The Nova Medical 3T 32 Channel Head Coil is to be used in conjunction with a Magnetic Resonance (MR) Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
Model # 3832016 is used with GE 3T MRI Scanner Discovery MR750.
Model # 38320169 is used with GE 3T MR Scanners Signa Architect, Discovery MR750W and Signa PET/MR.

Device Description

The Nova Medical 3T 32 Channel Head Coil is receive only MR coil for imaging the human head when used with GE Healthcare 3T MR Systems. The head coil has 32 RF elements that are tuned to 127.75 MHz. The head coil is constructed of a two part rigid plastic housing with an opening for patient viewing and comfort. The 3T 32 Channel Head Coil comprises a split design for easy patient positioning, measures approximately 17.5" long x 12″ high x 15″ wide without the tray and has an approximate weight of 20 lbs. The device comes with optional accessories; Mirror for patient viewing and Foam Cushions for patient comfort and head positioning.

AI/ML Overview

The provided text describes a 510(k) summary for the "3T 32 Channel Head Coils." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific clinical acceptance criteria for diagnostic performance.

Therefore, many of the requested details, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training sets, are not applicable to this type of submission.

The acceptance criteria and performance data provided are related to the safety and engineering characteristics of the head coil, ensuring it functions as intended and is safe for use in conjunction with an MRI scanner.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Internal Requirements, National/International Standards)	Reported Device Performance
Biocompatibility testing per ISO 10993-1	Passed
Electrical safety testing per IEC 60601-1	Passed
Electrostatic discharge testing per IEC 61000-4-2 (per IEC 60601-1-2)	Passed
Safety & essential performance of magnetic resonance equipment per IEC 60601-2-33	Passed
Magnetic Resonance Diagnostic Devices Testing per NEMA MS 6	Passed
Transport Testing per ISTA Procedure 2B	Passed
Performance Testing (Internal, design & development process)	Results deemed acceptable
Clinical Image Quality	Acceptable Image Quality

Regarding the other requested information:

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

Test Set Sample Size: Not applicable. The performance testing described relates to engineering and safety standards, not a clinical diagnostic performance test on a specific patient dataset.
Data Provenance: Not applicable for a clinical diagnostic test set. The clinical images obtained were to demonstrate acceptable image quality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable for a diagnostic performance ground truth.
Qualifications: "A Chief Medical Physicist" certified the acceptable image quality of the clinical images.

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

Not applicable. There was no diagnostic test set requiring adjudication in this submission.

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:

No. This submission is for an MRI head coil, not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not applicable.

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

No. This is an MRI head coil, not a standalone diagnostic algorithm.

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

For the engineering and safety tests, the "ground truth" is adherence to established national and international standards (e.g., ISO, IEC, NEMA).
For clinical images, the "ground truth" was an assessment of acceptable image quality by a Chief Medical Physicist. This is a technical assessment of image integrity, not a diagnostic accuracy ground truth.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of an AI/machine learning algorithm.

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

Not applicable, as there is no training set for this device.

Summary

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510(k) Summary

3T 32 Channel Head Coils

K182737

1. Submission Sponsor

Nova Medical, Inc.

150 West Street, Suite 201

Wilmington

MA, 01887

USA

Contact: Cheryl Ledden

Title: Vice President

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: (512) 327.9997

Contact: Julie Powell

Title: VP, Quality Assurance

3. Date Prepared

April 9, 2019

4. Device Identification

Trade/Proprietary Name: 3T 32 Channel Head Coils

Model 3832016 is compatible with GE MRI Scanner Discovery MR750;

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Model 38320169 is compatible with GE MRI Scanners SIGNA Architect, Discovery MR750W and SIGNA PET/MR.

Common/Usual Name:	MRI Head Coils
Classification Name:	Magnetic Resonance Diagnostic Device, Accessory
Regulation Number:	892.1000
Product Code:	MOS
Device Class:	Class II
Classification Panel:	Radiologv

5. Legally Marketed Predicate Device and Reference Device

Predicate Device: K072931; MC 3003G - 32 R Head Coil; MR Instruments Inc.

Reference Device: K142098; SIGNA PET/MR with 3.0T HNU Coil; GE Medical Systems, LLC

6. Indication for Use Statement

Model # 3832016 is used with GE 3T MRI Scanner Discovery MR750.

Model # 38320169 is used with GE 3T MRI Scanners Signa Architect, Discovery MR750W and Signa PET/MR.

