(830 days)
Not Found
No
The description focuses on image processing, magnetic location, and navigation based on pre-operative images and intra-operative tool position, without mentioning AI or ML algorithms for image analysis, decision support, or other functions.
No.
The MAGELLAN™ system is an image-guided neurosurgery navigation system that assists in planning and performing surgical procedures by displaying images and tracking tools, rather than directly treating a disease or condition itself.
No
Explanation: The MAGELLAN™ system is described as an image-guided neurosurgery navigation system. Its functions include processing and displaying images, providing intra-operative image control, and integrating with location systems and tools for surgical planning and guidance. It is used during procedures to help navigate complex anatomies or avoid critical structures, not to diagnose a disease or condition itself. While it uses images of lesions or malfunctions, its purpose is for navigation during treatment, not for diagnosing the presence or nature of those lesions.
No
The device description explicitly states that the MAGELLAN™ system is comprised of a medical workstation, a magnetic location system, and a range of locatable tools, in addition to software. This indicates it is a hardware and software system, not software-only.
Based on the provided information, the MAGELLAN™ system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- MAGELLAN™ System's Intended Use: The MAGELLAN™ system is clearly described as an image-guided neurosurgery navigation system. Its functions involve processing and displaying pre-operative images, providing intra-operative image control based on tool position, integrating a magnetic location system and tools, and storing/retrieving image data.
- Circumstances and Disease/Conditions: The circumstances and indicated disease/conditions relate to using the system during surgical planning and procedures for patients with lesions or malfunctions in the head.
- Device Description: The description confirms it's a navigation system used with locatable accessory devices and viewing stations for applications like cardiac mapping and other intrabody mapping and navigation.
The system's purpose is to assist surgeons with navigation and guidance during surgical procedures based on imaging and tool location within the body, not to perform diagnostic tests on biological specimens outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HAW
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.
Mentions image processing
- 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
- store/retrieve image data on computer access media (e.g. hard disks, archive media)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic images
Anatomical Site
intrabody, cardiac, head (subcortical brain, skull-based tumors, sinus diseases, corpus callosotomies)
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)
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 questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 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: | MagellanTM |
| Classification name: | Programmable diagnostic computer
(per 21 CFR 870.1425) |
| Common device name: | Location system |
| Legally marketed device to which
substantial equivalence is being
claimed | Biosense CARTO system
510(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.
1
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.
2
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.
3
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
4
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:
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.
| CONFIDENTIAL | Prescription Use (Per 21 CFR 801.109) | R-1 |
|---|---|---|
| -------------- | --------------------------------------- | ----- |