The intended use of the AtamA™ System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging.

The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed.

The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Device Description

The AtamA"" System is comprised of two subsystems:

(i) MR Head Coil
(ii) Patient Stabilization System

These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. In addition, the patient head fixation ring subsystem and patient board can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed. Also, the head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.

Specifically, the AtamA System allows a streamlined workflow for procedures requiring the patient to undergo MRI examination before, during, or after neurosurgical procedures. The AtamA System maintains patient head fixation while providing a patient board for convenient, safe and effective method of moving the patient from an OR table to transport gurney to MRI couch without the need to unpin and re-pin the patient.

This submission clears the use of the additional 3.0 Telsa AtamA Head Coil for use with specific Siemens and Imris 3.0 Telsa MRI Systems, and the expanded labeling of the components of the Patient Stabilization System for their compatibility with both 1.5 Tesla and 3.0 Telsa systems.

AI/ML Overview

This document is a 510(k) Pre-market Notification (K132444) for the Monteris Medical AtamA™ System, seeking to expand its compatibility to 3.0 Tesla MRI systems. This notification is not for an AI device, therefore, the requested information regarding acceptance criteria and studies for AI/algorithm performance is not applicable.

The submission focuses on demonstrating the substantial equivalence of the modified AtamA™ System (specifically, the addition of a 3.0 Tesla MR head coil and expanded labeling for the patient stabilization system) to its predicate device (K110411), which was cleared for 1.5 Tesla MR Systems. The primary form of evidence presented is bench testing for MR compatibility.

Here's an analysis of the information provided, tailored to what is relevant to the 510(k) submission's purpose:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state acceptance criteria in a quantitative table format for performance. Instead, it aims for "substantial equivalence" to the predicate device, particularly concerning safety and efficacy in the 3.0T MRI environment. The "acceptance criteria" here are qualitative for MR compatibility, meaning the device must not introduce new safety concerns or compromise image quality when used with 3.0T MRI.

Parameter or Characteristic	Predicate AtamA™ System Performance (K110411)	New AtamA™ System Performance (K132444)
MRI Compatibility of Head Coil	1.5T Conditional	1.5T / 3.0T Conditional
MRI Compatibility of Stabilization Subsystem	1.5T Conditional	1.5T / 3.0T Conditional
Safety & Efficacy	Established for 1.5T MR environments	Bench testing demonstrated safe and effective for 1.5T and 3.0T MR environments

2. Sample size used for the test set and the data provenance:

The document does not detail a "test set" in the context of subject-based performance evaluation as it would for an AI algorithm. The testing described is bench testing (laboratory-based) with the physical device. Therefore, there is no human subject sample size or data provenance in terms of country of origin or retrospective/prospective clinical data for this submission.

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):

Not applicable. There is no "ground truth" to be established by experts in the context of an AI algorithm for this device. The evaluation is based on engineering principles and NEMA standards for MR compatibility.

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

Not applicable. As this is not a clinical study involving human assessment of results, there is no 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:

Not applicable. This is not an AI device submission.

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

Not applicable. This is not an AI device submission.

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

The "ground truth" equivalent for this type of device is established engineering standards and specifications (e.g., NEMA Standards for MRI compatibility). The device is evaluated against these physical and electrical compatibility requirements, not against clinical outcomes or expert diagnoses.

8. The sample size for the training set:

Not applicable. This is not an AI device; therefore, there is no training set.

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

Not applicable. As there is no training set for an AI algorithm, this question does not apply.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the (implied) acceptance criteria of 3.0 Tesla MR Conditional compatibility for both the head coil and the patient stabilization subsystem is summarized as follows:

Study Type: Bench testing.
Methodology: The 3.0 Tesla MR Head Coil underwent bench testing "in accordance with NEMA Standards" to demonstrate compatibility with 3.0 Tesla MRI systems. For the Patient Stabilization Subsystem, an "analysis of materials has shown" compatibility with 3.0 Tesla MR environments.
Conclusion: The bench testing and material analysis concluded that the Monteris Medical AtamA System is safe and effective for use in both 1.5T and 3.0T MRI environments and can be labeled with both 1.5T and 3.0T MR Conditional Compatibility. The submission argues that these tests demonstrate the new device does not raise new issues of safety or efficacy compared to the predicate device.

In essence, this 510(k) submission relies on standard engineering tests for MR safety and compatibility, rather than clinical performance studies typically required for AI or new therapeutic devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold letters, with the word "MEDICAL" in smaller letters underneath. Above the word "MONTERIS" is a graphic of several small circles arranged in a semi-circular shape.

