GYRO TIP EP CATHETER
K955847 · Cardiac Assist Devices, Inc. · DRF · Jan 29, 1997 · Cardiovascular
Device Facts
| Record ID | K955847 |
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| Device Name | GYRO TIP EP CATHETER |
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| Applicant | Cardiac Assist Devices, Inc. |
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| Product Code | DRF · Cardiovascular |
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| Decision Date | Jan 29, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 870.1220 |
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| Device Class | Class 2 |
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Intended Use
Monitor and record intra-cardiac electrical activities
Device Story
Gyro Tip EP Catheter is a deflectable tip recording catheter used for monitoring and recording intra-cardiac electrical activities. Operated by physicians in clinical settings, the device is inserted into the heart to capture electrical signals. These signals are transmitted to external recording equipment, allowing clinicians to visualize cardiac electrical activity, diagnose arrhythmias, and guide clinical decision-making during electrophysiological procedures. The deflectable tip mechanism allows for precise positioning within the cardiac chambers to optimize signal acquisition.
Clinical Evidence
Bench testing only; includes electrical and mechanical performance testing and material biocompatibility assessment.
Technological Characteristics
Deflectable tip electrode recording catheter. Class II device per 21CFR870.1280. Features include mechanical tip deflection mechanism for positioning. Biocompatible materials used. No established performance standards.
Indications for Use
Indicated for patients requiring electrophysiological monitoring and recording of intra-cardiac electrical signals.
Regulatory Classification
Identification
An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
Predicate Devices
- Bard Dynamic Tip Catheter (K912213)
- Bard Tip Deflecting Catheter (K904080)
- Bard Tip Deflecting Electrode Catheter (K891908)
- Steerocath (K900765)
Related Devices
- K022380 — LIVESIRE ELECTROPHYSIOLOGY CATHETER · St Jude Medical · Oct 1, 2002
- K033963 — EP DEFLECTABLE CATHETERS · Ep Medsystems, Inc. · Apr 15, 2004
- K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID · Biosense Webster, Inc. · Jul 10, 2023
- K051220 — REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS · Sterilmed, Inc. · Jun 14, 2005
- K160390 — Map-it Diagnostic Mapping Catheters · Access Point Technologies Ep, Inc. · Apr 11, 2016
Submission Summary (Full Text)
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Cardiac Assist Devices, Inc.
11000 Cedar Ave. Suite # 451
Cleveland, Ohio 44106-3052
Phone: (216) 791-2234
Fax: (216) 281-4639
JAN 29 1997
Premarket Notification 510(k)
Device: Gyro Tip EP Catheter
Device Class: II
K955847
# December 18, 1995
Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center (HFZ-401)
9200 Corporate BLVD.
Rockville, Maryland 20850
# The Safe Medical Device Act Summary
RE: Premarket Notification for
Gyro Tip EP Catheter
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
In accordance with Section 510(K) of the Federal Food, Drug and Cosmetic Act, notification is hereby made of the intention of the Cardiac Assist Devices, Inc. to market the following device:
1. Device Name: Gyro Tip EP Catheter
Classification Name: Electrode Recording Catheter
Common Name: Deflectable Tip Recording Catheter
Trade Name: Gyro Tip EP Catheter
Intended Use: Monitor and record intra-cardiac electrical activities
2. Cardiac Assist Devices, Inc. has submitted form FDA-2891 (Initial Registration of Medical Device Establishment) for its manufacturing facility located at 11000 Cedar Ave. Suite 451, Cleveland, Ohio 44106-3052, to FDA.
3. Classification: Electrode Recording Catheters have been officially classified as CLASS II as described in 21CFR870.1280
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{1}
Cardiac Assist Devices, Inc.
11000 Cedar Ave. Suite # 451
Cleveland, Ohio 44106-3052
Phone: (216) 791-2234
Fax: (216) 281-4639
Premarket Notification 510(k)
Device: Gyro Tip EP Catheter
Device Class: II
# The Safe Medical Device Act Summary (continue)
4. Performance Standards: None Established
5. Draft Labelling of the Gyro Tip EP Catheter is presented in Section 9 of this document. This Draft Labeling includes: Direction for Use, Indications, Cautions, Description, Warnings and Precautions.
6. Substantial Equivalence: The Gyro Tip EP Catheter is substantially equivalent to Bard Dynamic Tip Catheter (K912213), Bard Tip Deflecting Catheter (K904080), Bard Tip Deflecting Electrode Catheter (K891908), and Steerocath (K900765). Section 4 of this document contains a detailed statement of substantial equivalence.
7. Section 1 (Executive Summary) of this document is a more comprehensive summary statement that includes additional information regarding the material biocompatibility, physical characteristics, results of electrical and mechanical tests and a general description of the Gyro Tip EP Catheter.
If you have any questions or require any additional information regarding the content of this document, please call me at (216) 791-2234 or fax to: (216) 281-4639.
Sincerely yours,
*Rassoll Rashidi*
Rassoll Rashidi, BME.
President
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