POLESTAR, MODEL N-30

K092308 · Medtronic Navigation Israel, Ltd. · LNH · Mar 16, 2010 · Radiology

Device Facts

• Record ID: K092308
• Device Name: POLESTAR, MODEL N-30
• Applicant: Medtronic Navigation Israel, Ltd.
• Product Code: LNH · Radiology
• Decision Date: Mar 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The PoleStar N-30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of the head selected by the physician. The images produced by the PoleStar N-30 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: sections of the head selected by the physician. Nuclei excited: H-1 Diagnostic uses: T1, T2, T2* and density weighted imaging. The PoleStar N-30 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 N30 is a compact, open-design intraoperative MRI system utilizing a permanent magnet (0.13T) to acquire 2D and 3D images of the head. Device operates in standard operating rooms; movable between operating table and storage cabinet. Input: H-1 proton magnetic resonance signals. Processing: pulse sequences including spin echo, gradient echo, fast spin echo, and steady state free precession. Output: transverse, sagittal, coronal, and oblique MR images displayed for physician interpretation. System aids clinical decision-making by providing real-time diagnostic information during surgery. Benefits include intraoperative visualization without moving patient to radiology suite.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, technical specifications, and comparison of imaging performance parameters (reconstruction times, matrix sizes, pulse sequence capabilities) against the predicate device.

Technological Characteristics

Permanent magnet MRI system; 0.13T field strength; open-bore design (24.9 x 42 cm). Imaging modes: 2D/3D, spin echo, gradient echo, fast spin echo. Connectivity: DICOM 3.0 interface. Power: 3x208V. Passive and active shimming. Gradient strength: 23.5 mT/m. Computer: P4 2.8GHz, 160GB storage. No cryogen use.

Indications for Use

Indicated for diagnostic imaging of head sections in patients requiring intraoperative MRI. Intended for use by trained physicians in a standard operating room environment.

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-20 (K032541)

Submission Summary (Full Text)

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MAR 1 6 2010

# Traditional 510(k) Summary of Safety and Effectiveness

K092308

The Following Traditional 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: | Yair Penias -Quality and Regulatory Manager |
|-----------------|---------------------------------------------|
| Address: | P.O. Box 548, Yokneam Elit 20692, ISRAEL |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Contact Person: | Yair Penias -Quality and Regulatory Manager |
| Date: | March 11, 2009 |

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

| Trade Name and Common Name: | PoleStar N30 - Magnetic Resonance<br>Diagnostic Device, Also known as<br>"PoleStar® N30 Surgical MRI System". |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| 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 N30 is comparable to:

| Medical<br>Device Name | Applicant Name | 510(k)<br>Number | Classification |
|------------------------|------------------------|------------------|-----------------|
| PoleStar N-20 | ODIN Technologies Ltd. | K032541 | Class II device |

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

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

The PoleStar N30 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 N30 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N30 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 Indication For Use:

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

The PoleStar N30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of the head selected by the physician. The images produced by the PoleStar N30 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: sections of the head selected by the physician. .
- . Nuclei excited: H-1
- T1, T2, T2* and density weighted imaging. Diagnostic uses: .

The PoleStar N30 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

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Image /page/3/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol above the word "Medtronic". The symbol depicts a person in three different positions within the circle, suggesting movement or transformation. The word "Medtronic" is written in a bold, sans-serif font.

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

| Model | Odin | Medtronic Navigation |
|-------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| parameter | PoleStar N-20 (K032541) | PoleStar (Model: N30) |
| Clinical application | Extremities and selected<br>sections of the head | sections of the head<br>selected by the physician |
| Magnet type | Permanent | Permanent |
| Field strength | 0.13T | 0.13T |
| 5 gauss fringe field<br>(radial/axial, m) | 2.2 | 2.2 |
| Shimming | Passive, active | Passive, active |
| Gradient subsystem | | |
| Strength mT/m | 22 | 23.5 |
| Rise time to 10mT/m | <1 | <0.15 |
| msec | | |
| Computer system | | |
| - CPU: | Pentium 586 | P4 2.8GHZ |
| - Memory Cache size [MB] | 1 | 1 |
| array processor | 4xDSP C44 TI | 4xDSP C44 TI |
| - Memory size [GB] | 40 | 160 |
| storage media | magnetic disk, floppy disk | magnetic disk, floppy disk |
| number of images stored | 1,310,720 | 5,242,880 |
| Imaging modes: | | |
| - single | Yes | Yes |
| - multislice | Yes | Yes |
| - volume study | Yes | Yes |
| - other | No | No |
| Reconstruction time: | | |
| - single slice, sec | <3/slice | <2/slice |
| - multislice, sec | <3/slice | <1/slice |
| - volume sec | <20/volume | <16/volume |
| Cardiac gating | No | No |
| Model | Odin | Medtronic Navigation |
| parameter | PoleStar N-20 (K032541) | PoleStar (Model: N30) |
| (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 | 2.5-150 |
| - 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/Anatomical<br>regions: | | |
| - spine | No | No |
| - knee | Yes | No |
| - neck | No | No |
| - TMJ | No | No |
| - extremity | Yes | No |
| - head | Yes | Yes |
| - breast | No | No |
| - shoulder | No | No |
| - others | No | No |
| Bore diameter or WxH, cm | 25.2x42 | 24.9 x42 |
| Model parameter | Odin<br>PoleStar N-20 (K032541) | Medtronic Navigation<br>PoleStar (Model: N30) |
| Bore features | Open access to patient | Open access to patient |
| Cooling system type | Closed loop water cooling<br>(Gradients only). | No |
| Cryogen use | No | No |
| Magnet weight, kg | 400 | 330 |
| HxWxD, cm | 153x97x120 | 145x97x120 |
| Filed Of View (FOV),cm | 5-20 | 5-20 |
| Dicom 3.0 interface | Yes | Yes |
| Power requirements: | | |
| - line voltage, V | 3x208 (3 phase) | 3x208 (3 phase) |
| - Kva | 15 | 8 |
| - A/C, BTU/hr | <10000 | <10000 |

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KO92308 Page 5 of 6

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Image /page/5/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic above the word "Medtronic". The graphic contains a stylized representation of a human figure in motion, repeated in a circular pattern. The word "Medtronic" is written in a bold, sans-serif font.

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and the state of the same of the same

:

KC92308 Page 6 of 6

:

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Yair Penias Quality and Regulatory Manager Medtronic Navigation Israel, Ltd. Kochav Yokneam Bldg, P.O. Box 548 Yokneam Elit, 20692 ISRAEL

MAR 1 3 2010

Re: K092308

Trade/Device Name: PoleStar N-30 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 18, 2010 Received: February 22, 2010

Dear Mr. Penias:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510/8) rremarket notification. The FDA finding of substantial equivalence of your device to a legally ronaketed 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollefree no [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Amiit J. Patel

Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K092308

Device Name: PoleStar N-30

Indication For Use:

The PoleStar N-30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of be bead selected by the physician. The images produced by the PoleStar N-30 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance.

The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and T2*

Anatomical regions: sections of the head selected by the physician.

Nuclei excited: H-1

Diagnostic uses: T1, T2, T2* and density weighted imaging.

The PoleStar N-30 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 X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Eva

510K K092308

Dogecoin2

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