(196 days)
No
The device description focuses on the physical characteristics and function of an MR coil, which is a hardware component for image acquisition. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No.
The device is used to produce images and/or spectra for diagnosis, not for treating any condition.
No
The device is a head coil, which is a component of an MR scanner, used to produce images. It does not directly provide a diagnosis; rather, the images it helps create are interpreted by a trained physician to assist in diagnosis.
No
The device description clearly outlines a physical hardware component (a head coil) with specific dimensions, weight, and construction materials. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nova Medical 3T 32 Channel Head Coil is an accessory used with an MRI scanner. Its function is to receive radiofrequency signals from the patient's head during an MRI scan to produce images.
- Intended Use: The intended use is to produce images and/or spectra of the head that, when interpreted by a trained physician, may assist in diagnosis. This is a function of the imaging system itself, not a test performed on a biological sample.
The device is a component of a medical imaging system used for diagnostic purposes, but it does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) Scanner
Anatomical Site
head
Indicated Patient Age Range
All ages and body types
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: 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. 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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;
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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
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 | |
| device | Magnetic Resonance diagnostic | |
| device | ||
| Indications for Use | 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. | The MR Instrument MC 3003G-32R | |
| Head Coil is to be used in | ||
| conjunction with a 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. | ||
| Channel Array / Coil Type | 32 Channel Whole-Brain Receive-only | |
| Array | 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 3T | |
| MRI Scanner Discovery MR750. | ||
| Model # 38320169 is used with GE 3T | ||
| MRI Scanners Signa Architect, | ||
| Discovery MR750W and Signa | ||
| PET/MR. | Use with GE Discovery MR750 | |
| Scanner | ||
| 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 cm | ||
| Head Coil with Tray dimensions: | ||
| • Coil Length 38.5 cm | ||
| • Coil Width 44 cm | ||
| • Coil Height 29.25 cm | ||
| Weight - 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 for | ||
| patient viewing and tray | Rigid plastic, cylindrical case with | |
| an 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 between | |
| 20 min. – 1 hour | Generally between | |
| 20 min. – 1 hour | ||
| Software Microprocessor | No | No |
| Complies with ISO 10993-1 | Yes | Unknown |
| Electrical Safety Testing | ANSI/AAMI ES 60601-1 | |
| IEC 60601-2-33 | ||
| 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.
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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
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
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