(400 days)
Monitor and record intra-cardiac electrical activities
Not Found
This document is a premarket notification (510(k)) for a medical device called the "Gyro Tip EP Catheter." It is for a device used to "monitor and record intra-cardiac electrical activities."
Unfortunately, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document is primarily a summary for a 510(k) submission, focusing on:
- Device Identification: Name, classification, intended use.
- Regulatory Information: Manufacturer registration, classification.
- Labeling: Mention of draft labeling, including directions for use, indications, cautions, warnings, and precautions.
- Substantial Equivalence: A claim that the device is substantially equivalent to existing devices (Bard Dynamic Tip Catheter, Bard Tip Deflecting Catheter, Bard Tip Deflecting Electrode Catheter, and Steerocath).
- General Information: Reference to a more comprehensive summary for material biocompatibility, physical characteristics, and results of electrical and mechanical tests.
There is no mention of specific acceptance criteria, performance metrics, a study design, sample sizes, ground truth establishment, or expert involvement as requested. The "None Established Performance Standards" point further reinforces that no specific numerical performance standards are detailed in this summary.
Therefore, I cannot populate the table or answer the specific questions about the study from the provided text.
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Premarket Notification 510(k)
vice: Gyro Tip EP Catheter
Device Class: II
Fax: (216) 281-4639
JAN 2 9 1997
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
- Premarket Notification for RE: 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 |
- Cardiac Assist Devices, Inc. has submitted form FDA-2891 (Initial 2. Registration of Medical Device Establishment) for its manufacturing facility located at 11000 Cedar Ave. Suite 451, Cleveland, Ohio 44106-3052, to FDA.
-
- Classification: Electrode Recording Catheters have been officially classified as CLASS II as described in 21CFR870.1280
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The Safe Medical Device Act Summary (continue)
- None Established Performance Standards: 4.
- Draft Labelling of the Gyro Tip EP Catheter is presented in Section 9 of રું. This Draft Labeling includes: Direction for Use, this document. Indications, Cautions, Description, Warnings and Precautions.
- Substantial Equivalence: The Gyro Tip EP Catheter is substantially 6. 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.
- (Executive Summary) of this document is a more 7. Section 1 comprehensive summary statement that includes additional information regarding the material biocompatibilty, 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
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
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.(b)
Classification. Class II (performance standards).