(30 days)
To facilitate the placement of ballon dilation Catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wire, J Shape series is not to be used in the cerebral vasculature.
The Asahi PTCA Guide Wire, ] Shape series is steerable guide wire with a maximum diameter of 0.014" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire ourside the body. The wire is constructed from a stainless steel core with varying core lengths and diameter for each design. The core wre and coil are soldered, for some items welding is used for up parts instead of soldering. The distal end of the guide wire has a radiopaque up that is available as a pre shaped ""[" and is made soft to easily bend with the vessel curve. The coanng (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE. H on the product code indicates hydrophilic coating, and J indicates pre shaped "J" tip of the guide wire.
The provided text describes a 510(k) premarket notification for the Asahi PTCA Guide Wire, J Shape series, and focuses on establishing substantial equivalence to predicate devices, rather than a study proving specific acceptance criteria for a new AI/software device. Therefore, much of the requested information (like AI-specific criteria, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, standalone performance, and ground truth for AI) is not applicable or present in this document.
However, I can extract the relevant information regarding the device's acceptance criteria and the study performed, framed within the context of a medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | Met acceptance criteria |
| Biocompatibility Testing | Met acceptance criteria |
| Performance Similarity | Performed similarly to predicate devices |
Explanation: The document states that "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire, J Shape series met the acceptance criteria and performed similarly to the predicate devices." It also explicitly mentions that "No new safety or effectiveness issues were raised during the testing."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "bench and biocompatibility testing" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes a physical medical device (guide wire) and its performance, not an AI/software device requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes a physical medical device and its performance, not an AI/software device requiring an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
This information is not applicable as the document describes a physical medical device and its performance, not an AI/software device that would typically undergo an MRMC study.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established through bench testing (evaluating physical properties and functions against predefined specifications) and biocompatibility testing (evaluating biological safety according to established standards). These tests inherently define the "truth" of whether the device meets its design and safety requirements.
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the document describes a physical medical device, not an AI/software device that requires a training set and its associated ground truth establishment.
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Asahi Intecc Co., Ltd. December 2004
JAN 1 2 2005
510(k) Summary of Safety and Effectiveness
| Date Prepared: | November 8, 2004 |
|---|---|
| Submitted: | Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-ku, Nagoya,Aichi, 463-0024, Japan |
| Contact Person: | Yoshi TeraiDirector of Asahi Intecc US Office |
| Address: | 1301 Dove St. Suite 350 Newport Beach, CA 92660 |
| Phone Number: | Phone : (949)756-8252 |
| Fax Number: | Fax : (949)756-8165 |
| Device Trade Name: | Asahi Wire Asahi PTCA Guide Wire, J Shape series |
| Classification Name: | Catheter Guide Wire, Class II (21 CFR 870.1330) |
| Predicate Device: | JoWire Neo's PTCA Guide Wire K022762JoWire Asahi PTCA Guide Wire K031277Asahi Wire Asahi PTCA Guide Wire K032615Asahi Wire Asahi PTCA Guide Wire Confianza Pro K04153 |
Device Description:
The Asahi PTCA Guide Wire, ] Shape series is steerable guide wire with a maximum diameter of 0.014" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire ourside the body. The wire is constructed from a stainless steel core with varying core lengths and diameter for each design. The core wre and coil are soldered, for some items welding is used for up parts instead of soldering. The distal end of the guide wire has a radiopaque up that is available as a pre shaped ""[" and is made soft to easily bend with the vessel curve. The coanng (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE. H on the product code indicates hydrophilic coating, and J indicates pre shaped "J" tip of the guide wire.
Intended Use:
The Asahi PTCA Guide wire, J Shape series is intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasm (PTCA) and percuraneous transluminal angioplasty (PTA). The Asahi PTCA Guide wire, J Shape series is not to be used in the cerebral blood vessel
Device Technological Characteristics and Comparison to Predicate Device:
The Asahi PTCA Guide Wire, J Shape series is made of the same materials, available in the same diamerers and lengths, have the same design and indications for use as the predicate devices and other currently marketed PTCA Guide Wires.
38
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Asahi Intecc Co., Ltd. December 2004
Performance Data:
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire, J Shape series met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.
Conclusion:
The Asahi PTCA Guide Wire, J Shape series is substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.
Ko4342
Premarket Notification [510(k)] Number
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes resembling human profiles or waves. The emblem is black, and the background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2005
Mr. Yoshi Terai Director Asahi Intecc US Office 1301 Dove St., Suite 350 Newport Beach, CA 92660
Re: K043422
Trade/Device Name: Asahi PTCA Guide Wire, J Shape Series Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: December 3, 2004 Received: December 13, 2004
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.
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
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Page 2 – Mr. Yoshi Terai
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic roral in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. procletter will allow you to begin marketing your device as described in your Section 510(k) rms leket notification. The FDA finding of substantial equivalence of your device to a legally premaince no dicate 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,
Dana R. Lochner
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
510(k) Number (if known):_K043422
Device Name: Asahi PTCA Guide Wire, J Shape series
Indications For Use:
To facilitate the placement of ballon dilation Catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wire, J Shape series is not to be used in the cerebral vasculature.
X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (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. Lochner
(Division Sic n-Off) Division of Cardiovascular Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.