CAROTID COIL GE 1.5T

K113280 · Tursiop Technologies, LLC · MOS · Nov 23, 2011 · Radiology

Device Facts

• Record ID: K113280
• Device Name: CAROTID COIL GE 1.5T
• Applicant: Tursiop Technologies, LLC
• Product Code: MOS · Radiology
• Decision Date: Nov 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the neck and lower cranium.

Device Story

Receive-only 2-channel RF coil; designed for 1.5T MRI systems (GE Twinspeed HDx). Input: hydrogen nuclei excitation signals from carotid arteries; Output: high-resolution MR images. Used in clinical imaging settings by trained MRI technologists/radiologists. Coil consists of two independent rectangular loops (7 cm x 4.5 cm) with active/PIN diode-enabled blocking circuitry to prevent coupling during transmission. Provides optimized signal-to-noise ratio (SNR) for a 7 cm field of view. Output images assist clinicians in visualizing carotid artery anatomy for diagnostic purposes.

Clinical Evidence

Bench testing only. Side-by-side performance comparison with the GE 3-inch General Purpose Coil demonstrated equivalent SNR and image quality. Compliance with IEC 60601-1, IEC 60601-2-33, UL 94, ISO 10993-1, and NEMA MS-6/MS-9 standards verified safety and effectiveness.

Technological Characteristics

Receive-only 2-channel phased array coil; 1.5T static magnetic field compatibility; polycarbonate housing; active/PIN diode-enabled blocking circuitry; 7 cm x 4.5 cm element dimensions; 7 cm field of view. Standards: IEC 60601-1, IEC 60601-2-33, UL 94 (flammability), ISO 10993-1 (biocompatibility), NEMA MS-6, NEMA MS-9.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the carotid arteries in the neck and lower cranium using a GE Twinspeed HDx 1.5T MRI system.

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

• TT1 General Purpose Coil (K083434)
• GE 3-inch General Purpose Coil

Submission Summary (Full Text)

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NOV 23 2011

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## A. GENERAL INFORMATION

| Classification Name | Magnetic Resonance Diagnostic Device (21 CFR 892.1000) | |
|-------------------------------|---------------------------------------------------------------------------------------------------------|--|
| Device Trade Name: | Carotid Coil GE1.5T | |
| Applicant's Name and Address: | Tursiop Technologies, LLC<br>11000 Cedar Ave. Suite 280<br>Cleveland OH 44106 | |
| Submitter: | Raju Viswanathan<br>Chief Technology Officer<br>Tursiop Technologies, LLC<br>11000 Cedar Ave. Suite 280 | |
| | Telephone: [phone]<br>Email: [e-mail] | |

#### B. INTENDED USE

The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the neck and lower cranium.

## C. DEVICE DESCRIPTION

The Carotid Coil GE1.5T is a receive-only 2-channel coil for operation at a magnetic field strength of 1.5T with the GE Twinspeed HDx system. The coil is a two-element coil consisting of two independent rectangular loops, each of approximate size 7 cm x 4.5 cm. Coupling of either coil element to the transmitted field is prevented through respective active blocking circuits.

The Carotid Coil GE1.5T is specially designed for MR imaging of the carotid arteries in the region of the neck and lower cranium. The coil provides optimum signal to noise ratio and coverage in the area of the carotid arteries, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 7 cm Field of View.

## D. PERFORMANCE TESTING & STANDARDS

- IEC 60601-1 (1988): Medical electrical equipment Part 1: General requirements for safety, . including Amendment 1 (1991) and Amendment 2 (1995).
- . IEC 60601-2-33 (2006): Medical electrical equipment-Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
- . UL 94; Tests for Flammability of Plastic Materials for parts in Devices and Appliance
- . ISO 10993-1 (2009): Biological evaluation of medical devices-Evaluation and testing within a risk management process
- . NEMA: MS-6 (2008) Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images

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- . NEMA: MS-9 (2008) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- . NEMA Standardized 510(k) Pre-Market Notification Submission Template for RF Coil Accessories Intended for Use with Magnetic Resonance Diagnostic Imaging Devices

## E. PREDICATE DEVICES

The Carotid Coil GE1.5T is substantially equivalent to the predicate devices. The table below identifies similarities between the devices. Although the GE 3-inch General Purpose Coil is in commercial distribution it is not included in the FDA 510(k) database and/or has been purged from the FDA PMA Tursiop Technologies LLC has conducted side by side testing between the Carotid Coil database. GE1.5T and the GE 3-inch General Purpose Coil to verify substantial equivalence.

