(172 days)
No.
The device description and performance studies do not mention any AI models or related technologies; it describes a physical guide wire and its material properties and performance.
No.
The device is a guide wire intended to facilitate the placement and exchange of therapeutic devices, not to provide therapy itself.
No
This guide wire is intended to facilitate the placement and exchange of therapeutic devices, not to diagnose a condition.
No
The device description, intended use, and performance studies clearly indicate this is a physical medical device (a guide wire) made of various materials for neurovascular use, not a software product. There is no mention of software components, algorithms, or digital processing.
No.
This device is a guide wire, which is an invasive surgical tool used to facilitate the placement of other therapeutic devices. It does not perform any in vitro examination of specimens derived from the human body.
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 CHIKAI Nexus 014 consists of a stainless-steel tapered core wire, with an inner coil and outer coil made of radiopaque Pt-Ni alloy and stainless-steel. Surrounding the inner coil and the distal core wire is a radiopaque Pt-Ni alloy and stainless-steel outer coil. The radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy. Outer and inner coils are soldered to the tapered core wire with Ag-Sn solder. A similar coil design is used with other ASAHI guide wires, such as the predicate CHIKAI black (K141751).
Additionally, the CHIKAI Nexus 014 employs hydrophilic, polyurethane, PTFE, and silicone coatings which are used in the predicate and reference devices.
The nominal outer diameter of the CHIKAI Nexus 014 is 0.36 mm (0.014 inch). The device is available in two lengths: 215 cm and 300 cm.
Both sizes are available with straight, pre-shape, and angled designs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray fluoroscopy
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)
Sterilization Validation: 100% EO is used to sterilize the device to achieve a SAL of at least 10-6. The device was adopted into an EO sterilization processing group in accordance with AAMI TIR28:2016. Validation of the EO sterilization cycle was performed using the half-cycle, overkill approach described in ISO 11135:2014. Results of evaluation by AAMI TIR28 justified adoption of the CHIKAI Nexus 014 into the EO sterilization processing group. Additional testing was conducted to validate and ensure sterilization.
EO and ECH Residuals: Measured EO and ethylene chlorohydrin (ECH) residuals per AAMI/ANSI/ISO 10993-7:2008. The residual traces of EO and ECH remaining in the CHIKAI Nexus 014 after exposure to the EO sterilization process met the appropriate criteria with sufficient aeration time.
Bacterial Endotoxin Levels: Limulus amebocyte lysate (LAL) testing was conducted in accordance with ANSI/AAMI ST72:2011/(R) 2016, USP , and USP , using the kinetic chromogenic method. The CHIKAI Nexus 014 met the acceptance criteria of Rabbit Pyrogen Test (Material Mediated):** Determine the potential presence of material-mediated pyrogen. Non-pyrogenic.
Hemocompatibility ISO 10993-4 Rabbit Blood Direct and Indirect (Extract) Hemolysis: Determine the potential hemolytic activity, via the induction of increased levels of free plasma hemoglobin in rabbit blood, in response to the test article (direct) and its extract (indirect). Non-hemolytic in both direct and indirect hemolysis tests.
Hemocompatibility ISO 10993-4 Complement Activation (SC5b-9): Human plasma was exposed to the device (direct contact) to determine the potential activation of the SC5b-9 complement system. Non-activator; The concentration of SC5b-9 in the plasma exposed to the device was not statistically different from those of negative and untreated control.
Hemocompatibility ISO 10993-4 Thrombogenicity: Compared and evaluated the thrombogenicity properties of direct blood contacting components of the subject and predicate devices in vivo. Subject and predicate devices showed similar thrombogenic potential.
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 black (K141751)
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 PTCA Guide Wire Soft (K022762, K163426), ASAHI Neurovascular Guide Wire CHIKAI Round Curve (K160659), ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (K191714)
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.
FDA 510(k) Clearance Letter - CHIKAI Nexus 014
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 21, 2025
ASAHI INTECC CO., LTD.
℅ Cynthia Valenzuela
Director, Regulatory Affairs
ASAHI INTECC USA, INC.
3002 Dow Avenue, Suite 212
Tustin, California 92780
Re: K243383
Trade/Device Name: CHIKAI Nexus 014
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter Guide Wire
Regulatory Class: Class II
Product Code: MOF
Dated: March 19, 2025
Received: March 19, 2025
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 (the 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 available 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.
