(29 days)
Not Found
No
The description focuses on the physical construction and materials of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), which are medical procedures performed to treat coronary artery disease and peripheral artery disease, respectively. These are therapeutic interventions aimed at improving patient health.
No
The device is a guide wire intended to facilitate the placement of balloon dilatation catheters, which is a therapeutic rather than a diagnostic function.
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 device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The ASAHI PTCA Guide Wire, Fielder FC J is a physical device used within the body (in vivo) to facilitate the placement of other devices (balloon catheters) during a medical procedure (PTCA/PTA). It does not examine specimens from the body.
- Intended Use: The intended use clearly describes a procedural function within the circulatory system, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, this device falls under the category of an invasive medical device used for interventional procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ASAHI PTCA Guide Wire, Fielder FC J is intended 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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Asahi PTCA Guide Wire, Fielder FC J 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 for 180cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made soft and easily bendable with the vessel curve, and is provided in a pre-shaped J configuration. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire and dimethylpolysiloxane (silicone oil - not contacting blood) is applied to gape space in spring-coil in the tip part. The proximal section of this 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 (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 PTCA Guide Wire, Fielder FC J performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Asahi PTCA Guide Wire, Fielder - K052022, Asahi PTCA Guide Wire, Fielder FC- K063819
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 23 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 PTCA Guide Wire, Fielder FC J |
| COMMON NAME: | Guide Wire |
| CLASSIFICATION
NAME: | Catheter Guide Wire |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX |
| PRIMARY
PREDICATE DEVICE: | Asahi PTCA Guide Wire, Fielder - K052022
Asahi PTCA Guide Wire, Fielder FC- K063819 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Asahi PTCA Guide Wire, Fielder FC J 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 for 180cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made soft and easily bendable with the vessel curve, and is provided in a pre-shaped J configuration. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire and dimethylpolysiloxane (silicone oil - not contacting blood) is applied to gape space in spring-coil in the tip part. The proximal section of this guide wire is coated with PTFE.
1
K072705
INDICATION FOR USE:
The ASAHI PTCA Guide Wire, Fielder FC J is intended 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.
TECHNICAL CHARACTERISTICS:
The ASAHI PTCA Guide Wire. Fielder FC J 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 PTCA Guide Wire, Fielder FC J performs as intended.
SUMMARY/CONCLUSION:
The ASAHI PTCA Guide Wire, Fielder FC J 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
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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2007
Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
Re: K072705
ASAHI PTCA Guide Wire, Fielder FC J Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DOX Dated: September 10, 2007 Received: September 24, 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M. G. Helvenner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K072705
Device Name: ASAHI PTCA Guide Wire, Fielder FC J
Indications for Use:
The ASAHI PTCA Guide Wire, Fielder FC J is intended 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.
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)
W.g. Hillebrand
Division of Čardiovascular Devices
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510(k) Number_K072709
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