POLESTAR N-20

K032541 · Odin Medical Technologies , Ltd. · LNH · Sep 12, 2003 · Radiology

Device Facts

• Record ID: K032541
• Device Name: POLESTAR N-20
• Applicant: Odin Medical Technologies , Ltd.
• Product Code: LNH · Radiology
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The PoleStar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the PoleStar N-20 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*. The PoleStar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.

Device Story

PoleStar N-20 is a compact, open-design intraoperative MRI system utilizing a permanent magnet. Device acquires 2D and 3D images of extremities and head sections using various pulse sequences (spin echo, gradient echo, fast spin echo, steady state free precession). Operated by clinical staff in standard operating rooms; unit is mobile, moving between operating table and storage cabinet. System transforms proton magnetic resonance signals into visual images based on T1, T2, T2*, and proton density. Output is displayed for physician interpretation to aid intraoperative clinical decision-making. Benefits include real-time or intraoperative diagnostic imaging capability without requiring patient transport to a dedicated radiology suite.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of imaging parameters, magnet specifications, and system performance characteristics against the predicate device.

Technological Characteristics

Permanent magnet MRI system; 0.13T field strength. Features closed-loop water cooling for gradients. Imaging modes: 2D/3D, spin echo, gradient echo, fast spin echo. Connectivity: DICOM 3.0 interface. Computer system: Pentium 586 CPU, 64MB RAM, 4xDSP C44 TI array processor. Form factor: compact, mobile unit for intraoperative use. No cryogens used.

Indications for Use

Indicated for patients requiring diagnostic imaging of extremities and selected sections of the head. Used intraoperatively in standard operating rooms to provide MR images for physician interpretation 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

• PoleStar N-10 (K010850)

Submission Summary (Full Text)

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SEP 1 2 2003

Image /page/0/Picture/2 description: The image shows the logo for Odin Medical Technologies. The logo features the word "ODIN" in bold, sans-serif font, with the words "Medical Technologies" in a smaller font size underneath. A stylized, incomplete circle or ring is positioned to the right of the word "ODIN", with a small, solid circle placed at the top of the ring, giving the impression of a planet with a ring system. The overall design is clean and modern.

# Special 510(k) Summary of Safety and Effectiveness

The Following Special 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).

#### 807.92(a)(1) - Submitter Details:

| Submitter name:<br>Address:<br>Phone:<br>Fax:<br>E-mail: | Einav Shlomovitz -- Quality and Regulatory Director<br>P.O. Box 548, Yokneam Elit 20698, Israel<br>[phone]<br>[phone]<br>[e-mail] |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Einav Shlomovitz -Quality and Regulatory Director |
| Date: | August 4, 2003 |

### 807.92(a)(2) - Device Details:

| Trade Name and Common Name: | PoleStar N-20 - Magnetic Resonance<br>Diagnostic Device |
|-----------------------------|-----------------------------------------------------------------------------------------------|
| Classification: | 21 CRF 892.1000 Magnetic Resonance<br>Diagnostic Device. |
| Class: | II<br>MRDD were reclassified by FDA from<br>Class III to Class II effective July 28,<br>1998. |
| Product Code: | LNH – Magnetic Resonance Imaging<br>System |

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### 807.92(a)(3) -- Predicate Devices:

The PoleStar N-20 is comparable to Odin's PoleStar N-10

| Medical<br>Device Name | Applicant Name | 510(k)<br>Number | Classification |
|------------------------|---------------------------------------------------|------------------|-------------------|
| | PoleStar N-10 Odin Medical Thechnologies Ltd. | K010850 | l Class Il device |

Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.

#### 807.92(a)(4) - Device Description:

The PoleStar N-20 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The PoleStar N-20 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N-20 can be moved within the room between procedures, from the operating table to its Magnet Storage Cabinet, thus allowing the operating room to be used for any type of surgery.

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### 807.92(a)(5) - Device Intended Use:

#### The general purpose of the device as defined in 21 CFR 892.1000:

The PoleStar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the PoleStar N-20 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*.

- . Anatomical regions:
Diagnostic uses:

extremities and selected sections of the head.

- . Nuclei excited:
.

T1, T2, T2* and density weighted imaqing.

The PoleStar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.

H-1

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Image /page/3/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in bold, sans-serif font, with the "o" slightly larger than the other letters. Below "odin" is the phrase "Medical Technologies" in a smaller, italicized font. A circular design element is to the right of the word "odin".

