1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484

K091902 · Invivo · MOS · Aug 21, 2009 · Radiology

Device Facts

• Record ID: K091902
• Device Name: 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484
• Applicant: Invivo
• Product Code: MOS · Radiology
• Decision Date: Aug 21, 2009
• 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 an MR scanner as an accessory to produce images of the upper and lower extremities, as an aid to diagnosis.

Device Story

The 1.5T and 3.0T 8-Channel Small Extremity Coil is a receive-only accessory for MR scanners. It captures radio frequency signals from bone, soft tissue, musculoskeletal, and vascular structures in small extremities. The coil transforms these signals into data for MR image reconstruction. Used in clinical settings by trained MR technologists under physician supervision. The resulting high-resolution images assist clinicians in diagnosing extremity pathologies. The device benefits patients by providing detailed anatomical visualization for improved diagnostic accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Receive-only RF coil for 1.5T and 3.0T MR scanners. Manufactured using materials similar to predicate Invivo Corporation coils. Operates by receiving RF signals from tissue. No software or active electronic components described.

Indications for Use

Indicated for patients requiring MR imaging of upper and lower extremities to aid in diagnosis. Used on physician order.

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

• Musculoskeletal Flex Coil Package: Upper Extremity Flex Coil and Lower Extremity Flex Coil (K983109)

Submission Summary (Full Text)

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K09/902

## 510(k) Summary of Safety and Effectiveness 1.5T and 3.0T 8-Channel Small Extremity Coil

# AUG 21 2009

| Submitted By: | Invivo Corporation<br>3545 SW 47th Ave.<br>Gainesville, FL 32608 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 23, 2009, revised August 6, 2009 |
| Contact Person: | Elizabeth Wheeler, Regulatory Affairs Engineer<br>Tel: [phone], ext 164 Fax: [phone] |
| Proprietary Name: | 1.5T and 3.0T 8-Channel Small Extremity 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 and 3.0T 8-Channel Small Extremity Coils are based on design features of the predicate device Musculoskeletal Flex Coil Package: Upper Extremity Flex Coil. The Small Extremity Coils are designed as receive only for high resolution diagnostic imaging of bone, soft tissue, musculoskcletal and vascular structures in small extremity Coils are manufactured of materials that are similar to those used to manufacture the predicate device and other Invivo Corporation coils.

#### Indications for Use:

The coil is indicated for use on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the upper and lower extremities, as an aid to diagnosis.

#### Technological Charactcristics:

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, Musculoskeletal Flex Coil Package: Upper Extremity Flex Coil and Lower Extremity Flex Coil-K983109, cleared 10/06/98, substantial equivalcnce is based on similarities in intended use, and technological characteristics.

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Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle emblem is composed of three curved shapes, resembling feathers or wings.

## 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

# AUG 21 2009

Ms. Elizabeth Wheeler, MST, RAC Regulatory Engineer Invivo Corporation 3545 SW 47th Ave GAINESVILLE FL 32608

Re: K091902

Trade/Device Name: 1.5T and 3.0T 8-Channel Small Extremity Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 6, 2009 Received: August 7, 2009

### Dear Ms. Wheeler:

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 (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/indr/ 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,

Lamme M. Mouch

Janine M. Morris Acting 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

510(k) Number (if known): K091902

Device Name: 1.5T and 3.0T 8-Channel Small Extremity Coil

Indications for Use:

The coil is indicated for use on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the upper and lower extremities, 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)

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(Division Sign Off)

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(Division Sign-Off). Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number