(300 days)
No
The description focuses on traditional image registration techniques using a transformation matrix based on user-selected points, with no mention of AI/ML terms or concepts like training/test sets for learning algorithms.
No.
The device is used to localize a surgical field and guide the surgeon, not to directly treat a condition.
No
The device is described as an "Intraoperative Guidance Device to Localize a Surgical Field." It uses pre-operative images and real-time tracking to guide a surgeon during a procedure, but it does not make a diagnosis. Its function is to assist in surgical navigation, not to identify or determine the nature of a disease or condition.
No
The device description explicitly mentions "the location of the RN instrument," implying a physical instrument or probe is part of the system, which is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Intraoperative Guidance Device to Localize a Surgical Field for Intra/Extracranial Usage." This describes a device used during surgery to help the surgeon navigate based on pre-operative images.
- Device Description: The description details how the device uses pre-operative images and patient registration to display the instrument's location on those images. This is a navigation and guidance function, not a diagnostic test performed on biological samples.
- Lack of Biological Sample Analysis: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological samples.
- Focus on Spatial Localization: The core function is to determine the spatial relationship between the surgical instrument and the patient's anatomy as depicted in the images.
In summary, the Regulus Navigator is a surgical navigation system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Regulus™ Navigator (RN) is an intraoperative guidance device which uses reference markers or anatomical references to localize the surgical field. The RN is for intra/extracranial usage.
Product codes
84 HAW
Device Description
The Regulus Navigator (RN) incorporates preoperative CT and MRI images into a surgical computer system. A minimum of three points (reference markers or anatomical points) are selected with the RN on the patient in the operating room (OR space) and the corresponding locations on the images (image space) are determined and selected by the surgeon. These corresponding points in the OR space and the image space are utilized to calculate a "transformation matrix" which is used to transform the location of the RN instrument into the image space. The location of the RN instrument is interactively displayed as a cursor on the diagnostic images and then used as a tool to guide the surgeon during the intra/extracranial procedure. The Regulus Navigator has many components and accessories. Components are pieces of the RN which are necessary to perform any surgical procedure. Accessories are additional equipment that allow for adaptation to other surgical systems (COMPASS Stereotactic System, etc.), enable another registration method and provide for phantom maintenance testing. Regulus Navigator Components include a Magnetic Field Digitizer, Regulus Treatment Planning Software (allows a surgeon to pick target points and define tumor boundaries from radiological data and interactively track instrument location, with features like Tip Location and Tips-Eye View), a Workstation, and Regulus Instruments (pointer tip and/or suction tip). Regulus Navigator Accessories include radiolucent adhesive radiographic markers, a locking mobile metal cabinet for housing the magnetic field digitizer and computer workstation, a mobile wheel stand, a 3 Point Pinion headholder adaptor, a transmitter mount, a yoke assembly (for use with the COMPASS Stereotactic System only), RS-232 cables and a CT/MRI Test Phantom.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Imaging, MRI Imaging
Anatomical Site
Intra/Extracranial
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
Non-Clinical Tests: Twelve phantom tests performed utilizing CT scans. Average three-dimensional error was 1.02mm with a standard deviation of 0.16mm. Nine phantom tests performed utilizing MRI scans. Average three-dimensional error was 1.67mm with a standard deviation of 0.42mm. The non-clinical testing supports the claim of substantial equivalence.
Clinical Registration Tests: Sample size of 221 patients. Overall mean accuracy of 2.56mm with a standard deviation of 1.15mm. Registration accuracy was 5mm or less in 97% of cases. Patients requiring conventional surgery of intra/extracranial pathology were included. Exclusion criteria was any patient with a metal object implanted in the head for MRI data. No adverse safety and/or effectiveness reports during this study.
Key Metrics
Non-Clinical Tests (Phantom Testing): Mean of 1.02mm (CT), Mean of 1.67mm (MR).
Clinical Registration Testing: Mean of 2.56mm. Registration accuracy was 5mm or less in 97% of cases.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten alphanumeric characters. The sequence appears to be 'K964229'. The characters are written in a dark ink, and the background is white. The numbers are not evenly spaced.
Image /page/0/Picture/1 description: The image shows the logo for Compass International. The logo has the word "Compass" in a serif font, followed by the word "International" in a sans-serif font inside of a black rectangle. To the right of the word "International" is a black rectangle with a white image of a globe. Below the logo is the address "Cascade Business Park - 919 37th Avenue NW - Rochester, MN 55901".
