NOGA

K960542 · Biosense, Ltd. · DRF · Apr 15, 1996 · Cardiovascular

Device Facts

• Record ID: K960542
• Device Name: NOGA
• Applicant: Biosense, Ltd.
• Product Code: DRF · Cardiovascular
• Decision Date: Apr 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Biosense NOGA system is designed to acquire, analyze, and display electro-anatomical maps of the human heart.

Device Story

NOGA system acquires, analyzes, and displays electro-anatomical heart maps; utilizes STAR catheters with integrated Biosense sensors for simultaneous intracardiac electrogram and endocardial location data; replaces traditional fluoroscopy-based mapping; operates by reconstructing geometry as a function of time over cardiac cycle; used in clinical settings by physicians; reduces ionizing radiation exposure for patient and physician; improves procedural efficiency by eliminating need for contrast-based ventriculography.

Clinical Evidence

Non-clinical bench and animal testing performed. No human clinical trial data provided. Testing demonstrated safety and effectiveness equivalent to the predicate device.

Technological Characteristics

Cardiac mapping system; non-fluoroscopic location technology; STAR catheters with integrated sensors; complies with IEC 601-1, IEC 601-1 A1, IEC 601-1 A2, IEC 601-2-27, and EN 60601-1-2 standards; electromagnetic compatibility per 89/336/EEC.

Indications for Use

Indicated for cardiac mapping in patients requiring electro-anatomical assessment of the heart. No specific age or gender contraindications provided.

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

• Biosense CARTO system (K954403)

Submission Summary (Full Text)

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Biosense, Ltd. k960542

POB 297, Einstein Building, Etgar Street, New Industrial Area, Tirat HaCarmel, 39101 ISRAEL Tel: [phone] Fax: [phone]

APR 15 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: [phone] Fax: [phone] |
| --- | --- |
| Contact person: | Susan J. Zachman, Director of Regulatory Affairs |
| Proprietary device name: | NOGA™ |
| 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 electro-anatomical 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 non-fluoroscopic 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

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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 601-1/1988
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.