(120 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
Explanation: The device is intended to facilitate the exchange and placement of diagnostic and therapeutic devices, not to perform therapeutic actions itself.
No
The device is a guide wire intended to facilitate the exchange and placement of diagnostic and therapeutic devices, not to perform diagnosis itself.
No
The device description clearly outlines physical components like a core wire, coil assembly, coatings, and accessories, indicating it is a hardware medical 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 that the device is for use in the peripheral vasculature to facilitate the exchange and placement of diagnostic and therapeutic devices. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a physical guide wire designed to be inserted into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnostic purposes.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This guide wire is a tool used during a medical procedure within the body.
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 coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.
Product codes
DQX
Device Description
The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16. The coil and taper core wire of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is soft in order to easily bend in accordance with the vessel curve. The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is available in various lengths and tip shapes. Accessories such as a Torque device, Shaping device and Inserter are included in the packaging of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16.
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
Non clinical laboratory testing was performed on the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 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 Vascular Guide Wire ASAHI Meister® 16 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)
K052022, K062186, K072705, K141751, K111485
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 graphic of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Asahi Intecc Co., Ltd. % Ms. Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K161584
Trade/Device Name: ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide wire Regulatory Class: Class II Product Code: DQX Dated: September 8, 2016 Received: September 9, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. 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 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,
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
2
Indications for Use
510(k) Number (if known) K161584
Device Name
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16
Indications for Use (Describe)
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 coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.
| 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
Image /page/3/Picture/1 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features a stylized red "A" followed by the company name in dark green, sans-serif font. The company name is written in all capital letters, with a comma between "CO" and "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 Vascular Guide Wire ASAHI Meister® 16 510(k) K161584
| DATE PREPARED: | October 4, 2016 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 1703 Wakita-cho, Moriyama-ku | |
| Nagoya, Aichi 463-0024, Japan | |
| CONTACT | 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 Vascular Guide Wire ASAHI Meister® 16 |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Catheter, Guide, Wire |
| PRODUCT CODE | DQX- Catheter Guide Wire |
| PREDICATE DEVICES: | ASAHI® Peripheral Vascular Guide Wire: ASAHI® CHIKAI® V |
| (K113716) | |
| REFERENCE DEVICES: | • ASAHI® PTCA Guide Wire: ASAHI Fielder (K052022, K062186) |
| • ASAHI® PTCA Guide Wire: ASAHI Fielder FC J (K072705) | |
| • ASAHI® Neurovascular Guide Wire: ASAHI® CHIKAI® black 18 (K141751) | |
| • Boston Scientific Fathom™ Steerable Guidewires (K111485) |
INTENDED USE/INDICATIONS FOR USE
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16
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 coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.
4
DEVICE DESCRIPTION:
The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16. The coil and taper core wire of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is soft in order to easily bend in accordance with the vessel curve. The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is available in various lengths and tip shapes. Accessories such as a Torque device, Shaping device and Inserter are included in the packaging of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16.
COMPARISON WITH PREDICATE DEVICE:
Comparisons of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 and predicate device shows that the technological characteristics of the Subject device 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 of the Subject Device and its primary predicates are identical. The indications are very similar, with the indications for the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 being a subset of that for the ASAHI CHIKAI V. There are specific design features of the Subject device that are similar to the primary predicate but not identical.
| Name of Device | ASAHI Peripheral Vascular Guide
Wire ASAHI Meister 16 | ASAHI CHIKAI V Peripheral
Vascular Guide Wire |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Current Application | K113716 |
| Intended Use and
Indications | 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
coronary arteries, lower limb blood
vessels, neurovasculature and carotid
arteries. | 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. |
| Target Body Location | Peripheral | |
| Overall Lengths | 135 cm, 165 cm, and 180 cm | 165, 180 cm |
| Nominal OD | 0.016in | 0.014 in |
| Outer Coil Material | Platinum-Nickel, Stainless Steel | |
| Core Wire Material | Stainless Steel | |
| Hydrophilic coating | Yes | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 Years | |
5
NON CLINICAL TESTING / PERFORMANCE DATA:
Non clinical laboratory testing was performed on the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 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 Vascular Guide Wire ASAHI Meister® 16 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 Vascular Guide Wire ASAHI Meister® 16 was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates/reference devices, the biocompatibility of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 was leveraged from predicates/reference devices for all endpoints other than complement activation.
CONCLUSION:
The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 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 and reference devices. Performance data demonstrates that the device functions as intended.
Therefore, the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is substantially equivalent to the predicate device.