(49 days)
No
The 510(k) summary describes a physical guide wire and its mechanical and biocompatibility testing. There is no mention of software, algorithms, image processing, AI, or ML.
No.
The device facilitates the placement of diagnostic and therapeutic devices during procedures but is not itself described as performing a therapeutic function.
No
The "Intended Use / Indications for Use" section states that the device is intended to "facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures," rather than being a diagnostic device itself.
No
The device description clearly outlines a physical guide wire constructed from stainless steel and other materials, with physical performance testing described.
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 device is for use in the peripheral vasculature to facilitate the exchange and placement of diagnostic and therapeutic devices. This is a surgical/interventional use, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a physical guide wire used within the body during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guide wire does not perform such a function.
N/A
Intended Use / Indications for Use
ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in neuro- or coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The ASAHI CHIKAI V Peripheral Vascular Guide Wire is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 165 cm and 180 cm lengths. The guide 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 the same as the 510k cleared ASAHI CHIKA! Neurovascular Guide Wire with K110584. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion and core wire of the guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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)
In vitro bench testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence, catheter compatibility, particulate testing and shelf life testing as listed below were conducted on the ASAHI CHIKAI V Penipheral Vascular Guide Wire. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI CHIKAI V Peripheral Vascular Guide Wire performs as intended.
The biocompatibility has been established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products. The biocompatibility testing as listed below was leveraged from the predicate devices with identical materials and manufacturing process.
Performance test/evaluation summary:
Device performance: Tensile Strenath Turns to Failure (Torque Strength) Torqueability (Torque Response) Tip Flexibility Coating Adhesion Slipping Ability of Guide Wire with Microcatheter Additional bench testing Particulate testing
Biocompatibility/evaluation:
Systemic Toxicity Study In Vitro Hemolysis Study Intracutaneous Study Cytotoxicity Study Sensitization Study Pyrogen Study Plasma Recalcification Time Coagulation Study In Vivo Thromboresistance Study C3a Complement Activation Study SC5b-9 Complement Activation Study
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, K110584, K022762, K971254
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.
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.
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K113716 page. 1 of 3
FEB - 6 2012
510(K) SUMMARY
-510(K) Summary 9.0
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 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: yoshi.terai@asahi-intecc.com |
| TRADE NAME: | ASAHI CHIKAI V Peripheral Vascular Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATION
NAME: | Wire, Guide; Catheter |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX - Catheter Guide Wire |
| PREDICATE DEVICE: | 1. Micro Therapeutics, Inc. / EV3 - SilverSpeed Hydrophilic Guidewire - 510(k)
K993257
2. Asahi - ASAHI CHIKAI Neurovascular Guide Wire - 510(k) K110584
3. Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K022762
4. BSC/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -510(k)
K971254
Additional referenced 510(k) cleared device:
5. Asahi - ASAHI SION PTCA Guide Wire - 510(k) K100578 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ASAHI CHIKAI V Peripheral Vascular Guide Wire is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 165 cm and 180 cm lengths. The guide wire is constructed from a stainless steel core wire with platinumnickel 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 the same as the 510k cleared ASAHI CHIKA! Neurovascular Guide Wire with K110584. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion and core wire of the guide wire.
1
INDICATION FOR USE:
ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in neuro- or coronary vasculature.
TECHNICAL CHARACTERISTICS:
Comparisons of the ASAHI CHIKAI V Peripheral Vascular Guide Wire and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices. The ASAHI CHIKAI V Peripheral Vascular Guide Wire is similar in design - device dimensional specifications, and intended use, manufacturing process, operating principle, shelf life and sterilization process are the same and materials that have been used in other predicate devices in that its core wire, tip coils and solders remain the same.
PERFORMANCE DATA:
Enclosed within this submission is performance data that demonstrates that the ASAHI CHIKAI V Peripheral Vascular Guide Wire meets all predetermined performance criteria. All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains reference to predicate ASAHI devices that use the same materials as used in the subject device.
In vitro bench testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence, catheter compatibility, particulate testing and shelf life testing as listed below were conducted on the ASAHI CHIKAI V Penipheral Vascular Guide Wire. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI CHIKAI V Peripheral Vascular Guide Wire performs as intended.
The biocompatibility has been established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products. The biocompatibility testing as listed below was leveraged from the predicate devices with identical materials and manufacturing process.
Performance test/evaluation summary:
Device performance: Tensile Strenath Turns to Failure (Torque Strength) Torqueability (Torque Response) Tip Flexibility Coating Adhesion Slipping Ability of Guide Wire with Microcatheter Additional bench testing Particulate testing
CONFIDENTIAL Asahi Intecc December 16, 2011
2
K113716 page 3 of 3
510(K) Summary
Biocompatibility/evaluation:
Systemic Toxicity Study In Vitro Hemolysis Study Intracutaneous Study Cytotoxicity Study Sensitization Study Pyrogen Study Plasma Recalcification Time Coagulation Study In Vivo Thromboresistance Study C3a Complement Activation Study SC5b-9 Complement Activation Study
SUMMARY/CONCLUSION:
න්
The ASAHI CHIKAI V Peripheral Vascular Guide Wire characteristics are substantially equivalent to the specified predicate device and other currently marketed devices for the same indication for use.
CONFIDENTIAL Asahi Intecc December 16, 2011
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is on a white background. There is a logo to the left of the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 6 2012
Asahi Intecc USA, Inc. c/o Mr. Yoshi Terai President, CEO 2500 Red Hill Ave. Suite 210 Santa Ana, CA 92705
Re: K113716
K 113716
Trade/Device Name: ASAHI CHIKAI V Peripheral Vascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: December 16, 2011 Received: December 19, 2011
Dear Mr. Terai:
We have reviewed your Section 510(k) premarket notification of intent to market the tevice We have reviewed your Section 3 IQ(x) premaited is substantially equivalent (for the indications
referenced above and have determined the disated as subscripes in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally market produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue, commerce prior to May 28, 1970, the chacminent and other of the Federal Food, Drug, devices that have been reclassined in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The and Cosmetic Act (Act) that do not require approval or a prel. controls provisions of the Act. The
You may, therefore, market the device, subject to the general consustions You may, therefore, market the device, subject of the gentral or annual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the Act mends can probibitions against misbranding and devices, good manufacturing placitic, naoching, and programst nrelated to contract liability.
adulteration. Please note: CDRH does not evaluate information related adulteration. Please note: CDKH does not cvainate information in the misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in be If your device is classified (see above) micr einse it (spioas affecting your device can be
may be subject to additional controls. Existing major regulation FDA may may be subject to additional controls: Exismig Title 21, Parts 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a found in the Code of Federal Regulations, This 20, This 20,
publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Yoshi Terai
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT 2.0
510(k) Number (if known): K113716
Device Name: ASAHI CHIKAI V Peripheral Vascular Guide Wire
Indications for Use:
ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in neuro- or coronary vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number C113716
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