(214 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide wire, with no mention of AI or ML.
No
The device is described as a guide wire intended to facilitate the placement and exchange of therapeutic devices, not as a therapeutic device itself.
No
The device is a guide wire intended to facilitate the placement and exchange of therapeutic devices in the neuro vasculature, not to diagnose a condition.
No
The device description clearly states it is a physical guide wire constructed from stainless steel with a coil assembly, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Device Description and Intended Use: The provided text clearly describes a guide wire intended for use within the neuro vasculature to facilitate the placement of other therapeutic devices. This is an invasive medical device used directly on the patient's anatomy, not for testing samples outside the body.
The description focuses on the physical characteristics and performance of the guide wire itself, not on analyzing biological samples.
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 ASAHI CHIKAI 008, ASAHI Neurovascular Guide Wire ASAHI CHIKAI black, and the ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18 (ASAHI CHIKAI series) is a line extension of the ASAHI CHIKAI (K110584) and the ASAHI CHIKAI 10 (K112979).
The ASAHI CHIKAI series of steerable guide wires are constructed from a stainless steel core wire with a coil assembly consisting of an inner and outer coil soldered to the core wire. Distal outer diameter and tip shape of the ASAHI CHIKAI series range from 0.008 inches (0.20mm) with a straight tip for the ASAHI CHIKAI 008, to 0.014 inches (0.36mm) Round Curve or Angled 90º tip for the ASAHI CHIKAI black, to 0.018 inches (0.45mm) with a Round Curve tip for the ASAHI CHIKAI 18. The ASAHI CHIKAI and ASAHI CHIKAI black 18 are 200cm long, and the ASAHI CHIKAI black is available in 200cm and 300cm lengths.
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)
Non-clinical Performance Data:
The safety and effectiveness of the ASAHI CHIKAI series line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document: Coronary and Cerebrovascular Guidewire Guidance.
- Tensile Strength: 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: All test articles met the acceptance criteria. Acceptance criteria determined by evaluation of predicate devices and ASAHI's established torque strength specifications.
- Torqueability: All test articles met the acceptance criteria. Torque response is similar or better than predicate.
- Tip Flexibility: 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: Test results confirmed that the integrity of the coating was maintained during simulated clinical use in all test articles.
- Coating Integrity & Particulate Characterization: This testing characterized the coating integrity and particulate generation during simulated use.
- Catheter Compatibility: All test articles met the acceptance criteria. Resistance to catheter withdrawal is similar or better than predicate.
- Bench (Simulated) Testing: Test results on all test articles confirmed guide wire performance. Guidewire reached target area and interventional catheter was successfully advanced over guidewire to target site.
All neurovascular guide wires in the ASAHI CHIKAI series met the acceptance criteria for each of the bench tests.
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.
K993257, K002212, K110584, K112979, K022762, K052022
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2015
Asahi Intecc Co., Ltd. % Mr. Semih Oktay President CardioMed Device Consultants LLC 5523 Research Park Drive Suite 205 Baltimore, Maryland 21228
Re: K141751
Trade/Device Name: Asahi Neurovascular Guide Wire ASAHI CHIKAI 008, Asahi Neurovascular Guide Wire ASAHI CHIKAI Black, and Asahi Neurovascular Guide Wire ASAHI CHIKAI Black 18 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: December 29, 2014 Received: December 31, 2014
Dear Mr. Semih Oktay,
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. 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
1
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 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 FD/△
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) K141751
Device Name
ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008 ASAHI Neurovascular Guide Wire ASAHI CHIKAI black ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18
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) |
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3
510(k) SUMMARY
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
Applicant:
Asahi Intecc Co., Ltd. 1703 Wakita-cho, Moriyama-ku Nagoya, Aichi 463-0024 Japan
Official Correspondent:
Yoshi Terai President. CEO 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
Date Prepared: January 27, 2015
Device Information:
| Proprietary Name: | ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008
ASAHI Neurovascular Guide Wire ASAHI CHIKAI black
ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Guide Wire |
| Regulation Name: | Neurovascular Catheter Guide Wire |
| Regulatory Class: | Class II |
| Product Code: | MOF |
Predicate Devices:
- Micro Therapeutics Silverspeed Hydrophilic Guidewires (K993257) ●
- Micro Therapeutics Mirage Hydrophilic Guidewire (K002212) ●
- ASAHI Neurovascular Guide Wire ASAHI CHIKAI (K110584) .
- ASAHI Neurovascular Guide Wire ASAHI CHIKAI 10 (K112979) .
- ASAHI Prowater and Marker Wire Guide Wires (JoWire Neo's PTCA Guide Wire ● K022762)
- ASAHI PTCA Guide Wire Fielder (K052022) ●
4
Device Description:
The ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008, ASAHI Neurovascular Guide Wire ASAHI CHIKAI black, and the ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18 (ASAHI CHIKAI series) is a line extension of the ASAHI CHIKAI (K110584) and the ASAHI CHIKAI 10 (K112979).
