(96 days)
No
The device description and performance studies focus on the physical properties and function of a guide wire, with no mention of AI or ML.
No.
The device facilitates the placement of other therapeutic devices (balloon dilatation catheters) but is not itself performing a therapeutic function.
No
Explanation: The device is described as a guide wire used to facilitate the placement of balloon dilatation catheters. Its function is to aid in the delivery of other devices, not to diagnose a condition or disease.
No
The device description clearly states it is a physical guide wire constructed from stainless steel with a radiopaque tip and coating, 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 clearly describes a device used during a medical procedure (PTCA and angioplasty) to facilitate the placement of other devices (balloon dilatation catheters). This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a physical guide wire used for navigation within blood vessels. This is consistent with an interventional device, not a diagnostic test that analyzes samples like blood or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device is an interventional medical device used within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal blood vessel transluminal coronary angioplasty (1 YOA) and poroculared in the cerebral blood vessel.
Product codes
DQX
Device Description
The Asahi PTCA Guide Wiles are stechable gelde is constructed from a 0.014" and available in 150 cm and oo of the guide wire has a radiopaque tip that is stainless steel core wire. The distal end of the guide wire The coating stainless steel core wire. The distar end of the gd with the vessel curve. The coating available straight and is made soft to easily bend with wire guide wire. The available straignt and is thade soll to casily bonion of the wire guide wire. The (Hydrophilie or onlooms) is coated with PTFE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary angioplasty; 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
PERFORMANCE DATA: All components that come in direct contact with the patient have a long history of use in All components that come in offect bontact with the for use in the vasculature. This medical devices and are proven to be blocombilibe for ass in the demonstrates that 5 folk) notice installing performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Asahi PTCA Guide Wire Confianza Pro K041531, JOWIRE Asahi PTCA Guide Wire K031277, JOWIRE Neo's PTCA Guide Wire K022762
Reference Device(s)
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
SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
This 510(k) summary of safety and effectiveness information is being submitted in
tell in the summer of same and 1000 and 21 CEP 807 92 This 510(K) summary of Salety and Sheety 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.
1301 Dove Street, Suite 350
Newport Beach, CA 92660
Tel: (949) 756-8252
FAX (949) 756-8165
e-mail: yoshi@asahi-intecc.com |
| TRADE NAME: | Asahi PTCA Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATION
NAME: | Catheter Guide Wire |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX |
| PREDICATE DEVICE: | Asahi PTCA Guide Wire Confianza Pro K041531
JOWIRE Asahi PTCA Guide Wire K031277
JOWIRE Neo's PTCA Guide Wire K022762 |
Description of the Device Subject to Premarket Notification:
DESCRIPTION OF THE DEVICE SUBSEVED TO TO TO LE Wires with a maximum diameter of The Asani PTCA Guide Wiles are stechable gelde is constructed from a 0.014" and available in 150 cm and oo of the guide wire has a radiopaque tip that is
stainless steel core wire. The distal end of the guide wire The coating stainless steel core wire. The distar end of the gd with the vessel curve. The coating
available straight and is made soft to easily bend with wire guide wire. The available straignt and is thade soll to casily bonion of the wire guide wire. The (Hydrophilie or onlooms) is coated with PTFE.
INDICATION FOR USE:
To facilitate the placement of balloon dilatation catheters during percularied and To facilitate the placement of balloon dilation sus transluminal angioplasty
transluminal coronary angioplasty (PTCA) and percutaneous transluminal blood vessel transluminal coronary angloplasty (1 YOA) and poroculared in the cerebral blood vessel.
Asahi Intecc August 14, 2005
1
TECHNICAL CHARACTERISTICS:
TECHNICAL CHARACTERISTICS:
The Asahi PTCA Guide Wire is made of the same materials that have been used in the The Asahi PTCA Guide Wire is made of the same indications are the equilie predicate Asahi products with the same incation for citications are the equivalent to specifications and the galacting cleared predicate devices.
PERFORMANCE DATA:
PERFORMANCE DATA:
All components that come in direct contact with the patient have a long history of use in All components that come in offect bontact with the for use in the vasculature. This medical devices and are proven to be blocombilibe for ass in the demonstrates that 5 folk) notice installing performs as intended.
SUMMARY/CONCLUSION:
The ASAHI Guide Wire characteristics are substantially equivalent to the specified The ASAHI Guide Wire characteristics are substantially oquine ame indication for use.
Bench testing demonstrates that the device functions as intended.
2
Image /page/2/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
NOV 3 0 2005
Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO 1301 Dove Street, Suite 350 Newport Beach, CA 92660
Re: K052339 Asahi PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: October 27, 2005 Received: October 31, 2005
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Bran D. Zuckerman, M.D.
Bram D. Zyckerman, M.D. Director Division of/Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT 2,0
Page 1 of 1
510(k) Number (if known); ____________________________________________________________________________________________________________________________________________________
Device Name: ASAHI PTCA Guide Wire
Indications for Use:
To facilitate the placement of balloon dilatation catheters during perculaneous I o facilitate the placement of between the perculaneous transluminal transfuminal coronary angloplasty (r 1 one ports are not to be used in the cerebral blood vessel.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-On)
Division of Cardiovascular Devices
| 510(k) Number | K052339 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use
(Optional Format 1-96) |
| ------------------------------------------ | --- | ---- | ------------------------------------------------ |
|---|
Page 15Asah: Intecc August 14, 2005