(30 days)
ASAHI CHIKAI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200 cm and 300 cm lengths. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The coil assembly construction is identical to the 510(k) cleared ASAHI CHIKAI Neurovascular Guide Wire (K110584). The distal end of the quide wire has a radiopaque tip to achieve visibility. This change introduces a rounded tip configuration designed to bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.
This document describes the premarket notification (510(k)) for the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study with detailed performance metrics and ground truth establishment for an AI device.
Therefore, many of the requested categories for a study of an AI device's acceptance criteria and performance cannot be directly extracted from this document. However, I can provide the available information regarding the device's acceptance criteria and the testing performed.
1. Table of acceptance criteria and the reported device performance
The document states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" for the performed tests. However, the specific quantitative acceptance criteria for each test are not provided in this summary. The reported performance is qualitative (met criteria, performed similarly).
| Test Performed | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|---|
| Tensile Strength | (Unspecified quantitative threshold) | Met all acceptance criteria |
| Torque Strength | (Unspecified quantitative threshold) | Met all acceptance criteria |
| Torqueability | (Unspecified quantitative threshold) | Met all acceptance criteria |
| Tip Flexibility | (Unspecified quantitative threshold) | Met all acceptance criteria |
| Biocompatibility | Same as predicate device | Verified to be the same as the predicate |
The following information cannot be extracted from the provided document as it pertains to AI/algorithm studies, which is not the subject of this 510(k) submission:
- Sample size used for the test set and the data provenance: This is a physical medical device, not an AI/algorithm. Sample sizes for bench testing are not detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for physical device bench testing.
- Adjudication method: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for physical device bench testing. The "ground truth" for these tests would be the established engineering and materials science standards for guide wires.
- The sample size for the training set: Not applicable (not an AI device).
- How the ground truth for the training set was established: Not applicable (not an AI device).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2016
ASAHI Intecc Co., Ltd. % Ms. Candace Cederman Senior Regulatory Affairs Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228
Re: K160659
Trade/Device Name: ASAHI CHIKAI Neurovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: March 7, 2016 Received: March 8, 2016
Dear Ms. Candace Cederman:
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S/^
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160659
Device Name ASAHI CHIKAI Neurovascular Guide Wire
Indications for Use (Describe)
ASAHI CHIKAI Neurovascular Guide Wire is intended to be used in the neuro vasculate to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (as required by 21 CFR 807.92)
II INTECC CO. L
1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel. +81-52-768-1211 Fax. +81-52-768-1221 Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Round Curve
| DATE PREPARED: | March 7, 2016 |
|---|---|
| APPLICANT | ASAHI Intecc Co., Ltd. |
| 1703 Wakita-cho, Moriyama-ku | |
| Nagoya, Aichi 463-0024, Japan | |
| OFFICIAL CORRESPONDENT | Carroll Councilman |
| Sr. RA Manager | |
| ASAHI Intecc USA, Inc. | |
| 2500 Red Hill Avenue, Suite 210 | |
| Santa Ana, CA 92705 | |
| Tel: (949) 756-8252 | |
| FAX: (949) 756-8165 | |
| e-mail: ASAHI.ra-fda@ASAHI-intecc.com | |
| TRADE NAME: | ASAHI CHIKAI Neurovascular Guide Wire |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Wire, Guide, Catheter, Neurovasculature |
| PRODUCT CODE | MOF- Catheter Guide Wire |
| PREDICATE DEVICES: | ASAHI CHIKAI Neurovascular Guide Wire (K110584) |
510(k) [K160659]
Intended Use/Indications for Use
ASAHI CHIKAI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
Device Description:
The ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200 cm and 300 cm lengths. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil
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Special 510(k) Premarket Notification ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Round Curve
assembly is soldered to the core wire. The coil assembly construction is identical to the 510(k) cleared ASAHI CHIKAI Neurovascular Guide Wire (K110584).
The distal end of the quide wire has a radiopaque tip to achieve visibility. This change introduces a rounded tip configuration designed to bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.
COMPARISON WITH PREDICATE DEVICES:
Comparisons of the CHIKAI Round Curve to its predicate device show that the technological characteristics of the Subject device such as the product performance, intended use/indications, components, materials, sterilization method, shelf life, manufacturing process, and operating principle are identical to the currently marketed predicate devices. There are only minor shape variations between the Subject and predicate device.
| Name of Device | ASAHI CHIKAI NeurovascularGuide Wire (Round Curve) | ASAHI CHIKAI NeurovascularGuide Wire |
|---|---|---|
| 510(k) | Current Application | K110584 |
| Intended Use andIndications | ASAHI Neurovascular Guide Wire is intended to be used in theneuro vasculature to facilitate the placement and exchange oftherapeutic devices such as cerebral catheters duringintravascular therapy. This guide wire is intended for use only inthe neuro vasculature. | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 Years | |
| Target Body Location | Neuro Vascular | |
| Outer Distal Hydrophiliccoating | Yes | |
| Proximal Coating | PTFE (300cm only) | |
| Outer Coil Material | Stainless SteelPlatinum-Nickel | |
| Core Wire Material | Stainless Steel | |
| Inner Coil Material | Stainless Steel | |
| Distal Tip Shape | Round Curve | Straight |
| Overall Length | 200-300 cm | |
| Outer coil length | 30cm | |
| Outer Coil Outer Diameter | 0.36mm | |
| Distal Outer Coating | Hydrophilic | |
| Outer Coil | Radiopaque Coil |
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Non Clinical testing / Performance Data:
Confirmatory non clinical laboratory testing was performed on the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) to determine substantial equivalence.
The following testing/assessments were performed:
- Tensile Strength
- Torque Strength ●
- Torqueability ●
- . Tip Flexibility
The in vitro bench tests demonstrated that the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate devices.
BIOCOMPATIBILITY:
The ASAHI CHIKAJ Neurovascular Guide Wire (Round Curve) was compared to the predicate device. Based on the identical materials and manufacturing process used in the subject device to its predicate, the biocompatibility of the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) was verified to be the same as those of the predicate.
Conclusion:
The ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) has identical intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended.
Therefore, the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is substantially equivalent to the predicate device.
§ 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.