(130 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 capabilities.
No
The device is a guide wire intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures, but it is not therapeutic itself.
No
The device is a guide wire intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is a tool for a procedure, not a device that itself diagnoses a condition.
No
The device description clearly details physical components like a coil-type distal end, plastic covering, radiopaque material, PTFE coating, core shaft, and extension wire, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the product is for "facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures." This describes a tool used during a medical procedure, not a device used to perform tests on samples taken from the body (which is the definition of an IVD).
- Device Description: The description details a physical guide wire used for navigation within blood vessels. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with IVD devices. The performance studies focus on physical properties and functionality, not analytical performance on biological samples.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.
Product codes
DQX
Device Description
The ASAHI Peripheral Guide Wires in this submission have a coil-type distal end or a plastic covered-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy.
The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. ASAHI INTECC detachable extension wire (hereafter "extension wire") (previously cleared as part of K083145 and K101985) is available to connect with the proximal end of the guide wire with a length of less than 300 cm. The total length of the system after the connection with be 300cm to 400cm. Torque device may be included in the same package.
The ASAHI Peripheral Guide Wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter range of 0.36 to 0.45 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral 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
Non clinical laboratory testing was performed on the ASAHI Peripheral Guide Wire to determine substantial equivalence. The following testing/assessments were performed:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Adhesion/Integrity
- Catheter Compatibility
The in vitro bench tests demonstrated that the ASAHI Peripheral Guide Wire 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)
K133865, K963702, K033742, K112979
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 seal is a stylized symbol featuring three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2015
ASAHI Intecc Co., Ltd. % Candace Cederman Senior Regulatory Affairs Consultant Cardiomed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, MD 21228
Re: K150445
Trade/Device Name: ASAHI Peripheral Guide Wires (ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 3, 2015 Received: June 4, 2015
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
1
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 (QS) 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,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150445
Device Name
ASAHI Peripheral Guide Wires (ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV)
Indications for Use (Describe)
This product is intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.
| 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) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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ASAHI 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
510(k) Summary [as required by 21 CFR 807.92(c)]
ASAHI Peripheral Guide Wires
ASAHI Peripheral Guide Wire ASAHI Gladius ASAHI Peripheral Guide Wire ASAHI Halberd ASAHI Peripheral Guide Wire ASAHI Gaia PV
510(k) -
| DATE PREPARED: | 2/19/2015 |
|---|---|
| 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 | |
| TRADE NAME: | ASAHI Peripheral Guide Wire series |
| • ASAHI Peripheral Guide Wire ASAHI Gladius | |
| • ASAHI Peripheral Guide Wire ASAHI Halberd | |
| • ASAHI Peripheral Guide Wire ASAHI Gaia PV | |
| DEVICE | |
| CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION | |
| NAME: | Catheter, Guide, Wire |
| PRODUCT CODE | DQX- Catheter Guide Wire |
| PREDICATE | |
| DEVICES: | Primary Predicates: |
| ASAHI Regalia XS 1.0 Peripheral Guide Wire (K083146) | |
| ASAHI ASTATO 30 Peripheral Guide Wire 10 (K071721) | |
| ASAHI ASTATO XS20 Peripheral Guide Wire (K103057) | |
| Reference Devices: | |
| ASAHI PTCA Guide Wire ASAHI Gaia Third (K133865) | |
| Abbott Vascular HI-TORQUE IRON MAN Guide Wire (K963702) | |
| Boston Scientific V-18 Control Wire Guidewire (K033742) | |
| ASAHI CHIKAI (K112979) |
4
Intended Use/Indications for Use
This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
Description:
The ASAHI Peripheral Guide Wires in this submission have a coil-type distal end or a plastic covered-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy.
The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. ASAHI INTECC detachable extension wire (hereafter "extension wire") (previously cleared as part of K083145 and K101985) is available to connect with the proximal end of the guide wire with a length of less than 300 cm. The total length of the system after the connection with be 300cm to 400cm. Torque device may be included in the same package.
The ASAHI Peripheral Guide Wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter range of 0.36 to 0.45 mm.
COMPARISON WITH PREDICATE DEVICES:
Comparisons of the ASAHI Peripheral Guide Wire and predicate devices show that the technological characteristics of the ASAHI Peripheral Guide Wires such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.
The intended use/indications between 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. Additional predicate devices have been used to demonstrate equivalence for these similar features.
| Name of Device | ASAHI Peripheral Guide Wire ASAHI Gladius ASAHI Halberd ASAHI Gaia PV | Regalia XS 1.0 ASTATO XS 20 ASTATO 30 |
|---|---|---|
| 510(k) | Current Application | K083146 |
| K103057 | ||
| K071721 | ||
| Intended Use and | ||
| Indications | This product is intended to facilitate the placement and exchange of | |
| diagnostic and therapeutic devices during intravascular procedures. | ||
| This device is intended for peripheral vascular use only. | ||
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 Years | |
| Target Body Location | Peripheral |
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Traditional 510(k) Premarket Notification ASAHI Peripheral Guide Wires
| Outer Distal | Yes |
|---|---|
| Hydrophilic coating | |
| Proximal Coating | PTFE |
| Overall Length | 180-300 cm |
| Nominal OD | 0.36-0.45 mm (0.014-0.018inches) |
| Outer Coil Material | Platinum-Nickel Austenitic Stainless Steel (316 SS) |
| Core Wire Material | Austenitic Stainless Steel (304 SS) |
Non Clinical testing / Performance Data:
Non clinical laboratory testing was performed on the ASAHI Peripheral Guide Wire to determine substantial equivalence. The following testing/assessments were performed:
- Tensile Strength
- Torque Strength ●
- Torqueability ●
- Tip Flexibility ●
- Coating Adhesion/Integrity ●
- Catheter Compatibility ●
The in vitro bench tests demonstrated that the ASAHI Peripheral Guide Wire 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 Peripheral Guide Wire was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates, the biocompatibility of the ASAHI Peripheral Guide Wire was verified to be the same as those of the predicates.
Conclusion:
The ASAHI Peripheral Guide Wire 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 Peripheral Guide Wire is substantially equivalent to the predicate devices.