ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES

K052078 · Philips Medical Systems Nederland B.V. · LNH · Sep 7, 2005 · Radiology

Device Facts

• Record ID: K052078
• Device Name: ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LNH · Radiology
• Decision Date: Sep 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The ACHIEVA , INTERA and PANORAMA 1.0T Release 2-series 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.

Device Story

ACHIEVA, INTERA, and PANORAMA 1.0T Release 2-series are MRI systems producing cross-sectional images and spectroscopy data. Operated by trained clinicians in clinical settings. New functionalities include: Fiber Tracking (DTI) for white matter visualization; SmartScan for automated geometry planning and acquisition via ExamCard; Regional Perfusion Imaging (Arterial Spin Labeling) for mapping flow territories in the brain; and kt-BLAST/kt-SENSE for accelerated dynamic/multi-phase study acquisition. Data is processed to generate images/spectra for physician interpretation to assist in diagnosis. Systems utilize same software/hardware platform as predicate Release 1-series.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological similarities and design consistency with predicate devices.

Technological Characteristics

Magnetic resonance diagnostic device (LNH). Hardware and software platform shared with predicate Release 1-series. Features include DTI, Arterial Spin Labeling, and parallel imaging (SENSE/kt-BLAST). Complies with NEMA, FDA MR guidance, UL, and IEC 60601 safety standards.

Indications for Use

Indicated for whole-body magnetic resonance diagnostic imaging and spectroscopy in patients requiring cross-sectional internal structure visualization to assist in clinical diagnosis.

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

• ACHIEVA (K043147)
• INTERA (K043147)
• PANORAMA 1.0T (K041602)

Submission Summary (Full Text)

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SEP = 7 2005

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

## General information

| Company Name: | Philips Medical Systems Nederland BV<br>Attn: Budhy Fredriksz, MR Q & RA |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Veenpluis 4-6<br>5684 PC Best, Netherlands, |
| Registration No.: | 300376277 |
| Contact person: | Lynn Harmer<br>Manager, Regulatory Submissions<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | 26 July 2005 |
| Device (Trade) Name: | ACHIEVA , INTERA and PANORAMA 1.0T. |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Regulatory Number: | 892.1000 |
| Classification: | Class II |
| Product code: | LNH |
| Performance standards: | NEMA voluntary standards, FDA MR Diagnostic<br>Device Guidance, UL and IEC 60601 appropriate safety<br>standards and/or draft standards are used. |

#### Predicate Device(s):

The ACHIEVA , INTERA and PANORAMA 1.0T Release 2-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA 1.0T release 1-series. (FDA references K043147, K043147 & K041602).

#### Indications for use:

The ACHIEVA , INTERA and PANORAMA 1.0T Release 2-series 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.

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### Device description:

The ACHIEVA , INTERA and PANORAMA 1.0T Release 2-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA 1.0T release 1-series. The Release 2-series introduces the new functionalities:

- Fiber Tracking .
Diffusion Tensor Imaging (DTI) extends the functionality of Diffusion Weighted Imaging (DWI) to measure the directional dependence of the diffusion coefficient in tissue. With Fiber Tracking the directional dependency can be used to visualize the white matter structure in the brain.

- Smart Scan .
SmartScan enables automatic planning of geometries and acquisition. When needed the user can control and confirm the automatically planned acquisition. The ExamCard provides the fully automated process of data acquisition.

Regional Perfusion Imaging (Arterial Spin Labeling)

Regional Perfusion Imaging with Arterial Spin Labeling provides a noninvasive acquisition method for selectively mapping of the flow territories and to determine the regional perfusion in the human brain.

- kt-BLAST and kt-SENSE. .
Kt-BLAST (Broad-use Linear Acquisition Speed-up Technique) reduces scan time of dynamic and multi-phase studies by also using k-space data from other dynamics / phases. Kt-SENSE combines kt-BLAST with SENSE parallel imaging. Kt-blast and kt-SENSE can be applied to reduce scan time or improve temporal resolution of dynamic or multi-phase studies.

The ACHIEVA, INTERA and PANORAMA 1.0T Release 2-series are the successors of the predicate devices ACHIEVA , INTERA and PANORAMA 1.0T Release 1-series. The design of the Release 2-series are based on the same software platform and hardware technology as their predicate devices.

## General Safety and Effectiveness

The ACHIEVA, INTERA and PANORAMA 1.0T Release 2-series do not induce any other risks than already indicated for their predicate devices with the same safety and effectiveness.

## Substantial Equivalence

It is the opinion of Philips Medical Systems that the Philips ACHIEVA, INTERA and PANORAMA 1.0T Release 2-series are substantially equivalent to their predicate devices Release 1-series.

End

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems Nederland BV % Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems North America 22100 Bothell Everett Highway BOTHELL WA 98021-8431

Re: K052078

Trade/Device Name: Achieva, Intera & Panorama 1.0T Release 2-series Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH

Dated: July 28, 2005 Received: August 1, 2005

Dear Ms. Harmer:

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.

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 of your (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.

SEP - 7 2005

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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 promation would be 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 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" (21 CFR 807.97). 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/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Hogdon

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):

Korzu78

Device Name :

ACHIEVA, INTERA & PANORAMA 1.0T Release 2-series.

Indication For Use :

The ACHIEVA , INTERA and PANORAMA 1.0T Release 2-series 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.

Prescription Use × (Per 21 CFR 801.109)

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel P. Lyons
(Division Sign-Off)

Division of Reproductive, and Radiological Devices 510(k) Number