3T 32 Channel Head Coil

{0}------------------------------------------------ ## 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; {1}------------------------------------------------ - 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 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 MRI Scanners Signa Architect, Discovery MR750W and Signa PET/MR. #### 7. 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. #### 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. {2}------------------------------------------------ | 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 diagnostic<br>device | Magnetic Resonance diagnostic<br>device | | Indications for Use | The Nova Medical 3T 32 Channel<br>Head Coil is to be used in conjunction<br>with a Magnetic Resonance (MR)<br>Scanner to produce images and/or<br>spectra of the head, that when<br>interpreted by a trained physician<br>yield information that may assist in<br>diagnosis.<br>Model # 3832016 is used with GE 3T<br>MRI Scanner Discovery MR750.<br>Model # 38320169 is used with GE 3T<br>MRI Scanners Signa Architect,<br>Discovery MR750W and Signa<br>PET/MR. | The MR Instrument MC 3003G-32R<br>Head Coil is to be used in<br>conjunction with a MR Scanner to<br>produce images and /or spectra of<br>the head, that when interpreted by<br>a trained physician yield<br>information that may assist in<br>diagnosis. | | Channel Array / Coil Type | 32 Channel Whole-Brain Receive-only<br>Array | 32 Channel Whole-Brain Receive-<br>only Array | | Application | High Sensitivity Neuroimaging/<br>fMRI/spectroscopy | High Sensitivity Neuroimaging/<br>fMRI/spectroscopy | | Conditions of Use | Model # 3832016 is used with GE 3T<br>MRI Scanner Discovery MR750.<br>Model # 38320169 is used with GE 3T<br>MRI Scanners Signa Architect,<br>Discovery MR750W and Signa<br>PET/MR. | Use with GE Discovery MR750<br>Scanner | | Maximum Static Field | 3T | 3T | | Manufacturer | Nova Medical | MR Instruments | | Trade Name | 3T 32 Channel Head Coil<br>(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:<br>• Outside Housing width 25.7 cm<br>• Inside Housing width 18 cm<br>• Outside Housing height 27.6 cm<br>• Inside Housing height 22 cm<br>Head Coil with Tray dimensions:<br>• Coil Length 38.5 cm<br>• Coil Width 44 cm<br>• Coil Height 29.25 cm<br>Weight - 20 lbs. including the Tray | • Inner Dimensions – 23.5cm<br>• Coil Size – 29cm W x 30cm L<br>• Coil Base – 41cm W x 48cm L<br>• Weight – 6.8kg with base | | Shape | Rigid plastic,<br>cylindrical case, with an opening for<br>patient viewing and tray | Rigid plastic, cylindrical case with<br>an opening for patient viewing | | Anatomical Location | Head | Head | | Patient population (including age,<br>anatomy) | All ages and body types | All ages and body types | | Housing Materials | Plastic | Plastic | | Duration of Body Contact | Generally between<br>20 min. – 1 hour | Generally between<br>20 min. – 1 hour | | Software Microprocessor | No | No | | Complies with ISO 10993-1 | Yes | Unknown | | Electrical Safety Testing | ANSI/AAMI ES 60601-1<br>IEC 60601-2-33<br>IEC 61000-4-2 per IEC 60601-1-2 | Unknown | ### Table 5A – Comparison of Characteristics {3}------------------------------------------------ #### 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. {4}------------------------------------------------ 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.