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K243383 - Cynthia Valenzuela
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243383 - Cynthia Valenzuela
Page 3
assistance/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,
Naira Muradyan -S
Naira Muradyan, 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K243383
Device Name
CHIKAI Nexus 014
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.
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
[As required by 21 CFR § 807.92(c)]
Global Headquarters and R&D Center
3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan
TEL: +81-561-48-5551 FAX: +81-561-48-5552
http://www.asahi-intecc.co.jp/
CHIKAI Nexus 014
510(k) K243383
DATE PREPARED: 14th April 2025
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
Email: cynthiav@asahi-intecc-us.com
ALTERNATE CONTACT: Mr. Katsuhiko Fujimura
Group Manager, Regulatory Affairs
ASAHI INTECC CO., LTD.
3-100 Akatsuki-cho
Seto, Aichi, Japan 489-0071
Email: katsuhiko.fujimura@asahi-intecc.com
TRADE NAME: CHIKAI Nexus 014
DEVICE CLASSIFICATION: Class II, 21 CFR § 870.1330
CLASSIFICATION NAME: Neurovascular Catheter Guide Wire
PRODUCT CODE: MOF
PREDICATE DEVICE(S): ASAHI Neurovascular Guide Wire CHIKAI black (K141751)
REFERENCE DEVICE(S): ASAHI PTCA Guide Wire Soft (K022762, K163426)
ASAHI Neurovascular Guide Wire CHIKAI Round Curve (K160659)
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (K191714)
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.
K243383 CHIKAI Nexus 014
Page 1 of 8
Page 6
K243383 CHIKAI Nexus 014
Page 2 of 8
Device Description
The CHIKAI Nexus 014 consists of a stainless-steel tapered core wire, with an inner coil and outer coil made of radiopaque Pt-Ni alloy and stainless-steel. Surrounding the inner coil and the distal core wire is a radiopaque Pt-Ni alloy and stainless-steel outer coil. The radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy. Outer and inner coils are soldered to the tapered core wire with Ag-Sn solder. A similar coil design is used with other ASAHI guide wires, such as the predicate CHIKAI black (K141751).
Additionally, the CHIKAI Nexus 014 employs hydrophilic, polyurethane, PTFE, and silicone coatings which are used in the predicate and reference devices.
The nominal outer diameter of the CHIKAI Nexus 014 is 0.36 mm (0.014 inch). The device is available in two lengths: 215 cm and 300 cm.
Both sizes are available with straight, pre-shape, and angled designs.
Accessories
CHIKAI Nexus 014 is packaged with a shaping device, torque device, and inserter.
The shaping device can be used to facilitate shaping the distal end of the guide wire.
The torque device can be attached to the proximal end of the guide wire and used to facilitate the rotation of the guide wire during clinical use.
The inserter device can be used to assist the insertion of guide wire into the catheter.
Comparison with Predicate and Reference Devices
The subject, predicate, and reference devices:
- Have the same or similar intended use and indications for use
- Use the same operating principle
- Incorporate the same basic design
- Incorporate the same materials
The following technological differences exist between the subject and the predicate or the reference devices:
- Different inner coil structure
- Different lineup of usable length
- Different coating length
Page 7
K243383 CHIKAI Nexus 014
Page 3 of 8
| Device name | CHIKAI Nexus 014 Subject | CHIKAI black Predicate | PTCA Guide Wire Soft Reference | CHIKAI Round Curve Reference | CHIKAI X 014 soft Reference |
|---|---|---|---|---|---|
| 510(k) | K243383 | K141751 | K022762 K163426 | K160659 | K191714 |
| Manufacturer | ASAHI INTECC | ||||
| Regulation Number | 21 CFR 870.1330 | ||||
| Regulation Name | Catheter Guide Wire | ||||
| Regulatory Class | II | ||||
| Product code | MOF | MOF | DQX | MOF | MOF |
| 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. | 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 PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature. | 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 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. |
Page 8
K243383 CHIKAI Nexus 014
Page 4 of 8
| CHIKAI Nexus 014 | CHIKAI black | PTCA Guide Wire Soft | CHIKAI Round Curve | CHIKAI X 014 soft | |
