MR INSPIRE WITH EXTENDED KIT

K100164 · Paramed S.R.L. · LNH · Apr 5, 2010 · Radiology

Device Facts

• Record ID: K100164
• Device Name: MR INSPIRE WITH EXTENDED KIT
• Applicant: Paramed S.R.L.
• Product Code: LNH · Radiology
• Decision Date: Apr 5, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The intended use of Paramed's Mr. Inspire with Extended is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), with limitation to joint pathologies (no turnors, no angiography) If equipped with the Extended kit (code 01-1872-01) the MrJ Inspire device can also produce images of the C-Spine and L-Spine joinls. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

Device Story

Mr Inspire is a permanent 'C'-shaped magnet MRI system designed for small clinics/hospitals to minimize installation footprint and claustrophobia. Device detects spatial distribution of protons (hydrogen nuclei) using MR parameters (T1, T2, proton density, chemical shift, flow velocity). System generates transverse, sagittal, coronal, and oblique cross-sectional images. Operated by trained medical professionals; images interpreted by physicians to determine diagnosis. Includes new wider knee coil and flexible linear coils for improved anatomical fit. System utilizes fire-preventing materials. Output provides internal structural visualization of joints/limbs to aid clinical decision-making.

Clinical Evidence

Bench testing only. Evidence includes final inspection reports, phantom testing, and imaging of healthy volunteers to validate image quality and SNR for the new wider knee coil and flexible linear coils. No clinical patient data provided.

Technological Characteristics

Permanent 'C'-shaped magnet MRI; 0.22 T field strength; < 5 ppm homogeneity over 20 cm DSV; 30 mT/m/ms slew rate; ± 20 mT/m max theoretical gradient strength. Includes fire-preventing materials. Connectivity/software details not specified beyond standard MRI diagnostic imaging parameters.

Indications for Use

Indicated for diagnostic MRI of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, TMJ, C-spine, and L-spine in patients requiring joint pathology assessment. Contraindicated for tumor imaging and angiography.

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

• Paramed MrJ (K033507)
• Paramed MrJ Extended (K080098)

Submission Summary (Full Text)

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14100164 age 1/3

# Special 510(K) Summary

The following Special 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(c).

# Manufacturer Information

APR - 5 2010

Manufacturer:

Address:

Paramed Srl Corso Perrone 73R 16152 Genova, Italy 3004994584

Establishment registration number:

# 807.92(a)(1)

Submitter Information

Correspondent:

Joe Ouellette, 39 High Street North Andover, MA 01845 USA. 978.975.7530 x4345 Ph: 978.975.9930 Fax: Joe Ouellette,

Contact person:

#### 807.92(a)(2)

| Trade Name: | Mr Inspire |
|---------------------------------------------------------------|--------------------------------------------|
| Common Name: | Magnetic resonance diagnostic system |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging |
| Classification and class of device: 21 CFR 892.1000, class II | |

Paramed s.r.l Sede Legale e Operativa: Corso F.M. Perrone, 73r - 16152 Genova Tel. Fax- ++39 010 7404530 e-mail: [e-mail] - www.paramed.it

Codice Fiscale e Iscrizione al Registro delle Imprese di Genova 01195740095 IVA 01195740095 - C.C.I.A.A. (REA) Genova 373591 Capitale Sociale € 15 600 1.V.

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Image /page/1/Picture/0 description: The image shows the logo for "Paramed Medical Systems". The word "Paramed" is in a bold, sans-serif font, with each letter filled with a textured pattern. Below "Paramed" is the phrase "Medical Systems" in a smaller, sans-serif font. To the right of "Paramed" is a stylized, cursive design element.

Classification Number:

90LNH807.92(a)(3)

#### Predicate Devices

| Paramed | MrJ | K033507 |
|---------|--------------|---------|
| Paramed | MrJ Extended | K080098 |

#### 807.92(a)(4)

The Mr Inspire is a magnetic resonance imaging device characterized by an open structure to minimize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.

It is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C-spine with limitation to joint pathologies (no tumors, no angiography).

The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

#### 807.92(a)(5)

### Device Intended Use(s)

The intended use of Paramed's Mr Inspire product is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ). C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography).

### 807.92(a)(6)

#### Technological Characteristics

The Mr Inspire MRI system is substantially equivalent to

- . Paramed MrJ K033507 under all aspects except some very limited new function due to design restyling
- Paramed MrJ Extended K080098 under all the aspects excluding some design . restyling to keep the same drawing lines as the MrJ Inspire

Neither the intended use nor the technological characteristics of this model differ from those of the referenced models.

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## 807.92(b)(1)

The determination of substantial equivalence is based on the design similarities and final inspection report data here referenced and kept in Paramed's files.

A table of the equivalence between the two models is hereunder supplied for the most important specified characteristics: .

| Parameter | Mr Inspire = MrJ |
|--------------------------------------------------|-----------------------------------------------------------|
| Magnetic field strength | 0.22 T |
| Stray field 5G | maximum 80 cm from magnet covers |
| Weight | 4200 Kg |
| Homogeneity | < 5 ppm over 20 cm DSV (FWHM) |
| SAR (Head worst case) | 0,57 +/- 0,15 W/Kg |
| dB/dt | 19,8 T/s with τ = 600 µs Gradient coil diameter<br>850 mm |
| FOV | up to 220 mm visualized FOV |
| Gradient maximum theoretic<br>strength | ± 20 mT/m |
| Gradient maximum clinically<br>employed strength | ± 15 mT/m |
| Slew rate | 30 mT/m/ms |

### 807.92(b)(2)

A new Knee coil aimed to host larger anatomies is inserted in this file which is equivalent to the standard cleared knee coil but wider.

Three new linear coils are inserted which can be employed to scan the same anatomies for which the device is cleared but that are flexible and may be opened to be more easily be fitted on the joint to be scanned.

For these coils the clinical output is documented at section Validation activities.

### 807.92(b)(3)

On the basis of the internal final inspection data reports, summarized in the above 807.92(b)(1) point and of the test images performed both on phantoms and on healthy volunteers, we declare that the Mr Inspire device is at least as safe and effective as the predicate MrJ K033507 cleared device and the same is true for the two Extended kit code 01-1872-00 K080098 and the present one code 01-1872-01. For some aspects it is also safer (due to the fire preventing materials) without loosing its effectiveness, as demonstrated both by the acceptable SNR and by the image quality (phantom and volunteer).

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's seal on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. A horizontal line is placed underneath the text. The seal consists of a stylized human figure within a circular border containing the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

Paramed S.r.l. % Mr. Joe Ouellette Official Correspondent 39 High Street NORTH ANDOVER MA 01845

# APR - 5 2010

Re: K100164

Trade/Device Name: Mr Inspire (code 01-2000-01) with Extended kit (code 01-1872-01) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 8, 2010 Received: March 11, 2010

Dear Mr. Ouellette:

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 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(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 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Aruld J. H. B

St.Pierre Donald J. 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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# Indications for Use

510(k) Number (if known): K100164

Device Name: Mr Inspire (code 01-2000-01) with Extended kit (code 01-1872-01)

Indications for Use:

The intended use of Paramed's Mr. Inspire with Extended is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), with limitation to joint pathologies (no turnors, no angiography) If equipped with the Extended kit (code 01-1872-01) the MrJ Inspire device can also produce images of the C-Spine and L-Spine joinls. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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K100164

| (Division Sign-Off) |
|------------------------------------------------------------|
| Division of Radiological Devices |
| Office of In Vitro Diagnostic Device Evaluation and Safety |

| 510(k) Number_______________________________________________________________________________________________________________________________________________________________

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