ACHIEVA FAMILY

K043147 · Philips Medical Systems North America Co. · LNH · Feb 15, 2005 · Radiology

Device Facts

• Record ID: K043147
• Device Name: ACHIEVA FAMILY
• Applicant: Philips Medical Systems North America Co.
• Product Code: LNH · Radiology
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The ACHIEVA 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

ACHIEVA family is a magnetic resonance diagnostic device (MRDD) producing cross-sectional images, spectroscopy images, and spectra of the whole body. It functions as a successor to the Intera Achieva family, utilizing the same software platform and hardware technology. Enhancements include improved contrast-enhanced MRA techniques, faster scanning capabilities, SENSE Body wrap coil, and expanded multi-nuclei spectroscopy with 3T coils. Operated by trained medical professionals in clinical settings, the device provides images for physician interpretation to assist in diagnosis. It does not introduce new risks compared to the predicate device.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological similarities and design enhancements to the predicate device.

Technological Characteristics

Magnetic resonance diagnostic device (MRDD). Hardware and software platform shared with predicate. Features SENSE Body wrap coil and 3T coils for multi-nuclei spectroscopy. Complies with NEMA voluntary standards, FDA MR Diagnostic Device Guidance, UL, and IEC 601 safety standards.

Indications for Use

Indicated for patients requiring diagnostic cross-sectional imaging, spectroscopy images, or spectra of the whole body 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

• INTERA ACHIEVA family release 1-series (K031815)

Submission Summary (Full Text)

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FEB 1 5 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 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | 9 November 2004 |
| Device (Trade) Name: | ACHIEVA family |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification: | Class II |
| Product code: | LNH |
| Performance standards: | NEMA voluntary standards, FDA MR Diagnostic<br>Device Guidance, UL and IEC 601 appropriate safety<br>standards and/or draft standards are used. |

#### Predicate Device(s):

The Philips Medical Systems ACHIEVA is the successor of the already cleared (predicate device) INTERA ACHIEVA family release 1-series (ref.K031815).

#### Indications for use:

The ACHIEVA 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.

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## Device description:

The ACHIEVA family is the successor of the predicate Intera Achieva family release 1-series.

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

The ACHIEVA family is extended with enhancements and new functionalities for contrast enhanced MRA techniques and faster scanning techniques. Furthermore it is extended with SENSE Body wrap coil RF-coil and extension of multi-nuclei spectroscopy with 3T coils.

## General Safety and Effectiveness

The ACHIEVA 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 family is substantially equivalent to its predicate device Intera Achieva.

End

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 5 2005

Mr. Lynn T. Harmer Manger, Regulatory Submissions Phillips Medical Systems North America 22100 Bothell Evert Highway Post Office Box 3003 98141-3003 BOTHELL WA 98021-8431

Re: K043147 Trade/Device Name: Achieva Family Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 10, 2005 Received: January 12, 2005

Dear Mr. Harmer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced wore 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 the enerosate) to te enactment date of the Medical Device Amendments, or to devices that have been May 20, 1770, the characterith 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 do not require approvisions of the Act. The general controls provisions of the Act active, subjoct to the general 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 n your de rise to be subject to such additional controls. Existing major regulations affecting your Applo rary, It may of only 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 I rease of awrised of early ination 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 I caran states and roganding, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, morements practice requirements as set forth in the quality systems (QS) (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) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket nothleadon: "The PDP Intentige of our 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 If you desire specific acried for your are 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 Arso, picaso note the regulation on your responsibilities under the Act from the 807.77). Tou may ooually cater general and Consumer Assistance at its toll-free number (800) DIVISION of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.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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510(k) Number (if known):

Device Name :

ACHIEVA family

K04 3147

Indication For Use :

ACHIEVA family consists of diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal mages, spootroboopy integre these images when interpreted by a trained physician, yield information that may assist in diagnosis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Namenc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043147