## 807.92(a)(6) – Substantial Equivalence Comparison Table:

| Model | Odin | Odin |
|-------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| parameter | PoleStar N-10 (K010850) | PoleStar N-20 |
| Clinical application | Extremities and selected<br>sections of the head | Extremities and selected<br>sections of the head |
| Magnet type | Permanent | Permanent |
| Field strength | 0.12T | 0.13T |
| 5 gauss fringe field<br>(radial/axial, m) | 1.5 | 2.2 |
| Shimming | Passive, active | Passive, active |
| Gradient subsystem | | |
| Strength mT/m | 25 | 22 |
| Rise time to 10mT/m | <1 | <1 |
| msec | | |
| Computer system | | |
| - CPU: | Pentium 586 | Pentium 586 |
| - Memory size [MB] | 64 | 64 |
| array processor | 4xDSP C44 TI | 4xDSP C44 TI |
| - Memory size [MB] | 4000 | 4000 |
| storage media | magnetic disk, floppy disk | magnetic disk, floppy disk |
| number of images stored | 5000 | 5000 |
| Imaging modes: | | |
| - single | Yes | Yes |
| - multislice | Yes | Yes |
| - volume study | Yes | Yes |
| - other | No | No |
| Reconstruction time: | | |
| - single slice, sec | <3/slice | <3/slice |
| - multislice, sec | <3/slice | <3/slice |
| - volume sec | <20/volume | <20/volume |
| Model | Odin | Odin |
| parameter | PoleStar N-10 (K010850) | PoleStar N-20 |
| Cardiac gating<br>(ECG/peripheral) | No | No |
| Respiratory gating | No | No |
| Angiography | Optional | Optional |
| Spectroscopy | No | No |
| Imaging: | | |
| - pulse sequence | Spin Echo, Fast Spin Echo,<br>Gradient Echo, 2D 3D | Spin Echo, Fast Spin Echo,<br>Gradient Echo, 2D 3D |
| - repetition time, msec | 10-5000 increments of 1 | 10-5000 increments of 1 |
| - echo time, msec | 3-150 | 3-150 |
| - inversion time, msec | N/A | N/A |
| - slice thickness, mm | 2-10 | 2-10 |
| - scan orientation | Transverse, coronal,<br>sagittal, oblique | Transverse, coronal,<br>sagittal, oblique |
| - measuring matrix | 64x64 to 256x256 steps of<br>1 in phase encoding | 64x64 to 256x256 steps of<br>1 in phase encoding |
| - display matrix | 1024x768 | 1024x768 |
| - pixel intensity | 0-4095 | 0-4095 |
| Surface coils: | | |
| - spine | No | No |
| - knee | Yes | Yes |
| - neck | No | No |
| - TMJ | No | No |
| - extremity | Yes | Yes |
| - head | Yes | Yes |
| - breast | No | No |
| - shoulder | No | No |
| - others | No | No |
| Model | Odin | |
| parameter | PoleStar N-10 (K010850) | PoleStar N-20 |
| Bore diameter or WxH, cm | 24.5x39 | 25.2x42 |
| Bore features | Open access to patient | Open access to patient |
| Cooling system type | Closed loop water cooling<br>(Gradients only) | Closed loop water cooling<br>(Gradients only). |
| Cryogen use | No | No |
| Magnet weight, kg | 330 | 400 |
| HxWxD, cm | 145x96x120 | 153x97x120 |
| Filed Of View (FOV),cm | 5-18 | 5-20 |
| Dicom 3.0 interface | Yes | Yes |
| Power requirements: | | |
| - line voltage, V | 3x208 (3 phase) | 3x208 (3 phase) |
| - Kva | 16 | 15 |
| - A/C, BTU/hr | <10000 | <10000 |

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Image /page/4/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in bold, black letters, with the words "Medical Technologies" in a smaller font below. There is a circular design to the right of the word "odin".

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Image /page/5/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in large, bold, sans-serif font, with a stylized circle above the "i". Below "odin" are the words "Medical Technologies" in a smaller, sans-serif font. A partial circle is behind the word "odin".

·

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2003

Mr. Einav Shlomovitz Ouality and Regulatory Director Odin Medical Technologies Ltd. P.O. Box 548 Yokneam Elit, 20698 ISRAEL

Re: K032541

Trade/Device Name: PoleStar N-20 Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: August 4, 2003 Received: August 18, 2003

Dear Mr. Shlomovitz:

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 (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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Page 2

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 the 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 (301).594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/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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510(k) Number (if known):

Device Name: PoleStar N-20

Indication For Use:

The PoleStar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the PoleStar N-20 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*.

Anatomical regions: extremities and selected sections of

the head.

| Nuclei excited: | H-1 |
|------------------|----------------------------------|
| Diagnostic uses: | T1, T2, T2* and density weighted |
| imaging. | |

The PoleStar N-20 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.

(PLEASE DO NOT WRITE BELOW THE LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Daniel A. Bergman

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