(13 days)
To be used in conjunction with Magnetic Resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
The NeoCoil 1.5T 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 greater SNR due to its unique eight channel layout and a larger field-of-view due to the antenna layout. 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 two transmit decoupling circuits; one active and the other passive. Active decoupling is achieved by PIN 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. The passive switched diodes detune the antennas further during RF transmit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NeoCoil 1.5T 8-Channel Shoulder Array Coil:
It's important to note that the provided text is a 510(k) summary for a medical device (an MRI coil), not an AI algorithm. Therefore, many of the requested categories related to AI performance, ground truthing, and expert review are not applicable or explicitly mentioned in this type of submission. The focus here is on hardware performance and safety compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1, IEC 60601-2-33, and general medical device safety requirements (no new potential hazards, does not alter MRI scanner safety). | Each antenna equipped with active (PIN diodes) and passive (crossed diodes) transmit decoupling circuits. |
| Image Quality (SNR) | Substantially equivalent or superior to predicate devices (specifically Invivo Corp. 8-Channel Shoulder Array and Medical Advances Inc. 4-Channel Shoulder Coil). | "Submitted device offers greater SNR due to its unique eight channel layout." |
| Image Quality (Uniformity) | Satisfies design objectives, comparable to predicate devices. | "Image uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives." |
| Field-of-View (FOV) | Larger or comparable to predicate devices. | "Larger field-of-view due to the antenna layout." |
| Functionality | Suitable for obtaining diagnostic images of the shoulder that can be interpreted by a trained physician. | Designed as a multi-element phased array receive-only coil for imaging the shoulder. |
| Mechanical/Physical Design | Semi-flexible foam covered housing, eight antennas, appropriate overlap to cancel mutual coupling, pre-amplifier decoupling, cross-body strap for positioning. | Described features match the design. |
| Substantial Equivalence | Overall determination of substantial equivalence to predicate devices (Invivo K053017 and Medical Advances K021433). | "In all material respects, the NeoCoil 1.5T 8-Channel Shoulder Array is substantially equivalent to the Invivo Shoulder coil Assembly." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The summary mentions performance testing related to SNR and image uniformity but does not specify the number of subjects, scans, or the nature of the data (e.g., phantom, in vivo, retrospective/prospective, country of origin). This type of detail is typically found in the full submission, not the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is largely not applicable in the context of an MRI coil 510(k) submission. The "ground truth" for a medical device like an MRI coil is its physical performance (SNR, uniformity, safety), not an interpretation of images by experts to create a diagnostic ground truth. The "interpretation by a trained physician" is part of the intended use, implying the images produced are clinically usable, which is assessed through the performance metrics.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for this type of device submission. Adjudication methods are relevant for diagnostic AI algorithms where expert consensus resolves discrepancies in image interpretations.
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, an MRMC comparative effectiveness study was not done. This device is an MRI coil, a hardware component, not an AI algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This is a hardware device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance assessment appears to be based on:
- Quantitative measurements: For SNR, likely using established phantom protocols (as per NEMA MS-6) and potentially in vivo measurements.
- Image uniformity assessment: Likely through specific phantom scans and potentially clinical image review against visual standards or quantitative metrics.
- Safety testing: Compliance with IEC standards, evaluation of decoupling circuits, and potential in-vitro safety tests (e.g., heating).
- Comparison to predicate devices: The functionality and performance are benchmarked against other legally marketed MRI shoulder coils.
It is not based on expert consensus, pathology, or outcomes data related to diagnostic accuracy in the way an AI algorithm's performance would be. The "ground truth" is about the physical and imaging characteristics of the coil itself.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This is a hardware device, not an AI algorithm, so there is no training set in the machine learning sense. The device developers would have performed internal testing and optimization during the design and manufacturing process, but this is not referred to as a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for the same reasons as #8.
