HFO SHOULDER COIL

K080120 · Philips Medical Systems MR Finland · MOS · Mar 10, 2008 · Radiology

Device Facts

• Record ID: K080120
• Device Name: HFO SHOULDER COIL
• Applicant: Philips Medical Systems MR Finland
• Product Code: MOS · Radiology
• Decision Date: Mar 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended 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. 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 Story

HFO Shoulder Coil is a cup-shaped, plastic-enclosed, receive-only MRI coil; contains three coil elements, tuning/decoupling electronics, and preamplifiers. Device placed on patient shoulder; cable connects to patient table for power, control, and RF signal transfer. Operates as part of Philips High Field Open (1.0T) Panorama system. Used by trained clinicians to acquire MR images of shoulder anatomy. Output is raw RF signal processed by the MRI system into diagnostic images; assists physicians in soft tissue structure assessment and diagnosis. Benefits include specialized imaging of shoulder region.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and bench testing confirming the coil functions as a receive-only accessory without altering the safety profile of the host MRI system.

Technological Characteristics

Cup-shaped plastic enclosure; three-element receive-only coil; includes tuning/decoupling electronics and preamplifiers. Interfaces with Philips High Field Open (1.0T) Panorama system via cable. Hydrogen nuclei excitation. No changes to system safety specifications (static field, SAR, acoustic noise).

Indications for Use

Indicated for imaging of shoulder and adjacent regions using hydrogen nuclei in patients requiring MRI diagnostics. Used with the High Field Open (1.0T) Panorama system for soft tissue structure visualization.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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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 Systems<br>MR Technologies Finland Oy |
|----------------------|---------------------------------------------------------|
| Address: | Ayrities 4<br>PO Box 185<br>FIN-01510<br>Vantaa 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 Road<br>Cleveland, OH 44143 OH | |
| Telephone #: | [phone] | |
| Telephone # | [phone] | |
| Facsimile #: | [phone] | |
| E-mail:[e-mail] | | |

# 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

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.

### 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 [phone] or [phone] 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.

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.

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