AUG 1 9 1997
510(k) SUMMARY* of SAFETY and EFFECTIVENESS
A. General Information
Submitter's Name: Address:
Telephone: Fax: Contact Person: Date Prepared:
COMPASS International, Inc. 919 37th Avenue NW Rochester, MN 55901 507-281-2143 507-281-1736 Debrah A. Fisher, RAC August 14, 1997
B. Device
| Name: | Regulus™ Navigator |
|---|---|
| Trade Name: | Regulus™ Navigator |
| Common Name: | Intraoperative Guidance Device |
| Classification Name: | Stereotactic Instrument |
| Product Code: | 84 HAW |
| Class: II |
C. Identification of Predicate Devices
The Regulus Navigator (RN) as described in this submission is substantially equivalent to the Regulus Measurement Unit (RMU), K935456, which is currently manufactured and marketed by COMPASS International, Inc. The RN also incorporates some of the features that were previously provided by the COMPASS Stereotactic Positioning System, K871046.
The RN incorporates components that are substantially equivalent in function and accuracy to other legally marketed devices including the ISG Family of Viewing Wands, K960714.
1
REGULUS NAVIGATOR 510(k) Summary of Safety and Effectiveness
D. Description of the Device
1. Description:
The Regulus Navigator (RN) incorporates preoperative CT and MRI images into a surgical computer system. A minimum of three points (reference markers or anatomical points) are selected with the RN on the patient in the operating room (OR space) and the corresponding locations on the images (image space) are determined and selected by the surgeon. These corresponding points in the OR space and the image space are utilized to calculate a "transformation matrix" which is used to transform the location of the RN instrument into the image space. The location of the RN instrument is interactively displayed as a cursor on the diagnostic images and then used as a tool to guide the surgeon during the intra/extracranial procedure.
The Regulus Navigator has many components and accessories. Components are pieces of the RN which are necessary to perform any surgical procedure. Accessories are additional equipment that allow for adaptation to other surgical systems (COMPASS Stereotactic System, etc.), enable another registration method and provide for phantom maintenance testing.
Regulus Navigator Components
- Magnetic Field Digitizer -- the location of the surgical field can be defined in the digitizer's coordinate system using the RN, providing the basic function of a conventional stereotactic system. Registration of CT and/or MRI images to the digitizer coordinate system (in OR space) requires locating "reference locations" in the images whose location can be determined in the digitizer's coordinate system in the operating room.
- Regulus Treatment Planning Software -- software that allows a surgeon to pick target points and define tumor boundaries from radiological data and interactively track instrument location. Features include:
Tip Location (single and MPR): this function allows the positioning of an instrument anywhere in the surgical field and view its corresponding location on the closest pixel on closet CT or MRI images in interactive fashion (can be done with single slice or multiplanar reconstructions).
Tips-Eye View (single and cine loop): this function allows the projection of an instrument's trajectory onto either the currently Active target slice or all of the images in a series in a cine loop.
- Workstation -- a computer system which runs the treatment planning Computer software and displays CT/MRI images.
- Regulus Instruments -- the RN utilizes instruments such as a pointer tip and/or a suction tip.
2
Regulus Navigator Accessories
- include -- radiolucent adhesive radiographic markers (to affix to a Accessories patient's head as fiducial markers), a locking mobile metal cabinet for housing the magnetic field digitizer and computer workstation, a mobile wheel stand, a 3 Point Pinion headholder adaptor, a transmitter mount, a yoke assembly (for use with the COMPASS Stereotactic System only), RS-232 cables and a CT/MRI Test Phantom (for testing accuracy of the RN system)
The design, materials, manufacturing processes and specifications of the RN are similar to the legally marketed device, the Regulus Measurement Unit (RMU) and do not raise any unresolved issues relating to safety and/or effectiveness.
E. Intended Use Statement
The Regulus™ Navigator (RN) is an intraoperative guidance device which uses reference markers or anatomical references to localize the surgical field. The RN is for intra/extracranial usage.
F. Substantial Equivalence
The RN is substantially equivalent to the Regulus Measurement Unit (RMU) and the ISG Viewing Wand in terms of its technology, accuracy and intended uses. A direct comparison of significant technology characteristics for these predicate devices and the RN is summarized below. Differences that exist between these devices, relating to technical specifications, materials, physical appearance and design do not affect the relative safety and effectiveness of the RN.
