The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis

Device Description

The Transmit Receive Quadrature Body Coil 3.0T is a bird-cage type transmit/receive coil designed for use in the Intera 3.0T system. In transmit mode the coil is used in almost every kind of scan. In receive mode the coil is mainly used for imaging with a large field of view. The QBC has a fixed position inside the gradient coil.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Transmit/Receive Quadrature Body Coil 3.0T." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the typical sense of algorithm-based or diagnostic efficacy studies.

Therefore, many of the typical acceptance criteria and study details you'd expect for an AI or diagnostic imaging device are not applicable to this submission. The "acceptance criteria" here are primarily regulatory: demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's how to address your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Substantial Equivalence and Safety)	Reported Device Performance (from submission)
Safety: Device operates safely and does not introduce new hazards.	"The safety of the INTERA 3.0T system with the Transmit/Receive Quadrature Body Coil 3.0T remain the same as with the FDA cleared INTERA 1.5T (re. K001796)." "The QBC 3.0T does not result in any new potential hazard." Implicitly, the device meets NEMA voluntary standards, FDA MRDD guidance's, UL and IEC 601 appropriate safety standards and/or draft standards (as stated in the General Information section for the product).
Intended Use Equivalence: Device performs the same functions for the same indications as the predicate.	"The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis." This is an expansion of the system's capability, making the 3.0T system a whole-body scanner, similar to the 1.5T predicate.
Design/Technological Equivalence: Device design and technology are substantially similar to the predicate.	"The Transmit Receive Quadrature Body Coil 3.0T is a bird-cage type transmit/receive coil designed for use in the Intera 3.0T system." "The Transmit/Receive Quadrature Body Coil 3.0T is equivalent to Quadrature Body Coil used with the INTERA 1.5T system."

The "study" proving the device meets these (mostly implicit) acceptance criteria is the substantial equivalence comparison presented in the 510(k) submission itself.

2. Sample size used for the test set and the data provenance

Not Applicable. This is a hardware component submission based on substantial equivalence. There is no test set of patient data or images mentioned for performance evaluation in the context of diagnostic accuracy, as would be expected for an AI or diagnostic tool. The comparison is against an existing hardware component.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. See point 2. There's no clinical "ground truth" establishment in this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 2.

5. 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. This is a hardware component (MRI coil), not an AI device. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a hardware component (MRI coil), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable (in the clinical diagnostic sense). The "ground truth" for this submission is regulatory: the proven safety and effectiveness of the predicate device (the Quadrature Body Coil used with the INTERA 1.5T system), to which the new device is being compared for substantial equivalence.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI or algorithm-driven device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" or corresponding ground truth establishment process.

In summary:

This 510(k) submission for the Transmit/Receive Quadrature Body Coil 3.0T is a technical submission focused on demonstrating that a new hardware component built for an existing MR system is substantially equivalent to a previously cleared hardware component for a different MR system from the same manufacturer. The "study" here is the engineering and regulatory comparison of design, materials, and intended use, rather than a clinical performance study involving patient data.

Summary

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KO1 3894

Philips Medical Systems PMG Magnetic Resonance XJR-148-4750/bf 2001-11-16

JAN 1 8 2002

Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

General information

Company Name	: Philips Medical Systems North America Company.
Address	: 22100 Bothell Everett HighwayP.O. Box 3003
Registration No.	: Bothell, WA 98041-3003
Contact person	: Lynn Harmer
Device (Trade) Name	: Transmit/Receive Quadrature Body Coil 3.0T.
Classification Name	: Magnetic Resonance Diagnostic Device (MRDD).
Classification	: Class II.
Product code	: MOS
Performance standards	: NEMA voluntary standards, FDA MRDD guidance's, ULand IEC 601 appropriate safety standards and/or draftstandards are used.
Common/Usual Name	: Transmit/Receive Quadrature Body Coil 3.0T

Predicate Device(s):

The Transmit/Receive Quadrature Body Coll 3.0T is an extension to the MRDD Philips INTERA 3.0T System (re K003516). The Transmit/Receive Quadrature Body Coil 3.0T is equivalent to Quadrature Body Coil used with the INTERA 1.5T system.

Indications for use:

Device description:

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Page 2 of 2

General Safety and Effectiveness.

The safety of the INTERA 3.0T system with the Transmit/Receive Quadrature Body Coil 3.0T remain the same as with the FDA cleared INTERA 1.5T (re. K001796).The Transmit/Receive Quadrature Body Coil 3.0T permits the INTERA 3.0T system to be used as a whole body scanner. It was distributed as a head scanner only. The QBC 3.0T does not result in any new potential hazard.

Substantial Equivalence.

It is the opinion of Philips Medical Systems that the Transmit/Receive Quadrature Body Coil 3.0T is substantially equivalent to its predicate device quadrature body coil used in the INTERA 1.5T (re.K001796)

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 1 8 2002

Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431

Re: K013894

Trade/Device Name: Transmit/Receive Quadrature Body Coil 3.0T System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 21, 2001 Received: November 23, 2001

Dear Ms. Harmer:

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); 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.

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This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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Page 1 of 1.

510(k) Number (if known):

Kol 3894

Device Name :

Transmit/Receive Quadrature Body Coil 3.0T

Indication For Use :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Nancy C. Burgdon

and Rac 510(k) Num

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.