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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Regulus™ Navigator, based on the provided 510(k) summary:

Regulus™ Navigator Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance (Regulus™ Navigator)
Non-Clinical Testing
CT Phantom Accuracy (Mean)	Not explicitly stated, but benchmarked against predicate devices (RMU: 2.10mm, ISG Viewing Wand: 1-2mm)*	1.02mm (CT)
MRI Phantom Accuracy (Mean)	Not explicitly stated, but benchmarked against predicate devices (RMU: 2.10mm, ISG Viewing Wand: 1-2mm)*	1.67mm (MR)
Clinical Registration Testing
Overall Mean Accuracy	Not explicitly stated, but benchmarked against predicate devices (RMU: 2.78mm, ISG Viewing Wand: 2.51mm)*	2.56mm
Accuracy ≤ 5mm	Not explicitly stated	97% of cases (Accuracy was 5mm or less)

Note: The document implicitly uses the performance of predicate devices as a benchmark for substantial equivalence, rather than setting explicit numerical acceptance criteria for the Regulus™ Navigator prior to testing. However, the reported performance clearly demonstrates it is either better than or comparable to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical Tests (Phantom Testing):
- CT Scans: 12 phantom tests
- MRI Scans: 9 phantom tests
- Data Provenance: Not explicitly stated, but implies laboratory/bench testing, not patient data. Likely within the US (Rochester, MN being the submitter's address).
Clinical Registration Tests:
- Sample Size: 221 patients
- Data Provenance: Not explicitly stated, but given the company's location in Rochester, Minnesota, U.S.A., it is highly probable the data is from the U.S. hospital settings. The study is prospective by definition, as it involves "patients requiring conventional surgery."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For Non-Clinical (Phantom) Tests: No human experts are mentioned for establishing ground truth. Phantom testing typically uses physical measurements against known values, so the "ground truth" would be the precisely known configuration of the phantom.
For Clinical Registration Tests: The document does not specify a number of experts or their qualifications for establishing the ground truth of the clinical registration accuracy. The "registration accuracy" itself is a technical measurement (likely comparing the RN's displayed location to a known anatomical point or a fiducial marker's true location). The surgeon's interactive use and selection of points (described in Section D.1) suggests their role in the process, but not in establishing an independent ground truth for accuracy validation. The clinical study's focus is on measuring the device's accuracy in a real-world surgical setting.

4. Adjudication Method for the Test Set

For Non-Clinical (Phantom) Tests: No adjudication method is mentioned as it's a technical measurement against a known phantom.
For Clinical Registration Tests: No adjudication method is explicitly stated. The accuracy measurement (2.56mm) would likely be a direct technical measurement of the system's output against a reference in the surgical field.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study, particularly one assessing how much human readers improve with AI vs. without AI assistance, was not explicitly described or conducted. This submission is for an intraoperative guidance device, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting images. The closest comparison is "Intra-operative Guidance," where the device provides information to the surgeon, but it's not framed as an "AI assistance" study in the modern sense. The "Tip Location Software Feature" and "Tip's Eye View Software Feature" could be considered forms of assistance, but there's no comparative study of surgeon performance with and without this specific device.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Yes, the Non-Clinical Phantom Tests represent the standalone performance of the device's measurement accuracy.
- For CT scans, the average three-dimensional error was 1.02mm with a standard deviation of 0.16mm over 12 tests.
- For MRI scans, the average three-dimensional error was 1.67mm with a standard deviation of 0.42mm over 9 tests.
- These tests measure the inherent accuracy of the system in a controlled environment, largely independent of human intervention other than setting up the phantom.

7. Type of Ground Truth Used

Non-Clinical (Phantom) Tests: The ground truth for these tests would be the known, precisely defined physical dimensions and locations within the CT/MRI test phantoms. These phantoms are designed with specific, measurable targets.
Clinical Registration Tests: The ground truth for clinical registration accuracy is likely derived from direct anatomical measurements or the known location of fiducial markers, measured against the system's reported position. While "expert consensus" is not explicitly stated for determining the ground truth of accuracy, the surgeon's input is crucial for selecting reference points. However, the accuracy is a technical measurement against these established reference points.

8. Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning (AI). This device appears to be a stereotactic instrument that uses traditional computational geometry and image processing techniques to transform coordinates, rather than a machine learning model that requires a distinct training phase. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. The software components are described as "treatment planning software" and features like "Tip Location" and "Tip's Eye View" which are deterministic algorithms.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" for an AI/ML model is not described or implied by the device's functionality, information on how its ground truth was established is not provided in the document. The device relies on mathematical transformations and measurements, where parameters might be calibrated, but there isn't a "ground truth" for a learning process in the AI sense.

Summary

{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 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 ViewingWand	RN
Headframe	Yes	No	No
Skull Clamp	No	Yes	Yes
Magnetic Field Digitizer	Yes	No	Yes
Reference Markers or AnatomicalPoints	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 ViewingWand	RN
CT Imaging	Yes	Yes	Yes
MRI Imaging	Yes	Yes	Yes
DSA (Digital Subtraction Angiography)Imaging	Yes	No	No
Pre-operative Planning of SurgicalProcedure	Yes	Yes	Yes
Intra-operative Guidance	Yes	Yes	Yes
Cross-sections for Manipulation andGuidance	Yes	No	No
Multiplanar Reconstruction SoftwareFeature	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	SuperficialCranial	Cranial	Intra/ExtraCranial
Accuracy - Phantom Testing	Mean of2.10mm	Mean of1-2mm*	Mean of1.02mm (CT)
			Mean of1.67mm (MR)
Accuracy - Clinical RegistrationTesting	Mean of2.78mm	Mean of2.51mm*	Mean of2.56mm

{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.

{5}------------------------------------------------

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)

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).