(13 days)
Not Found
No
The device description focuses on the hardware components and physical design of an MRI coil, with no mention of software algorithms, AI, or ML. The performance studies are based on hardware metrics like SNR and image uniformity.
No
The device is described as producing diagnostic images and has a function for increasing SNR and wider field view, which are used to generate outputs for diagnostic purposes. There is no mention of treating or preventing a disease or condition.
No
This device is a coil used in Magnetic Resonance Imaging (MRI) systems to acquire diagnostic images, but it does not perform the diagnostic interpretation itself. The diagnostic images it produces are then interpreted by a trained physician.
No
The device description explicitly details physical hardware components, including a multi-element phased array receive only coil, semi-flexible foam covered housing, antennas, a system interface cable, a cross body strap, and transmit decoupling circuits (PIN diodes and crossed diodes). This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The provided 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 images of the body, not to analyze samples from the body.
- Intended Use: The intended use is "to produce diagnostic images of the shoulder that can be interpreted by a trained physician." This aligns with imaging modalities, not in vitro testing.
Therefore, based on the provided information, this device is an imaging accessory for an MRI system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
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. 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.
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
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)
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): 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
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 Brown |
| Executive Director | |
| NeoCoil | |
| N27 W23910A Paul Rd | |
| Pewaukee, WI 53072 | |
| 262-347-1250 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: 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 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.
:
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 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. |
| 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 this
submission is substantially equivalent to the previously cleared Invivo
Corporation 8 Channel Shoulder Array Assembly (K053017) and the Medical
Advances Inc. 4-Channel Shoulder Coil (K021433). Remaining differences do
not 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 is
substantially equivalent to the Invivo Shoulder coil Assembly. SNR and image
uniformity testing was performed which support the conclusion that the submitted
device satisfies design objectives. |
| Conclusion: | | The NeoCoil 1.5T 8-Channel Shoulder Array is substantially equivalent to the
predicate device. Use of the NeoCoil 1.5T 8-Channel Shoulder Array does not
result in any new potential hazards and does not alter the safety of the MRI
scanner. |
:
- September 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
.
2
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
3
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
4
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
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