(90 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 intended use states that the device facilitates the placement of therapeutic devices, but is not a therapeutic device itself.
No
The device is a guide wire used to facilitate the placement and exchange of other diagnostic and therapeutic devices, but it does not perform a diagnostic function itself. Its radiopaque coil helps in positioning, which is an aid to a procedure, not a diagnostic act.
No
The device description clearly details a physical guide wire with specific material coatings, dimensions, and a radiopaque coil, indicating it is a hardware device, not software only.
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 facilitating the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This describes a device used in vivo (within the body) to aid in medical procedures, not a device used in vitro (outside the body) to test samples like blood, urine, or tissue for diagnostic purposes.
- Device Description: The description details a guide wire with physical characteristics like a coil, coatings, length, and diameter. These are features of a medical device used for navigation within blood vessels, not a diagnostic test kit or instrument.
- Performance Studies: The performance studies focus on physical properties and functionality of the guide wire (tensile strength, torque, flexibility, coating adhesion, catheter compatibility). These are typical tests for a medical device used in procedures, not for evaluating the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guide wire does not perform such tests.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The ASAHI Astato XS 40 Peripheral Guide Wire in this submission has a coil-type distal end. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the quide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). The distal end is coated with a hydrophilic coating. The ASAHI Astato XS 40 guide wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter of 0.36 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical laboratory testing was performed on the ASAHI Astato XS 40 to determine substantial equivalence. The following testing/assessments were performed:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility (compared to secondary predicate, ASAHI Astato 30)
- Coating Adhesion/Integrity
- Catheter Compatibility
The in vitro bench tests demonstrated that the ASAHI Astato XS 40 met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.
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.
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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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 stylized eagle or bird-like figure with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
Asahi Intecc Co., Ltd. % Ms. Candace Cederman Senior Regulatory Affairs Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K153443
Trade/Device Name: Asahi Astato XS 40 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 25, 2015 Received: January 8, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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,
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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Indications for Use
510(k) Number (if known) K153443
Device Name ASAHI Astato XS 40
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary [as required by 21 CFR 807.92(c)]
ASAHI Astato XS 40
510(k) K153443
Date Prepared: Fi February 2016
A-A
.
| APPLICANT | ASAHI Intecc Co., Ltd.
1703 Wakita-cho, Moriyama-ku
Nagoya, Aichi 463-0024, Japan |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL CORRESPONDENT | Carroll Councilman
Sr. RA Manager
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 Astato XS 40 |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Catheter, Guide, Wire |
| PRODUCT CODE | DQX- Catheter Guide Wire |
| PREDICATE DEVICES: | Primary Predicate:
ASAHI Astato XS 20 Peripheral Guide Wire (K103057)
Secondary Predicate:
ASAHI Astato 30 Peripheral Guide Wire (K071721)
Reference Device:
ASAHI RG3 (K141339) |
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.
4
Device Description:
The ASAHI Astato XS 40 Peripheral Guide Wire in this submission has a coil-type distal end. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the quide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). The distal end is coated with a hydrophilic coating. The ASAHI Astato XS 40 guide wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter of 0.36 mm.
Comparison with predicate devices:
Comparisons of the ASAHI Astato XS 40 and predicate devices show 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/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 Astato XS 40 | Astato XS 20
• Astato 30 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) | Current Application | 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 | |
| Outer Distal
Hydrophilic coating | Yes | |
| Proximal Coating | PTFE | |
| Overall Length | 200-300 cm | 180-300 cm |
| Nominal OD | 0.36 mm (0.014in)
with tapered end | Astato XS 20:
0.36 mm (0.014in) with tapered end
Astato 30:
0.45 mm (0.018in) with tapered end |
| Outer Coil Material | Platinum-Nickel | |
| Core Wire Material | Stainless Steel | |
Non Clinical testing / Performance Data:
Non clinical laboratory testing was performed on the ASAHI Astato XS 40 to determine substantial equivalence. The following testing/assessments were performed:
- Tensile Strength ●
- Torque Strength
5
- Torqueability ●
- . Tip Flexibility (compared to secondary predicate, ASAHI Astato 30)
- Coating Adhesion/Integrity ●
- . Catheter Compatibility
The in vitro bench tests demonstrated that the ASAHI Astato XS 40 met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.
BIOCOMPATIBILITY:
The ASAHI Astato XS 40 was compared to the primary predicate device and to the reference device ASAHI PTCA Guide Wire RG3. Based on the similar intended use, as well as the similarities of the materials and manufacturing methods used in the subject device and its predicate/reference devices, no additional biocompatibility testing of the ASAHI Astato XS 40 was conducted.
Conclusion:
The ASAHI Astato XS 40 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 Astato XS 40 is substantially equivalent to the predicate devices.