(119 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and materials of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device aids another therapeutic device (coronary balloon dilation catheter) to reach a lesion but does not directly provide therapy itself.
No
Explanation: The device is intended for use in percutaneous procedures to reach and cross stenotic lesions, which is an interventional/therapeutic action, not a diagnostic one. Its purpose is to facilitate the insertion of a balloon dilation catheter, not to diagnose a condition.
No
The device description clearly describes a physical guidewire made of stainless steel and other materials, which is a hardware component.
Based on the provided information, the Clyde Coronary Guidewire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous procedures to reach and cross stenotic lesions within the body prior to inserting a balloon catheter. This is an in vivo procedure, meaning it's performed on a living organism.
- Device Description: The description details a physical guidewire used for navigation within blood vessels. It does not describe a device used to examine specimens outside the body (in vitro).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Clyde Coronary Guidewire is a medical device used for a therapeutic and interventional procedure within the body.
N/A
Intended Use / Indications for Use
The Clyde Coronary Guidewire is intended for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.
Product codes
DOX
Device Description
The Clyde Coronary Guidewire is a 0.014" guidewire manufactured in lengths of 100-400 cm. The guidewire is made of a stainless steel, PTFE coated proximal shaft, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coil. The distal 3 cm of the coil are very flexible and shapeable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary
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
Equivalence in technological characteristics was substantiated by a detailed comparison of the Clyde and C-Thru coronary guidewire design and materials. Because of the similarity in materials a reduced biocompatibility battery, consisting of hemolysis and cytotoxicity, was conducted.
The results of these comparisons indicated that the Clyde coronary guidewire is equivalent to the C-Thru coronary guidewire and is, therefore, safe for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
JUN 10-1997
510(k) Summary for Clyde Coronary Guidewire
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is
| Date Prepared: | February 10, 1997 |
|---|---|
| Sponsor: | Schneider (Europe) AG |
| Ackerstrasse 6 | |
| PO Box CH-8180 | |
| Bulach, Switzerland | |
| Contact: | Rudolf Ott |
| V.P. Clinical and Regulatory Affairs | |
| Phone: 011-411-8721179 | |
| Trade/Proprietary Name: | Clyde Coronary Guidewire |
| Classification: | Class II |
| Equivalent Devices | C-Thru Coronary Guidewire |
Device Description
The Clyde Coronary Guidewire is a 0.014" guidewire manufactured in lengths of 100-400 cm. The guidewire is made of a stainless steel, PTFE coated proximal shaft, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coil. The distal 3 cm of the coil are very flexible and shapeable.
Intended Use
The Clyde Coronary Guidewire is intended to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.
Technological Characteristics
Equivalence in technological characteristics was substantiated by a detailed comparison of the Clyde and C-Thru coronary guidewire design and materials. Because of the similarity in materials a reduced biocompatibility battery, consisting of hemolysis and cytotoxicity, was conducted.
The results of these comparisons indicated that the Clyde coronary guidewire is equivalent to the C-Thru coronary guidewire and is, therefore, safe for the intended use.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, arranged in a row. The profiles are simple and abstract, with only the basic outline of the face visible. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1997
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Mr. R. Ott Vice-President Clinical and Requlatory Affairs Schneider (Europe) AG Pfizer Hospital Products Group Ackerstrasse 6, P.O. Box CH-8180 Bulach/Switzerland
Re: K970528 CLYDE™ Coronary Guidewire Regulatory Class: II (two) Product Code: DOX Dated: May 26, 1997 Received: May 28, 1997
Dear Mr. Ott:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
2
regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
ત્વ
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510(k) Number (if known):
Device Name:
Clyde Coronary Guidewire
Indications for Use:
The Clyde Coronary Guidewire is intended for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tuf. Re.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1970224 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)