(261 days)
No reference devices were used in this submission.
No
The summary describes a system for electromagnetic navigation and tracking using physical instruments and trackers. There is no mention of AI or ML in the intended use, device description, or performance studies. The system relies on detecting magnetic fields and displaying the location based on pre-existing image data or digitized landmarks.
No.
The device is described as an aid for precisely locating anatomical structures and tracking patient position during navigated surgical procedures, not for treating a condition.
No
The device is described as an aid for precisely locating anatomical structures and tracking patient position during navigated surgical procedures, not for diagnosing conditions.
No
The device description explicitly states that the devices are "single-use, sterile devices" and "incorporates a tracking system within the instrument or tracker." The performance studies also include testing for physical properties like chemical resistance, electrical safety, shipping, MRI compatibility, and biocompatibility, which are relevant to hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures." It is used as an aid for precisely locating anatomical structures during surgery.
- Device Description: The device description explains that it's an electromagnetically navigated device used for "localizing patient anatomy, patient registration, and tracking patient location during stereotactic surgery procedures."
- Lack of In Vitro Testing: The performance studies listed focus on system accuracy, simulated environment accuracy, skin shift, chemical resistance, electrical safety, shipping, general performance, MRI compatibility, usability, accelerated life, tool cards, and biocompatibility. None of these tests involve analyzing samples taken from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- No Mention of Diagnostic Purpose: The documentation does not mention any diagnostic purpose for the device. It is purely a tool for surgical navigation and tracking.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body or on the body surface) and is used for surgical guidance, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Non-Invasive Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Skull-Mount Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Stylet is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Stylet is indicated for use in the following procedures:
- General ventricular catheter placement
- Pediatric ventricular catheter placement
- Tumor resections
- Skull base procedures
- Craniotomies/craniectomies
- Transsphenoidal procedures
The Tracer® Pointer is indicated for use in registering patient anatomy and in precisely locating anatomical structures during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computerassisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Touch-n-Go Pointer is indicated for use in registent anatomy during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Navigation Pointer is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medironic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Navigation Pointer is indicated for use in the following procedures:
- General tumor resections
- Pediatric tumor resections
- Skull base procedures
- Craniotomies/craniectomies
- Transsphenoidal procedures
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The AxiEM™ Instruments (Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer) and Trackers (Skull-Mount Patient Tracker. Non-Invasive Patient Tracker) are singleuse, sterile devices compatible with AxiEM™-enabled Medtronic computer assisted surgery systems. The instruments and trackers are electromagnetically navigated devices used for the purpose of localizing patient anatomy, patient registration, and tracking patient location during stereotactic surgery procedures. Each device incorporates a tracking system within the instrument or tracker. The mobile emitter of the navigation system generates a low-energy magnetic field that is detected by the tracking system within the device. The navigation system software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Anatomical Site
Skull, patient anatomy (cranial and ENT procedures)
Indicated Patient Age Range
Adult and pediatric patients (for Non-Invasive Patient Tracker, Tracer® Pointer, and Touch-n-Go Pointer)
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)
System Accuracy Test:
Results: The system has demonstrated accuracy with a mean positional error of
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in black and are arranged to create a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Medtronic Navigation, Inc. Mr. Christopher Perman Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K141833
Trade/Device Name: Stylet, 23cm, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer, Touch-n-Go Pointer, Navigation Pointer Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: February 20, 2015 Received: February 23, 2015
