The MAGELLAN™ system, which is comprised of a medical workstation, a magnetic location system and a range of locatable tools is intended to be used as an image guided neurosurgery navigation system to pre-operatively and intra-operatively perform the following functions:

process and display pre-operatively radiographic images on a monitor; .
provide intra-operative image control based on the position and orientation of a . user directed tool;
. allow for the integration and usage of the Blosense magnetic location system and a range of different tool attachments; and
store/retrieve image data on computer access media (e.g. hard disks, archive . media)

Circumstances:
The MAGELLAN™ system is intended to be used during planning of a procedure, when more than one approach (c.g. cntry point, trajectory, craniotomy size) is being considered, and also during surgery when:

. the target or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy;
방 the target or approach is in a region where normal landmarks have been distorted either by disease or by previous surgery;
the target or approach is in close proximity to critical structures) e.g. venous sinuses, air sinuses, blood vessels, nerves) which must be avoided or negotiated; Or
the target delineation is important and will not move significantly during the . implementation of the approach (e.g. skull-based tumors. sinus diseases, corpus callosotomies).

I Jisease or Conditions:
The MAGELLAN™ system is indicated for patients who have imaged space occupying lesions or malfunctions (both soft tissue and osscous) in the head.

Device Description

The Magellan system is a subset of the CARTO system. The CARTO system consists of the location system and the viewing station for the EP application combined together in one product. The Magellan system is the same location system used in CARTO, to be sold separately for use with a range of different 510(k) approved locatable accessory devices and viewing stations for applications.

AI/ML Overview

The provided text describes the Magellan system, a location system intended for intrabody mapping and navigation, specifically for image-guided neurosurgery. However, it does not contain information regarding acceptance criteria, device performance, or any specific study detailing such performance.

The document states that "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." This statement implies that the device was evaluated against a predicate device (Biosense CARTO system, K954395), and the testing confirmed substantial equivalence. However, no specific data, acceptance criteria, or study details are provided to support this claim.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Information on standalone performance.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The provided text focuses on the 510(k) summary, regulatory compliance (EMC directive, IEC standards), and the intended use and indications for the Magellan system, along with its substantial equivalence to the CARTO system. It does not elaborate on the specific performance studies that would include the requested criteria.

Summary

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AUG 2 4 1998

:Biosense, Ltd.

POB 297, Einstein Building, Etgar Street, New Industrial Area, Tirat HaCarmel, 39101 ISRAEL Tel: +972-4-576057 Fax: +972-4-571071

161903

510(k) summary for the Magellan system - 2 May 1996

510(k) Notification submitted by:	Biosense Ltd.Einstein Building, Etgar Street, New Industrial ZonePOB 297, Tirat HaCarmel, 39101 ISRAELTel: +972-4-576057 Fax: +972-4-571071
Contact person:	Susan J. Zachman, Director of Regulatory Affairs
Proprietary device name:	MagellanTM
Classification name:	Programmable diagnostic computer(per 21 CFR 870.1425)
Common device name:	Location system
Legally marketed device to whichsubstantial equivalence is beingclaimed	Biosense CARTO system510(k) No. K954395

The Magellan system is a subset of the CARTO system.

The CARTO system consists of the location system and the viewing station for the EP application combined together in one product. The Magellan system is the same location system used in CARTO, to be sold separately for use with a range of different 510(k) approved locatable accessory devices and viewing stations for applications.

The intended use of both systems is the same: intrabody location for mapping and navigation. The specific application of the system in the case of CARTO is cardiac mapping, where the Magellan system may be used for cardiac applications as well as for other intrabody mapping and navigation applications.

The Magellan 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.

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品Biosense, Ltd.

The Magellan 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
and animal I he non-cinnical belief and animal testing on which it is being compared and does
effective as the previously marketed device to which it is being compared and does cricetive as they questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, suggesting a sense of community and service.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Ms. Susan J. Zachman Director Regulatory Affairs and Quality Assurance Biosense, Limited P.O. Box 297, 7 Etgar Street Beit Einstein Building Tirat HaCarmel 39101 Israel

Re: K961903 Trade Name: Magellan™ Regulatory Class: II Product Code: HAW Dated: May 21, 1998 Received: May 26, 1998

Dear Ms. Zachman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Susan J. Zachman

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Colia M. Witten, Ph.D., M.D.

M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the logo for Biosense Webster. The logo consists of a stylized "B" followed by the word "Biosense" in a bold, sans-serif font. Underneath the word "Biosense" is the text "a Johnson & Johnson company" in a smaller font. The logo is black and white.

Johnson&Johnson company

Einstoin Building, Etgar St., New Industrial Zone, POB 2009. Tirat HaCarmel 39120 ISRAEL Tcl: +972-4-8576057 Fax: +972-4-8571071 e-mail: mail@biosense.co.il

F nelosure B - Indications for Use Statement

Device Name: MAGELLAN System

510(k) Number: K961903

Indications for Use:

process and display pre-operatively radiographic images on a monitor; .
provide intra-operative image control based on the position and orientation of a . user directed tool;
. allow for the integration and usage of the Blosense magnetic location system and a range of different tool attachments; and
store/retrieve image data on computer access media (e.g. hard disks, archive . media)

Circumstances:

The MAGELLAN™ system is intended to be used during planning of a procedure, when more than one approach (c.g. cntry point, trajectory, craniotomy size) is being considered, and also during surgery when:

. the target or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy;
방 the target or approach is in a region where normal landmarks have been distorted either by disease or by previous surgery;
the target or approach is in close proximity to critical structures) e.g. venous sinuses, air sinuses, blood vessels, nerves) which must be avoided or negotiated; Or
the target delineation is important and will not move significantly during the . implementation of the approach (e.g. skull-based tumors. sinus diseases, corpus callosotomies).

I Jisease or Conditions:

The MAGELLAN™ system is indicated for patients who have imaged space occupying lesions or malfunctions (both soft tissue and osscous) in the head.

CONFIDENTIAL	Prescription Use (Per 21 CFR 801.109)	R-1
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Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).