The Monteris Medical UFO™ is intended to provide stereotactic guidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.

Device Description

The Monteris Medical UFO™ (Universal Frameless platform for neur() surgical applications) is designed to facilitate stereotactic targeting and positioning of various neurosurgical devices through a burr hole in the patient's skull. These devices could include laser probes, biopsy needles, electrodes and catheters.

The UFO is comprised of three telescoping legs connected to a center ball joint. Each of the legs can be attached to the patient's skull with two MR1-compatible titanium bone screws. By adjusting the height of each leg, and the axis of the rotatable center ball, various trajectories can be obtained for the guide that runs through the center ball. UFO is MRI compatible

Multiple center ball adapters are available to interface with the center ball guide tube. These adapters reduce the guide tube diamcter down to an inner diameter that is compatible with the outer diameter of the tools that the user may want to place through the UFQ. The adapter for a specific tool ensures the tool remains lined up along the intended axis of the UFO.

Several accessories are provided with the UFO to improve its utility during the preparation for stereotactic neurological procedures. They are all made of MRI compatible materials only.

All devices are single use only and ethylene oxide sterilized.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Monteris Medical UFO™ (Universal Frameless platform for neurosurgical applications) system. As such, it reports the device's substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial report would.

Based on the provided text, here’s a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or a performance table in the format usually found in a clinical study report. Instead, it relies on demonstrating substantial equivalence to predicate devices (Navigus Trajectory Guide and Navigus II Trajectory Guide).

The "performance" is generally described as:

Category	Reported Device Performance
Biocompatibility	In compliance with ISO 10993
Bench Testing	In compliance with the product specification, expectations of the medical community, and product labeling
Intended Use	Substantially equivalent in intended use to predicate devices
Technology	Substantially equivalent in technology to predicate devices
Design	Substantially equivalent in design to predicate devices
Materials	Substantially equivalent in materials to predicate devices
Physician Use	Substantially equivalent in physician use to predicate devices

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document makes no mention of a "test set" in the context of clinical performance or accuracy testing involving patients or expert review of outputs. The studies reported are bench testing and biocompatibility analysis. Therefore, information on sample size, data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable to this submission as described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since there is no "test set" for clinical performance described in the provided text, there is no information on the number of experts or their qualifications for establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Given no described "test set" for clinical performance, there is no information on an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The Monteris Medical UFO™ is a stereotaxic instrument guide, not an AI or imaging diagnostic device that would typically involve a multi-reader multi-case (MRMC) study. The document does not mention any MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a physical instrument for surgical guidance, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench testing, the "ground truth" would be the engineering specifications and expected physical performance parameters for the device (e.g., mechanical stability, accuracy of trajectory guidance relative to a target). For biocompatibility, the ground truth is adherence to ISO 10993 standards. No clinical ground truth (like pathology or outcomes data from patients) is mentioned.

8. The sample size for the training set

The document does not describe any machine learning or AI components, so the concept of a "training set" with a sample size is not applicable.

9. How the ground truth for the training set was established

As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary

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Section 5: 510(k) Summary

AUG 0 6 2009

Device Information:
Category	Comments
Sponsor:	Monteris Medical, Inc.100 - 78 Innovation DriveWinnipeg, ManitobaCANADA R3T 6C2Tel: 204-272-2220Fax: 204-272-2219www.monteris.com
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416
Device Common Name:	Frameless Stereotaxic Instrument Guide
Device Classification &Product Code:	Class II,HAW
Device Classification Name &Citation	Stereotaxic Instrument21 CFR 882.4560
Device Proprietary Name:	Monteris Medical UFO™

Predicate Device Information:

ERIS

Predicate Devices:	Navigus Trajectory Guide
Predicate Device Manufacturers:	Image Guided Neurologics
K#	992304
Predicate Device Common Name:	Frameless Stereotaxic Instrument Guide t
Predicate Device Classification Name &	Stereotaxic Instrument
Citation:	21 CFR 882.4560
Predicate Device Classification &	Class II,
Product Code:	HAW

Predicate Devices:	Navigus II Trajectory Guide
Predicate Device Manufacturers:	Image Guided Neurologics
K#	012366
Predicate Device Common Name:	Frameless Stereotaxic Instrument Guide t
Predicate Device Classification Name &	Stereotaxic Instrument
Citation:	21 CFR 882.4560
Predicate Device Classification &	Class II,
Product Code:	HAW

b. Date Summary Prepared

30 January 2009

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c. Description of Device

Several accessories are provided with the UFO to improve its utility during the preparation for stereotactic neurological procedures. They are all made of MRI compatible materials only.

All devices are single use only and ethylene oxide sterilized.

d. Intended Use

e. Comparison to Predicate Device

The Monteris Medical UFO™ is substantially equivalent in intended use, technology, design, materials, and physician use to the Navigus Trajectory Guides (K992304 & K012366).

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

f. Summary of Supporting Data

Biocompatibility analysis demonstrates that the UFO is in compliance with ISO 10993.

Bench testing has demonstrated that the device is in compliance with the product specification, the expectations of the medical community and the product labeling.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread.

Public Health Service

AUG 0 62009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Monteris Medical, Inc. c/o Craig Coombs President Coombs Medical Device Consultant, Inc. 1193 Sherman St. Alameda, CA 94501

Re: K090240

Trade/Device Name: Monteris Medical UFO Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: July 6, 2009 Received: July 8, 2009

Dear Mr. Coombs:

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.

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ru. li. M., 46 for

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510(k) Number (if known): K09D240

Monteris Medical UFO™ Device Name:

Indications For Use:

The Monteris Medical UFO™ is intended to provide stereotactic quidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Prescription Use.
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

K090240

510(k) Number.

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).