(18 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a physical guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guide wire intended to facilitate the placement and exchange of diagnostic and therapeutic devices, not to provide therapeutic treatment itself.
No
The device is a guide wire intended to facilitate the placement and exchange of diagnostic and therapeutic devices, not to perform diagnosis itself.
No
The device description clearly outlines a physical guide wire constructed from stainless steel, a spring, and coatings, indicating it is a hardware medical 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 during intravascular procedures to facilitate the placement and exchange of diagnostic and therapeutic devices. This is an in vivo procedure (within the living body), not an in vitro procedure (outside the living body, typically involving samples like blood or tissue).
- 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 analyzing samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, based on the provided information, the ASAHI Astato 30 Peripheral Guide Wire is a medical device used for in vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The ASAHI Astato 30 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 peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire. The wire is constructed from a stainless steel core wire with spring. The core wire and coil are soldered together. The distal end of the guide wire has a radiopaque tip that is straight and is made soft to easily bend with the vessel curve. The hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.
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)
This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Astato 30 Peripheral Guide Wire performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061984, K974773, K990639, K982876, K052339
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
9.0 510(K) SUMMARY
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 | JUL 13 2007 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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@asahi-intecc.com | |
| TRADE NAME: | ASAHI Astato 30 Peripheral Guide Wire | |
| COMMON NAME: | Guide Wire | |
| CLASSIFICATION
NAME: | Catheter Guide Wire | |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1330 | |
| PRODUCT CODE | DQX | |
| PREDICATE DEVICE: | Asahi Treasure Guide Wire - K061984
Guidant Hi-Torque Floppy Guide Wire - K974773
Guidant Hi-Torque Cross-IT - K990639
Guidant Hi-Torque Steel Core 18 - K982876
Asahi PTCA Guide Wire - K052339 | |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Asahi peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire. The wire is constructed from a stainless steel core wire with spring. The core wire and coil are soldered together. The distal end of the guide wire has a radiopaque tip that is straight and is made soft to easily bend with the vessel curve. The hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.
1
INDICATION FOR USE:
The ASAHI Astato 30 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:
The ASAHI Astato 30 Peripheral Guide Wire is of the same materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for the intended use.
Performance Data:
This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Astato 30 Peripheral Guide Wire performs as intended.
SUMMARY/CONCLUSION:
The ASAHI Astato 30 Peripheral Guide Wire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.
Bench testing demonstrates that the device functions as intended.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines. The symbol is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a sans-serif font. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2007
Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
Re: K071721
Trade/Device Name: Asahi Astato 30 Peripheral Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: May 28, 2007 Received: June 25, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. buchner
A Bram Zuckerman, M.D. Director. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT 2.0
510(k) Number (if known): K07172
Device Name: ASAHI Astato 30 Peripheral Guide Wire
Indications for Use:
The ASAHI Astato 30 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)
umne R. W. hussil
ivision Sign-Off) vision of Cardiovascular Devices
- Number_ Ko 11721
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