(30 days)
No
The device description and performance studies focus on the physical construction and mechanical performance of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The guide wire's intended use is to facilitate the placement and exchange of therapeutic devices, not to provide therapy itself.
No
Explanation: The device is described as a guide wire intended to facilitate the placement and exchange of therapeutic devices, not to diagnose a condition. Its function is interventional, not diagnostic.
No
The device description clearly details a physical guide wire constructed from stainless steel, platinum-nickel, and coils, with a hydrophilic coating and radiopaque tip. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guide wire is used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices during intravascular therapy. This describes a device used within the body for a therapeutic procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details the physical construction of a guide wire designed for navigation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), providing diagnostic information, or any of the typical components or functions associated with IVD devices (reagents, assays, analyzers, etc.).
Therefore, this device is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This 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.
Product codes (comma separated list FDA assigned to the subject device)
MOF
Device Description
The ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (hereafter "CHIKAI X 014 soft") is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200cm length. The extension wire is connected to the end of the guide wire outside the body for 200cm wire. The guide wire is constructed from a stainless steel core wire with a 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 distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The coil assembly construction is similar to the 510(K) cleared ASAHI Neurovascular Guide Wire CHIKAI with K110584.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The substantial equivalence of the CHIKAI X 014 soft line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary and Cerebrovascular Guidance, January 1995. Only those tests impacted by the device modifications were repeated.
Test: Tensile Strength
Results / Conclusions: All test articles met established acceptance criteria. Acceptance criteria determined by evaluation of predicate devices and ASAHI's established tensile strength specifications.
Test: Torque Strength
Results / Conclusions: All test articles met established acceptance criteria. Acceptance criteria determined by evaluation of predicate devices and ASAHI's established torque strength specifications.
Test: Torqueability
Results / Conclusions: All test articles met the acceptance criteria. Acceptance criteria determined by evaluation of predicate devices and ASAHI's established torqueability specifications.
Test: Tip Flexibility
Results / Conclusions: All test articles met established Tip Flexibility acceptance criteria. Acceptance criteria determined by evaluation of predicate devices and ASAHI's established tip flexibility specifications.
Test: Coating Adherence
Results / Conclusions: Test results confirmed the integrity of the coating was maintained during simulated clinical use in all test articles.
Test: Catheter Compatibility
Results / Conclusions: All test articles met the acceptance criteria. Resistance to catheter withdrawal is similar or better than predicate.
Test: Bench Testing
Results / Conclusions: Test results on all test articles confirmed guidewire performance. Guidewire reached target area and interventional catheter was successfully advanced over quide wire to target site.
The in vitro bench tests demonstrated that the CHIKAI X 014 soft 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 device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ASAHI Neurovascular Guide Wire CHIKAI (K110584)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ASAHI Neurovascular Guide Wire CHIKAI black (K141751)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION".
July 26, 2019
ASAHI INTECC CO., LTD % Cynthia Valenzuela Director, Regulatory Affairs ASAHI INTECC USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, California 92780
Re: K191714
Trade/Device Name: ASAHI Neurovascular Guide Wire (CHIKAI X 014 soft) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: June 26, 2019 Received: June 26, 2019
Dear Cynthia Valenzuela:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Xiaolin Zheng, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191714
Device Name
ASAHI Neurovascular Guide Wire (CHIKAI X 014 soft)
Indications for Use (Describe)
This 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary [as required by 21CFR § 807.92(c)]
Image /page/3/Picture/1 description: The image shows the logo and contact information for ASAHI INTECC CO., LTD. The logo is in red and black. Below the logo is the text "Global Headquarters and R&D Center", followed by the address "3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan". The phone number is +81-561-48-5551, the fax number is +81-561-48-5552, and the website is http://www.asahi-intecc.co.jp/.
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
| DATE PREPARED: | 27JUN2019 |
|---|---|
| APPLICANT: | ASAHI INTECC CO., LTD |
| 3-100 Akatsuki-cho, Seto | |
| Aichi 489-0071, Japan | |
| PRIMARY CONTACT: | Mrs. Cynthia Valenzuela |
| Director, Regulatory Affairs | |
| ASAHI INTECC USA, INC. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, California 92780 | |
| Phone: (714) 442 0575 | |
| Fax: (949) 377 3255 | |
| Cell Phone: (949) 413 0071 | |
| Email: cynthiav@asahi-intecc-us.com | |
| ALTERNATE CONTACT: | Mr. Yoshi Terai |
| President, CEO | |
| ASAHI INTECC USA, INC. | |
| Tustin, CA 92780 USA | |
| Phone: (949) 756 8901 | |
| Fax: (949) 377 3255 | |
| Email: yoshi@asahi-intec-us.com | |
| TRADE NAME: | ASAHI Neurovascular Guide Wire (CHIKAI X |
| 014 soft) | |
| DEVICE CLASSIFICATION: | Class II, 21CFR § 870.1330 |
| CLASSIFICATION NAME: | Wire, Guide, Catheter, Neurovascular |
| PRODUCT CODE: | MOF - Catheter Guide Wire |
| PREDICATE DEVICE(S): | Primary Predicate: |
| ASAHI Neurovascular Guide Wire CHIKAI | |
| (K110584) | |
| Reference Device: | |
| ASAHI Neurovascular Guide Wire CHIKAI | |
| black(K141751) |
4
Intended Use/Indications for Use
This quide 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.
