(101 days)
The ASAHI PTCA Guide Wire, Fielder 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.
The Asahi PTCA Guide Wire, Fielder J shape is 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 available as a pre shape "J" and 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.
The provided document describes a medical device, the ASAHI PTCA Guide Wire, Fielder J, and its substantial equivalence to predicate devices, supported by bench testing. However, it does not contain the level of detail requested for a comprehensive description of acceptance criteria and the study proving it.
Based on the provided text, here's what can be extracted and what is missing:
Description of Acceptance Criteria and Study Findings for ASAHI PTCA Guide Wire, Fielder J
The provided 510(k) summary indicates that the ASAHI PTCA Guide Wire, Fielder J demonstrated substantial equivalence to predicate devices through mechanical and functional bench testing. The acceptance criteria are implicitly met by demonstrating that the device "performs as intended" and its "characteristics are substantially equivalent to the specified predicate devices." No specific quantitative acceptance criteria or detailed study results are provided in the summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as intended (mechanical & functional) | Bench testing demonstrates the device functions as intended. |
| Substantial equivalence to predicate devices (materials, dimensions, design) | The device is of the same materials as predicate devices. Dimensional specifications and design ensure compatibility for intended use. Characteristics are substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified, but generally, bench testing data would be generated in a laboratory setting, likely at the manufacturer's location in Japan, or a designated testing facility. This is a retrospective analysis of the device's physical properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable, as this was mechanical and functional bench testing, not a clinical study involving human assessment.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Not applicable, as this was mechanical and functional bench testing, not a study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed based on the provided document. The submission relies solely on bench testing for substantial equivalence.
6. Standalone (Algorithm Only) Performance
- No, this refers to a medical device (guide wire), not an algorithm or AI. Therefore, standalone algorithm performance is not applicable.
7. Type of Ground Truth Used
- Bench Testing Standards/Specifications: The ground truth for the bench testing would be established by pre-defined engineering and performance specifications and standards for guide wires, which dictate acceptable mechanical and functional properties (e.g., tensile strength, flexibility, lubricity, torque transmission, etc.). Comparison to predicate devices also serves as a "ground truth" for substantial equivalence.
8. Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device (guide wire), not an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
Summary of Limitations Based on Provided Text:
The document serves as a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to predicate devices through bench testing. It does not provide the detailed level of information (e.g., specific quantitative ranges for performance metrics, detailed study protocols, sample sizes for specific tests, or clinical data) that would be present in a comprehensive study report or a publication detailing a clinical trial. The "acceptance criteria" are implied by the claim of functioning as intended and substantial equivalence.
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SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
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 | NOV - 9 2006 |
|---|---|---|
| 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 | |
| TRADE NAME: | ASAHI PTCA Guide Wire, Fielder J | |
| COMMON NAME: | Guide Wire | |
| CLASSIFICATIONNAME: | Catheter Guide Wire | K062186 |
| DEVICECLASSIFICATION: | Class 2 per 21 CFR §870.1330 | |
| PRODUCT CODE | DQX | |
| PREDICATE DEVICE: | Asahi PTCA Guide Wire, Fielder K052022Asahi PTCA Guide Wire, J Shape Series K043422Guidant HI-Torque Floppy Guide Wire K974773Guidant ACS HI-Torque Cross IT K990639 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Asahi PTCA Guide Wire, Fielder J shape is 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 available as a pre shape "J" and 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.
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INDICATION FOR USE:
The ASAHI PTCA Guide Wire, Fielder J is intended to facilitate the placement of balloon The ROATH I TOA Oulde viro, Holdovinal coronary angioplasty (PTCA) and dilation catherers during poloatanover (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel. 11/2017 11:12:14 PM 11/2 11/2 11:11 11/2 11/2 11:11 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11/2 11
TECHNICAL CHARACTERISTICS:
The ASAHI PTCA Guide Wire, Fielder 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 ASAHI PTCA Guide Wire, Fielder J performs as intended.
SUMMARY/CONCLUSION:
The ASAHI PTCA Guide Wire, Fielder 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.
Kc62186
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV -- 9 2006
Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO 1301 Dove Street, Suite 350 Newport Beach, CA 92660
Rc: K062186
ASAHI PTCA Guide Wire, Fielder J Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DQX Dated: July 10, 2006 Received: July 31, 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,
Brimmer for
Brain 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): 1002 Bb
Device Name: ASAHI PTCA Guide Wire, Fielder J
Indications for Use:
The ASAHI PTCA Guide Wire, Fielder 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.
Prescription Use
(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)
Blumming
of Sign-Off I wision of Cardiovaso 510(k) Number
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§ 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.