7. Device Description

8. Substantial Equivalence Discussion

The following table compares the Nova Medical, Inc. 3T 32 Channel Head Coil to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

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Manufacturer	Nova Medical	MR Instruments
Trade Name	3T 32 Channel Head Coil	MC 3003G-32R Head Coil
	(3T 32 CH Head Coil)
510(k) Number	K182737	K072931
Attribute
Product Classification	Class II	Class II
Product Code	MOS	MOS
Regulation Number	892.100	892.100
Regulation Name	Magnetic Resonance diagnosticdevice	Magnetic Resonance diagnosticdevice
Indications for Use	The Nova Medical 3T 32 ChannelHead Coil is to be used in conjunctionwith a Magnetic Resonance (MR)Scanner to produce images and/orspectra of the head, that wheninterpreted by a trained physicianyield information that may assist indiagnosis.Model # 3832016 is used with GE 3TMRI Scanner Discovery MR750.Model # 38320169 is used with GE 3TMRI Scanners Signa Architect,Discovery MR750W and SignaPET/MR.	The MR Instrument MC 3003G-32RHead Coil is to be used inconjunction with a MR Scanner toproduce images and /or spectra ofthe head, that when interpreted bya trained physician yieldinformation that may assist indiagnosis.
Channel Array / Coil Type	32 Channel Whole-Brain Receive-onlyArray	32 Channel Whole-Brain Receive-only Array
Application	High Sensitivity Neuroimaging/fMRI/spectroscopy	High Sensitivity Neuroimaging/fMRI/spectroscopy
Conditions of Use	Model # 3832016 is used with GE 3TMRI Scanner Discovery MR750.Model # 38320169 is used with GE 3TMRI Scanners Signa Architect,Discovery MR750W and SignaPET/MR.	Use with GE Discovery MR750Scanner
Maximum Static Field	3T	3T
Manufacturer	Nova Medical	MR Instruments
Trade Name	3T 32 Channel Head Coil(3T 32 CH Head Coil)	MC 3003G-32R Head Coil
RF (nominal)	127.75 MHz	127.8 MHz
Resolution	Scanner Sequence Dependent	Scanner Sequence Dependent
Size	Head Coil dimensions:• Outside Housing width 25.7 cm• Inside Housing width 18 cm• Outside Housing height 27.6 cm• Inside Housing height 22 cmHead Coil with Tray dimensions:• Coil Length 38.5 cm• Coil Width 44 cm• Coil Height 29.25 cmWeight - 20 lbs. including the Tray	• Inner Dimensions – 23.5cm• Coil Size – 29cm W x 30cm L• Coil Base – 41cm W x 48cm L• Weight – 6.8kg with base
Shape	Rigid plastic,cylindrical case, with an opening forpatient viewing and tray	Rigid plastic, cylindrical case withan opening for patient viewing
Anatomical Location	Head	Head
Patient population (including age,anatomy)	All ages and body types	All ages and body types
Housing Materials	Plastic	Plastic
Duration of Body Contact	Generally between20 min. – 1 hour	Generally between20 min. – 1 hour
Software Microprocessor	No	No
Complies with ISO 10993-1	Yes	Unknown
Electrical Safety Testing	ANSI/AAMI ES 60601-1IEC 60601-2-33IEC 61000-4-2 per IEC 60601-1-2	Unknown

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of 3T 32 Channel Head Coils and in showing substantial equivalence to the predicate device, Nova Medical, Inc. completed a number of non-clinical performance tests. The 3T 32 Channel Head Coils meet all the requirements for overall design, performance, biocompatibility, and electrical safety, confirming that the design output meets the design inputs and specifications for the device.

Reference Device, K142098 (SIGNA PET/MR with 3.0T HNU Coil; GE Medical Systems, LLC), was a device used along with the Nova Medical 3T 32 Channel Head Coil for a study performed on GE SIGNA PET/MR, which is part of the 'Performance Testing' referenced below.

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The 3T 32 Channel Head Coils passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

. Biocompatibility testing per ISO 10993-1
. Electrical safety testing per IEC 60601-1
Electrostatic discharge testing per IEC 61000-4-2 (per IEC 60601-1-2).
Safety & essential performance of magnetic resonance equipment per IEC 60601-2-33
. Magnetic Resonance Diagnostic Devices Testing per NEMA MS 6
. Transport Testing per ISTA Procedure 2B
. Performance Testing: A number of performance tests were performed by Nova Medical, Inc. as part of the design and development process; results were deemed acceptable.

10. Clinical Performance Data

Clinical images were obtained in accordance with the FDA Guidance (November 18, 2016) for Submission of Premarket Notification for Magnetic Resonance Diagnostic Devices. The clinical images were deemed to be of acceptable image quality and were certified by a Chief Medical Physicist.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

The Nova Medical, Inc. 3T 32 Channel Head Coils, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

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Image /page/5/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Nova Medical, Inc. % Ms. Julie Powell Vice President, Quality Assurance Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 AUSTIN TX 78746

April 12, 2019

Re: K182737

Trade/Device Name: 3T 32 Channel Head Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: March 22, 2019 Received: March 25, 2019

Dear Ms. Powell:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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.