(68 days)
No
The description focuses on electroanatomical mapping using sensor-equipped catheters and does not mention AI or ML technologies for analysis or display.
No
The device is designed to acquire, analyze, and display electroanatomical maps of the heart, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is described as acquiring, analyzing, and displaying electroanatomical maps of the human heart, which are used to assess the heart's electrical activity and structure. This process is inherently diagnostic, as it provides information used to identify and characterize medical conditions.
No
The device description explicitly mentions "STAR catheters, which are locatable-tip catheters equipped with a Biosense sensor" and the use of "Biosense nonfluoroscopic location technology," indicating the system includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the Biosense NOGA system clearly states it acquires, analyzes, and displays electroanatomical maps of the human heart using intracardiac electrograms and locatable-tip catheters. This is a direct interaction with the patient's heart, not the examination of a specimen taken from the body.
- The intended use is for mapping the heart, not for diagnosing a condition based on a specimen. The purpose is to create a map of the heart's electrical activity and geometry, which is a procedural tool rather than a diagnostic test performed on a sample.
Therefore, the Biosense NOGA system falls under the category of a medical device used for a procedure within the body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biosense NOGA system is designed to acquire, analyze, and display electroanatomical maps of the human heart.
Product codes
Not Found
Device Description
The Biosense NOGA system is designed to acquire, analyze, and display electroanatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of a plurality of intracardiac electrograms with their respective endocardial locations. In the NOGA system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using STAR catheters, which are locatable-tip catheters equipped with a Biosense sensor. The NOGA system also allows presentation of electro-anatomical maps as a function of time over the cardiac cycle. The NOGA system uses the same Biosense nonfluoroscopic location technology used in the CARTO system. The NOGA system additionally uses this technology to collect additional information about the heart chamber geometry as a function of time over the cardiac cycle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart
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
The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Biosense, Ltd.
POB 297, Einstein Building, Etgar Street, New Industrial Area, Tirat HaCarmel, 39101 ISRAEL Tel: +972-4-576057 Fax: +972-4-571071
APR 1 5 1996
510(k) summary for the NOGA system - 5 February 1996
| 510(k) Notification submitted by: | Biosense Ltd.
Einstein Building, Etgar Street, New Industrial Zone
POB 297, Tirat HaCarmel, 39101 ISRAEL
Tel: +972-4-576057 Fax: +972-4-571071 |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Susan J. Zachman, Director of Regulatory Affairs |
| Proprietary device name: | NOGATM |
| Classification name: | Programmable diagnostic computer
(per 21 CFR 870.1425) |
| Common device name: | Cardiac mapping system |
| Legally marketed device to which
substantial equivalence is being
claimed | Biosense CARTO system
510(k) No. K954403 |
The Biosense NOGA system is designed to acquire, analyze, and display electroanatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of a plurality of intracardiac electrograms with their respective endocardial locations. In the NOGA system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using STAR catheters, which are locatable-tip catheters equipped with a Biosense sensor. The NOGA system also allows presentation of electro-anatomical maps as a function of time over the cardiac cycle.
Currently, cardiac mapping is performed using a roving mapping catheter, a computerized mapping system, and fluoroscopy to determine the location of the tip of the mapping catheter. In the conventional procedure both the patient and the physician are exposed to harmful ionizing radiation during the course of the lengthy procedure.
The recently introduced Biosense CARTO system (510(k) No. K954395) enables cardiac mapping using a non-fluoroscopic catheter tip location technology. The Biosense NOGA system is for the most part identical in design and construction to the Biosense CARTO system. The NOGA system uses the same Biosense nonfluoroscopic location technology used in the CARTO system. The NOGA system additionally uses this technology to collect additional information about the heart chamber geometry as a function of time over the cardiac cycle. Conventionally, such
1
器Biosense, Ltd.
information would be collected using fluoroscopy or cine while injecting a radiopaque contrast agent into the heart chamber (ventriculography).
The NOGA system complies with the European EMC directive; 89/336/EEC as amended by 92/31/EEC and 93/68/EEC and the CE mark may be affixed to the product.
The NOGA system complies with the following standards:
IEC 601-11988 IEC 601-1 A1/1991 IEC 601-1 A2/1995 IEC 601-2-27/1994 EN 60601-1-2/1993
The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness. The use of the non-fluoroscopic location technology may reduce the exposure to dangerous ionizing radiation to the both the physician and the patient, and may also reduce total mapping procedure time.