(22 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide wire, with no mention of AI or ML capabilities.
No
The device is a guide wire used to facilitate the placement of other catheters; it does not directly treat a medical condition.
No
Explanation: The device, a guide wire, is described as facilitating the placement of balloon dilatation catheters. Its function is to aid in a therapeutic procedure (angioplasty) by guiding other instruments, not to diagnose a condition.
No
The device description clearly outlines a physical medical device (guide wire) constructed from materials like stainless steel with various coatings and a radiopaque tip. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This describes a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a physical guide wire used within blood vessels.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition. IVDs are used for diagnostic purposes in vitro (in glass, or outside the living organism).
Therefore, the Asahi PTCA Guide Wires are a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Asahi PTCA Guide wires are intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (I'TA). The Asahi PTCA Guide wires are not to be used in the cerebral blood vessel
Product codes
DQX
Device Description
The Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" 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 wire is constructed from a stainless steel core wire. The core wire and coil are soldered except tip which uses welding, The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic and silicone) is applied to the distal portion of the wire 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
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.
Key Metrics
Not Found
Predicate Device(s)
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
SEP 1 6 2003
Asahi Intecc Co., Ltd. August 2003
Asahi PTCA Guide Wire Special 510(k)
510(k) Summary of Safety and Effectiveness
| Date Prepared: | August 12, 2003 |
|---|---|
| Submitted: | Asahi Intecc Co., Ltd. |
| 1703 Wakita-cho, Moriyama-ku, Nagoya, | |
| Aichi, 463-0024, Japan | |
| Contact Person: | Yoshi Terai |
| Director of Asahi Intecc US Office | |
| Phone Number: | Phone : (949)756-8252 |
| Fax Number: | Fax : (949)756-8165 |
| Device Trade Name: | Asahi Wire Asahi PTCA Guide Wire |
| Classification Name: | Catheter Guide Wire, Class II (21 CFR 870.1330) |
| Predicate Device: | JoWire Neo's PTCA Guide Wire K022762 |
| JoWire Asahi PTCA Guide Wire K031277 |
Device Description:
The Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" 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 wire is constructed from a stainless steel core wire. The core wire and coil are soldered except tip which uses welding, The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.
Intended Use:
The Asahi PTCA Guide wires are intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (I'TA). The Asahi PTCA Guide wires are not to be used in the cerebral blood vessel
Device Technological Characteristics and Comparison to Predicate Device:
The Asahi PTCA Guide Wires are made of the same materials, available in the same diameters and lengths, have the same design and indications for use as the predicate devices and other currently marketed PTCA Guide Wires.
1
KC32615
Asahi Intecc Co., Ltd. August 2003
Asahi PTCA Guide Wire Special 510(k)
Performance Data:
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.
Conclusion:
The Asahi PTCA Guide Wires are substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.
Premarket Notification [510(k)] Number
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, with flowing lines representing hair or clothing.
SEP 1 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asahi Intecc Co., LTD. c/o Yoshi Terai Director of Asahi Intecc US Office 1100 Quail St., Suite 207 Newport Beach, CA 92660
K032615 Re: Asahi PTCA Guide Wires Regulation Number: 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: August 12, 2003 Received: August 25, 2003
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 (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 Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
V. Q
cBram D. Zuckerman, M.D.
Bram D. Zuc Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Asahi Intecc Co., Ltd. August 2003
Asahi PTCA Guide Wire Special 510(k)
510(k) Number (if known): C032615
Device Name: Asahi PTCA Guide Wires
, i
Indications for Use:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.
The intended use and indications for use of the modified device as described in its labeling have not change. The fundamental scientific technology of the modified device has not changed.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| Prescription Use | X (Per 21 CFR 801.19) |
|---|---|
| OR | |
| Over-the Counter Use | ____________________ |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K032615 |
16