Dear Mr. Perman,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S 同公
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K141833
Device Name Non-Invasive Patient Tracker
Indications for Use (Describe)
The Non-Invasive Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
510(k) Number (if known) K141833
Device Name Skull-Mount Patient Tracker
Indications for Use (Describe)
The Skull-Mount Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known) K141833
Device Name Stylet, 23 cm
Indications for Use (Describe)
The Stylet is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Stylet is indicated for use in the following procedures:
- · General ventricular catheter placement
- · Pediatric ventricular catheter placement
- · Tumor resections
- · Skull base procedures
- · Craniotomies/craniectomies
- · Transsphenoidal procedures
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
510(k) Number (if known) K141833
Device Name Tracer Pointer
Indications for Use (Describe)
The Tracer® Pointer is indicated for use in registering patient anatomy and in precisely locating anatomical structures during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computerassisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(k) Number (if known) K141833
Device Name Touch-n-Go Pointer
Indications for Use (Describe)
The Touch-n-Go Pointer is indicated for use in registent anatomy during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
510(k) Number (if known) K141833
Device Name Navigation Pointer
Indications for Use (Describe)
The Navigation Pointer is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medironic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Navigation Pointer is indicated for use in the following procedures:
- · General tumor resections
- Pediatric tumor resections
- · Skull base procedures
- · Craniotomies/craniectomies
- · Transsphenoidal procedures
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
510(k) Summary
I. SUBMITTER
Medtronic Navigation. Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA
Telephone: 720-890-3200 Fax: 720-890-3500
Contact Person: Christopher Perman Date Prepared: March 24, 2015
II. DEVICE
Name of Device: Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker Common Name: Stereotaxic Instrument Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Regulatory Class: Class II (21 CFR 882.4560) Product Code: HAW
III. PREDICATE DEVICE
StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option, K001284 Catheter Introducer for the StealthStation® System, K022126 StealthStation® System Update, K050438
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The AxiEM™ Instruments (Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer) and Trackers (Skull-Mount Patient Tracker. Non-Invasive Patient Tracker) are singleuse, sterile devices compatible with AxiEM™-enabled Medtronic computer assisted surgery systems. The instruments and trackers are electromagnetically navigated devices used for the purpose of localizing patient anatomy, patient registration, and tracking patient location during stereotactic surgery procedures.
Each device incorporates a tracking system within the instrument or tracker. The mobile emitter of the navigation system generates a low-energy magnetic field that is detected by the tracking system within the device. The navigation system software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.
9
V. INDICATIONS FOR USE
Stylet, 23cm
The Stylet is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Stylet is indicated for use in the following procedures:
- General ventricular catheter placement ●
- Pediatric ventricular catheter placement ●
- Tumor resections
- Skull base procedures ●
- Craniotomies/craniectomies ●
- Transsphenoidal procedures
Tracer® Pointer
The Tracer® Pointer is indicated for use in registering patient anatomy and in precisely locating anatomical structures during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Touch-n-Go Pointer
The Touch-n-Go Pointer is indicated for use in registering patient anatomy during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
10
Navigation Pointer
The Navigation Pointer is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Navigation Pointer is indicated for use in the following procedures:
- General tumor resections
- Pediatric tumor resections ●
- Skull base procedures
- Craniotomies/craniectomies ●
- Transsphenoidal procedures ●
Skull-Mount Patient Tracker
The Skull-Mount Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Non-Invasive Patient Tracker
The Non-Invasive Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
11
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
Stylet, 23cm
| Item | Subject Device
(Stylet, 23cm) | Predicate Devices |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Stylet is indicated for use in
precisely locating anatomical structures
during navigated cranial procedures. It
is indicated for use with Medtronic
computer-assisted surgery systems using
electromagnetic navigation and cranial
software.
