(56 days)
No
The document describes a physical guide wire and its materials, with no mention of software, algorithms, or any terms related to AI/ML.
No.
Explanation: The device is a guide wire used to facilitate the placement of balloon dilatation catheters, not to provide therapy itself. It is an accessory device used in a therapeutic procedure (angioplasty).
No
Explanation: The device is described as a guide wire for facilitating the placement of balloon dilatation catheters during angioplasty, making it a therapeutic or interventional device rather than a diagnostic one. Its purpose is to aid in a procedure, not to detect or identify a condition.
No
The device description clearly describes a physical guide wire made of stainless steel with various coatings and a radiopaque tip, indicating it is a hardware device.
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 is a procedure performed within the body to treat blockages in blood vessels.
- Device Description: The device is a guide wire used to navigate blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body as a tool for a medical procedure.
N/A
Intended Use / Indications for Use
To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.
Product codes
DQX
Device Description
'I'he Asahi PTCA Guide Wire Confianza Pro is steerable guide wire with a maximum 0.014" and available in 180 cm and 300 cm length. The extension wire is diameter of 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. 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
coronary, cerebral blood vessel (contraindicated)
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)
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Confianza Pro met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Asahi Intecc Co., Ltd. June 2004
AUG - 3 2004
510(k) Summary of Safety and Effectiveness
| Date Prepared: | April 30, 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 | |
| Phone Number: | Phone : (949)756-8252 |
| Fax Number: | Fax : (949)756-8165 |
| Device Trade Name: | Asahi Wire Asahi PTCA Guide Wire Confianza Pro |
| 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:
'I'he Asahi PTCA Guide Wire Confianza Pro is steerable guide wire with a maximum 0.014" and available in 180 cm and 300 cm length. The extension wire is diameter of 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. 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 wire Confianza Pro is intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasty (PTCA) and percutancous transluminal angioplasty (PTA). 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 Wire Conflanza Pro is 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
Performance Data:
Perormation Data.
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Confianza Pro 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 Confianza Pro is substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.
KC41531
Premarket Notification [510(k)] Number
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name around the perimeter. Inside the circle is a stylized image of an eagle, which is a common symbol of the United States. The eagle is depicted with its wings spread, and it appears to be in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2004
Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai Director of Asahi Intecc US Office 1703 Wakita-cho, Moriyama-ku, Nagoya Aichi, 463-0024, Japan
Re: K041531
Trade Name: Asahi PTCA Wire Confianza Pro Regulation Number: 21 CFR 870.1330 Regulation Name: Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: July 15, 2004 Received: July 22, 2004
Dear Mr. Terai:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 Prease be advised ullat I Dri 3 issuated of a oudevice complies with other requirements of the Act that IDA has made a decorminations administered by other Federal agencies. You must of any I cuttal statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFR Fart 807), adoling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oom or provisions (stime ) our device as described in your Section 510(k) This letter will anow you to oegin maneting of substantial equivalence of your device to a legally premarket nothleation: "The PDF intelling of easification 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 If you desire specific at 1301) 594-4646. Additionally, for questions on the comact the Office of Ochiphants at (200), please contact the Office of Compliance at (301) 594promotion and acrorability or grulation entitled, "Misbranding by reference to premarket 4057. Allso, productions and 807.97) you may obtain. Other general information on your nontreation (21 OF Act may be obtained from the Division of Small Manufacturers, Itsponsional 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;
Dura R. Sohner
Bram D
Director
Division
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): __K041531
Asahi PTCA Guide Wire Confianza Pro ---------Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
To facilitate the placement of balloon dilatation catheters during perculaneous 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 this labeling have not change. The fundamental scientific technology of the modified device has not changed.
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. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
-10(k) Number_K041531
Page 1 of ____________________________________________________________________________________________________________________________________________________________________