1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL

K111673 · Invivo Corporation · MOS · Dec 23, 2011 · Radiology

Device Facts

• Record ID: K111673
• Device Name: 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
• Applicant: Invivo Corporation
• Product Code: MOS · Radiology
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images, as an aid to diagnosis.

Device Story

The 1.5T and 3.0T 8-channel Medium General Purpose Flex Coils are receive-only radio frequency (RF) coils used in magnetic resonance imaging (MRI). The device captures RF signals emitted from patient tissue during an MRI scan. These signals are processed by the host Philips 1.5T or 3.0T MR scanner to generate diagnostic images of musculoskeletal structures, specifically the hip, knee, foot/ankle, shoulder, and elbow. The device is operated by trained MRI technologists or radiologists in a clinical setting. By providing high-resolution imaging of regional anatomy, the coil assists clinicians in diagnosing musculoskeletal conditions. The device design is a variation of existing predicate flex coils, differing primarily in housing dimensions to accommodate specific anatomical regions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design features and technological characteristics; bench testing only.

Technological Characteristics

Receive-only RF coil; 8-channel configuration; compatible with Philips 1.5T and 3.0T MR scanners. Materials are similar to predicate devices. Operates by receiving RF signals from tissue. No active electronic components or software algorithms integral to the coil itself.

Indications for Use

Indicated for patients requiring MR imaging of the hip, knee, foot/ankle, shoulder, and elbow regions. Used as an accessory with Philips 1.5T and 3.0T MR scanners on the order of a physician.

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

• 1.5T and 3.0T 8-channel General Purpose Flex Coil (K093842)

Submission Summary (Full Text)

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Invivo Corporation Traditional 510(k): 1.5T and 3.0T 8-Channel Medium General Purpose Coil

.K111673

June 13, 2011

510(k) Summary of Safety and Effectiveness
1.5T and 3.0T 8-Channel Medium General Purpose Flex Coils

DEC 2 3 2011

| Submitted By: | Invivo Corporation<br>3545 SW 47TH Ave.<br>Gainesville, FL 32608 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 13, 2011 |
| Contact Person: | Elizabeth Wheeler, Regulatory Affairs Engineer<br>Tel: [phone], ext 164 Fax: [phone] |
| Proprietary Name: | 1.5T and 3.0T 8-channel Medium General Purpose Flex<br>Coils |
| Common Name: | Coil, Magnetic Resonance, Specialty |
| Classification Name and Reference: | 21 CFR 892.1000. A magnetic resonance diagnostic<br>device, for general diagnostic use to present images<br>which reflect the spatial distribution and/or magnetic<br>resonance spectra which reflect frequency and<br>distribution of nuclei exhibiting nuclear magnetic<br>resonance, class II. |
| Device Product Code and Panel Code: | MOS / Radiology / 90 |

### Device Description:

The design of the 1.5T and 3.0T 8-channel Medium General Purpose (GP) Flex Coils are based on design features of the predicate device, 1.5T and 3.0T 8-channel General Purpose Flex Coil. The Medium GP Flex Coils are designed as receive only for high resolution diagnostic imaging of regional structures of the musculoskeletal hip, knee, foot/ankie, shoulder, and elbow. The Medium GP Flex Coils are manufactured of materials that are similar to those used to manufacture the predicate devices.

### Indications for Use:

The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the hip, knee, foot/ankle, shoulder and elbow regions, as an aid to diagnosis.

### Technological Characteristics:

The fundamental scientific technology of a radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest.

The new devices designs are similar to the predicates with the exception of the dimensions of the housings. The fundamental scientific technology of the subject described in this submission has not been altered from the predicate devices.

### Substantial Equivalence Information:

When compared to the predicate devices, 1.5T and 3.0T 8-channel General Purpose Flex Coil - K093842, cleared 3/5/10. substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics.

CONFIDENTIAL

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling an eagle or a bird in flight.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Lisa Simpson Regulatory Engineer Invivo Corporation 3545 SW 47th Avenue GAINSVILLE FL 32608

DEC 2 3 2011

Re: K111673

Trade/Device Name: 1.5T and 3.0T 8-Channel Medium General Purpose Flex Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: December 21st, 2011 Received: December 22nd, 2011

Dear Ms. Simpson:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in vour 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Patil

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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December 21, 2011

# Indications for Use

510(k) Number (if known): K111673

Device Name: 1.5T and 3.0T 8-Channel Medium General Purpose Flex Coils

Indications for Use:

The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images, as an aid to diagnosis.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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

***(Division Sign-Off)***

510K 1/1/673

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