(85 days)
No
The description focuses on the physical construction and materials of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guide wire intended to facilitate the placement of therapeutic devices, not to provide therapy itself.
No
Explanation: The device, an ASAHI Neurovascular Guide Wire, is intended to facilitate the placement and exchange of therapeutic devices. Its description details its physical components and coatings for navigation and visibility (e.g., radiopaque outer coil), and the performance studies focus on physical properties and functionality. There is no mention of it being used to diagnose conditions or capture diagnostic information.
No
The device description clearly details a physical guide wire made of core wire and coil assembly, with coatings and accessories. 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 in vivo (within the body) for a therapeutic procedure.
- Device Description: The description details a physical device (guide wire) with specific materials, coatings, and accessories designed for navigating blood vessels.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This guide wire does not perform any such testing on biological samples.
The information provided describes a medical device used for interventional procedures within the body, not an in vitro diagnostic test.
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
MOF
Device Description
The ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) consists of a core wire and a coil assembly. The coil assembly consists of a stainless steel distal safety wire and an outer coil, soldered to the core wire. The outer coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010). The coil and taper core wire of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) is soft in order to easily bend in accordance with the vessel curve. Accessories such as a Torque device. Shaping device and Inserter are included in the packaging of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010).
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
Non clinical laboratory testing was performed on the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) to determine substantial equivalence. The following testing/assessments were performed: Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence, Coating Integrity / Particulate Characterization, Catheter Compatibility, Bench Testing (Simulated).
The in vitro bench tests demonstrated that the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAN® X 010) 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 29, 2019
ASAHI INTECC CO., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, Maryland 21401
Re: K183070
Trade/Device Name: ASAHI Neurovascular Guide Wire (ASAHI CHIKAI X 010) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: October 31, 2018 Received: November 5, 2018
Dear 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183070
Device Name
ASAHI Neurovascular Guide Wire (ASAHI CHIKAI X 010)
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
AHI INTECC CO.,LTD.
-100 Akatsuki-cho, Seto, Aichi 489-0071, Japan Tel. +81-52-768-1211 Fax. +81-52-768-1221 Branch office: Tokyo, Nagoya, Osaka, Hong, EU, Singapore, Beijing, India, Middle Eastern Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi
510(k) Summary [as required by 21 CFR 807.92(c)]
ASAHI Neurovascular Guide Wire ASAHI® CHIKAI® X 010 510(k) K183070
| DATE PREPARED: | 06 January 2019 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 3-100 Akatsuki-cho | |
| Seto, Aichi 489-0071, Japan | |
| CONTACT | Yoshi Terai |
| President/CEO | |
| ASAHI INTECC USA, INC. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, CA 92780 | |
| Tel: (949) 756-8252, FAX: (949) 756-8165 | |
| e-mail: ASAHI.ra-fda@ASAHI-intecc.com | |
| TRADE NAME: | ASAHI® Neurovascular Guide Wire |
| (ASAHI® CHIKAI® X 010) | |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Catheter, Guide, Wire |
| PRODUCT CODE | MOF- Catheter Guide Wire |
| PREDICATE DEVICES: | ASAHI® Neurovascular Guide Wire ASAHI® CHIKAI® 008, ASAHI® |
| CHIKAI® black 18 (K141751) | |
| REFERENCE DEVICES: | ASAHI SION (K100578) |
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.
DEVICE DESCRIPTION:
The ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) consists of a core wire and a coil assembly. The coil assembly consists of a stainless steel distal safety wire and an outer coil, soldered to the core wire. The outer coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010). The coil and taper core wire of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) is soft in order to easily bend in accordance with the vessel curve. Accessories such as a Torque device. Shaping device and Inserter are included in the packaging of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010).
4
COMPARISON WITH PREDICATE DEVICE:
Comparisons of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) and the predicate devices show that the technological characteristics of the subject device such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate and reference device utilizes a distal safety wire similar to the reference device, whereas the predicate devices utilize an inner coil.
The intended use and indications for use statement of the subject device and its primary predicates are identical. There are specific design features of the subject device that are similar to the primary predicate but not identical.
| Name of Device | ASAHI Neurovascular Guide Wire
ASAHI® CHIKAI® X 010 | ASAHI Neurovascular Guide Wire
ASAHI® CHIKAI® 008
ASAHI® CHIKAI® black 18 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 510(k) | Current Application | K141751 |
| Intended Use and
Indications | 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. | |
| Target Body Location | Neuro vasculature | |
| Overall Lengths | 200 cm | |
| Nominal OD | 0.010in | 0.008in, 0.018in |
| Outer Coil Material | Platinum-Nickel | Platinum-Nickel or
Platinum-Nickel/Stainless Steel |
| Core Wire Material | Stainless Steel | |
| Hydrophilic coating | Yes | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 Years | |
NON CLINICAL TESTING / PERFORMANCE DATA:
Non clinical laboratory testing was performed on the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) to determine substantial equivalence. The following testing/assessments were performed:
| 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 | |
| tensile strength 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 & advanced through simulated | ||
| model. Distal tip is held stationary while | ||
| proximal end is rotated until failure. | All test articles met the acceptance | |
| criteria. Acceptance criteria | ||
| determined by evaluation of | ||
| predicate devices and ASAHI's | ||
| established torque strength | ||
| specifications. | ||
| Torqueability | To determine torque response, guide wire is | |
| inserted through catheter & into Rotational | ||
| Response model. Proximal end is rotated | ||
| from 0 o to 720o. Torque response at distal end | ||
| is measured at each 90o angle. | All test articles met the acceptance | |
| criteria. Torque response is similar | ||
| or better than predicate. |
5
| Test | Test Method Summary | Results/Conclusions | |
|---|---|---|---|
| Tip Flexibility | To determine flexibility of the distal end, the | ||
| force to deflect the guide wire 45° and 90° at | |||
| 5, 10 and 20 mm from distal tip is measured | |||
| 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 & core wire is | ||
| determined before, and after, pretreatment | |||
| and manipulation in excess of that expected | |||
| in clinical use. | Test results confirmed that the | ||
| integrity of the coating was | |||
| maintained during simulated | |||
| clinical use in all test articles. | |||
| Coating Integrity / | |||
| Particulate | |||
| Characterization | The total quantity and size of the particulates | ||
| generated during the simulated use of the | |||
| device is measured. | Test results are similar to the | ||
| predicate. | |||
| 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 | |||
| (Simulated) | To simulate clinical use, guide wire is | ||
| inserted through guide catheter placed in | |||
| simulated model and advanced to target area. | |||
| Interventional catheter is inserted over guide | |||
| wire & advanced to target cerebral artery | |||
| multiple times. |
The in vitro bench tests demonstrated that the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAN® X 010) 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 Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates / reference devices, the biocompatibility of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) was leveraged from the predicate and reference devices.
CONCLUSION:
The ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) 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 devices. Performance data demonstrates that the device functions as intended.
Therefore, the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) is substantially equivalent to the predicate device.