The Medtronic computer assisted surgery
system and its associated applications are
intended as an aid for precisely locating
anatomical structures in either open or
percutaneous procedures. Their use is
indicated for any medical condition in
which the use of stereotactic surgery may
be appropriate, and where reference to a
rigid anatomical structure, such as the
skull, can be identified relative to a CT- based or MR-based model, fluoroscopy
images, or digitized landmarks of the
anatomy. | StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option
(K001284)
The StealthStation® System is intended as an aid for precisely locating anatomical
structures in either open or percutaneous procedures. The StealthStation® System is
indicated for any medical condition in which the use of stereotactic surgery may be
appropriate, and where reference to a rigid anatomical structure, such as the skull, a long
bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy
images of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
Cranial biopsies
Tumor resections
Craniotomies/Craniectomies
Skull base procedures
Thalamotomies/Pallidotomies
ENT Procedures:
Transphenoidal procedures |
| | The Stylet is indicated for use in the
following procedures:
• General ventricular catheter
placement
• Pediatric ventricular catheter
placement
• Tumor resections
• Skull base procedures
• Craniotomies/craniectomies
• Transsphenoidal procedures | Catheter Introducer for the StealthStation® System
(K022126)
The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
Cranial Biopsies
Placement
Tumor Resections |
12
| Craniotomies/ Craniectomies
Skull Base procedures
Thalamotomies/Pallidotomies
Pituitary Tumor Removal
CSF Leak Repair
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement
ENT Procedures:
| Transphenoidal Procedures |
|---|
| StealthStation® System Update |
| (K050438) |
| The StealthStation® System is intended as an aid for precisely locating anatomical |
| structures in either open or percutaneous procedures. The StealthStation® System is |
| indicated for any medical condition in which the use of stereotactic surgery may be |
| appropriate, and where reference to a rigid anatomical structure, such as the skull, a long |
| bone, or vertebra, can be identified relative to a CT based or MR-based model, fluoroscopy |
| images, or digitized landmarks of the anatomy. |
| For the optical-based and EM-based system, example procedures include, but are not |
| limited to: |
| Cranial Procedures: |
| Cranial Biopsies |
| Tumor Resections |
| Craniotomies/ Craniectomies |
| Skull Base procedures |
| Thalamotomies/Pallidotomies |
| Pituitary Tumor Removal |
| CSF Leak Repair |
| Pediatric Catheter Shunt Placement |
| General Catheter Shunt Placement |
| ENT Procedures: |
| Transphenoidal Procedures |
13
| Establishment
of
Stereotactic
Coordinates
(Tracking
Method) | Electromagnetic | StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option
(K001284)
Electromagnetic
Catheter Introducer for the StealthStation® System
(K022126)
Electromagnetic or Optical
StealthStation® System Update
(K050438)
Electromagnetic or Optical |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System
Accuracy | The system has demonstrated accuracy
with a mean positional error of StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option
(K001284) |
|-----------|----------------------------------------------------|--------------------------------------------------------------------------------------|
| | | -Medical Grade SS
-Titanium |
| | | -Plastic |
| Sterility | ETO Sterile/ Single Use | StealthStation® System Update
(K050438) |
| | | ETO Sterile/ Single Use |
Navigation Pointer
| Item | Subject Device
(Navigation Pointer) | Predicate Devices | Item | Subject Device
(Skull-Mount Patient Tracker) | Predicate Devices |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Navigation Pointer is indicated for
use in precisely locating anatomical
structures during navigated cranial
procedures. It is indicated for use with
Medtronic computer-assisted surgery
systems using electromagnetic
navigation and cranial software.
The Medtronic computer assisted
surgery system and its associated
applications are intended as an aid for
precisely locating anatomical structures
in either open or percutaneous
procedures. Their use is indicated for
any medical condition in which the use
of stereotactic surgery may be
appropriate, and where reference to a
rigid anatomical structure, such as the
skull, can be identified relative to a CT-
based or MR-based model, fluoroscopy
images, or digitized landmarks of the
anatomy.
