HTS EXTREMITY COIL, HTS SURFACE COIL

K112293 · Time Medical Systems, Inc. · MOS · Sep 30, 2011 · Radiology

Device Facts

• Record ID: K112293
• Device Name: HTS EXTREMITY COIL, HTS SURFACE COIL
• Applicant: Time Medical Systems, Inc.
• Product Code: MOS · Radiology
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

HTS Surface Coil is used to image peripheral anatomies, such as, wrist, ankle, Temporo-mandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System. HTS Extremity Coil is predominantly used for imaging anatomies, such as, knee, ankle, and wrist. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

Device Story

HTS Surface and Extremity Coils are receive-only radiofrequency (RF) coils for MRI imaging; designed for peripheral anatomy (wrist, ankle, TMJ, eye, finger, knee). Coils utilize liquid nitrogen (LN2) cooling to achieve high-temperature superconductivity (HTS). Devices connect to Time Medical 0.35T PICA Whole Body MRI System. Coils capture RF signals from patient anatomy; signals are processed by the MRI system to generate diagnostic images. Used in clinical settings by trained MRI technologists/radiologists. Output provides anatomical visualization for clinical diagnosis. Benefit includes high-sensitivity imaging of peripheral structures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison, design, and material similarity to predicate devices.

Technological Characteristics

High-temperature superconducting (HTS) receive-only RF coils. Cooling: Liquid Nitrogen (LN2). Construction: ABS plastic. Configuration: Single-channel (Surface coil for HTS Surface Coil; Volume coil for HTS Extremity Coil). Energy: Passive RF receive-only. Connectivity: Proprietary interface for Time Medical 0.35T PICA MRI system.

Indications for Use

Indicated for imaging peripheral anatomies (wrist, ankle, TMJ, eye, finger, knee) in patients requiring MRI examination. Compatible with Time Medical 0.35T PICA Whole Body MRI System. No specific contraindications listed.

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

• HTS Coil as Accessory of the MONA MRI System (K092230)
• HTS Coil (K022863)

Submission Summary (Full Text)

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#### TIME MEDICAL SYSTEMS

510(k) Report for HTS Surface Coil, HTS Extremity Coil

| | | Attachment 2: 510(k) Summary | | |
|-----|----------------------------------|------------------------------|--|---|
| | Attachment 2 | K112293 | | |
| | 510 (k) Summary | SEP 30 2011 | | |
| 2.1 | summary | | | 1 |
| 2.2 | General Safety and Effectiveness | | | 2 |
| 2.3 | Substantial Equivalence | | | 2 |

# 2.1 SUMMARY

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| Comparison<br>Element | Filing Device | Predicate Device | | | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K092230<br>(Mona<br>Orthopedic<br>MRI System)<br>(an accessory<br>of LNH) | K022863 | | |
| Product Code | MOS | MOS | | | |
| Applicant | Time Medical | Time Medical | University of Hong Kong | | |
| Regulation Number | 892.1000 | 892.1000 | 892.1000 | | |
| Panel | Radiology | Radiology | Radiology | | |
| Class | Class II | Class II | Class II | | |
| Device Name (Model<br>Number) | HTS Surface Coil<br>(TM-HTS-SF001-0R35),<br>HTS Extremity Coil<br>(TM-HTS-KN001-0R35) | HTS Coil as<br>Accessory of<br>the MONA MRI<br>System | HTS Coil<br>(HTS Coil) | | |
| Characteristics | HTS Surface Coil | | HTS Extremity<br>Coil | K092230 | K022863 |
| Intended Use | HTS Surface Coil is<br>used to image<br>peripheral<br>anatomies, such as,<br>wrist, ankle,<br>Temporo-mandibular<br>Joints (TMJ), Eye,<br>finger and other<br>parts of the body,<br>close to the surface<br>of skin. It is<br>compatible to be<br>used with Time<br>Medical's 0.35T<br>PICA Whole Body<br>MRI System. | | HTS Extremity<br>Coil is<br>predominantly<br>used for<br>imaging<br>anatomies,<br>such as, knee,<br>ankle, and<br>wrist. It is<br>compatible to<br>be used with<br>Time Medical's<br>0.35T PICA<br>Whole Body<br>MRI System. | HTS Surface<br>Coil is used to<br>image<br>peripheral<br>anatomies<br>such as, Wrist,<br>Ankle, TMJ,<br>Eye, Finger<br>and other parts<br>of the body,<br>close to the<br>surface of the<br>skin. | MRI surface coil for<br>peripheral<br>anatomical imaging<br><br>Anatomical region:<br>Temporo-mandibular<br>joint (TMJ), wrist<br>and other anatomies<br>that are no deeper<br>than 1.5 inches from<br>the skin. |
| Applicable Systems | Time Medical,<br>Pica Whole-body<br>MRI System | | Time Medical,<br>Pica Whole-body<br>MRI System | Time Medical,<br>Mona<br>Orthopedic<br>MRI System | GE<br>0.2T Signa Profile<br>MRI System |
| Mode of Operation | Single-Channel | | Single-Channel | Single-Channel | Single-Channel |
| Coil Configuration (Linear,<br>Quad, array, etc) | Single Channel<br>surface coil | | Single Channel<br>Volume coil | Single Channel<br>surface coil | Single Channel<br>surface coil |

