(39 days)
Not Found
No
The device description focuses on the hardware (RF coils) and their function in receiving MR signals. There is no mention of software processing, algorithms, or any terms related to AI/ML. The performance studies also focus on hardware performance and image acquisition, not algorithmic interpretation or analysis.
No
The device is described as an RF coil for an MRI scanner used to produce diagnostic images. It does not provide any therapeutic function.
No
The device is a receive-only RF coil used in conjunction with MRI scanners to produce diagnostic images, but it does not perform the diagnosis itself. The interpretation of the images for diagnosis is done by a trained physician.
No
The device description explicitly states it is a "receive-only phased array RF coil" and details its physical components and function in receiving magnetic resonance signals, indicating it is a hardware device. The performance studies also include extensive bench testing of physical properties like electrical safety, surface temperature, and blocking network analysis, further confirming it is not software-only.
No, 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 provided description clearly states that this device is an RF coil used in conjunction with MRI scanners to produce diagnostic images of the shoulder. It works by receiving magnetic resonance signals from the body.
- No Sample Analysis: The device does not analyze any samples taken from the body. It interacts directly with the body to generate images.
Therefore, based on the intended use and device description, this is a medical imaging accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
1.5T 16ch Shoulder Coil:
To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
3.0T 16ch Shoulder Coil:
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are receive-only phased array RF coils designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Maqnetic Resonance Imaging (MRI) scanners. The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings.
Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy.
The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.
The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are intended for use in a manner that is identical to the predicate device described in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
shoulder (Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
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)
Performance testing - Bench:
A Test Report Summary for non-clinical Bench Testing performed, including testing to FDArecognized consensus standards identified as relevant in FDA guidance document Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016 is outlined below:
| Test Performed | Objective(s) of the Test | Test Method Description | Pre-defined pass/fail criteria | Results Summary | Discussions / Conclusions |
|---|---|---|---|---|---|
| Biocompatibility Assessment | Assess potential biological risks | Evaluation of data; historical use, biologic testing where warranted | Acceptable level of risk | Pass | No identified significant risks. |
| Electrical Safety | Basic electrical safety/essential performance, 60601-1 | Test Lab | Pre-defined performance standards | Pass | Applicable requirements for basic electrical safety and essential performance met. |
| Electrical Safety | Particular electrical requirements; MR equipment, 60601-2-33 | Test Lab | Pre-defined performance standards | Pass | Applicable requirements of the particular standard were met. |
| Electrical Safety | Collateral electrical safety/essential performance, 60601-1-2 | Test Lab / Bench Testing | Pre-defined performance standards | Pass | Applicable requirements of the collateral standard were met. |
| Usability Assessment | Devices meet customer, end user and patient needs | Actual, simulated or retrospective evaluation of the device and/or data | Pre-defined requirements | Pass | The devices met the needs of the customer, end user and patient. |
| Entrapment, Trapping Zone and Cable Looping (assessment w/ scanner) | Assess the device for pinch points, entrapment, cable looping - interfacing with MRI scanner | Evaluation of coil-to-scanner entrapment, trapping and cable looping not covered by test lab assessments. | Requirements based on pre-defined requirements in 60601-1 and customer requirements | Pass | Requirements were met. |
| Surface Temperature | Surface temperatures do not exceed limits | MRI scanner test | Pre-defined performance standards | Pass | Surface temperatures were within IEC limits. |
| Unplugged Surface Temperature | Devices remain safe in first fault condition | MRI scanner test | Acceptable level of risk | Pass | Surface temperatures were within IEC limits when the coil is left unplugged in the MRI scanner. |
| Blocking Network Analysis | Ensures devices are designed with adequate active and passive transmit decoupling | Theoretical calculations | Adequate transmit decoupling | Pass | Blocking network demonstrates adequate active and passive transmit decoupling. |
| Maximum B1 Peak | Demonstrate the devices can withstand the maximum B1 peak without obvious signs of arcing, burning, voltage breakdown | MRI scanner test and visual inspection | Pre-defined performance standards | Pass | Coils were able to withstand maximum B1 peak without obvious signs of arcing, burning or voltage breakdown. |
| B1 Field Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | MRI scanner test | Pre-defined performance standards | Pass | B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. |
| B0 Filed Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | MRI scanner test | Pre-defined performance standards | Pass | B0 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. |
| NEMA MS 6-2008 | Evaluate single-channel non-volume special purpose radio-frequency (RF) coils for use with magnetic resonance (MR) imaging (MRI) systems | MRI scanner test | Pre-defined performance standards | Pass | SNR and Image Uniformity are consistent with the requirements for indications for use. |
Performance testing - Clinical:
Clinical data exhibits a mix of technical factors and anatomy as recommended in the FDA guidance, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016.
