(15 days)
No
The description focuses on the hardware components and physical design of an MRI coil, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to produce diagnostic images, not directly treat a condition.
Yes
Explanation: The "Intended Use/Indications for Use" explicitly states that the device is "to produce diagnostic images of the shoulder that can be interpreted by a trained physician," directly indicating its role in diagnosis. The "Device Description" also refers to it as being "used for obtaining diagnostic images."
No
The device description clearly outlines physical hardware components including a coil, antennas, housing, strap, and cables. It also describes hardware-based safety features and performance testing related to the physical coil.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems." It is a component of an MRI system used to capture signals from the body in vivo (within the living organism).
- Intended Use: The intended use is to "produce diagnostic images of the shoulder that can be interpreted by a trained physician." This involves imaging the body directly, not analyzing specimens taken from the body.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used in conjunction with 3.0T GE HD series Magnetic Resonance scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The NeoCoil 3.0T 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers easier patient setup and greater SNR due to its compatibility with 3.0T MRI scanners.
The submitted device consists of semi-flexible foam covered housing, consisting of eight antennas. The antennas are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas or decoupled from an adjacent antenna using a transformer. Pre-amplifier decoupling reduces any remaining decoupling between the antennas.
The coil is held in place over the imaging area via a cross body strap. A system interface cable connects to the coil at the top of the housing. The flexible foam covered housing along with the body strap enable the proper positioning on the patient before laying down and holds the coil in place while scanning is being performed.
To ensure safety, each antenna is equipped with active and passive transmit decoupling circuits. Active decoupling is achieved via diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. These passive switches provide additional safety in case the active circuitry does not receive signal from the scanner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
shoulder
Indicated Patient Age Range
Not Found
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)
SNR and image uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 of Safety and Effectiveness
Device Name: Proprietary Name: Common/Usual Name: Classification Name: Classification Number: Classification Panel: CDRH Product Code: Regulatory Class: Reason for 510(k): Applicant:
Preparation date: Est. Registration No:
Standards:
Performance:
Voluntary:
NeoCoil 3.0T 8-Channel Shoulder Array Coil NeoCoil 3.0T 8-Channel Shoulder Array Coil Magnetic Resonance Specialty Coil Magnetic Resonance Specialty Coil 892.1000 Radiology Device Panel MOS ll New device Brian Brown Executive Director NeoCoil N27 W23910A Paul Rd Pewaukee, WI 53072
5/21/2007
262-347-1250 x 12 (office) 261-347-1251 (fax) brian.brown@neocoil.com
Intended Use: To be used in conjunction with 3.0T GE HD series Magnetic Resonance scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety IEC 60601-2-33 Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis NEMA MS-6 Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images
Device Description:
The NeoCoil 3.0T 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers easier patient setup and greater SNR due to its compatibility with 3.0T MRI scanners.
The submitted device consists of semi-flexible foam covered housing, consisting of eight antennas. The antennas are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas or decoupled from an adjacent antenna using a transformer. Pre-amplifier decoupling reduces any remaining decoupling between the antennas.
1
The coil is held in place over the imaging area via a cross body strap. A system interface cable connects to the coil at the top of the housing. The flexible foam covered housing along with the body strap enable the proper positioning on the patient before laying down and holds the coil in place while scanning is being performed.
To ensure safety, each antenna is equipped with active and passive transmit decoupling circuits. Active decoupling is achieved via diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. These passive switches provide additional safety in case the active circuitry does not receive signal from the scanner.
Predicate Devices: USA Instruments Inc. Mark III Phased Array Shoulder Coil (K042009). NeoCoil 1.5T Shoulder Array Coil Model NC008 (K071311)
Comparison to Predicate:
It is our opinion that the NeoCoil 3.0T 8-Channel Shoulder Array Coil in this submission is substantially equivalent to the previously cleared USA Instruments Inc. Mark III Phased Array Shoulder Coil (K042009), and the NeoCoil 1.5T Shoulder Array Coil Model NC008 (K071311).
In all material respects, the NeoCoil 3.0T 8-Channel Shoulder Array is substantially equivalent to the referenced predicate devices. SNR and image
Summary of Studies:
Conclusion:
uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives. The NeoCoil 3.0T 8-Channel Shoulder Array is substantially equivalent to the
predicate device. Use of the NeoCoil 3.0T 8-Channel Shoulder Array does not result in any new potential hazards and does not alter the safety of the MRI scanner.
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Image /page/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its wings and a wavy line representing its body. The text "Department of Health & Human Services USA" is arranged around the circle's perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 2 8 2007
NeoCoil
% Mr. Daniel Lehtonen Senior Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 . TWINSBURG OH 44087
Re: K071611
Trade/Device Name: NeoCoil 3.0T 8-Channel Shoulder Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 12, 2007 Received: June 13, 2007
Dear Mr. Lehtonen:
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 controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/11 description: The image is a circular seal with the text "1826-1926" at the top. Below that is the text "PA" in large, bold letters. Underneath "PA" is the word "Centennial" in a cursive font. There are three stars below the word "Centennial". The text "PENNSYLVANIA DEPARTMENT OF FORESTS AND WATERS" is around the bottom of the seal.
coloring and Promoting Publio Hoalth
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
4071611 510(k) Number (if known):
Device Name: NeoCoil 3.0T 8-Channel Shoulder Array Coil
Indications For Use:
To be used in conjunction with 3.0T GE HD series Magnetic Resonance scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Heeler Remm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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