ACHIEVA 1.5T & INERA 1.5T FAMILY

K052013 · Philips Medical Systems Nederland B.V. · LNH · Aug 2, 2005 · Radiology

Device Facts

• Record ID: K052013
• Device Name: ACHIEVA 1.5T & INERA 1.5T FAMILY
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: LNH · Radiology
• Decision Date: Aug 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The ACHIEVA 1.5T & INTERA 1.5T family consists of 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

The ACHIEVA 1.5T & INTERA 1.5T family is a magnetic resonance imaging (MRI) system designed for whole-body diagnostic imaging and spectroscopy. It functions by generating cross-sectional images and spectra of internal body structures. The system utilizes an upgraded gradient configuration compared to its predecessor, featuring an improved slew rate that enables shorter echo times (TE), echo spacing (ES), and repetition times (TR). Operated by trained medical professionals in clinical settings, the device provides images that are interpreted by physicians to assist in clinical diagnosis. The system shares the same software platform and hardware technology as the predicate ACHIEVA family release 1-series, ensuring consistent operational workflows and diagnostic utility while offering enhanced performance capabilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Magnetic resonance diagnostic device (MRDD). 1.5T field strength. Features upgraded gradient configurations with improved slew rates. Complies with NEMA voluntary standards, FDA MR Diagnostic Device Guidance, and applicable UL/IEC 601 safety standards. Software platform shared with predicate device.

Indications for Use

Indicated for diagnostic imaging and spectroscopy of the whole body internal structures in patients requiring MR examination. Images are interpreted by trained physicians to assist in 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 family release 1-series (K043147)

Submission Summary (Full Text)

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AUG 2 - 2005

# APPENDIX Va

# 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 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Veenpluis 4-6<br>Best, Netherlands, 5684 PC |
| Registration No.: | 1217116 |
| Contact person: | Lynn Harmer<br>Manager, regulatory Submissions<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | July 12, 2005 |
| Device (Trade) Name: | ACHIEVA 1.5T & INTERA 1.5T family |
| 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 Device<br>Guidance, UL and IEC 601 appropriate safety standards<br>and/or draft standards are used. |

### Predicate Device(s):

The Philips Medical Systems ACHIEVA 1.5T & INTERA 1.5T are the successors of the already cleared (predicate device) ACHIEVA family release 1-series (ref. K043147).

#### Indications for use:

The ACHIEVA 1.5T & INTERA 1.5T consists of diagnostic devices that produce crosssectional 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 1.5T & INTERA 1.5T family is the successor of the predicate ACHIEVA family release 1-series.

The design of ACHIEVA 1.5T & INTERA 1.5T family is based on the same software platform and hardware technology as its predicate device. All MR system parts of the ACHIEVA 1.5T & INTERA 1.5T family have the same appearance.

The new gradient configurations are more powerful than their previous versions available on the Intera 1.5T and Achieva 1.5T systems. Especially the slewrate of these systems is improved. This improved slewrate allows for shorter echo times (TE), Echo Spacing (ES) and repetition times (TR).

### General Safety and Effectiveness

The ACHIEVA 1.5T & INTERA 1.5T family does not induce any other risks than already indicated for its predicate device with the same safety and effectiveness.

#### Substantial Equivalence

It is the opinion of Philips Medical Systems that the Philips ACHIEVA 1.5T & INTERA 1.5T family is substantially equivalent to its predicate device ACHIEVA family.

End

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems Nederland BV % Mr. Marc M. Mouser Senior Project Engineer/Reviewer UL Conformity Assessment Services Underwriters Laboratories, Inc. West Coast Division, Camas Office 2600 N.W. Lake Road CAMAS WA 98607-8542

Re: K052013

AUG 2 - 2005

Trade/Device Name: Achieva 1.5T & Intera 1.5T Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 22, 2005

Received: July 26, 2005

Dear Mr. Mouser:

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 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.

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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 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 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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## APPENDIX Vb

# Indication for use

510(k) Number (if known):

1052013

Device Name:

ACHIEVA 1.5T & INTERA 1.5T family

Indication For Use:

ACHIEVA 1.5 & INTERA 1.5T family consists of 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 X (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)

Nancy brogelon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052013