(94 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML.
No
The device, a guide wire, is intended to facilitate the placement and exchange of therapeutic devices, not to be a therapeutic device itself.
No
Explanation: The device is described as a guide wire intended to facilitate the placement and exchange of therapeutic devices. Its function is to guide other medical instruments, not to diagnose a condition or disease.
No
The device description clearly states it is a physical guide wire constructed from stainless steel and other materials, and the performance studies involve bench testing of physical properties like tensile strength and torque.
No, 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 medical procedure, not a device used to test samples outside the body.
- Device Description: The description details the physical construction of a guide wire designed to be inserted into blood vessels.
- Performance Studies: The performance studies focus on physical properties like tensile strength, torque strength, torqueability, and tip flexibility, as well as simulated clinical use within a model. These are all relevant to a device used in a medical procedure, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
In summary, this device is an invasive medical device used for a therapeutic procedure, not an in vitro diagnostic device.
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 CHIKAI Black 14 Soft Tip neurovascular guide wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and length of 200cm. The quide 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 similar to that of the 510(k) cleared ASAHI CHIKAI black neurovascular guide wire (K141751).
The distal end of the guide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire.
This change introduces a soft tip version of the round curve tip configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuro Vascular
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
The substantial equivalence of the ASAHI CHIKAI black line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document: Coronary and Cerebrovascular Guidewire Guidance. Only those tests impacted by the device modifications were repeated.
- 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 & 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 & into Rotational Response model. Proximal end is rotated and the torque response at distal end is measured. 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 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.
- Bench (Simulated) 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 & advanced to target cerebral artery multiple times. Test results on all test articles confirmed guide wire performance. Guidewire reached target area and microcatheter was successfully advanced over guidewire to target site.
Key Metrics
Not Found
Predicate Device(s)
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black (K141751)
Reference Device(s)
Not Found
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/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" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
ASAHI INTECC CO., LTD. % Ms. Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228
Re: K161912
Trade/Device Name: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Black 14 Soft Tip Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: September 15, 2016 Received: September 16, 2016
Dear Ms. 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. 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 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
1
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 and Part 809), 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,
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
2
Indications for Use
510(k) Number (if known) K161912
Device Name
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Black 14 Soft Tip
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 (Ref. 21 CFR 201. Subpart D) |
|---|---|
| Over-The-Counter Use (21 CFR 201. Subpart C) |
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 (as required by 21 CFR 807.92) SAHI INTECC CO.,LTD.
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 Black 14 Soft Tip
| DATE PREPARED: | September 15, 2016 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 1703 Wakita-cho, Moriyama-ku | |
| Nagoya, Aichi 463-0024, Japan | |
| CONTACT | Yoshinori Terai, President and 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 | |
| TRADE NAME: | ASAHI Neurovascular Guide Wire: |
| ASAHI CHIKAI Black 14 Soft Tip | |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Wire, Guide, Catheter, Neurovasculature |
| Product Code | MOF- Catheter Guide Wire |
| PREDICATE DEVICES: | ASAHI Neurovascular Guide Wire: |
| ASAHI CHIKAI black (K141751) |
510(k) K161912
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 CHIKAI Black 14 Soft Tip neurovascular guide wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and length of 200cm. The quide 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 similar to that of the 510(k) cleared ASAHI CHIKAI black neurovascular guide wire (K141751).
4
The distal end of the guide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire.
This change introduces a soft tip version of the round curve tip configuration.
COMPARISON WITH PREDICATE DEVICES:
Comparisons of the ASAHI CHIKAI Black 14 Soft Tip 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 dimensional variations in the core wire taper and inner coil between the subject and predicate device.
| Name of Device | ASAHI Neurovascular Guide
Wire (ASAHI CHIKAI Black 14
Soft Tip) | ASAHI Neurovascular Guide
Wire (ASAHI CHIKAI black) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 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. | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | | 3 Years |
| Target Body Location | Neuro Vascular | |
| Outer Coil Material | Stainless Steel
Platinum-Nickel | |
| Core Wire Material | Stainless Steel | |
| Inner Coil Material | Stainless Steel | |
| Distal Tip Shape | Round Curve | Round Curve |
| | | ANGLED 90° |
| Overall length | 200 cm | 200-300 cm |
| Outer coil length | 30cm | |
| Outer Coil Outer Diameter | 0.36mm | |
| Distal Outer Coating | | Hydrophilic |
| Outer Coil | Radiopaque Coil | |
Non Clinical testing / Performance Data:
The substantial equivalence of the ASAHI CHIKAI black line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document: Coronary and Cerebrovascular Guidewire Guidance. 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.
5
| 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 & 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 & into | ||
| Rotational Response model. Proximal | ||
| end is rotated and the torque response | ||
| at distal end is measured. | 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 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. |
Table 2 ASAHI CHIKAI series Bench Test Summary
| Bench
(Simulated)
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 & advanced to target cerebral
artery multiple times. | Test results on all test articles
confirmed guide wire performance.
Guidewire reached target area and
microcatheter was successfully
advanced over guidewire to target
site. |
| --------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
T acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate device.
BIOCOMPATIBILITY:
The ASAHI CHIKAI Black 14 Soft Tip 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 Black 14 Soft Tip was verified to be the same as those of the predicate.
Conclusion:
The ASAHI CHIKAI Black 14 Soft Tip 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 Black 14 Soft Tip is substantially equivalent to the predicate device.