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K07 1311
510(k) Summary of Safety and Effectiveness
MAY 2 2 2007
| Device Name: | NeoCoil 1.5T 8-Channel Shoulder Array Coil |
|---|---|
| Proprietary Name: | NeoCoil 1.5T 8-Channel Shoulder Array Coil |
| Common/Usual Name: | Magnetic Resonance Specialty Coil |
| Classification Name: | Magnetic Resonance Specialty Coil |
| Classification Number: | 892.1000 |
| Classification Panel: | Radiology Device Panel |
| CDRH Product Code: | MOS |
| Regulatory Class: | II |
| Reason for 510(k): | New device |
| Applicant: | Brian BrownExecutive DirectorNeoCoilN27 W23910A Paul RdPewaukee, WI 53072262-347-1250 x 12 (office)261-347-1251 (fax)brian.brown@neocoil.com |
| Preparation date: | 4/3/2007 |
| Est. Registration No: |
Intended Use: To be used in conjunction with Magnetic Resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Standards:
| Performance: | No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act. |
|---|---|
| Voluntary: | IEC 60601-1 Medical Electrical Equipment—Part 1: GeneralRequirements for Safety |
| IEC 60601-2-33 Medical Electrical Equipment—Part 2:Particular Requirements for the Safety ofMagnetic Resonance Equipment for Medical Diagnosis | |
| NEMA MS-6 Characterization of Special Purpose Coils forDiagnostic Magnetic Resonance Images |
Device Description: The NeoCoil 1.5T 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 greater SNR due to its unique eight channel layout and a larger field-of-view due to the antenna layout. 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.
:
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| The coil is held in place over the imaging area via a cross body strap. A systeminterface cable connects to the coil at the top of the housing. The flexible foamcovered housing along with the body strap enable the proper positioning on thepatient before laying down and holds the coil in place while scanning is beingperformed. | ||
|---|---|---|
| To ensure safety, each antenna is equipped with two transmit decouplingcircuits; one active and the other passive. Active decoupling is achieved by PINdiodes that receive signals from the scanner to turn the coil to a high impedancestate during system RF transmit. Crossed diodes are installed on each antennaacting as passive switches. The passive switched diodes detune the antennasfurther during RF transmit. | ||
| Predicate Devices: | Invivo Corporation 8 Channel Shoulder Array (K053017)Medical Advances Inc. 4 Channel Shoulder coil (K021433) | |
| Comparison to Predicate: | It is our opinion that the NeoCoil 1.5T 8-Channel Shoulder Array Coil in thissubmission is substantially equivalent to the previously cleared InvivoCorporation 8 Channel Shoulder Array Assembly (K053017) and the MedicalAdvances Inc. 4-Channel Shoulder Coil (K021433). Remaining differences donot impact indications for use or have an impact on safety. | |
| Summary of Studies: | In all material respects, the NeoCoil 1.5T 8-Channel Shoulder Array issubstantially equivalent to the Invivo Shoulder coil Assembly. SNR and imageuniformity testing was performed which support the conclusion that the submitteddevice satisfies design objectives. | |
| Conclusion: | The NeoCoil 1.5T 8-Channel Shoulder Array is substantially equivalent to thepredicate device. Use of the NeoCoil 1.5T 8-Channel Shoulder Array does notresult in any new potential hazards and does not alter the safety of the MRIscanner. |
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NeoCoil
% Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K071311
Trade/Device Name: NeoCoil 1.5T 8-Channel Shoulder Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: May 8, 2007 Received: May 9, 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/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "PA" are in the center of the seal in a bold, stylized font. The word "Centennial" is below the letters "PA". Three stars are at the bottom of the seal.
Protecting and Promoting Public Health
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Page 2 -
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 C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K_071311 510(k) Number (if known):
Device Name: NeoCoil 1.5T 8-Channel Shoulder Array Coil
Indications For Use:
To be used in conjunction with Magnetic Resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
- Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
- 2071311
Prescription Use × (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)
510(k) Number
Page 1 of 1
§ 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.