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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MRgFUS Pelvic Coil:

Summary of Acceptance Criteria and Device Performance:

The document describes the MRgFUS Pelvic Coil as a device substantially equivalent to a predicate device (Pelvic Array Coil by USA Instruments, Inc.). The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device and meeting relevant established performance standards for medical electrical equipment and MRI coils. The reported device performance is that it conforms to these standards and specifications.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence (Functional/Technical)	- Receive-only coil	Meets: Receive-only coil
	- Dual elements coil as a basic structure component	Meets: Dual elements coil as a basic structure component
	- Comparable dimensions and weight	Meets: Comparable dimensions and weight
	- Compatibility with 1.5 T GE MRI Systems	Meets: Compatibility with 1.5 T GE MRI Systems
	- Active and passive RF Decoupling circuits	Meets: Active and passive RF Decoupling circuits
	- Employ hydrogen nuclei excitation for imaging	Meets: Employs hydrogen nuclei excitation for the imaging of the scanned organ
	- Operation with InSightec FUS for MR thermometry	Meets: Operation in conjunction with the InSightec Focused UltraSound (FUS) treatment employing MR thermometry to monitor temperature
	- Optimal Signal to Noise Ratio (SNR), coverage, and high-resolution imaging	Meets: Optimal Signal to Noise Ratio (SNR) and coverage and high-resolution imaging
Safety Standards	- IEC 60601-1 (1988) w/ Amendments (1991, 1995)	Conforms to relevant recognized standards
	- IEC 60601-2-33 (2002-05)	Conforms to relevant recognized standards
	- UL 94 (Flammability)	Conforms to relevant recognized standards
MRI Coil Performance Standards	- NEMA MS 6 (Characterization of Special Purpose Coils)	Conforms to relevant recognized standards
FDA Guidance	- FDA Guidance for Diagnostic Submission of Premarket Notification for Magnetic Resonance Diagnostic Devices	Conforms to relevant recognized standards
Device Specifications	- Meets its specifications	Device was tested to verify it meets its specifications
New Safety/Effectiveness Issues	- No new safety and/or effectiveness issues raised by minor differences	Substantially equivalent, not raising new safety and/or effectiveness

Study Information Based on Provided Text:

The provided document is a 510(k) summary for a premarket notification, which largely focuses on demonstrating substantial equivalence. It does not describe a detailed clinical or comparative effectiveness study in the way a traditional research paper would. Instead, it relies on testing against established standards and direct comparison of technical characteristics to a predicate device.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify a sample size or test set in terms of patient data. The "testing" mentioned refers to engineering and performance testing of the device itself against technical specifications and recognized standards, not a clinical study on human subjects or image data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not applicable as no clinical "test set" requiring ground truth establishment by experts is described in the document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as no clinical "test set" requiring adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done or reported for this device based on the provided text. This device is a hardware component (an RF coil) for an MRI system, not an AI or software assistant for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware component, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of a clinical performance study. The "ground truth" for this submission revolves around established engineering standards (IEC, UL, NEMA) and the technical specifications of the predicate device.
The sample size for the training set:
- Not applicable. No training set for an algorithm or AI model is mentioned or implied.
How the ground truth for the training set was established:
- Not applicable. As no training set is described, there's no ground truth establishment for it.

Conclusion:

The provided 510(k) summary for the MRgFUS Pelvic Coil details a submission focused on demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing technical characteristics and showing compliance with established safety and performance standards. It does not include a clinical trial, AI performance study, or any form of human-reader evaluation study. The "study" largely refers to engineering tests and comparisons against a predicate, rather than the types of clinical performance studies often associated with AI medical devices.

Summary

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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.: 001-972-544-881-399 Email: Oril@InSightec.com

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 can be used in conjunction with the InSightec Focused UltraSound (FUS) treatment.

5.14Device Description:

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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 (800) 638-2041 or (240) 276-3150

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:

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

(Division Sign-Off)

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

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.