No adverse events were reported during clinical performance testing.
Key Results: This submission demonstrates by means of nonclinical and clinical testing that the 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are safe and effective and perform as well as or better than the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007 for the indications claimed.
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.
Not Found
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
June 2, 2020
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NeoCoil, LLC % Ms. Katie Gonzalez Regulatory & Quality Engineering Manager N27 W23910A Paul Road PEWAUKEE WI 53072
Re: K201101
Trade/Device Name: 1.5T 16ch Shoulder Coil. 3.0T 16ch Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: April 22, 2020 Received: April 24, 2020
Dear Ms. Gonzalez:
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/cfpmp/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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K201101
Device Name 1.5T 16ch Shoulder Coil
Indications for Use (Describe)
To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
Indications for Use
510(k) Number (if known)
Device Name 3.0T 16ch Shoulder Coil
Indications for Use (Describe)
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
4
Image /page/4/Picture/1 description: The image contains the logo for NeoCoil. The logo consists of a black circular shape with a white crescent moon shape inside, and a black arrow pointing to the right. To the right of the logo is the word "NeoCoil" in blue and black lettering.
K201101
5. Traditional 510(k) Summary
-
5.1. Applicant
NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA -
5.2. Contact
Katie Gonzalez Regulatory & Quality Engineering Manager 262-522-6124 (office) 262-347-1251 (fax) Katie.Gonzalez@neocoil.com -
5.3. Preparation Date
April 22, 2020 -
5.4. Name of Device
- Trade/Proprietary name(s): 1.5T 16ch Shoulder Coil . 3.0T 16ch Shoulder Coil . Common name: Magnetic Resonance Specialty Coil . Classification name: 21 CFR 892.1000, Magnetic resonance diagnostic device, Product Code MOS
5.5. Predicate Device
NeoCoil 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007.
5.6. Device Description
The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are receive-only phased array RF coils designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Maqnetic Resonance Imaging (MRI) scanners. The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings.
Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy.
The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.
The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are intended for use in a manner that is identical to the predicate device described in this submission.
5
Image /page/5/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like symbol with an arrow on the left side, followed by the word "NeoCoil" in blue and black. The "Neo" part of the word is in blue, while the "Coil" part is in black.
Proposed labeling is documented in the Instructions for Use manuals for the 1.5T 16ch Shoulder Coil (NC143IFUF-EN) and 3.0T 16ch Shoulder Coil (NC143IFU-EN).
- 5.7. Intended Use
The intended use for the 1.5T 16ch Shoulder Coil and the 3.0T 16ch Shoulder Coil are identical to that of the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007.
The intended use is:
ldentical to that of routine imaging; specifically to produce diagnostic images of the shoulder.
Use of the device in conjunction with an MRI scanner is unchanged.
- 5.8. Indications for Use
1.5T 16ch Shoulder Coil:
To be used in coniunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
3.0T 16ch Shoulder Coil:
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
5.9. Technological Characteristics
Both the 1.5T 16ch Shoulder Coil and the 3.0T 16ch Shoulder Coil are similar in design, material, chemical composition and energy source to the legally marketed device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007.
