The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below.

The High Field Open (1.0T) Panorama system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2), and (3) display the soft tissue structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Device Description

The HFO Shoulder Coil consists of a cup-shaped, plastic enclosure containing three coil elements for receiving of RF signals from the shoulder and adjacent region. The enclosure is placed on patient's shoulder for imaging. The enclosure contains tuning and decoupling electronics circuitry and preamplifiers. The coil enclosure has a cable attached to it and the cable connector is plugged into the system connector on the patient table. The cable provides the coil with supply and control voltages and transfers the received RF signals to the system. The cable connector contains coil interface circuitry for the system.

AI/ML Overview

Here's an analysis of the provided 510(k) submission for the Philips Medical Systems HFO Shoulder Coil, based on the information available:

The provided document is a 510(k) summary for a Magnetic Resonance (MR) specialty coil, not a diagnostic AI device or software. Therefore, many of the requested sections related to AI performance criteria, ground truth, and clinical study designs (like MRMC or standalone performance) are not applicable to this type of submission.

This submission focuses on demonstrating substantial equivalence to a predicate device for hardware components used in an existing MR system. The "performance" in this context refers to the coil's ability to produce quality MR images within the existing safety and efficacy profile of the MRI system it's used with.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

As this is a hardware accessory (MR coil) and not an AI or diagnostic software, explicit "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC are not presented in this document. The primary acceptance criteria for such a device would revolve around:

Safety: Meeting established safety standards for MRI coils (e.g., SAR, static field, time-varying magnetic fields, acoustic noise) when integrated with the specific MRI system.
Functionality: Correct operation, successful image acquisition.
Image Quality: Producing images comparable to or better than previously cleared coils for the same anatomical region, enabling diagnostic interpretation.
Substantial Equivalence: Alignment with the design, materials, and intended use of a legally marketed predicate device.

Acceptance Criteria (Implied for MR Coils)	Reported Device Performance
Safety: No change to existing safety specifications (static field, time-varying magnetic fields, SAR, acoustic noise) of the Philips HFO (1.0T) Panorama system. No additional potential hazards compared to currently marketed, receive-only coils.	"The use of the HFO Shoulder Coil does not result in any changes to the safety specifications for the safety parameters (i.e., static field, time-varying magnetic fields, SAR, or acoustic noise) of the Philips HFO (1.0T) Panorama system. The use of this device does not result in additional potential hazards when compared to currently marketed, receive-only coils." (Section 2.3 Safety Information)
Intended Use: Consistent with the existing indications for use of the cleared High Field Open (1.0T) Panorama system for producing interpretable MR images of the shoulder and adjacent regions using Hydrogen nuclei.	"The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system... The HFO Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Region: Shoulder and adjacent regions, Nuclei Excited: Hydrogen." (Section 2.2 Intended Use) The general system indications for use describe the production of images useful for diagnostic determination when interpreted by a trained physician. While not explicitly stated as "performance metrics," the implication is that the coil would facilitate this existing performance.
Substantial Equivalence: Demonstrated equivalence to a legally marketed predicate device.	"The HFO Shoulder Coil is substantially equivalent to the Invivo Corporation Shoulder Array Coil Set QSC-127-INT." (Section 2.4 Conclusion). This equivalence is based on similar technology, intended use, and safety profile.

Study Proving Acceptance Criteria:

The document explicitly states: "The use of the HFO Shoulder Coil does not result in any changes to the safety specifications for the safety parameters (i.e., static field, time-varying magnetic fields, SAR, or acoustic noise) of the Philips HFO (1.0T) Panorama system." and "The use of this device does not result in additional potential hazards when compared to currently marketed, receive-only coils." This implies that testing (likely in-house engineering and phantom testing, and possibly animal or human subject scanning for image quality assessment, though not detailed in this summary) was conducted to verify that the coil operates within the established safety envelope of the MRI system and produces diagnostically acceptable images. The primary "study" here is the comparison to the predicate device and verification against established MRI safety standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided summary. For an MR coil, "test set" would typically refer to phantom data, cadaver data, and/or small numbers of healthy volunteer or patient scans. This document does not provide details on the number of subjects or phantom scans.
Data Provenance: Not specified. Testing would likely be conducted by the manufacturer, Philips Medical Systems, in Finland (where the coil is manufactured) or at a Philips testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable: For an MR coil, the concept of "ground truth" for diagnostic accuracy is not directly applied in the same way as for AI software. The "truth" is established by the accepted physics and engineering principles of MRI, and the output is images that trained radiologists use for diagnosis, not a primary diagnostic output from the device itself. While image quality would be assessed, it's typically done by trained MR physicists or radiologists ensuring the images are suitable for interpretation, rather than establishing a specific "ground truth" for a diagnostic outcome.

