1.5T MRGFUS PELVIC COIL

K071966 · Insightec-Txsonics, Inc. · MOS · Sep 5, 2007 · Radiology

Device Facts

• Record ID: K071966
• Device Name: 1.5T MRGFUS PELVIC COIL
• Applicant: Insightec-Txsonics, Inc.
• Product Code: MOS · Radiology
• Decision Date: Sep 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE 1.5T MRI systems manufactured by GE Medical Systems. The Pelvic Array Coil can be used in conjunction with the InSightec Focused UltraSound (FUS) treatment.

Device Story

MRgFUS Pelvic Coil is a receive-only, quadrature phased array RF coil; captures hydrogen nuclei excitation signals for diagnostic MR imaging of pelvis and hips. Used with GE 1.5T MRI systems; integrates with InSightec Focused UltraSound (FUS) treatment to monitor temperature via MR thermometry. Housed in rigid/semi-flexible, fire-rated, high-impact material. Operated by radiology staff in clinical settings. Output provides high-resolution images and SNR for diagnostic assessment and treatment monitoring; assists clinicians in visualizing anatomy and guiding FUS procedures.

Clinical Evidence

Bench testing only. Device performance verified against IEC 60601-1, IEC 60601-2-33, UL 94, and NEMA MS 6 standards to ensure safety, electromagnetic compatibility, and image quality (SNR/resolution).

Technological Characteristics

Receive-only, quadrature phased array RF coil. Dual-element structure. Fire-rated, high-impact, tensile-strength housing. Active and passive RF decoupling circuits. Compatible with GE 1.5T MRI systems. Standards: IEC 60601-1, IEC 60601-2-33, UL 94, NEMA MS 6.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of the pelvis and hips. Compatible with GE 1.5T MRI systems and InSightec Focused UltraSound (FUS) treatment.

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

• Pelvic Array Coil (USA Instruments, Inc.) (K033753)

Submission Summary (Full Text)

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#### 510(K) SUMMARY

SEP - 5 2007

510(K) Number K071966

# 5.1 Applicant's Name:

INSIGHTEC, LTD. 5 Nahum Heth st. Tirat Carmel, 39120 ISRAEL

#### 5.2 Contact Person:

Ori Lubin InSightec Ltd Regulatory Affairs Manager Nahum Heth St. Tirat Carmel, Israel, 39120 Tel.: [phone] Email: [e-mail]

#### 5.3 Date Prepared:

July 2007

#### 5.4 Trade Name:

MRgFUS Pelvic Coil

#### 5.5 Classification Name:

Magnetic Resonance Diagnostic Device

#### 5.6 Medical Specialty:

Radiology

5.7 Product Code: MOS

5.8 Device Class: II

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#### 5.9 Regulation Number:

CFR 892.1000

# 5.10Panel:

Radiology

#### 5.11Predicate Device:

Pelvic Array Coil (USA Instruments, Inc.), K033753.

#### 5.12Performance 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 (2002-05); 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

NEMA: MS 6 Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images

FDA Guidance for Diagnosis Submission of Premarket Notification for Magnetic Resonance Diagnostic Devices, FDA, CDRH

#### 5.13Intended Use / Indication for Use:

The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE 1.5T MRI systems manufactured by GE Medical Systems.

The Pelvic Array Coil can be used in conjunction with the InSightec Focused UltraSound (FUS) treatment.

#### 5.14Device Description:

The MRgFUS Pelvic Array Coil is a receive-only, quadrature phased array RF coil, used for obtaining diagnostic MR images of the pelvis, including the hips. The elements and associated circuitry are enclosed in both rigid and semi-flexible housing that is fire rated and has a high impact and tensile strength.

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#### 5.15Substantial Equivalence:

The MRgFUS pelvic array Coil manufactured by InSightec is equivalent to the pelvic array coil manufactured by USAI for InSightec

The MRgFUS Coil and its predicate device also share common technological characteristics and principles of operations. Specifically, similar to its predicate, it employs the following characteristics:

- . Receive-only coil.
- A dual elements coil as a basic structure component. .
- Comparable dimensions and weight. .
- Compatibility with 1.5 T GE MRI Systems. .
- Active and passive RF Decoupling circuits. .
- . Employ hydrogen nuclei excitation for the imaging of the scanned organ.
- Operation in conjunction with the InSightec Focused UltraSound . (FUS) treatment employing MR thermometry to monitor temperature.
- Optimal Signal to Noise Ratio (SNR) and coverage and high-. resolution imaging

In addition, the MRgFUS Coil was tested to verify that it meets its specifications and conforms to the relevant recognized standards, to ensure that any minor difference between the coil and its predicate does not raise any new questions of safety and effectiveness.

Based on the safety and performance testing results, and the analysis of similarities and differences summarized above, InSightec Ltd. believes that the MRgFUS Coil is substantially equivalent to its predicate device, without raising new safety and/or effectiveness issues.

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Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The central graphic consists of three curved, parallel lines that resemble a stylized bird or a flowing design. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services in the United States.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Nadir Alikacem Pole Manager InSightec-TxSonics, Inc. 2777 Stemmons Frwy, Suite 940 DALLAS TX 75204

Re: K071966

Trade/Device Name: MRgFUS Pelvic Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 8, 2007 Received: July 16, 2007

#### Dear Mr. Alikacem:

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 (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in a stylized font. Underneath the acronym, the word "Centennial" is written in cursive. There are three stars below the word "Centennial". The text "Food and Drug Administration" is written around the bottom of the circle.

alating and Promoting Our

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Page 2 -

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); 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.

This fetter 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C Hodgdon

Nancy C. Brogdon 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): K071966

Device Name: MRgFUS Pelvic Coil

#### Indications For Use:

The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE 1.5T MRI systems manufactured by GE Medical Systems. The Pelvic Array Coil can be used in conjunction with the InSightec Focused UltraSound (FUS) treatment.

AND/OR Prescription Use マ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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) Page 1 of 1

Whang

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(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 2071910 510(k) Number __