At a high level, the 1.5T 16ch Shoulder Coil and the 3.0T 16ch Shoulder Coil included as part of this submission and the predicate device are based on the following same technological elements:
- Prescription use;
- Coil designs are receive-only phased array coils; ●
- Decoupling methodology; ●
- Patient contacting materials and chemical composition are known materials that . have been assessed for compliance with recognized biocompatibility standards;
- . Energy source for the coils is the MRI scanner;
- . No energy is supplied by the coils;
- Coils designs are targeted for imaging the shoulder anatomy; .
- Mechanical designs are contoured for the shoulder anatomy: ●
- Manufactured for use with the same MRI scanner manufacturer.
The following technological differences exist between the subject and predicate devices:
- The exterior of the predicate device is a flexible foam whereas the 1.5T 16ch ● Shoulder Coil and 3.0T 16ch Shoulder Coil exterior is comprised of a rigid posterior array and a flexible anterior array;
- Predicate device incorporates 8 channels whereas the1.5T 16ch Shoulder Coil and . the 3.0T 16ch Shoulder Coil incorporate 16 channels;
6
Image /page/6/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with a white crescent shape inside, and a black arrow pointing to the right. To the right of the circular shape is the word "NeoCoil" in blue and black letters. The "Neo" part of the word is in blue, and the "Coil" part is in black.
- . Different system cable connectors for the 1.5T 16ch Shoulder Coil and the 3.0T 16ch Shoulder Coil compared to the predicate to interface with the newer MRI scanners.
- . Field strength for the 1.5T 16ch Shoulder Coil
The Indications for Use for the 1.5T 16ch Shoulder Coil is similar to the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007 differing in compatible scanner(s) and field strength.
With the exception of compatible scanner(s), the Indications for Use for the 3.0T 16ch Shoulder Coil are identical to the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007.
Clinical testing demonstrates that the differences in the compatible scanners of the devices do not affect the safety and/or the effectiveness of the device when used as labeled.
Clinical and non-clinical testing demonstrates that the safety and effectiveness of the 1.5T 16ch Shoulder Coil compared to the predicate device is not adversely affected as a result of the differences.
- 5.10. Testing
A combination of clinical and non-clinical performance data is included, referenced or relied on to demonstrate that the 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are safe and effective and perform in a manner that demonstrates substantial equivalence to the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/207.
Performance testing - Bench:
A Test Report Summary for non-clinical Bench Testing performed, including testing to FDArecognized consensus standards identified as relevant in FDA guidance document Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016 is outlined below:
| Test
Performed | Objective(s) of the
Test | Test Method
Description | Pre-defined
pass/fail
criteria | Results
Summary | Discussions /
Conclusions |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility
Assessment | Assess potential
biological risks | Evaluation of
data; historical
use, biologic
testing where
warranted | Acceptable
level of risk | Pass | No identified significant
risks. |
| Electrical
Safety | Basic electrical
safety/essential
performance, 60601-1 | Test Lab | Pre-defined
performance
standards | Pass | Applicable
requirements for basic
electrical safety and
essential performance
met. |
| Electrical
Safety | Particular electrical
requirements; MR
equipment, 60601-2-
33 | Test Lab | Pre-defined
performance
standards | Pass | Applicable
requirements of the
particular standard
were met. |
| Test
Performed | Objective(s) of the
Test | Test Method
Description | Pre-defined
pass/fail
criteria | Results
Summary | Discussions /
Conclusions |
| Electrical
Safety | Collateral electrical
safety/essential
performance, 60601-
1-2 | Test Lab /
Bench Testing | Pre-defined
performance
standards | Pass | Applicable
requirements of the
collateral standard were
met. |
| Usability
Assessment | Devices meet
customer, end user
and patient needs | Actual,
simulated or
retrospective
evaluation of
the device
and/or data | Pre-defined
requirements | Pass | The devices met the
