(36 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 Espree MRI System (including diagnostic coils), the Magnet Mover System, the OR Table Assembly and the Intra-operative Coil Kit.
The provided text is a 510(k) Summary of Safety and Effectiveness for the IMRIS Neuro II-SE Intra-Operative Magnetic Resonance Imaging System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, this document does not contain the information required to populate the provided table or answer the specific questions about acceptance criteria and study details.
Here's a breakdown of why the information is missing:
- Type of Document: A 510(k) summary focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. It typically avoids detailed performance studies with acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it relies on comparisons to the established safety and effectiveness of the predicate.
- Nature of the Device: The Neuro II-SE is an MRI system. Its "performance" refers to image quality metrics (signal to noise, uniformity, geometric distortion, etc.) and safety aspects (magnetic field effects, RF heating, acoustic noise), which are generally established through engineering and physical bench testing against industry standards or predicate device specifications, not typically through clinical performance studies involving human readers and ground truth as described in your prompt.
- Lack of AI/Algorithm: The Neuro II-SE is a hardware device for imaging, not an AI, algorithm, or software-as-a-medical-device (SaMD) that would have performance metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts.
Therefore, I cannot extract the requested information from the provided text. The document states:
- "Laboratory testing has been completed to verify the equivalence to the Siemens Magnetom Espree System and to verify the safe and effective intra-operation of the Neuro II-SE."
- "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."
These statements indicate that specific tests were performed, but the details of those tests, including specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment, are not included in this summary.
In summary, based on the provided text, I cannot complete the table or answer the questions as they pertain to a different type of device validation study than what is presented here.
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AUG 1 1 2006 APPENDIX F 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS REQUIRED BY 21 CFR 807.92)
Attached is the IMRIS 510(k) Summary of Safety and Effectiveness for the IMRIS Neuro II-SE Intra-Operative Magnetic Resonance Imaging System.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS REQUIRED BY 21 CFR 807.92)
1. GENERAL INFORMATION
| Establishment: | IMRIS Inc. |
|---|---|
| Address: | 1370 Sony PlaceWinnipeg, ManitobaCanadaR3T 1N5 |
| Registration Number: | 3003807210 |
| Contact Person: | Mrs. B. NewisQuality Assurance RepresentativeeMail: bnewis@imris.comPhone: 1-204-480-7080Fax: 1-204-480-7071 |
| Date of SummaryPreparation: | May 15, 2006 |
| 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, Drugand Cosmetic Act |
2. INDICATIONS FOR USE
The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body.
INTENDED USE OF THE DEVICE 3.
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 2. (T1) and spin-spin relaxation time (T2); and
-
- display the soft tissue structure of the head and whole 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 be used during intra-operative procedures when performed in an intraoperative 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 Espree MRI System (including diagnostic coils), the Magnet Mover System, the OR Table Assembly and the Intra-operative Coil Kit.
SAFETY AND EFFECTIVENESS 5.
The Neuro II-SE has been designed to provide MRI imaging in an intra-operative setting in the same manner as the Neuro II -S and Neuro II predicate devices. The Neuro II-SE Intra-operative System features including the Magnet Mover System, OR Table Assembly and Intra-operative Coil Kit are substantially equivalent to the same intra-operative features of the Neuro II -S and Neuro II. The Neuro II-SE 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 MRI system's software and hardware, excepting the Intra-operative Coil Kit and OR Table Assembly, 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.
The Neuro II-SE Intra-operative Coil Kit design is substantially equivalent to the Neuro II-S Intra-operative RF Coil. The use of the Intra-operative Coil Kit does not raise any new safety or effectiveness issues.
Laboratory testing has been completed to verify the equivalence to the Siemens Magnetom Espree System and to verify the safe and effective intra-operation of the Neuro II-SE.
The Neuro II-SE Intra-operative Magnetic Resonance Imaging System is substantially equivalent to the Siemens Magnetom Espree, the IMRIS Neuro II-SE and the Neuro II imaging systems.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 1 2006
IMRIS, Inc. % Mr. Thomas M. Tsakeris Devices & Diagnostics Consulting Group, Inc. 16809 Briardale Road ROCKVILLE MD 20855
Re: K061916
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: July 4, 2006 Received: July 6, 2006
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/3/Picture/10 description: The image shows a circular logo with the text "1806-1906" at the top and "Centennial" in the middle. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial".
oting Public S
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Page 2 -
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
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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火011916
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.
Prescription Use ✓
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K061916 |
|---|---|
| --------------- | --------- |
(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)
(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.