SYNERGY SPINE ARRAY COIL

• K Number: K033662
• Device Name: SYNERGY SPINE ARRAY COIL
• Manufacturer: PHILIPS MEDICAL SYSTEMS, INC.
• Date Cleared: 2004-02-02 ( 73 days)
• Product Code: MOS
• Regulation Number: 892.1000

Intended Use

The intended use of the Panorama 0.6T SSA coil is to be used in MR imaging of the spine. The Panorama 0.6T system is a whole body scanner and 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 internal 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 SSA coil is indicated for use in the following anatomic regions and with the designated nuclei: Thoracic and Lumbar or spine and sternum Anatomic Regions: Nuclei Excited: Hydrogen

Device Description

The SSA coil is an optional accessory to the Panorama 0.6T MR system. This receiveonly coil is designed for use when large imaging volume is required or when the patient is large or when easy usage is essential.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a receive-only coil for an MR system and does not mention any AI or ML capabilities in its description, intended use, or performance studies.

Therapeutic

No
Explanation: The device is an MR coil used for imaging to aid in diagnosis, not for treating a disease or condition.

Diagnostic

Yes

The text states that the images produced by the device "yield information that can be useful in the determination of a diagnosis" when interpreted by a trained physician. This indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device is described as a "receive-only coil," which is a hardware component used in MR imaging. The description focuses on its physical characteristics and intended use as an accessory to an MR system, not as a standalone software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The Panorama 0.6T SSA coil is an accessory for an MR imaging system. It is used to acquire images of the internal structure of the body based on the principles of Nuclear Magnetic Resonance (NMR).
• Intended Use: The intended use is for MR imaging of the spine and other anatomical regions. The images are then interpreted by a trained physician to aid in diagnosis. This is an in vivo (within the living body) imaging process, not an in vitro test on a sample.

The device's function and intended use clearly fall under the category of medical imaging equipment, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the Panorama 0.6T SSA coil is to be used in MR imaging of the spine. The Panorama 0.6T system is a whole body scanner and 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 internal 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 SSA coil is indicated for use in the following anatomic regions and with the designated nuclei:

Thoracic and Lumbar or spine and sternum Anatomic Regions:

Nuclei Excited: Hydrogen

Product codes

90 MOS

Device Description

The SSA coil is an optional accessory to the Panorama 0.6T MR system. This receiveonly coil is designed for use when large imaging volume is required or when the patient is large or when easy usage is essential.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance Imaging (MRI)

Anatomical Site

Spine, Thoracic and Lumbar or spine and sternum, head, extremities and whole body.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Phantom and clinical studies were performed to support the claim of substantial equivalence and to show that the technological differences do not raise new questions pertaining to safety and effectiveness.

Key Metrics

Not Found

Predicate Device(s)

Integrated Spine Array (ISA) coil for Philips Infinion 1.5T system

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Ko 33662

FEB - 2 2004

510(k) Summary

(As required by 21CFR 807.92)

I General Information

| Classification: | Class II
Classification Number 90 MOS
Magnetic Resonance Imaging (MRI) Accessory |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/usual name: | Magnetic Resonance Imaging (MRI) Coil |
| Proprietary Name: | Synergy Spine Array coil (SSA) |
| Predicate device(s): | Integrated Spine Array (ISA) coil for Philips Infinion 1.5T system |
| Establishment Registration: | Manufacturer:
Philips Medical Systems MR Technologies Finland, Inc.
Äyritie 4
FI-01510 Vantaa, Finland
Phone: [phone]
Fax: [phone]
FDA Facility Registration #9680194
FDA Owner #1217116

United States Contact:
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Highland Heights, Ohio 44143
Contact: Duane C. Praschan
Phone: [phone]
FDA Registration #1525965 |
| Performance Standards: | No applicable performance standards have been issued under section 514
of the Food, Drug and Cosmetic Act. |

Safety and Effectiveness Information Supporting Substantial Equivalence 【】

Intended use o

The intended use of the Panorama 0.6T SSA coil is to be used in MR imaging of the spine. The Panorama 0.6T system is a whole body scanner and 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 internal 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

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Koszalin
1 sie 2012

of a diagnosis.

The SSA coil is indicated for use in the following anatomic regions and with the designated nuclei:

Thoracic and Lumbar or spine and sternum Anatomic Regions:

Nuclei Excited: Hydrogen

Device Description

The SSA coil is an optional accessory to the Panorama 0.6T MR system. This receiveonly coil is designed for use when large imaging volume is required or when the patient is large or when easy usage is essential.

Relevant Technological Characteristics ം

The technological characteristics of the SSA coil are similar to the predicate ISA coil. The potential benefits associated with the SSA coil include improved patient handling and possibilities to image larger patients than with the Body & Spine coils in the Panorama 0.6T system.

Safety & Effectivness

The SSA coil is substantially equivalent to the Philips ISA Coil in safety and effectiveness. The safety parameters (Static Field, dB/dt, SAR and Acoustic Noise) and the performance parameters (SNR, Image Uniformity, Geometric Distortion, Slice Thickness & Spacing, and Spatial Resolution) for the Panorama 0.6T MR system are unaffected with the SSA coil.

Substantial Equivalence o

Phantom and clinical studies were performed to support the claim of substantial equivalence and to show that the technological differences do not raise new questions pertaining to safety and effectiveness.

. Conclusion

It is the opinion of Philips Medical Systems that the SSA coil of the Panorama 0.6T system is substantially equivalent to the predicate ISA coil of the Philips Infinion 1.5T system.

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three curved lines that resemble a bird in flight or a symbolic representation of human services. The emblem is positioned diagonally within the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2004

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

Re: K033662

Trade/Device Name: Synergy Spine Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 18, 2003 Received: November 21, 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 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.

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.

3

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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bryden

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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510(k) Number (if known): __ Ko 3 3 ما جاء 2

SYNERGY SPINE ARRAY COIL Device Name:

Indications for Use:

Intended Use

The Synergy Spine Array Coil does not change the existing indications as defined below.

The Panorama 0.6T MR Imaging 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 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 Synergy Spine Array Coil is indicated for use in the following anatomic regions and with designated nuclei:

Anatomic Regions:	Thoracic and lumbar
Nuclei Excited:	Hydrogen

(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)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K033462