needs of the customer,
end user and patient. |
| Entrapment,
Trapping Zone
and Cable
Looping
(assessment w/
scanner) | Assess the device for
pinch points,
entrapment, cable
looping - interfacing
with MRI scanner | Evaluation of
coil-to-scanner
entrapment,
trapping and
cable looping
not covered by
test lab
assessments. | Requirements
based on pre-
defined
requirements
in 60601-1
and customer
requirements | Pass | Requirements were
met. |
| Surface
Temperature | Surface temperatures
do not exceed limits | MRI scanner
test | Pre-defined
performance
standards | Pass | Surface temperatures
were within IEC limits. |
| Unplugged
Surface
Temperature | Devices remain safe in
first fault condition | MRI scanner
test | Acceptable
level of risk | Pass | Surface temperatures
were within IEC limits
when the coil is left
unplugged in the MRI
scanner. |
| Blocking
Network
Analysis | Ensures devices are
designed with
adequate active and
passive transmit
decoupling | Theoretical
calculations | Adequate
transmit
decoupling | Pass | Blocking network
demonstrates adequate
active and passive
transmit decoupling. |
| Maximum B1
Peak | Demonstrate the
devices can withstand
the maximum B1 peak
without obvious signs
of arcing, burning,
voltage breakdown | MRI scanner
test and visual
inspection | Pre-defined
performance
standards | Pass | Coils were able to
withstand maximum B1
peak without obvious
signs of arcing, burning
or voltage breakdown. |
| B1 Field
Distortion | Measure amount of
distortion produced
due to presence of an
RF coil in the scanner | MRI scanner
test | Pre-defined
performance
standards | Pass | B1 field inhomogeneity
meets performance
requirements and
demonstrates adequate
active and passive
transmit decoupling. |
| B0 Filed
Distortion | Measure amount of
distortion produced
due to presence of an
RF coil in the scanner | MRI scanner
test | Pre-defined
performance
standards | Pass | B0 field inhomogeneity
meets performance
requirements and
demonstrates adequate
active and passive
transmit decoupling. |
| Test
Performed | Objective(s) of the
Test | Test Method
Description | Pre-defined
pass/fail
criteria | Results
Summary | Discussions /
Conclusions |
| NEMA MS 6-
2008 | Evaluate single-
channel non-volume
special purpose radio-
frequency (RF) coils
for use with magnetic
resonance (MR)
imaging (MRI)
systems | MRI scanner
test | Pre-defined
performance
standards | Pass | SNR and Image
Uniformity are
consistent with the
requirements for
indications for use. |
7
Image /page/7/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue. The word "Neo" is in a lighter shade of blue than the word "Coil".
T
8
Image /page/8/Picture/1 description: The image contains the logo for NeoCoil. The logo consists of a black circular design with an arrow pointing to the right, followed by the word "NeoCoil" in blue and black. The word "Neo" is in blue, while the word "Coil" is in black.
Performance testing - Clinical:
Clinical data exhibits a mix of technical factors and anatomy as recommended in the FDA guidance, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016.
No adverse events were reported during clinical performance testing.
| 1.5T 16ch Shoulder Coil | 3.0T 16ch Shoulder Coil |
|---|---|
| Oblique Axial PD | Oblique Axial PD |
| Oblique Coronal T1 (no fat sat) | Oblique Coronal T1 (no fat sat) |
| Oblique Sagittal T2 (no fat sat) | Oblique Coronal T2 (fat sat) |
9
Image /page/9/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like shape with an arrow at the end, followed by the word "NeoCoil" in blue. The coil shape is on the left side of the logo, and the word "NeoCoil" is on the right side.
Image /page/9/Picture/2 description: This image shows two MRI scans of a shoulder, comparing the results from a 1.5T 16ch Shoulder Coil and a 3.0T 16ch Shoulder Coil. The scan on the left, labeled "Oblique Sagittal T2 (fat sat)," was taken using the 1.5T coil, while the scan on the right, labeled "Oblique Sagittal T2 (no fat sat)," was taken using the 3.0T coil. The image shows the difference in image quality and fat saturation between the two coils.
5.11. Conclusion
This submission demonstrates by means of nonclinical and clinical testing that the 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are safe and effective and perform as well as or better than the predicate device, the 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007 for the indications claimed.