Description:
The ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (hereafter "CHIKAI X 014 soft") is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200cm length. The extension wire is connected to the end of the guide wire outside the body for 200cm wire. The guide wire is constructed from a stainless steel core wire with a 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 distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The coil assembly construction is similar to the 510(K) cleared ASAHI Neurovascular Guide Wire CHIKAI with K110584.
Comparison with Predicate Device(s):
| Predicate Device: | Reference Device: |
|---|---|
| ASAHI Neurovascular Guide Wire CHIKAI (K110584) | ASAHI Neurovascular Guide Wire CHIKAI black |
| (K141751) |
Comparisons of the CHIKAI X 014 soft and predicate devices show that the technological characteristics of the CHIKALX 014 soft such as components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate device. A tabular comparison of the specific technological characteristics between the predicate device and subject device is provided below.
| Name of Device | ASAHI Neurovascular Guide
Wire CHIKΑΙ Χ 014 soft | ASAHI Neurovascular Guidewire
CHIKAI |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 510(K) | K191714 | K110584 |
| Intended Use and Indications | The 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. | |
| Sterilization | Ethylene Oxide to SAL 10-6 | |
| Shelf Life | 1 Year | 3 Years |
| Target Body Location | Neurovascular | |
| Outer Coil Material | Stainless-Steel | Stainless-Steel
Platinum-Nickel Alloy |
| Core Wire Material | Stainless-Steel | Stainless-Steel |
| Inner Coil Material | Platinum-Nickel Alloy | Stainless-Steel |
| Distal Tip Shape | Straight | Straight |
| Overall Length | 200cm | 200cm, 300cm |
5
| Distal Section Coating length | 1700mm | 1700mm |
|---|---|---|
| Outside Diameter of Wire | 0.36mm | 0.36mm |
Non Clinical Testing / Performance Data:
The substantial equivalence of the CHIKAI X 014 soft line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary and Cerebrovascular Guidance, January 1995. Only those tests impacted by the device modifications were repeated. The table below provides a summary of the bench test methods, results and conclusions. Acceptance criteria for each of the tests were determined by prior comparative testing with predicate devices, ASAHI's established guide wire specifications, and clinical experience.
| Test | Test Method Summary | Results / Conclusions |
|---|---|---|
| Tensile Strength | To determine maximum allowable | |
| tensile load between connections, guide | ||
| wire is fixed in the Tensile Testing | ||
| Machine and pulled until failure. | All test articles met established | |
| acceptance criteria. Acceptance | ||
| criteria determined by evaluation of | ||
| predicate devices and ASAHI's | ||
| established tensile strength | ||
| specifications. | ||
| Torque Strength | To determine torque strength, distal end | |
| is inserted and advanced through | ||
| simulated model. Distal tip is held | ||
| stationary while proximal end is rotated | ||
| until failure. | All test articles met established | |
| acceptance criteria. Acceptance | ||
| criteria determined by evaluation of | ||
| predicate devices and ASAHI's | ||
| established torque strength | ||
| specifications. | ||
| Torqueability | To determine torque response, | |
| guidewire is inserted through catheter | ||
| and into Rotational Response model. | ||
| Proximal end is rotated from 0° to | ||
| 720°. Torque response at distal end is | ||
| measured at each 90° angle. | All test articles met the acceptance | |
| criteria. Acceptance criteria | ||
| determined by evaluation of | ||
| predicate devices and ASAHI's | ||
| established torqueability | ||
| specifications. | ||
| Tip Flexibility | To determine flexibility of the distal end, | |
| the force to deflect the guide wire 45° | ||
| and 90° at 5, 10, and 20mm from distal | ||
| tip is measure by a force analyzer | ||
| attached to a load cell. | All test articles met established Tip | |
| Flexibility acceptance criteria. | ||
| Acceptance criteria determined by | ||
| evaluation of predicate devices and | ||
| ASAHI's established tip flexibility | ||
| specifications. | ||
| Coating Adherence | Integrity of coated outer coil and core | |
| wire is determined before, and after, | ||
| pretreatment and manipulation in | ||
| excess of that expected in clinical use. | Test results confirmed the integrity of | |
| the coating was maintained during | ||
| simulated clinical use in all test | ||
| articles. | ||
| Catheter Compatibility | Catheter compatibility is evaluated by | |
| measuring the force to withdraw the | ||
| guide wire that has been inserted | ||
| through the test catheter. | All test articles met the acceptance | |
| criteria. Resistance to catheter | ||
| withdrawal is similar or better than | ||
| predicate. | ||
| Bench Testing | To simulate clinical use, guidewire is | |
| inserted through guide catheter placed | ||
| in simulated model and advanced to | ||
| target area. Microcatheter is inserted | ||
| over guidewire and advanced to target | ||
| cerebral artery multiple times. | Test results on all test articles | |
| confirmed guidewire performance. | ||
| Guidewire reached target area and | ||
| interventional catheter was | ||
| successfully advanced | ||
| over quide | ||
| wire to target site. |
6
The in vitro bench tests demonstrated that the CHIKAI X 014 soft 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 device.
BIOCOMPATIBILITY:
There have been no changes in materials of the Subject device as compared to the Predicate device. For this reason, no additional biocompatibility information is required for this Special 510(K).
CONCLUSION:
The CHIKAI X 014 soft 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 and reference device. Performance data demonstrates that the device functions as intended.
Therefore, the CHIKAI X 014 soft is substantially equivalent to the predicate device.