(238 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
This device, a guide wire, is intended to facilitate the placement of balloon dilation catheters but does not itself provide therapy. It is an accessory device used for guiding other therapeutic devices.
No
The device is a guide wire used to facilitate the placement of balloon dilation catheters during angioplasty procedures, not to diagnose a condition.
No
The device description clearly details a physical guide wire with specific materials, dimensions, and coatings, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA)." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical guide wire used within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an interventional medical device used directly in a surgical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
Device Description
As a basic structure, the Fielder XT-A, Fielder XT-R, consists of a taper core wire and 2 types coils (a tapered outer coil and an inner rope coil). The taper core wire and the coils are soldered together. The coil is radiopaque so as to easily confirm its position under radioscopy.
The coil and distal part of tapered core wire of the products are coated with polyurethane and then covered with hydrophilic polymer. The proximal end of the tapered core wire is coated with PTFE.
The nominal outer diameter of both the Fielder XT-A and Fielder XT-R is 0.36mm. with a distal diameter of 0.26mm. Both the Fielder XT-A and Fielder XT-R are available in 190cm and 300cm, total length. The tip shape is straight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary and Peripheral
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)
Non clinical laboratory testing was performed on the ASAHI Fielder XT-A and ASAHI Fielder XT-R to determine substantial equivalence. The following testing/assessments were performed:
- Dimensional Verification
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Adhesion
- Catheter Compatibility
- Coating Integrity / Particulate testing
The in vitro bench tests demonstrated that the ASAHI Fielder XT-A and ASAHI Fielder XT-R met 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ASAHI Gaia First (K133865), ASAHI Fielder FC (K063819, K072705), ASAHI Fielder XT (K072431)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2016
Asahi Intecc Co., Ltd. % Candace Cederman Senior Regulatory Affairs Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228 US
Re: K153106
Trade/Device Name: Asahi Fielder XT-A, ASAHI Fielder XT-R Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 9, 2016 Received: May 10, 2016
Dear Candace 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
as set forth in 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 vou 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 yours,
Kenneth J. Cavanaugh -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name ASAHI Fielder XT-A, ASAHI Fielder XT-R
Indications for Use (Describe)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal any vnancon cance). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
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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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 PTCA Guide Wires ASAHI Fielder XT-A ASAHI Fielder XT-R
510(k)
| DATE PREPARED: | October 16, 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 PTCA Guide Wires: |
| • ASAHI Fielder XT-A | |
| • ASAHI Fielder XT-R | |
| DEVICE | |
| CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION | |
| NAME: | Catheter Guide Wire |
| PRODUCT CODE | DQX - Wire, Guide, Catheter |
| PREDICATE | |
| DEVICES: | ASAHI PTCA Guide Wire ASAHI Gaia First (K133865) |
| ASAHI PTCA Guide Wire ASAHI Fielder FC (K063819, K072705) | |
| ASAHI PTCA Guide Wire ASAHI Fielder XT (K072431) |
Intended Use/Indications for Use
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.
4
DESCRIPTION:
As a basic structure, the Fielder XT-A, Fielder XT-R, consists of a taper core wire and 2 types coils (a tapered outer coil and an inner rope coil). The taper core wire and the coils are soldered together. The coil is radiopaque so as to easily confirm its position under radioscopy.
The coil and distal part of tapered core wire of the products are coated with polyurethane and then covered with hydrophilic polymer. The proximal end of the tapered core wire is coated with PTFE.
The nominal outer diameter of both the Fielder XT-A and Fielder XT-R is 0.36mm. with a distal diameter of 0.26mm. Both the Fielder XT-A and Fielder XT-R are available in 190cm and 300cm, total length. The tip shape is straight.
COMPARISON WITH PREDICATE DEVICES:
Comparisons of the Fielder XT-A and Fielder XT-R and predicate devices show that the technological characteristics of the Subject devices 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 the same as the primary predicates.
| Name of Device | ASAHI Fielder XT-A
ASAHI Fielder XT-R | ASAHI Gaia First | ASAHI Fielder FC
ASAHI Fielder XT |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------------------------------------------|
| 510(k) | Current Application | K133865 | K063819, K072705
K072431 |
| Intended Use and
Indications | 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. | | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | | |
| Shelf Life | 3 Years | | |
| Target Body Location | Coronary and Peripheral | | |
| Inner coil | Yes | | No |
| Undercoating | Polyurethane | NA | Polyurethane |
| Outer Distal coating | Hydrophilic | | |
| Proximal Coating | PTFE | | |
| Overall Length | 190, 300 cm | | 180, 300 cm (FC)
190, 300 cm (XT) |
| Nominal OD | 0.36 mm (0.014 inches) | | |
| Outer Coil Material | | Platinum-Nickel | Platinum-Nickel and
Stainless Steel (FC),
Platinum-Nickel (XT) |
| Core Wire Material | Stainless Steel | | |
ASAHI Intecc Co., Ltd.
5
Non Clinical testing / Performance Data:
Non clinical laboratory testing was performed on the ASAHI Fielder XT-A and ASAHI Fielder XT-R to determine substantial equivalence. The following testing/assessments were performed:
- Dimensional Verification ●
- Tensile Strenath ●
- Torque Strength ●
- Torqueability ●
- . Tip Flexibility
- Coating Adhesion
- Catheter Compatibility ●
- Coating Integrity / Particulate testing ●
The in vitro bench tests demonstrated that the ASAHI Fielder XT-A and ASAHI Fielder XT-R met 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 Fielder XT-A and ASAHI Fielder XT-R were compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates, the biocompatibility of the ASAHI Fielder XT-A and ASAHI Fielder XT-R was verified to be the same as those of the predicates.
Conclusion:
The ASAHI Fielder XT-A and ASAHI Fielder XT-R have identical intended uses 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 devices function as intended.
Therefore, the ASAHI Fielder XT-A and ASAHI Fielder XT-R are substantially equivalent to the predicate devices.