DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)

K123492 · Philips Medical Systems · MOS · Dec 13, 2012 · Radiology

Device Facts

• Record ID: K123492
• Device Name: DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
• Applicant: Philips Medical Systems
• Product Code: MOS · Radiology
• Decision Date: Dec 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Ingenia 1.5T and Ingenia 3.0T are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis. In addition, the Ingenia 1.5T and Ingenia 3.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.

Device Story

Device consists of specialized radio frequency (RF) receive-only coils for Philips 1.5T and 3.0T MRI systems; coils receive RF signals from excited nuclei in patient anatomy; signals processed by MRI system to produce cross-sectional images, spectroscopy images, or spectra; used in clinical settings by trained physicians; facilitates diagnostic imaging and MR-guided interventional procedures in head, body, and extremities; provides high-resolution internal structure visualization; aids clinical decision-making through diagnostic image interpretation.

Clinical Evidence

No clinical data; bench testing only. Substantial equivalence based on design similarities to predicate.

Technological Characteristics

Receive-only RF coils for 1.5T and 3.0T MRI systems. Operates in conjunction with system body coil. No changes to electrical or mechanical design.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging or MR-guided interventional procedures of the head, body, and extremities. Used by trained physicians for diagnostic assistance.

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

• MRI Coil devices (K110151)

Submission Summary (Full Text)

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K123492 p //2

DEC 1 3 2012

## 510(k) Summary of Safety and Effectiveness

Submitted By:

Registration No:

Date:

Contact Person:

Proprietary Names:

Philips Medical Systems Nederland BV Veenpluis 4-6 5684 PC Best, Netherlands 5684 PC

3003768277

November 9, 2012

Lisa Simpson Regulatory Engineer / Philips Healthcare Tel: [phone] ext. 164 Fax: [phone] Email: [e-mail]

Philips Ingenia 1.5T & Ingenia 3.0T devices:

dS Anterior 1.5T dS Base 1.5T dS Head-Neck 1.5T dS Head 1.5T Flex S 1.5T Flex M 1.5T Flex L 1.5T

21 CFR 892.1000

dS Anterior 3.0T dS Base 3.0T dS Head-Neck 3.0T dS Head 3.0T Flex S 3.0T Flex M 3.0T Flex L 3.0T

Common Name:

Coil, Magnetic Resonance, Specialty

Classification Name and Reference:

A magnetic resonance diagnostic device, 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, class II.

Device Product Code and Panel Code: MOS / Radiology / 90

### Device Description:

The 510(k) subject devices are magnetic resonance coil is designed and intended for use with Philips 1.5T & 3.0T Magnetic Resonance Imaging (MRI) systems. The MR Coil devices work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as receive only for high resolution diagnostic imaging of internal body structures.

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# 510(k) Summary of Safety and Effectiveness

### Indications for Use:

The Ingenia 1.5T and Ingenia 3.0T are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

In addition, the Ingenia 1.5T and Ingenia 3.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.

#### Technological Characteristics:

The fundamental scientific technology of a radio frequency (RF) coil is that the coil receives radio frequency signals from the anatomy of interest.

### Substantial Equivalence Information:

When compared to the predicate MRI Coil devices (K110151, cleared 03/22/11), substantial equivalency of the 510(k) subject devices is based on design similarities and the same indications for use. The scope of this Special 510(k) is supplemental labeling to allow the MR I coil accessory devices to be packaged and labeled at another facility owned by Philips. There are no changes to the electrical or mechanical design of the MRI coil devices and no changes to the indications for use. The new labeling does not supplant any of the labeling for the MRI system as described in K110151.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the logo.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-002

December 13, 2012

Philips Medical Systems-Nederland BV % Ms. Lisa Simpson Regulatory Engineer Philips Medical Systems-Invivo Corporation 3545 W 47th Avenue GAINESVILLE FL 32608

Re: K123492

Trade/Device Name: Philips Ingenia 1.5T & 3.0T MR Coil Devices: dS Anterior 1.5T, dS Base 1.5T, dS Head-Neck 1.5T, Flex S 1.5T, Flex M 1.5T, Flex L 1.5T, dS Anterior 3.0T, dS Base 3.0T, dS Head-Neck 3.0T, dS Head 3.0T, Flex S 3.0T, Flex M 3.0T, Flex L 3.0T

Regulation Number: 21 CFR 892.1000

Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II

Product Code: MOS Dated: November 9, 2012 Received: November 13, 2012

Dear Ms. Simpson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2-Ms. Simpson

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Janine Mi Morris -S

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### k123492 510(k) Number (if known):

Philips Ingenia 1.5T & Ingenia 3.0T MR Coil Devices:

dS Anterior 1.5T dS Base 1.5T dS Head-Neck 1.5T dS Head 1.5T Flex S 1.5T Flex M 1.5T Flex L 1.5T

dS Anterior 3.0T dS Base 3.0T dS Head-Neck 3.0T dS Head 3.0T Flex S 3.0T Flex M 3.0T Flex L 3.0T

### Indications For Use:

Device Name:

The Ingenia 1.5T and Ingenia 3.0T are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

In addition, the Ingenia 1.5T and Ingenia 3.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.

Prescription Use × (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 In Vitro Diagnostics and Radiological Health (OIR)

| | Janine M. Morris -S |
|--|---------------------------------|
| | (Division Sign Off)/ |
| | 2012.12.13 12:10:30 -05'00' |
| | Division of Radiological Health |

Office of In Vitro Djagnostics and Radiological Health

510(K) K123492

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