(400 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description is not available to infer such capabilities.
No
The device is described as monitoring and recording electrical activities, which is diagnostic, not therapeutic. The predicate devices are also catheters, which are typically used for diagnostic or interventional procedures, but the specific function described here is monitoring, which is not therapeutic.
Yes
The device monitors and records intra-cardiac electrical activities, which is a form of physiological measurement used to assess the state of the heart, thus performing a diagnostic function.
Unknown
The provided summary lacks a device description, which is crucial for determining if the device is software-only. The intended use suggests it interacts with intra-cardiac electrical activities, which typically involves hardware components like catheters or electrodes. Without a description, it's impossible to confirm if the device is solely software processing data from such hardware or if it includes hardware itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Monitor and record intra-cardiac electrical activities." This describes a device that interacts directly with the patient's body to measure physiological signals.
- Anatomical Site: The anatomical site is "intra-cardiac," meaning inside the heart. This further reinforces that it's an in-vivo device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition based on the analysis of samples.
- Performing tests in a laboratory setting.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function of monitoring and recording electrical activity within the heart is a direct physiological measurement, not an in-vitro analysis of a sample.
N/A
Intended Use / Indications for Use
Monitor and record intra-cardiac electrical activities
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K912213, K904080, K891908, K900765
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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