(33 days)
The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body.
The Neuro II-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:
- correspond to the distribution of protons exhibiting MR characteristics;
- depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and
- display the soft tissue structure of the body.
When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Neuro II-SE may also be used during intra-operative procedures when performed in an intra-operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
The Neuro II-SE may also be used in a multi-room suite.
The Neuro II-SE system is a traditional MRI unit that has been suspended on an overhead rail system to facilitate intra-operative use. The main components of the Neuro II-SE system are the MRI system assembly (including diagnostic RF coils), the magnet mover assembly, the OR Table assembly, Head Fixation Device and the Intra-operative Coil.
The provided text describes the 510(k) summary for the IMRIS Neuro II-SE Intra-operative Imaging System. However, it does not contain specific acceptance criteria tables nor detailed study results with performance metrics that directly address all the requested points.
The submission focuses primarily on establishing substantial equivalence to predicate devices rather than providing a detailed clinical performance study with defined acceptance criteria and statistical analysis as one might expect for a new algorithmic device today.
Here's a breakdown of the information that is available and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria seem to be implicitly defined by "substantially equivalent" performance to predicate devices (IMRIS Neuro II-SE, Neuro II-S, and Siemens Magnetom Espree 1.5T MRI System) across various MRI imaging parameters.
- Reported Device Performance: The document states that "Laboratory testing has been completed to verify the equivalence to the Siemens Magnetom Espree System and to verify the safe and effective intra-operative operation of the Neuro II-SE." However, no quantitative performance metrics (e.g., SNR values, image uniformity measures, spatial resolution results) from this laboratory testing are reported.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The "laboratory testing" mentioned is not detailed enough to determine a sample size for a test set.
- Data Provenance: Not specified. It's implied that the testing was laboratory-based, but no information on country of origin or whether it was retrospective/prospective is provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified. The document states that images "When interpreted by a trained physician, ... yield information that can be useful in the determination of a diagnosis." This refers to the intended use of the images produced, not to a specific ground truth establishment process for a performance study.
- Qualifications of Experts: Not specified beyond "trained physician."
4. Adjudication Method for the Test Set
- Not specified. There is no mention of an adjudication process for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done according to this document. The focus is on device equivalence, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, in spirit, a standalone performance assessment was done, but not for an "algorithm" in the modern sense. The "device" itself (the MRI system) was assessed for its imaging capabilities in a standalone manner against the imaging characteristics of predicate devices. However, this is not an AI algorithm, but a hardware/software system. The document states: "The Neuro II-SE's (OR-DR-OR/OR-MB configurations) MRI imaging system's software and hardware are substantially equivalent to the Siemens Magnetom Espree 1.5T MRI System. ...effectiveness issues related to specification volume, signal to noise, image uniformity, and geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution." This implies a technical, quantitative assessment of the raw imaging output, which is a form of standalone performance. No detailed results are provided.
7. Type of Ground Truth Used
- Technical Specifications / Predicate Device Performance: The "ground truth" for the equivalence assessment appears to be the established technical performance specifications and image quality characteristics of the predicate devices (Siemens Magnetom Espree, IMRIS Neuro II-SE, and Neuro II-S). The Neuro II-SE was tested to confirm it met similar performance benchmarks in a laboratory setting. There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth for a diagnostic performance study.
8. Sample Size for the Training Set
- Not Applicable / Not Specified. This device is an MRI imaging system, not an AI algorithm trained on a dataset of images in the contemporary sense. Therefore, there is no "training set" for an AI model.
9. How Ground Truth for the Training Set Was Established
- Not Applicable / Not Specified. As above, there is no training set mentioned.
Summary of Device Performance (from the document, not a table):
The Neuro II-SE Intra-operative Imaging System was deemed "substantially equivalent" to its predicate devices (IMRIS Neuro II-SE, Neuro II-S, and Siemens Magnetom Espree 1.5T MRI System) based on:
- Design and Intra-operative Features: Equivalent to predicate Neuro II-SE and Neuro II-S.
- MRI Imaging System Software and Hardware: Substantially equivalent to Siemens Magnetom Espree 1.5T MRI System regarding safety (static magnetic field effects, changing magnetic field effects, RF heating, acoustic noise) and effectiveness (specification volume, signal to noise, image uniformity, geometric distortion, slice profile, thickness and gap, high contrast spatial resolution).
- Laboratory Testing: Conducted to verify equivalence for MRI System (to Siemens Magnetom Espree) and safe and effective intra-operative operation.
