(31 days)
Not Found
No
The description focuses on the physical components and intended use of a guide catheter, with no mention of AI/ML, image processing, or data analysis.
No.
The "Intended Use" states that the device is designed to provide a pathway for other medical instruments and "other therapeutic devices," indicating it is not a therapeutic device itself.
No
Explanation: The device is a guide catheter designed to provide a pathway for other medical instruments, not to diagnose a condition. Its function is to facilitate therapeutic procedures, not to identify a disease or condition.
No
The device description clearly outlines physical components (tube, proximal hub, protector) and materials (PTFE coating, Silicone oil coating), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide a pathway for introducing medical instruments into the coronary arteries. This is a therapeutic and interventional use, not a diagnostic one.
- Device Description: The description details the physical components of a catheter used for accessing blood vessels. There is no mention of reagents, samples, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Keywords: The document does not contain any keywords or phrases commonly associated with IVD devices, such as "in vitro," "sample," "assay," "analyte," "diagnosis," "testing," etc.
- Anatomical Site: The device is used within the body (in vivo) in the coronary artery, which is consistent with an interventional device, not an in vitro diagnostic device that analyzes samples outside the body.
In summary, the Precious Plus Guide Catheter is a medical device used for facilitating interventional procedures within the coronary arteries, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Precious plus guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
Product codes
DQY
Device Description
The Precious plus guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature. The Precious plus guide catheter consists of a tube, a proximal hub, and protector for the joint portion of the first 2 components. The surface of inner lumen of the shaft is coated with PTFE to enhance lubricity. The outer surface of the product is coated with Silicone oil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery applications
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 additional biocompatibility testing that was conducted on the actual device. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the Precious plus guide catheter performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Asahi Precious Guide Catheter - K061601, Guidant ACS Viking Guiding Catheter - K972484
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY 9.0
This 510(k) summary of safety and effectiveness information is being submitted in This STO(K) Summary of Streenents of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Asahi Intecc Co., Ltd.
1703 Wakita-cho, Moriyama-ku
Nagoya, Aichi 463-0024
Japan | | SEP 17 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: | Precious Plus Guide Catheter | | |
| COMMON NAME: | Guide Catheter | | |
| CLASSIFICATION
NAME: | Percutaneous Catheter | | |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1250 | | |
| PRODUCT CODE | DQY | | |
| PREDICATE DEVICE: | Asahi Precious Guide Catheter - K061601
Guidant ACS Viking Guiding Catheter - K972484 | | |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Precious plus guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature. The Precious plus guide catheter consists of a tube, a proximal hub, and protector for the joint portion of the first 2 components. The surface of inner lumen of the shaft is coated with PTFE to enhance lubricity. The outer surface of the product is coated with Silicone oil.
1
INDICATION FOR USE:
The Precious plus guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
TECHNICAL CHARACTERISTICS:
The Precious plus guide catheter 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 additional biocompatibility testing that was conducted on the actual device. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the Precious plus guide catheter performs as intended.
SUMMARY/CONCLUSION:
The Precious plus guide catheter 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 seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. The symbol is stylized and modern, representing the department's mission related to health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2007
Asani 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: K072316
Precious Plus Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: August 7, 2007 Received: August 17, 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,
R. bohner
A 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 STATEMENT 2.0
510(k) Number (if known): __K 072316
Device Name: Precious Plus Guide Catheter
Indications for Use:
The Precious Plus Guide Catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
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)
umer R. Vahnes
Sign-Off)
Cardiovascular Devices
510(k) Number_6 723 16
Page_( of of l
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