4. Adjudication Method for the Test Set

Not Applicable: As there's no clinical "ground truth" being established in the traditional sense for diagnostic performance, an adjudication method isn't relevant here.

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, Not Applicable: This device is an MR coil, not an AI or diagnostic software. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant to this submission.

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

No, Not Applicable: This is an MR coil, not an algorithm, so a standalone performance study as described is not relevant.

7. The Type of Ground Truth Used

Implicit Engineering and Clinical Acceptability: The "ground truth" for an MR coil is its ability to:
- Adhere to safety specifications (e.g., quantifiable SAR measurements, electromagnetic compatibility).
- Produce images with expected signal-to-noise ratio, uniformity, and artifact levels (often assessed against phantom standards and clinical expert opinion on diagnostic utility).
- Maintain the diagnostic capability of the overall MRI system.
Not Applicable in the sense of expert consensus, pathology, or outcomes data for a specific diagnosis, as the coil itself does not provide a diagnosis.

8. The Sample Size for the Training Set

Not Applicable: This is a hardware component. There is no "training set" in the context of machine learning or AI. Hardware design and development involve extensive engineering, simulation, and testing, but not training data for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not Applicable: No training set as described for AI/ML.

Summary

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Koso120

Philips Medical Systems Premarket Notification [510(k)] Submission

510(K) SUMMARY

This summary is being submitted in accordance with 21 CFR 807.92.

MAR 1 0 2008

1. GENERERAL INFORMATION

1.1. Submitter Information

Manufacturer's Name:	Philips Medical SystemsMR Technologies Finland Oy
Address:	Ayrities 4PO Box 185FIN-01510Vantaa FINLAND

Establishment Registration #

9680194

1.2. Contact Person Name and Information

Contact:	Catherine M. Connell
Title:	Quality & Regulatory Engineer
Company:	Philips Medical Systems (Cleveland), Inc.
Address:	595 Miner RoadCleveland, OH 44143 OH
Telephone #:	(440) 482-5581
Telephone #	(440) 483-5581
Facsimile #:	(440) 483-2648
E-mail:catherine.connell@philips.com

1.3. Trade name and common name of device

Trade name: HFO Shoulder Coil Magnetic resonance specialty Coil Common name:

1.4. Classification of the device

Classification:	Coil, Magnetic Resonance, Specialty
Regulation:	21 CFR 892.1000
Class:	Class II
Procode:	MOS

1.5. Predicate Device`

Invivo Corporation Shoulder Array Coil Set QSC-127-INT (K040288)

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2. BASIS FOR SUBSTANTIAL EQUIVALENCE DETERMINATION 2.1. Device Description

2.2. Intended use

The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below. The High Field Open (1.0T) Panorama system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spinlattice relaxation time (T1), and spin-spin relaxation time (T2), and (3) display the soft tissue structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

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

Anatomic Region:	Shoulder and adjacent regions
Nuclei Excited:	Hydrogen

2.3. Safety Information

The use of the HFO Shoulder Coil does not result in any changes to the safety specifications for the safety parameters (i.e., static field, time-varying magnetic fields, SAR, or acoustic noise) of the Philips HFO (1.0T) Panorama system. The use of this device does not result in additional potential hazards when compared to currently marketed, receive-only coils.

2.4. Conclusion

The HFO Shoulder Coil is substantially equivalent to the Invivo Corporation Shoulder Array Coil Set QSC-127-INT.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Philips Medical Systems MR Finland % Ms. Catherine Connell Quality & Regulatory Engineer Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143

MAR 1 0

Re: K080120

Trade/Device Name: HFO Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 4, 2008 Received: January 17, 2008

Dear Ms. Connell:

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/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a stylized font. Below the letters, the word "Centennial" is written in cursive. There are three stars at the bottom of the logo.

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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 (OS) 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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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INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

HFO Shoulder Coil

1080120

Indications for Use:

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

Anatomic Region: Shoulder and adjacent regions Nuclei Excited: Hydrogen

The addition of the HFO Shoulder Coil does not change the existing indications for use of the cleared High Field Open (1.0T) Panorama system, as defined below.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ammar M. Khan

510(k) Numbe

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.