(35 days)
Not Found
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
Explanation: The device is described as a guide wire intended to facilitate the placement and exchange of diagnostic and therapeutic devices, not to provide therapy itself.
No
The device is a guide wire intended to facilitate the placement and exchange of other diagnostic and therapeutic devices, but it is not itself a diagnostic device.
No
The device description clearly details a physical guide wire constructed from stainless steel and platinum-nickel, with a hydrophilic coating and PTFE coating. This is a hardware device, not software.
Based on the provided information, the ASAHI Astato XS 20 Peripheral Guide Wire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures." This describes a device used within the body to aid in medical procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details the physical construction of a guide wire, including materials, dimensions, and coatings. This aligns with a medical device used for navigation within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the ASAHI Astato XS 20 Peripheral Guide Wire is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Asahi Astato XS 20 Peripheral Guide Wire 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
DQX
Device Description
The ASAHI Astato XS 20 Peripheral Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The quide wire is constructed from a stainless steel core wire with platinum-nickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature.
A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.
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)
Enclosed within this submission is performance data that demonstrates that the Asahi Astato XS 20 Peripheral 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.
And In vitro bench testing and shelf-life testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence and catheter compatibility as listed below were conducted on the ASAHI Astato XS 20 Peripheral Guide Wire. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Astato XS 20 Peripheral Guide Wire performs as intended.
Performance test/evaluation summary: Device performance: Tensile Strength Turns to Failure (Torque Strength) Torqueability (Torque Response) Tip Flexibility Coating Adhesion Slipping Ability of Guide Wire in PTA Balloon Catheter Particulate testing
Biocompatibility: 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)
K071721, K061984, K022762, K052339, K070945
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
K.10305.7.
510(K) SUMMARY
9.0 510(K) SUMMARY
ல்
NOV 1 9 2010
This 510(k) summary of safety and effectiveness information is being submitted in This over, Summar 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 Astato XS 20 Peripheral Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATION
NAME: | Wire, Guide, Catheter |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX |
| PREDICATE DEVICE: | Asahi - Astato 30 Peripheral Guide Wire - 510(k) K071721
Asahi - Treasure Guide Wire - 510(k) K061984
Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K022762
Asahi - Asahi PTCA Guide Wire (Miracle bros 12/Confianza Pro 12)
Description of the Device Subject to Premarket Notification:
The ASAHI Astato XS 20 Peripheral Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The quide wire is constructed from a stainless steel core wire with platinumnickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature.
A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.
CONFIDENTIAL Asahi Intecc October 14, 2010
. 1)
1
INDICATION FOR USE:
The Asahi Astato XS 20 Peripheral Guide Wire 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.
TECHNICAL CHARACTERISTICS:
This submission represents minor dimensional specifications and the addition of a PTFE coating. All other specifications are equivalent to those listed for the currently cleared predicate devices.
Comparisons of the ASAHI Astato XS 20 Peripheral 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 ASAH! Astato XS 20 Peripheral 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 Astato XS 20 Peripheral 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.
And In vitro bench testing and shelf-life testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence and catheter compatibility as listed below were conducted on the ASAHI Astato XS 20 Peripheral Guide Wire. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Astato XS 20 Peripheral Guide Wire performs as intended.
Performance test/evaluation summary: Device performance: Tensile Strength Turns to Failure (Torque Strength) Torqueability (Torque Response) Tip Flexibility Coating Adhesion Slipping Ability of Guide Wire in PTA Balloon Catheter Particulate testing
Biocompatibility: Systemic Toxicity Study In Vitro Hemolysis Study
CONFIDENTIAL Asahi Intecc October 14, 2010
2
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:
The Asahi Astato XS 20 Peripheral 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 October 14, 2010
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings. Below the bird is a wavy line, possibly representing water or movement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
NOV 1 9 2010
Re: K103057
Trade/Device Name: Astato XS 20 Peripheral Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DOX Dated: October 14, 2010 Received: October 15, 2010
Dear Mr. Terai:
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 deville 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.
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 vour 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 vours.
vuna R.V. Ames
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
2.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K10503 t
NOV 1 9 2010
Device Name: ASAHI Astato XS 20 Peripheral Guide
Indications for Use:
……
.. #
The ASAH! Astato XS 20 Peripheral Guide Wire 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.
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)
una R. V. Aumer
(Division Sign-Off) Division of Cardiovascular Devices
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510(k) Number_K 163 05 7