INTERA I/T

K013344 · Philips Medical Systems North America Co. · LNH · Dec 11, 2001 · Radiology

Device Facts

• Record ID: K013344
• Device Name: INTERA I/T
• Applicant: Philips Medical Systems North America Co.
• Product Code: LNH · Radiology
• Decision Date: Dec 11, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

INTERA I/T is a whole body 1.5T Magnetic Resonance Diagnostic Device extended with optional hardware extensions to aid in the performance of 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

INTERA I/T is a 1.5T MRI system extension designed to facilitate interventional procedures. It enables patient transfer between a diagnostic workspot (e.g., X-ray) and the MR system via a modified patient support system (table) with an 8 cm extension. Hardware includes stationary pivot tables, transportable tables, ceiling-suspended interactive LCD displays, and specialized interventional RF coils (Synergy Flex). Used in clinical settings by physicians; the system allows real-time MR imaging to guide interventions. The device maintains the safety profile of the predicate INTERA 1.5T system. Benefits include seamless patient positioning between imaging modalities and improved access for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

1.5T MRI system; hardware extensions include modified patient support table (8 cm extension), stationary/pivot patient tables, ceiling-mounted LCD displays, and interventional RF coils (Synergy Flex). Operates within standard MR safety parameters. Connectivity includes standardized video signal input for displays. Complies with NEMA, UL, and IEC 60601 safety standards.

Indications for Use

Indicated for patients requiring interventional procedures in the head, body, and extremities facilitated by 1.5T MR imaging techniques, including real-time imaging. Requires use of MR-compatible instrumentation selected by a clinician.

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

• Philips INTERA 1.5T system (K001796)

Submission Summary (Full Text)

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K01 33 44

#### Philips Medical Systems

P.O. Box 10000, 5680 DA Be

# DEC 1 1 2001

XJB148-4709/bf 2001-09-18

PAGE 1 OF 2

#### 510(k) SUMMARY

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

| Company Name | : | Philips Medical Systems North America Company. |
|-----------------------|---|----------------------------------------------------------------------------------------------------------------------------------|
| Address | : | 472 Wheelers Farms Road<br>Milford, CT 06460. |
| Registration No. | : | 1217116 |
| Contact person | : | Peter Altman |
| Device (Trade) Name | : | INTERA I/T |
| Classification Name | : | Magnetic Resonance Diagnostic Device (MRDD). |
| Classification | : | Class II. |
| Product code | : | LNH |
| Performance standards | : | NEMA voluntary standards, FDA MRDD guidance's, UL and IEC<br>60601 appropriate safety standards and/or draft standards are used. |
| Common/Usual Name | : | INTERA I/T. |

#### Predicate Device(s).

The Philips cleared MRDD Philips INTERA 1.5T system with FDA ref.K001796.

#### Intended Use.

INTERA I/T is a whole body 1.5T Magnetic Resonance Diagnostic Device extended with optional hardware extensions to aid in the performance of 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 Description and Technological Characteristics

The INTERA I/T is based on the same platform as Philips INTERA 1.5T system (predicate device) with the same intended use but extended with additional hardware features. The optional hardware extensions are meant to aid in the performance of interventional procedures in the head, body and extremities, which may be assisted by existing MR techniques, such as real time imaging.

The extension provides the facility to transfer the patient including the patient tabletop from a diagnostic imaging device of other modality (workspot), e.g. X-ray, to the MR system viceversa. These additional workspots are located outside the 0.5mT-fringe field of the MR system.

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P.O. Box 10000, 5680 DA Best, The Netherland

XJB148-4709/bf 2001-09-18 Page 2 of 2

# The INTERA I/T will be offered in three optional versions

### INTERA I/T Standard.

The standard version is meant to aid the performance of interventional procedures, which do The standard version is meant to are the petier workspot, such as an another imaging device, to the MR system and vice-versa.

#### INTERA I/T Neurosurgery.

The Neurosurgery version is meant to aid the performance of interventional procedures in The Nead/neck area. The patient can be transferred from a workspot outside the 0.5 mT fringe field area to the MR system and vice-versa.

#### INTERA I/T CV.

The CV version is meant to aid the physician in the performance of interventional procedures The CV version is meant to are use pay be transferred from a workspot outside the 0.5 mT fringe field area to the MR system and vice-versa.

The hardware extensions comprises of:

#### Adaptation of the standard MR patient support system. .

Auapration of the suzzems the MR patient support (table) is provided with a mechanical I of the ITT EXA I T Systems the MIC packars so the additional table and vice-versa. The length of the MR tabletop has been extended with 8 cm compared to the INTERA 1.5T system..

# · Additional Patient Table (workspot outside the 0.5 mT fringefield).

Additional I anch Table (Worldpor of Tringefield. The additional (optional) Patient Table is A workspor is foacuted outches the MR system to another workspot and vice-versa. There are two types of additional patient tables:

- Stationary Pivot version on which the tabletop can be rotated over 0 180 degrees. -
- Stationaly I I vot version on which as suitine transportation of the tabletop over an additional distance of approximately 2-meter.
- Interactive Display with a rail ceiling suspension. The interactive display is provided with a . second LCD display with standardized video signal input (connection)
- Interventional received RF-coils: Synergy Flex (circular) Large, Medium and Rectangular. ●
- Intel ventional locessories: Head tilting device (Trendelenburg positioning possibility), straps and . an add-on table top extension.

#### Safety parameters.

The safety parameters of the INTERA I/T remains the same as with its predicate device INTERA 1.5T (ref.K0001796).

### General Safety and Effectiveness.

The safety and effectiveness of the INTERA I/T are the same with its predicate device the INTERA 1.5T (ref K001796.). It does not induce other safety issues and warnings than already valid for its predecessor and predicate device.

#### Substantial Equivalence.

The INTERA I/T is substantially equivalent to the predicate device Philips INTERA 1.5T with FDA ref. K001796.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC 1 1 2001

Mr. Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 472 Wheelers Farm Road P.O. Box 3828 MILFORD CT 06460

Re: K013344

Trade/Device Name: INTERA I/T MR System MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: October 5, 2001 Received: October 9, 2001

Dear Mr. Altman:

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 for associated in the 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 (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 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you deen office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of foreless to premium the Act may be obtained from the Division of Small Manufacturers, your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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P.O. Box 10000, 5680 DA Best, The Netherla

・ XJB148-4709/bf 2001-09-18

Page 1 of 1.

510(k) Number (if known): Device Name :

- Kol 3344 INTERA I/T

Indication For Use :

INTERA I/T is a whole body 1.5T Magnetic Resonance Diagnostic Device being extended with optional hardware extensions to aid in the performance of interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR

(Optional Format 1-2-96)

Nancyc Froodon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013344
510(k) Number