The document does not provide specific numerical values or a direct breakdown of how the Neuro II-SE performed against specific numerical acceptance criteria (e.g., "SNR must be > X dB"). Instead, it relies on the concept of substantial equivalence to already cleared devices.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS REQUIRED BY 21 CFR 807.92)
1. GENERAL INFORMATION
MAY 2 2 2007
| Establishment: | IMRIS Inc. |
|---|---|
| Address: | 100-1370 Sony PlaceWinnipeg, ManitobaCanadaR3T 1N5 |
| Registration Number: | 3003807210 |
| Contact Person: | Mrs. B. NewisQuality Assurance Representativeemail: bnewis@imris.comPhone: 1-204-480-7070 ext.7043Fax: 1-204-480-7071 |
| Date of Summary Preparation: | April 17, 2007 |
| Device Name: | Neuro II-SE Intra-operative Imaging System |
| Trade Name: | Neuro II-SE |
| Common Name: | MRDD (Magnetic Resonance Diagnostic Device) |
| Proprietary name: | Neuro II-SE |
| Classification name: | System, Nuclear Magnetic Resonance Imaging |
| Classification: | 21 CFR 892.1000 |
| Class: | Class II |
| Product Code: | LNH (Magnetic Resonance Imaging System) |
| Performance Standards: | None established under Section 514 of the Food, Drug and Cosmetic Act |
INDICATIONS FOR USE 2.
The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body.
3. INTENDED USE OF THE DEVICE
The Neuro II-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:
- correspond to the distribution of protons exhibiting MR characteristics; し、
- depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and 2. spin-spin relaxation time (T2); and
- display the soft tissue structure of the head and whole body. 3.
When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.
The Neuro II-SE may be used during intra-operative procedures when performed in an intra-operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
The Neuro II-SE may also be used for imaging in a multi-room suite.
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DEVICE DESCRIPTION 4.
The Neuro II-SE system is a traditional MRI unit that has been suspended on an overhead rail system to facilitate intra-operative use. The main components of the Neuro II-SE system are the MRI system assembly (including diagnostic RF coils), the magnet mover assembly, the OR Table assembly, Head Fixation Device and the Intra-operative Coil.
SAFETY AND EFFECTIVENESS 5.
The Neuro II-SE (OR-DR-OR/OR-MB configurations) have been designed to provide MRI imaging in an intra-operative setting in the same manner as the predicate Neuro II -- SE System and predicate Neuro II-S devices, The Neuro II-SE's (OR-DR-OR/OR-MB configurations) intra-operative features, including the Magnet Mover Assembly, OR Patient Table, Intra-operative Coil and Head Fixation Device are substantially equivalent to the same intra-operative features of the predicate Neuro II-SE and predicate Neuro II-S. The Neuro II-SE (OR-DR-OR/OR-MB configurations) does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting.
The Neuro II-SE's (OR-DR-OR/OR-MB configurations) MRI imaging system's software and hardware are substantially equivalent to the Siemens Magnetom Espree 1.5T MRI System. The Neuro II-SE does not raise any new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating or acoustic noise or effectiveness issues related to specification volume, signal to noise, image uniformity, and geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution.
Laboratory testing has been completed to verify the equivalence to the Siemens Magnetom Espree System and to verify the safe and effective intra-operative operation of the Neuro II-SE (OR-DR-OR/OR-MB configurations).
The Neuro II-SE (OR-DR-OR/OR-MB configurations) Intra-operative Magnetic Resonance Imaging System is substantially equivalent to the Siemens Magnetom Espree; the IMRIS predicate Neuro II-SE and the predicate Neuro II-S imaging systems.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2 2 2007
IMRIS, Inc. c/o Mr. Thomas M. Tsakeris President Devices & Diagnostics Consulting Group, Inc. 16809 Briardale Road ROCKVILLE MD 20855
K071099 Re:
Trade/Device Name: Neuro II-SE Intra-operative Magnetic Resonance Imaging System Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 16, 2007 Received: April 19, 2007
Dear Mr. Tsakeris:
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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular logo with the letters "FDA" in a stylized font in the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font, followed by three stars. The text "U.S. FOOD & DRUG ADMINISTRATION" is printed around the border of the circle.
Protecting and Promoting Public Health
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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 allthe 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.
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 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 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.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
6-0115
Enclosure
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Indications for Use Statement
| Ver/ 3 - 4/24/96 | |
|---|---|
| Applicant: | IMRIS Inc. |
| Device Name: | Neuro II-SE Intra-operative Magnetic Resonance Imaging System |
Indications For Use:
The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body.
The Neuro II-SE is intended for use as a diagnostic patient imaging device. This device produces
tomographic cross-sectional images that:
- correspond to the distribution of protons exhibiting MR characteristics;
- depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and
spin-spin relaxation time (T2); and - display the soft tissue structure of the body.
When interpreted by a trained physician, these images yield information that can be useful in the
determination of a diagnosis.
The Neuro II-SE may also be used during intra-operative procedures when performed in an intra-
operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
The Neuro II-SE may also be used in a multi-room suite.
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: 2071099
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
.
:
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.