(31 days)
No
The description focuses on the physical construction and materials of a guide wire, with no mention of AI, ML, or any computational processing.
No
The device is a guide wire used to facilitate the placement of other catheters; it does not directly treat a disease or condition.
No
The device is a guide wire used to facilitate the placement of balloon dilatation catheters, which is an interventional procedure, not a diagnostic one.
No
The device description clearly describes a physical guide wire made of stainless steel, platinum-nickel, and coated with PTFE and a hydrophilic coating. It is a tangible medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that the Asahi SUOH PTCA Guide Wire is a physical device used inside the body to facilitate the placement of other devices (balloon catheters) during procedures (PTCA and PTA). It is a tool for a medical procedure, not a device that analyzes biological samples.
The information provided focuses on the physical characteristics, function within the body, and performance through bench testing, all of which are typical for an invasive medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.
Product codes
DQX
Device Description
The Asahi SUOH PTCA 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 extension wire is connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless steel core wire with a platinum-nickel and stainless steel coil. The core wire and coil are soldered. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to easily bend with the vessel curve. A 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
Not Found
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
This 510(k) notice includes mechanical and functional bench testing that demonstrates that the Asahi SUOH PTCA Guide Wire performs as intended.
Key Metrics
Not Found
Predicate Device(s)
JoWire Neo's PTCA Guide Wire - 510(k) K022762, JoWire Asahi PTCA Guide Wire - 510(k) K031277, Asahi PTCA Guide Wire - 510(k) 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 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
JAN 29 2009
| TRADE NAME: | Asahi SUOH PTCA 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: JoWire Neo's PTCA Guide Wire - 510(k) K022762 | |
| JoWire Asahi PTCA Guide Wire - 510(k) K031277 | |
| Asahi PTCA Guide Wire - 510(k) K052339 |
Description of the Device Subject to Premarket Notification:
The Asahi SUOH PTCA 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 extension wire is connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless steel core wire with a platinum-nickel and stainless steel coil. The core wire and coil are soldered. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.
. .. Asahi Intecc December 25, 2008
1
INDICATION FOR USE:
The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percultaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.
TECHNICAL CHARACTERISTICS:
The Asahi SUOH PTCA Guide Wire is made of the same materials that have been used in other predicate devices that are labeled for the same indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.
PERFORMANCE DATA:
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. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the Asahi SUOH PTCA Guide Wire performs as intended.
SUMMARY/CONCLUSION:
The Asahi SUOH PTCA Guide Wire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.
Asahi Intecc December 25, 2008
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2009
Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President. CEO 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
Re:
Trade/Device Name: Asahi SUOH PTCA Guide Wire Common Name: Catheter guide wire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: December 25, 2008 Received: December 29, 2008
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.
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
3
Page 2 - Mr. Yoshi Terai
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. 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) 276-0210. 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 Biometrics' (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,
ht
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.0 1NDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Asahi SUOH PTCA Guide Wire
Indications for Use:
The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.
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)
Concurrence
Division Sign-Citt) isloh of Cardiovascular Devices (k) Number Kog39ey
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