The ASAHI CHIKAI series of steerable guide wires are constructed from a stainless steel core wire with a coil assembly consisting of an inner and outer coil soldered to the core wire. Distal outer diameter and tip shape of the ASAHI CHIKAI series range from 0.008 inches (0.20mm) with a straight tip for the ASAHI CHIKAI 008, to 0.014 inches (0.36mm) Round Curve or Angled 90º tip for the ASAHI CHIKAI black, to 0.018 inches (0.45mm) with a Round Curve tip for the ASAHI CHIKAI 18. The ASAHI CHIKAI and ASAHI CHIKAI black 18 are 200cm long, and the ASAHI CHIKAI black is available in 200cm and 300cm lengths.
Indication 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.
Comparison of Technological Characteristics
The indication, design, materials, and manufacturing methods of the ASAHI CHIKAI series are the same or similar to those used for the ASAHI CHIKAI and CHIKAI 10 neurovascular guide wires and share similarities with Micro Therapeutics' neurovascular guide wires. A summary table comparing the technological characteristics of the ASAHI CHIKAI series with the predicate neurovascular devices is shown in Table 1.
5
| MFR | ASAHI Neurovascular
Guide Wire | | | ASAHI Neurovascular
Guide Wire | | Micro
Therapeutics | Micro
Therapeutics Inc | | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|---------------|--|
| Device
Name | ASAHI
CHIKAI
008 | ASAHI
CHIKAI
black | ASAHI
CHIKAI
black 18 | ASAHI
CHIKAI | ASAHI
CHIKAI 10 | Inc. Silverspeed
Hydrophilic
Guidewires | Mirage
Hydrophilic
Guidewire | | |
| 510(k) | Subject 510k | | | K110584 | | K112979 | K993257 | K002212 | |
| Intended
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. | | | ASAHI 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. | | For general intravascular use to aid in
the selective placement of catheters in
the peripheral, visceral, and cerebral
vasculature during diagnostic and/or
therapeutic procedures. | | | |
| Class | 21 CFR 870.1330, Class II | | | Same | | Same | | | |
| Device
design | Stainless Steel core wire with an
outer and inner coils | | | Same | | Stainless steel core wire with an outer
coil | | | |
| Outer
Coating
Material | Hydrophilic
PTFE - proximal 300 cm length
CHIKAI black only | | | Hydrophilic
PTFE - proximal 300cm length
only | | Hydrophilic | | | |
| Outer
Coil OD | 0.20mm | 0.36mm | 0.45mm | 0.36mm | 0.26mm | 0.36, 0.41, & 0.45mm | 0.20mm | | |
| Overall
length | 200cm | 200cm,
300cm | 200cm | 200cm
300cm | 200cm
300cm | 200cm | 200cm | | |
| Tip shape | Straight | Round
Curve,
Angled
90° | Round
Curve | Straight | | Straight | | | |
| Sterilizing
Method/
Packaging | ETO sterilized guide wire is
inserted in a tube & placed in
peelable pack and then in a
packaging box.
CHIKAI black & black 18:
Angle protector & Product
fixture protective components | | | ETO sterilized guide wire is
inserted in a tube & placed in
peelable pack and then in a
packaging box. | | Not available | | Not available | |
Table 1 Comparison of ASAHI CHIKAI series to the predicate devices.
The materials used in the manufacture of the ASAHI CHIKAI series tapered core wire, coils and coating materials, and the manufacturing processes are the same as those used for ASAHI's Prowater and Marker Wire PTCA Guide Wires (K022762) and ASAHI PTCA Guide Wire Fielder (K052022), which were subject to full biocompatibility testing in accordance with ISO 10993.
6
Non-clinical Performance Data:
The safety and effectiveness of the ASAHI CHIKAI series line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document: Coronary and Cerebrovascular Guidewire Guidance. Table 2 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 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, guidewire is | |
| inserted through catheter & into Rotational | ||
| Response model. Proximal end is rotated | ||
| and the torque response at distal end is | ||
| measured. | All test articles met the acceptance | |
| criteria. Torque response is similar or | ||
| better than predicate. | ||
| Tip Flexibility | To determine flexibility of the distal end, the | |
| force to deflect the guide wire 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 | Coating integrity and particulates were | |
| evaluated. The test samples were advanced | ||
| through a microcatheter to the target | ||
| location, retracted and the coating inspected | ||
| under magnification. All particulate matter | ||
| generated during insertion/retraction of the | ||
| guidewire was counted & classified by their | ||
| particle sizes. | This testing characterized the coating | |
| integrity and particulate generation during | ||
| simulated use. | ||
| 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 | ||
| (Simulated) | ||
| Testing | To simulate clinical use, guidewire is | |
| inserted through guide catheter placed in | ||
| simulated model and advanced to target area. | ||
| Interventional catheter is inserted over | ||
| guidewire & advanced to target cerebral | ||
| artery multiple times. | Test results on all test articles confirmed | |
| guide wire performance. Guidewire | ||
| reached target area and interventional | ||
| catheter was successfully advanced over | ||
| guidewire to target site. |
Table 2 ASAHI CHIKAI series Bench Test Summary
7
All neurovascular guide wires in the ASAHI CHIKAI series met the acceptance criteria for each of the bench tests.
Conclusion
Based on the similar indication, design and materials, and the results of the bench testing, the ASAHI CHIKAI series line extension is considered substantially equivalent to the predicate devices listed above.