NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL

K071311 · Neocoil · MOS · May 22, 2007 · Radiology

Device Facts

• Record ID: K071311
• Device Name: NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
• Applicant: Neocoil
• Product Code: MOS · Radiology
• Decision Date: May 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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.

Device Story

Multi-element phased array receive-only coil; 8-channel layout; semi-flexible foam housing with 8 antennas. Used in MRI suites; operated by MRI technicians/radiologists. Antennas positioned with overlap to cancel mutual coupling; pre-amplifier decoupling used. Safety features include active decoupling via PIN diodes and passive decoupling via crossed diodes to detune antennas during RF transmit. Held in place over shoulder via cross-body strap. Provides diagnostic shoulder images for physician interpretation; improved SNR and field-of-view compared to previous designs.

Clinical Evidence

Bench testing only. SNR and image uniformity testing performed to support design objectives and substantial equivalence.

Technological Characteristics

Multi-element phased array receive-only coil; 8-channel configuration; semi-flexible foam housing. Active decoupling via PIN diodes; passive decoupling via crossed diodes. Complies with IEC 60601-1, IEC 60601-2-33, and NEMA MS-6.

Indications for Use

Indicated for use with MRI scanners to produce diagnostic shoulder images for interpretation by trained physicians.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Invivo Corporation 8 Channel Shoulder Array (K053017)
• Medical Advances Inc. 4 Channel Shoulder coil (K021433)

Submission Summary (Full Text)

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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 Brown<br>Executive Director<br>NeoCoil<br>N27 W23910A Paul Rd<br>Pewaukee, WI 53072<br>262-347-1250 x 12 (office)<br>261-347-1251 (fax)<br>[e-mail] |
| 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<br>Requirements for Safety |
| | IEC 60601-2-33 Medical Electrical Equipment—Part 2:<br>Particular Requirements for the Safety of<br>Magnetic Resonance Equipment for Medical Diagnosis |
| | NEMA MS-6 Characterization of Special Purpose Coils for<br>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.

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| | | The coil is held in place over the imaging area via a cross body strap. A system<br>interface cable connects to the coil at the top of the housing. The flexible foam<br>covered housing along with the body strap enable the proper positioning on the<br>patient before laying down and holds the coil in place while scanning is being<br>performed. |
|--------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | To ensure safety, each antenna is equipped with two transmit decoupling<br>circuits; one active and the other passive. Active decoupling is achieved by PIN<br>diodes that receive signals from the scanner to turn the coil to a high impedance<br>state during system RF transmit. Crossed diodes are installed on each antenna<br>acting as passive switches. The passive switched diodes detune the antennas<br>further during RF transmit. |
| Predicate Devices: | | Invivo Corporation 8 Channel Shoulder Array (K053017)<br>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<br>submission is substantially equivalent to the previously cleared Invivo<br>Corporation 8 Channel Shoulder Array Assembly (K053017) and the Medical<br>Advances Inc. 4-Channel Shoulder Coil (K021433). Remaining differences do<br>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<br>substantially equivalent to the Invivo Shoulder coil Assembly. SNR and image<br>uniformity testing was performed which support the conclusion that the submitted<br>device satisfies design objectives. |
| Conclusion: | | The NeoCoil 1.5T 8-Channel Shoulder Array is substantially equivalent to the<br>predicate device. Use of the NeoCoil 1.5T 8-Channel Shoulder Array does not<br>result in any new potential hazards and does not alter the safety of the MRI<br>scanner. |

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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.

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Protecting and Promoting Public Health

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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 [phone] or [phone]

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

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