Technological Characteristics Summary/Comparison Table
Regulus Measurement Unit (RMU) -- legally marketed predicate device, K935456 ISG Viewing Wand - legally marketed predicate device, K960714 Regulus Navigator (RN) -- 510(k) Submission, K964229
| Parameter | RMU | ISG Viewing
Wand | RN |
|-----------------------------------------------------|------------------------|---------------------|------------------------|
| Headframe | Yes | No | No |
| Skull Clamp | No | Yes | Yes |
| Magnetic Field Digitizer | Yes | No | Yes |
| Reference Markers or Anatomical
Points | Yes | Yes | Yes |
| Number of Markers/Points | 3 | Unknown | 3 or more |
| Instrument Orientation/Tip Position | Yes | Yes | Yes |
| Software | Yes | Yes | Augmented |
| Transformation Error | RMS | RMS | RMS |
| Comparison Table Cont. | RMU | ISG Viewing
Wand | RN |
| CT Imaging | Yes | Yes | Yes |
| MRI Imaging | Yes | Yes | Yes |
| DSA (Digital Subtraction Angiography)
Imaging | Yes | No | No |
| Pre-operative Planning of Surgical
Procedure | Yes | Yes | Yes |
| Intra-operative Guidance | Yes | Yes | Yes |
| Cross-sections for Manipulation and
Guidance | Yes | No | No |
| Multiplanar Reconstruction Software
Feature | No | Yes | Yes |
| Bench Testing | Yes | Yes | Yes |
| Clinicals | 31 Subjects | Yes | 221 Subjects |
| Tip Location Software Feature | Yes | Yes | Yes |
| Tip's Eye View Software Feature | Yes | No | Yes |
| Cine Loop Software Feature | Yes | Unknown | Yes |
| Peripheral Options | Yes | Yes | Yes |
| Memory (image manipulation) | Yes | Yes | Yes |
| Interfaces (data input) | Yes | Yes | Yes |
| O.R. Viewing | Yes | Yes | Yes |
| Environmental Conditions
(temperature/vibration) | Yes | Yes | Yes |
| Regulations | Yes | Yes | Yes |
| Dimensions (specifications) | Yes | Yes | Yes |
| Archiving Methods | Yes | Yes | Yes |
| Lesion Location | Superficial
Cranial | Cranial | Intra/Extra
Cranial |
| Accuracy - Phantom Testing | Mean of
2.10mm | Mean of
1-2mm* | Mean of
1.02mm (CT) |
| | | | Mean of
1.67mm (MR) |
| Accuracy - Clinical Registration
Testing | Mean of
2.78mm | Mean of
2.51mm* | Mean of
2.56mm |
3
REGULUS NAVIGATOR
510(k) Summary of Safety and Effectiveness
*Eric P. Sipos, M.D., Scot A. Tebo, B.S., S. James Zinreich, M.D., Donlin M. Long, M.D., Ph.D., Henry Brem, M.D., "In Vivo Accuracy Testing and Clinical Experience with the ISG Viewing Wand", Neurosurgery, Vol. 39, No. 1, July 1996.
4
REGULUS NAVIGATOR 510(k) Summary of Safety and Effectiveness
G. Performance Data
1. Standards
Currently there are no applicable Performance Standards established by FDA under section 514 of the Food, Drug and Cosmetic Act
2. Non-Clinical Tests
Twelve phantom tests were performed utilizing CT scans. The average threedimensional error over all twelve phantom tests was 1.02mm with a standard deviation of 0.16mm. Nine phantom tests were performed utilizing MRI scans. The average three-dimensional error over all nine phantom tests was 1.67mm with a standard deviation of 0.42mm. Therefore, the non-clinical testing of the RN supports the claim of substantial equivalence.
3. Clinical Registration Tests
In clinical registration testing (221 patients), the RN demonstrated an overall mean accuracy of 2.56mm with a standard deviation of 1.15mm. Registration accuracy was 5mm or less in 97% of cases.
Patients requiring conventional surgery of intra/extracranial pathology were included in the study. The only exclusion criteria was any patient with a metal object implanted in the head would be excluded from the use of MRI data in the procedure.
There were no adverse safety and/or effectiveness reports during this clinical study.
COMPASS International, Inc. believes the data in this submission supports the claim of substantial equivalence to the predicate devices.
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol. The logo is simple and recognizable, conveying the department's authority and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 1997
Ms. Debrah A. Fisher Regulatory Affairs/Clinical Monitoring Assistant COMPASS International, Inc. 919 37th Avenue, NW Rochester, Minnesota 55901
Re: K964229 Requlus Navigator (RN) Trade Name: Requlatory Class: II Product Code: 84HAW Dated: July 28, 1997 Received: July 29, 1997
Dear Ms. Fisher:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Ndministration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
6
Page 2 - Ms. Debrah A. Fisher
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.
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) 594-4648. 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 at (301) 443-6597.
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number: K964229
Device Name: Regulus™ Navigator
Indications for Use:
- Intraoperative Guidance Device to Localize a Surgical Field for ● Intra/Extracranial Usage ............
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahon
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K964224
Prescription Use
્રિર
OVER-THE-COUNTER USE (optional Form 1-2-96)