Premarket Notif cation K132444

510(k) Summary

JAN 2 7 2014

న

Device Information

Category	Comments
Date Summary Prepared	22 January 2014
Sponsor	Monteris Medical Corporation
	16305 36th Avenue North, Suite 200
	Plymouth, Minnesota 55446 USA
	Tel: 763-253-4710
	Fax: 763-746-0084
	Contact: Brooke Ren, Ph.D.
	Sr. VP of Operations
	BRen@Monteris.com
Correspondent Contact Information	Craig J. Coombs
	President, Coombs Medical Device
	Consulting, Inc.
	1193 Sherman St
	Alameda, CA 94501
	Tel: 510-337-0140
	Fax: 510-337-0416
	CraigJCoombs@gmail.com
Device Trade Name	AtamA™ System
Device Common Name	Head Coil and Patient Stabilization System
Device Classification & Product Code	Class II, MOS
Device Classification Name & Citation	Magnetic Resonance Diagnostic Device
	21CFR 892.1000
Device Proprietary Name	Monteris Medical AtamA™ System

Predicate Device Information

Predicate Device Trade Name	Monteris Medical AtamA™ Head Coil andStabilization System
Manufacturer	Monteris Medical
510(k) Number	K110411
Device Common Name	Head Coil and Patient Stabilization System
Device Classification Name & Citation	Magnetic Resonance Diagnostic Device21CFR 892.1000
Device Classification & Product Code	Class II, MOS

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Image /page/1/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" is a series of small circles arranged in a semi-circular pattern.

Premarket Notification K132444

Description of Device

The AtamA"" System is comprised of two subsystems:

(i) MR Head Coil
(ii) Patient Stabilization System

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Image /page/2/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are several small circles arranged in a semi-circular pattern.

Premarket Notification K132444

Indications for Use

The intended use of the AtamA™ System (comprised of two major subsystems: a MRhead coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging.

The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed.

The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Comparison to Predicate Device

The proposed Monteris Medical AtamA System is substantially equivalent in intended use, technology, design, materials, and physician use to the current Monteris Medical AtamA Head Coil and Patient Stabilization System, cleared under 510(k) Number K110411 for use in 1.5 Tesla MR Systems.

The testing described below demonstrates that the proposed addition of a 3.0 Tesla MR head coil and associated labeling changes on the AtamA System for 3.0 Tesla MR conditional compatibility do not raise any issues of safety or efficacy.

All patient contacting materials are identical in composition, source, and use with respect to the predicate device. The technical modes of action and technical principles are materially the same the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. Above the word "MONTERIS" are several small circles arranged in a semi-circular shape.

Premarket Notification K132444

Parameter orCharacteristic	Predicate AtamA™System	New AtamASystem
510(k) Number	K110411	K132444
FDA ProductClassification / Code	21 CFR 892.1000 / MOS	Same
Indications for Use	The intended use of the AtamA™ System(comprised of two major subsystems: a MRhead coil apparatus and a patient stabilizationapparatus), in conjunction with a magneticresonance (MR) imaging system, is thecollection of MR data and images of the humanbrain before, during, and at the end of brainsurgery, in a standard operating room, diagnosticMR rooms, or in a MR intra-operative room,while stabilizing the patient's head duringneurosurgical procedures and imaging.The patient head-stabilizing apparatus can alsobe used for other neurosurgical proceduresrequiring the patient's head to be stabilized orfixed.The head coil can also be used as a standarddiagnostic head coil for diagnostic MR imaging.When interpreted by a trained physician, theseimages provide information that can be useful indetermining diagnosis.	Same
Operating Principle /Technology	Receive-only, 8-channel split array head coilaccompanied by head fixation apparatus thatinterfaces with MRI systems.	Same
Design	The AtamA System is comprised of twosubsystems:• MR Head Coil• Patient Stabilization system	Same
Materials	Thermoplastics / Titanium / Brass	Same
Use Location	Operating Room / MRI Diagnostic Suite	Same
MRI Compatibility ofHead Coil	1.5T Conditional	1.5T / 3.0TConditional
MRI Compatibility ofStabilization Subsystem	1.5T Conditional	1.5T / 3.0TConditional

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Image /page/4/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. Above the word "MONTERIS" is a semi-circular arrangement of small, circular shapes, resembling cells or bubbles.

Page 5 of 5

Premarket Notification
K132444

Summary of Supporting Data

The proposed AtamA 3.0 Tesla MR Head Coil is made by the same manufacturer, and is of the same basic design. as the currently marketed AtamA 1.5 Telsa MR Head Coil. Bench testing in accordance with NEMA Standards has demonstrated that the 3.0 Tesla MR Head Coil is compatible with 3.0 Telsa MRI systems.

An analysis of materials has shown that the AtamA Patient Stabilization Subsystem is also compatible with 3.0 Tesla MR environments and can be labeled with 1.5T and 3.0 T MR Conditional Compatibility.

Conclusions

It can be concluded from the results that the Monteris Medical AtamA System is safe and effective for use in both the 1.5 and 3.0 Tesla MRI environments and can be labeled with both 1.5 T and 3.0 T MR Conditional Compatibility.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 27, 2014

MONTERIS MEDICAL BROOKE REN 1193 SHERMAN STREET ALAMEDA CA 94501

Re: K132444

Trade/Device Name: AtamA 10 System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: December 9, 2013 Received: December 11, 2013

Dear Dr. Ren:

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 contrôls 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 subiect 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 (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 Small Manufacturers, International and Consumer Assistance at its toll

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Page 2-Dr. Ren

free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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 Small Manufacturers, International and Consumer Assistance 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,

Hrehar D. O'Hara

For

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132444

Device Name

Monteris Medical AtamATM System

Indications for Use (Describe)

The patient head-stabilizing apparatus can also be used for other nequiring the paient's head to be stabilized or fixed.

The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Michael D. O'Hara
------------------------------------------------------------------------------	-------------------

FORM FDA 3881 (1/14)

PSC Publishing Services ( 10) ) 441-67-41 EF

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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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.