Intended Use: The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system. The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Indications for Use: The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Abdominal, pelvic and thoracic regions. Nuclei Excited: Hydrogen.

Device Description

The SENSE Body Coil is enclosed in a flexible, water-resistant fabric housing and is secured to the patient with Velcro straps. This receive-only coil is designed to give improved signal-to-noise, image resolution and image acquisition time over that of the standard body coil.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "SENSE Body Coil." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing direct evidence of device performance against specific acceptance criteria through a comprehensive clinical study.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in this document. The submission relies on demonstrating that the SENSE Body Coil is fundamentally similar to a previously cleared device (Philips Phased Array Flexible Cardiac Coil (K984588)).

Here's a breakdown of what can and cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (SENSE Body Coil)
Compatible MRI Systems	Philips 1.5T Infinion Systems	Same (Philips 1.5T Infinion Systems)
Mode of Operation	Receive-Only	Same (Receive-Only)
Antenna Configuration	Co-rotating saddle coils and loops (Predicate)	Two anterior loops and two posterior loops
Tuning/Impedance Matching	Fixed tuning and matching. Factory set.	Same (Fixed tuning and matching. Factory set.)
Method of Decoupling	Active PIN diode decoupling	Same (Active PIN diode decoupling)
Coil Enclosure	Flame rated foam and fabric	Same (Flame rated foam and fabric)
Number of Receive Channels	Four	Same (Four)
Intended Use	As a NMR device producing images of soft tissue structure for diagnosis by a trained physician.	Same (As a NMR device producing images of soft tissue structure for diagnosis by a trained physician.)
Indications for Use (Anatomic Regions)	Heart and associated structures in the thoracic region (Predicate)	Abdominal, pelvic and thoracic regions
Indications for Use (Nuclei Excited)	Hydrogen	Same (Hydrogen)

Note: The acceptance criteria are implied by the characteristics of the predicate device, K984588. The SENSE Body Coil's performance is reported by stating it is "Same" for most parameters, except for the antenna configuration and the specific anatomic regions for its Indications for Use, where a difference is noted and presumably deemed acceptable due to the nature of a body coil vs. a cardiac coil. The core functionality and safety are still considered equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document does not describe a clinical study with a test set of patient data. The submission is based on substantial equivalence to a predicate device, focusing on technical specifications and intended use.

3. 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)

Not applicable/Not provided. No test set or ground truth establishment by experts is described in this 510(k) submission.

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

Not applicable/Not provided. No test set or adjudication method is described.

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

Not applicable. This device is a passive MRI coil, not an AI or image processing algorithm. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is a passive MRI coil, not an algorithm.

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

Not applicable/Not provided. No ground truth type is mentioned as no clinical performance study for this device is detailed. The "ground truth" for this submission revolves around the technical specifications and safety profile being equivalent to a predicate device.

8. The sample size for the training set

Not applicable/Not provided. As this is not an AI/ML device, there is no training set in the conventional sense.

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

Not applicable/Not provided. There is no training set for this device.

Summary

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K031095

JUN 2 0 2003

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

General Information 1.

Classification:	Class IIMagnetic Resonance Imaging (MRI) Accessory
Common/Usual Name:	Magnetic Resonance Imaging (MRI) Coil
Proprietary Name:	SENSE Body Coil
Establishment Registration:	Philips Medical SystemsMR PMG Cleveland595 Miner RoadHighland Heights, Ohio 44143Contact: Duane C. PraschanPhone Number: (440) 483-3000FDA Owner Number: #1217116FDA Registration Number: #1525965
Performance Standards:	Not Applicable.

2. Intended Uses

The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system.

The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions:	Abdominal, pelvic and thoracic.
Nuclei Excited:	Hydrogen.

PHILIPS MEDICAL SYSTEMS	(SBC)	4/2/03	I - 1
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3. Device Description

Safety and Effectiveness 4.

The Philips SENSE Body Coil is substantially equivalent to the Philips Phased Array Flexible Cardiac Coil (K984588) in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence.

Parameter	SENSE Body Coil	Predicate Device: Phased ArrayFlexible Cardiac Coil (K984588)
Compatible MRISystems	Same.	Philips 1.5T Infinion Systems
Mode of Operation	Same.	Receive-Only
Antenna Configuration	Two anterior loops andtwo posterior loops.	Co-rotating saddle coils and loops
Tuning/ImpedanceMatching	Same.	Fixed tuning and matching. Factoryset.
Method of Decoupling	Same.	Active PIN diode decoupling
Coil Enclosure	Same.	Flame rated foam and fabric
Number of ReceiveChannels	Same.	Four
Intended Use	Same.	The 1.5T Infinion system is intendedfor use as a NMR device thatproduces images that: (1) correspondto the distribution of protonsexhibiting NMR, (2) depend uponNMR parameters (proton density,flow velocity, spin-lattice relaxationtime T1, spin-spin relaxation timeT2) and (3) display the soft tissuestructure of the head and whole body.When interpreted by a trainedphysician, these images yieldinformation that can be useful in thedetermination of a diagnosis.

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Parameter	SENSE Body Coil	Predicate Device: Phased ArrayFlexible Cardiac Coil (K984588)
Indications for Use	The Flexible Cardiac Coilis indicated for use in thefollowing anatomicregions and with thedesignated nuclei:	The Flexible Cardiac Coil isindicated for use in the followinganatomic regions and with thedesignated nuclei:
	Anatomic Regions:Abdominal, pelvic andthoracic regions.Nuclei Excited: Hydrogen	Anatomic Regions: Heart andassociated structures in the thoracicregion.Nuclei Excited: Hydrogen.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircles the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2003

Mr. Duane C. Praschan Manager, Regulatory Affairs Philips Medical Systems (Cleveland) Inc. 595 Miner Road Cleveland OH 44143

Re: K031095 Trade/Device Name: SENSE Body Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic imaging Regulatory Class: II Product Code: 90 MOS Dated: April 4, 2003 Received: April 30, 2003

Dear Mr. Praschan:

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 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SENSE Body Coil Device Name:

Indications for Use:

Intended Use

The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system.

The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time TI, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Indications for Use

The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: Abdominal, pelvic and thoracic regions

Hydrogen. Nuclei Excited:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Szyman

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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.