Prepared:	July 2005
Submitted:	Asahi Intecc Co., Ltd.
	1703 Wakita-cho, Moriyama-ku, Nagoya,
	Aichi, 463-0024, Japan
Contact Person:	Yoshi Terai
	Director of Asahi Intecc USA Inc.
Address:	1301 Dove Street,
	Suite #350 Newport Beach,
	CA, 92660, USA
Phone Number:	Phone: (949) 756-8252
Fax Number:	Fax: (949) 756-8165
Device Trade Name:	Asahi Wire Asahi PTCA Guide Wire Fielder
Classification Name:	Catheter Guide Wire, Class II (21 CFR 870.1330)
Predicate Device:	JoWire Neo's PTCA Guide Wire: K022762
	JoWire Asahi PTCA Guide Wire: K031277

Device Description:

Intended Use:

The Asahi PTCA Guide Wire Fielder is intended to facilitate the placement of balloon dilatation Catheter 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 Technological Characteristics and Comparison to Predicate Device:

The Asahi PTCA Guide Wire Fielder is made of the same materials and designed except polyurethane coating, available in the same diameters and lengths, and indications for use as the predicate devices and other currently marketed PTCA Guide Wires.

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11-052022 p. 202

Asahi Intecc Co., Ltd. July 2005

Asahi PTCA Guide Wire Fielder Special 510(k)

Performance Data:

Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Fielder met the acceptance criteria and performed equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing.

Conclusion:

The Asahi PTCA Guide Wire Fielder is substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.

Koszo 22 Premarket Notification [510(k)] Number

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

AUG 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai Director of Asahi Intecc USA Inc. 1301 Dove Street, Suite #350 Newport Beach, CA 92660

K052022 Re:

Asahi Wire Asahi PTCA Guide Wire Fielder Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 2005 Received: July 26, 2005

Dear Mr. Terai:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(t) promation is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interestate referenced above and have decembled the devices marketed in interstate for use stated in the encrosule) to tegally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the character with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that to not require approvate of the general controls of the Act. The
You may, therefore, market the device, subject to the general magatestion, list You may, therefore, market the device, seeject of the samual registration, listing of
general controls provisions of the Act include requirements michrending and general controls provisions of the Herbaco rep adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller "Littering component" be found in the Cour of Peaces one reasons one 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dilla R. Vachner

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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Asahi Intecc Co., Ltd. July 2005

Asahi PTCA Guide Wire Fielder Special 510(k)

Indications for Use

510(k) Number (if known): K052022

Device Name: Asahi PTCA Guide Wire Fielder

Indications For Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal 10 faciliate the procement of can't percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

Prescription Use X (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)

Donna R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K65022

Page 1 of 1

18 -

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.