The Navigation Pointer is indicated for
use in the following procedures:
• General tumor resections | StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option
(K001284)
The StealthStation® System is intended as an aid for precisely locating anatomical
structures in either open or percutaneous procedures. The StealthStation® System is
indicated for any medical condition in which the use of stereotactic surgery may be
appropriate, and where reference to a rigid anatomical structure, such as the skull, a long
bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy
images of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
Cranial biopsies
Tumor resections
Craniotomies/Craniectomies
Skull base procedures
Thalamotomies/Pallidotomies
ENT Procedures:
Transphenoidal procedures
StealthStation® System Update
(K050438)
The StealthStation® System is intended as an aid for precisely locating anatomical
structures in either open or percutaneous procedures. The StealthStation® System is
indicated for any medical condition in which the use of stereotactic surgery may be
appropriate, and where reference to a rigid anatomical structure, such as the skull, a long | Indications
for Use | The Skull-Mount Patient Tracker is indicated for
use as a stereotactic reference frame to track the
position of patient anatomy during navigated
cranial and ENT procedures. It is indicated for use
with Medtronic computer-assisted surgery systems
using electromagnetic navigation and cranial and
ENT software.
The Medtronic computer assisted surgery system
and its associated applications are intended as an
aid for precisely locating anatomical structures in
either open or percutaneous procedures. Their use
is indicated for any medical condition in which the
use of stereotactic surgery may be appropriate, and
where reference to a rigid anatomical structure,
such as the skull, can be identified relative to a CT-
based or MR-based model, fluoroscopy images, or
digitized landmarks of the anatomy. | StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option
(K001284)
The StealthStation® System is intended as an aid for precisely locating
anatomical structures in either open or percutaneous procedures. The
StealthStation® System is indicated for any medical condition in which the use
of stereotactic surgery may be appropriate, and where reference to a rigid
anatomical structure, such as the skull, a long bone, or vertebra, can be identified
relative to a CT or MR based model or fluoroscopy images of the anatomy.
StealthStation® System Update
(K050438)
The StealthStation® System is intended as an aid for precisely locating
anatomical structures in either open or percutaneous procedures. The
StealthStation® System is indicated for any medical condition in which the use
of stereotactic surgery may be appropriate, and where reference to a rigid
anatomical structure, such as the skull, a long bone, or vertebra, can be identified
relative to a CT based or MR-based model, fluoroscopy images, or digitized
landmarks of the anatomy. |
| | Pediatric tumor resections Skull base procedures Craniotomies/craniectomies Transsphenoidal procedures | bone, or vertebra, can be identified relative to a CT based or MR-based model, fluoroscopy
images, or digitized landmarks of the anatomy.
For the optical-based and EM-based system, example procedures include, but are not limited
to:
Cranial Procedures:
Cranial Biopsies
Tumor Resections
Craniotomies/ Craniectomies
Skull Base procedures
Thalamotomies/Pallidotomies
Pituitary Tumor Removal
CSF Leak Repair
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement
ENT Procedures:
Transphenoidal Procedures | Establishment
of
Stereotactic
Coordinates
(Tracking
Method) | Electromagnetic | StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option
(K001284)
Electromagnetic
StealthStation® System Update
(K050438)
Electromagnetic or Optical |
| Establishment
of
Stereotactic
Coordinates
(Tracking
Method) | Electromagnetic | StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option
(K001284)
Electromagnetic
StealthStation® System Update
(K050438)
Electromagnetic or Optical | System
Accuracy | The system has demonstrated accuracy with a
mean positional error of Biocompatibility | | |
| Cytotoxicity - MEM
Elution | Cell culture treated with test sample exhibited no
reactivity (Grade 0) | Non-cytotoxic |
| Maximization
Sensitization –
ISO 10993-10 | Intradermal injection of test sample showed no
evidence of sensitization. | Non-sensitizer |
| Intracutaneous Irritation
–
ISO 10993-10 | Intracutaneous injection of test sample showed no
evidence of irritation. | Non-irritant |
| Acute Systemic
Toxicity-ISO 10993-11 | Systemic injection of test sample showed no
mortality or toxicity. | Non-toxic |
| Pyrogenicity - USP | Intravenous injection of test sample showed no
evidence of pyrogenicity. | Non-pyrogenic |
21
VIII. CONCLUSIONS
The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker devices should perform as intended in the specified use conditions. The non-clinical data demonstrate that the Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker devices perform comparably to the predicate device that is currently marketed for the same intended use.