|---|---|---|---|---|---|
| Nominal Outer Diameter | 0.36 mm (0.014 inch) | 0.36 mm (0.014 inch) | 0.36 mm (0.014 inch) | 0.36 mm (0.014 inch) | 0.36 mm (0.014 inch) |
| Overall Length | 215 cm, 300 cm | 200 cm, 300 cm | 180 cm, 300 cm | 200 cm, 300 cm | 200 cm |
| Outer Coil | Austenitic stainless-steel Pt-Ni alloy | Austenitic stainless-steel Pt-Ni alloy | Austenitic stainless-steel Pt-Ni alloy | Austenitic stainless-steel Pt-Ni alloy | Austenitic stainless-steel |
| Tapered Core Wire | Austenitic stainless-steel | Austenitic stainless-steel | Austenitic stainless-steel | Austenitic stainless-steel | Austenitic stainless-steel |
| Inner Coil | Austenitic stainless-steel Pt-Ni alloy | Austenitic stainless-steel | N/A | Austenitic stainless-steel | Pt-Ni alloy |
| Tip Shape | Straight, Pre-shape, Angled | Round Curve, Angled | Straight | Round Curve, Straight | |
| Coating | Hydrophilic Silicone Polyurethane PTFE | Hydrophilic Polyurethane PTFE* *applicable to 300 cm model only | Silicone PTFE | Hydrophilic PTFE* *applicable to 300 cm model only | Hydrophilic Silicone |
| Solder | Ag-Sn | Ag-Sn | Ag-Sn | Ag-Sn | Ag-Sn |
| Sterilization | Ethylene oxide (EO) Sterility assurance level (SAL) 10-6 | EO SAL 10-6 | EO SAL 10-6 | EO SAL 10-6 | EO SAL 10-6 |
| Shelf Life | 6 months | 3 years | 3 years | 3 years | 3 years |
Page 9
K243383 CHIKAI Nexus 014
Page 5 of 8
Sterility and Shelf Life
The following tests were conducted to validate the sterility and shelf life of the subject device.
| Test | Test Method Summary | Results |
|---|---|---|
| Sterilization Validation | 100% EO is used to sterilize the device to achieve a SAL of at least 10-6. The device was adopted into an EO sterilization processing group in accordance with AAMI TIR28:2016. Validation of the EO sterilization cycle was performed using the half-cycle, overkill approach described in ISO 11135:2014. | Results of evaluation by AAMI TIR28 justified adoption of the CHIKAI Nexus 014 into the EO sterilization processing group. Additional testing was conducted to validate and ensure sterilization. |
| EO and ECH Residuals | Measured EO and ethylene chlorohydrin (ECH) residuals per AAMI/ANSI/ISO 10993-7:2008. | The residual traces of EO and ECH remaining in the CHIKAI Nexus 014 after exposure to the EO sterilization process met the appropriate criteria with sufficient aeration time. |
| Bacterial Endotoxin Levels | Limulus amebocyte lysate (LAL) testing was conducted in accordance with ANSI/AAMI ST72:2011/(R) 2016, USP , and USP , using the kinetic chromogenic method. | The CHIKAI Nexus 014 met the acceptance criteria of Rabbit Pyrogen Test (Material Mediated)** |
| Hemocompatibility ISO 10993-4 Rabbit Blood Direct and Indirect (Extract) Hemolysis | Determine the potential hemolytic activity, via the induction of increased levels of free plasma hemoglobin in rabbit blood, in response to the test article (direct) and its extract (indirect). | Non-hemolytic in both direct and indirect hemolysis tests |
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K243383 CHIKAI Nexus 014
Page 8 of 8
| Test | Test Method Summary | Results/Conclusion |
|---|---|---|
| Hemocompatibility ISO 10993-4 Complement Activation (SC5b-9) | Human plasma was exposed to the device (direct contact) to determine the potential activation of the SC5b-9 complement system. | Non-activator; The concentration of SC5b-9 in the plasma exposed to the device was not statistically different from those of negative and untreated control. |
| Hemocompatibility ISO 10993-4 Thrombogenicity | Compared and evaluated the thrombogenicity properties of direct blood contacting components of the subject and predicate devices in vivo. | Subject and predicate devices showed similar thrombogenic potential. |
CONCLUSION:
The CHIKAI Nexus 014 has the same intended use and the same or similar technological characteristics, such as components, design, materials, sterilization method, and operating principles as the predicate device. The differences between the subject and predicate device do not raise different or new questions of safety or effectiveness.
Performance data demonstrate that the device functions as intended. Therefore, the CHIKAI Nexus 014 is substantially equivalent to the predicate device.