(30 days)
Not Found
No
The description focuses on the physical construction and materials of a guide wire, with no mention of AI or ML capabilities.
No.
A guide wire is an accessory device used to facilitate the placement of other devices (balloon dilation catheters) and does not directly provide therapy.
No
This device is a guide wire used to facilitate the placement of balloon dilation catheters during angioplasty procedures. Its purpose is to aid in the mechanical aspect of the procedure (guidance and access), not to diagnose a condition or disease.
No
The device description clearly details a physical guide wire constructed from stainless steel with various coatings and a radiopaque tip, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Description and Intended Use: The description clearly states that this device is a guide wire used to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). These are procedures performed inside the body to treat blockages in blood vessels.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its function is purely procedural, aiding in the delivery of other devices within the body.
Therefore, based on the provided information, the Asahi PTCA Guide Wire, J Shape series is a therapeutic medical device used in interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Asahi PTCA Guide wire, J Shape series is intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasm (PTCA) and percuraneous transluminal angioplasty (PTA). The Asahi PTCA Guide wire, J Shape series is not to be used in the cerebral blood vessel.
To facilitate the placement of ballon dilation Catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wire, J Shape series is not to be used in the cerebral vasculature.
Product codes
DQX
Device Description
The Asahi PTCA Guide Wire, ] Shape series is steerable guide wire 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 ourside the body. The wire is constructed from a stainless steel core with varying core lengths and diameter for each design. The core wre and coil are soldered, for some items welding is used for up parts instead of soldering. The distal end of the guide wire has a radiopaque up that is available as a pre shaped ""[" and is made soft to easily bend with the vessel curve. The coanng (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. H on the product code indicates hydrophilic coating, and J indicates pre shaped "J" tip of the guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral blood vessel
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 Wire, J Shape series 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)
K022762, K031277, K032615, K04153
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
Asahi Intecc Co., Ltd. December 2004
JAN 1 2 2005
510(k) Summary of Safety and Effectiveness
| Date Prepared: | November 8, 2004 |
|---|---|
| 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 | |
| Address: | 1301 Dove St. Suite 350 Newport Beach, CA 92660 |
| Phone Number: | Phone : (949)756-8252 |
| Fax Number: | Fax : (949)756-8165 |
| Device Trade Name: | Asahi Wire Asahi PTCA Guide Wire, J Shape series |
| 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 | |
| Asahi Wire Asahi PTCA Guide Wire K032615 | |
| Asahi Wire Asahi PTCA Guide Wire Confianza Pro K04153 |
Device Description:
The Asahi PTCA Guide Wire, ] Shape series is steerable guide wire 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 ourside the body. The wire is constructed from a stainless steel core with varying core lengths and diameter for each design. The core wre and coil are soldered, for some items welding is used for up parts instead of soldering. The distal end of the guide wire has a radiopaque up that is available as a pre shaped ""[" and is made soft to easily bend with the vessel curve. The coanng (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. H on the product code indicates hydrophilic coating, and J indicates pre shaped "J" tip of the guide wire.
Intended Use:
The Asahi PTCA Guide wire, J Shape series is intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasm (PTCA) and percuraneous transluminal angioplasty (PTA). The Asahi PTCA Guide wire, J Shape series is not to be used in the cerebral blood vessel
Device Technological Characteristics and Comparison to Predicate Device:
The Asahi PTCA Guide Wire, J Shape series is made of the same materials, available in the same diamerers and lengths, have the same design and indications for use as the predicate devices and other currently marketed PTCA Guide Wires.
38
1
Asahi Intecc Co., Ltd. December 2004
Performance Data:
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire, J Shape series 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 Wire, J Shape series is substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.
Ko4342
Premarket Notification [510(k)] Number
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes resembling human profiles or waves. The emblem is black, and the background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2005
Mr. Yoshi Terai Director Asahi Intecc US Office 1301 Dove St., Suite 350 Newport Beach, CA 92660
Re: K043422
Trade/Device Name: Asahi PTCA Guide Wire, J Shape Series Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: December 3, 2004 Received: December 13, 2004
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic roral in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. procletter will allow you to begin marketing your device as described in your Section 510(k) rms leket notification. The FDA finding of substantial equivalence of your device to a legally premaince no dicate 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 (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours,
Dana R. Lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_K043422
Device Name: Asahi PTCA Guide Wire, J Shape series
Indications For Use:
To facilitate the placement of ballon dilation Catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wire, J Shape series is not to be used in the cerebral vasculature.
X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Lochner
(Division Sic n-Off) Division of Cardiovascular Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________