| Para<br>mete<br>r | Carotid Coil GE1.5T | TT1 General Purpose Coil<br>(K083434) | Predicate Coil: GE 3-inch General<br>Purpose Coil |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| d/Indications for<br>Use<br>Int. | The Carotid Coil GE1.5T is a<br>receive-only 2-channel diagnostic<br>MR imaging coil designed for use<br>at a static magnetic field strength of<br>1.5T with the GE Twinspeed HDx<br>1.5T MRI scanner/system. It is used<br>for obtaining diagnostic images of<br>the carotid arteries in the region of<br>the neck and lower cranium. | The TT1 General Purpose Coil is a<br>receive-only diagnostic MR imaging<br>coil designed for use at a static<br>magnetic field strength of 1.5T with<br>the GE Signa® 1.5T system. It is<br>used for obtaining diagnostic images<br>of a variety of small-to-medium<br>sized anatomical regions, such as<br>jaw, spine, neck, shoulder, thigh,<br>foot, ankle and joints. | The GE 3-inch General Purpose Coil<br>is a receive-only RF coil designed for<br>1.5T MR imaging of various<br>anatomical regions, such as jaw, spine,<br>neck, shoulder, thigh, foot, ankle and<br>joints. |
| Dimensions | Dimensions of each channel<br>element:<br>Coil length - 7 cm<br>Coil width - 4.5 cm<br>Similar in weight | Coil length - 7.5 cm<br>Coil width - 7.5 cm<br>Similar in weight | Coil length - 7.5 cm<br>Coil width – 7.5 cm<br>Similar in weight |
| Coil Architecture | Two channel receive-only for 1.5T<br>operation<br>Housing Type - Polycarbonate | Single channel receive-only for 1.5T<br>operation<br>Housing Type - ABS plastic | Single channel receive-only for 1.5T<br>operation<br>Housing Type - Fiberglass |
| | Primary Decoupling - Active/PIN<br>diode-enabled blocking circuitry for<br>each channel | Primary Decoupling - Active/PIN<br>diode-enabled blocking circuitry | Primary Decoupling - Active/PIN<br>diode-enabled blocking circuitry |
| Performance<br>& Safety | IEC 60601-1, IEC60601-2-33<br>Flammability UL 94, ISO 10993-<br>1,NEMA MS6, NEMA MS9 | IEC 60601-1, IEC60601-2-33<br>Flammability UL 94, ISO 10993-1,<br>NEMA MS6 | IEC 60601-1, IEC60601-2-33<br>Flammability UL 94, ISO 10993-1,<br>NEMA MS6 |

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| Principle of<br>Operation | Hydrogen nuclei excitation for<br>imaging of the scanned organ | Hydrogen nuclei excitation for<br>imaging of the scanned organ | Hydrogen nuclei excitation for<br>imaging of the scanned organ |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Technological<br>Characteristics | Optimal Signal to Noise Ratio<br>(SNR) and coverage<br>allowing high-resolution imaging,<br>while the sensitive region of the<br>coil covers an approximately 7 cm<br>Field of View. | Optimal Signal to Noise Ratio<br>(SNR) and coverage<br>allowing high-resolution imaging,<br>while the sensitive region of the coil<br>covers an approximately 10 cm Field<br>of View. | Optimal Signal to Noise Ratio<br>(SNR) and coverage and high<br>resolution imaging |

## F. SAFETY AND EFFECTIVENESS

Tursiop Technologies, LLC complies with FDA's GMPs and is ISO 13485-certified for the design and manufacture of magnetic resonance imaging coils. The Carotid Coil GE1.5T complies with voluntary standards for safety/effectiveness (IEC 60601, UL 94, ISO 10993-1) all of which mandate that relevant components are tested to minimize hazards (electrical, mechanical, flammability, biocompatibility). The patient contacting surface is polycarbonate painted with biocompatible paint. ISO-mandated risk management practices have been utilized to assess potential risks throughout the device life cycle to mitigate unacceptable levels of risk by conducting risk assessment (FMEA) procedures.

Tursiop Technologies, LLC has conducted testing to establish the safety and effectiveness concerning the Carotid Coil GE1.5T. Side by side comparison testing was conducted with one of the predicate devices, GE 3-inch General Purpose Coil which demonstrated substantially equivalent performance. The Carotid Coll GE1.5T does not introduce any new potential safety risks and operates in a manner similar to the predicate devices.

## G. SUBSTANTIAL EQUIVALENCE STATEMENT

The Carotid Coil GE1.5T is substantially equivalent to the GE 3-inch General Purpose Coil and the TT1 General Purpose Coil (K083434).

This opinion is based on the fact that comparing the Carotid Coil GE1.5T technological characteristics, coil architecture and operating principles with that of the predicate devices reveals that the devices comply with the same or equivalent standards and have the same or equivalent intended uses.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

## 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

Tursiop Technologies LLC. Mr. Mark Job Responsible Third Party Official % Regulatory Technology Services, LLC. 1394 25th Street NW BUFFALO MN 55313

NOV 2 3 2011

Re: K113280

Trade/Device Name: Carotid Coil GE 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 4, 2011 Received: November 7, 2011

#### Dear Mr. Job:

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. Iisting 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 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/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 Pastel

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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# Indications for Use Form

510(k) Number (if known): K113280

Device Name: Carotid Coil GE1.5T

Indications for Use:

The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the region of the neck and lower cranium.

Prescription Use x 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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Markel D'Oyle

sion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) 113280