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| Safety | | | | |
|------------------------------------|---------------------------|---------------------------|---------------------------|---------------------------|
| SAR (T/R Coils) | N/A, Receive<br>Only Coil | N/A, Receive<br>Only Coil | N/A, Receive<br>Only Coil | N/A, Receive Only<br>Coil |
| Power Input Protection (T/R Coils) | N/A, Receive<br>Only Coil | N/A, Receive<br>Only Coil | N/A, Receive<br>Only Coil | N/A, Receive Only<br>Coil |
| Material | ABS | ABS | ABS | PVC |

| Technological<br>Parameter | Filing Device:<br>HTS Surface Coil | HTS Extremity Coil | Predicate Device:<br>HTS Coil as Accessory of<br>K092230 (Mona Orthopedic MRI System) | HTS Coil (K022863) |
|----------------------------|------------------------------------|-------------------------------|---------------------------------------------------------------------------------------|--------------------------------|
| T/R | Receive-Only | Receive-Only | Receive-Only | Receive-Only |
| Coil Type | Single Channel<br>Surface Coil | Single Channel<br>Volume Coil | Single Channel<br>Surface Coil | Single Channel<br>Surface Coil |
| Cooling liquid | LN2 (Liquid<br>Nitrogen) | LN2 (Liquid<br>Nitrogen) | LN2 (Liquid<br>Nitrogen) | LN2 (Liquid<br>Nitrogen) |

## 2.2 GENERAL SAFETY AND EFFECTIVENESS

The technological characteristics of Time Medical's HTS Surface Coil and HTS Extremity Coil are similar to the predicate device. They work on the same principle, have similar design, are constructed of similar materials and are of similar safety and effectiveness.

lt does not induce other safety issues and warning than already valid for the current cleared RF external coils.

## 2.3 SUBSTANTIAL EQUIVALENCE

The HTS Surface coil and the HTS Extremity Coil are substantially equivalent to the other HTS coil(s) which has been cleared for commercial distribution as part of Time Medical Limited's MONA Orthopedic MRI System (ref. K092230), and the HTS coil of University of Hong Kong (K022863).

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Public Health Service

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

Time Medical Systems, Inc. % Mr. John Baby Director-Regulatory Affairs Time Medical Limited, G/F Bio-Informatics Centre No. 2 Science Park West Avenue Hong Kong Science Park, Shatin, New Territories. Hong Kong CHINA

SEP 3 0 2011

Re: KI12293

Trade/Device Name: HTS Surface Coil, HTS Extremity Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 1. 2011 Received: August 10. 2011

Dear Mr. Baby:

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 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,

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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510(k) Report for HTS Surface Coil, HTS Extremity Coil

TIME MEDICAL

Attachment 3: Indications of Use

### Indications for Use

510(k) Number (if known):

Device Name: HTS Surface Coil, HTS Extremity Coil

Indications for Use:

HTS Surface Coil is used to image peripheral anatomies, such as, wrist, ankle, Temporomandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

HTS Extremity Coil is predominantly used for imaging anatomies, such as, knee, ankle, and wrist. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

Prescription Use _____x______x

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Mary S. Pastel

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

**510(k) Number** K112293

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