(84 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is a guide wire intended to facilitate the placement and exchange of diagnostic and therapeutic devices, not to provide therapy itself.
No
Explanation: The device is a guide wire intended to facilitate the placement and exchange of other devices (both diagnostic and therapeutic), but it does not perform diagnostic functions itself. It is a tool for procedural support, not diagnosis.
No
The device description clearly details a physical guide wire constructed from stainless steel with a spring, coatings, and a radiopaque tip. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures." This describes a device used within the body for procedural guidance, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical guide wire designed for insertion into blood vessels. This is consistent with an interventional device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or performing tests to detect diseases or conditions.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This guide wire does not fit that description.
N/A
Intended Use / Indications for Use
The ASAHI Treasure guide wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
Product codes
DQX
Device Description
The Asahi Treasure peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm lengths. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire. The wire is constructed from a stainless steel core wire with spring. The core wire and coil are soldered together. The distal nod of the guide wire has a radiopaque tip that is straight and is soft to easily bend with the vessel curve. The hydrophilic coating is applied to the distal portion of the 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
peripheral vascular
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)
All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains reference to a predicate ASAHI devices that uses the same materials as used in the subject device. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Treasure guide wire performs as intended.
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
9.0 510(K) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
OCT = 5 2006
| 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: | Treasure |
| COMMON NAME: | Guide Wire |
| CLASSIFICATION
NAME: | Catheter Guide Wire |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX |
| PREDICATE DEVICE: | Boston Scientific V-18 guide wire (K033724)
HI-Torque Steelcore 18 guide wire (K982876)
JOMED JoWire (K022762) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Asahi Treasure peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm lengths. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire. The wire is constructed from a stainless steel core wire with spring. The core wire and coil are soldered together. The distal nod of the guide wire has a radiopaque tip that is straight and is soft to easily bend with the vessel curve. The hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.
Indication for Use:
The ASAHI Treasure guide wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
1
TECHNICAL CHARACTERISTICS:
The ASAHI Treasure guide wire is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.
PERFORMANCE DATA:
All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains reference to a predicate ASAHI devices that uses the same materials as used in the subject device. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Treasure guide wire performs as intended.
Summary/Conclusion:
The ASAHI Treasure guide wire 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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 2006
Asahi Intecc Co., LTD. c/o Mr. Yoshi Terai President. CEO 1301 Dove Street, Suite #350 Newport Beach, CA 92660
Re: K061984
Treasure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 20, 2006 Received: September 26, 2006
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.
R. Vuchner
Image /page/3/Picture/5 description: The image shows a black and white drawing of a signature. The signature is illegible, but it appears to be a stylized version of the letters 'S' and 'W'. The signature is drawn with thick lines and has a slightly messy appearance. The signature is located in the center of the image.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO61984
Device Name: Treasure
Indications for Use:
The ASAHI Treasure guide wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
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)
R. lochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K6661984
Page of of J
CONFIDENTIAL Asahi Intecc June 20, 2006