1.5T 16-CHANNEL HAND-WRIST COIL

K103149 · Invivo Corporation · MOS · Jan 3, 2011 · Radiology

Device Facts

• Record ID: K103149
• Device Name: 1.5T 16-CHANNEL HAND-WRIST COIL
• Applicant: Invivo Corporation
• Product Code: MOS · Radiology
• Decision Date: Jan 3, 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 GE 1.5T MR scanners as an accessory to produce images of the wrist and hand regions, as an aid to diagnosis.

Device Story

1.5T 16-Channel Hand-Wrist Coil is a receive-only radio frequency (RF) coil accessory for GE 1.5T MR scanners. Device captures RF signals from wrist and hand tissue to facilitate high-resolution diagnostic imaging. Operated by trained MR technologists in clinical settings. Output consists of raw signal data processed by the host MR scanner to generate diagnostic images. Assists physicians in diagnosing pathologies of the hand and wrist. Device design is based on the 1.5T 8-Channel Hand-Wrist Coil predicate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Receive-only RF coil for 1.5T MR scanners. 16-channel configuration. Materials are similar to predicate device. Fundamental technology involves receiving RF signals from tissue of interest.

Indications for Use

Indicated for patients requiring diagnostic imaging of the wrist and hand regions using GE 1.5T MR scanners. Prescription use only.

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 8-Channel Hand-Wrist Coil (K050622)

Submission Summary (Full Text)

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K103/49

## 510(k) Summary of Safety and Effectiveness 1.5T 16-Channel Hand-Wrist Coil

JAN - 3 2010

| Submitted By: | Invivo Corporation<br>3545 SW 47TH Ave.<br>Gainesville, FL 32608 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 22, 2010 |
| Contact Person: | Elizabeth Wheeler, Regulatory Affairs Engineer<br>Tel: [phone], ext 164 Fax: [phone] |
| Proprietary Name: | 1.5T 16-Channel Hand-Wrist Coil |
| 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 16-channel Hand-Wrist Coil is based on design features of the predicate device. · 1.5T 8-Channel Hand-Wrist Coil. The 16-Channel Hand-Wrist Coil is designed as receive only for high resolution diagnostic imaging of regional structures of the wrist and hand. The 16-Channel Hand-Wrist Coil is manufactured of materials that are similar to those used to manufacture the predicate device.

#### Indications for Use:

The coil is indicated for use on the order of a physician, in conjunction with GE 1.5T MR scanners as an accessory to produce images of the wrist and hand 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 fundamental scientific technology of the subject device described in this submission has not been altered from the predicate device.

#### Substantial Equivalence Information:

When compared to the predicate device, 1.5T 8-Channel Hand-Wrist Coil - K050622, cleared 04/08/05, substantial equivalence is based on similarities in design features, overall indications for use, and technological characteristics.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing its wings and a circular border around the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written along the circular border.

## 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. Elizabeth Wheeler Regulatory Engineer Invivo Corporation 3545 SW 47" Ave. GAINESVILLE FL 36208

JAN - 3 2010

Re: K103149

Trade/Device Name: 1.5T 16-Channel Hand-Wrist Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 22, 2010 Received: October 25, 2010

Dear Ms Wheeler:

and the works of the country of the states

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 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 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 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/ReportalProblem/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,

signature

David G. Brown, Ph.D. Acting 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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K103149

# Indications for Use

JAN - 3 2010

510(k) Number (if known):

Device Name: 1.5T 16-Channel Hand-Wrist Coil

Indications for Use:

The coil is indicated for use on the order of a physician, in conjunction with GE 1.5T MR scanners as an accessory to produce images of the wrist and hand regions, 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)

Mull D'O'h
(Division Sign-Off)

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Office of to Vitro D

510K K103149