(87 days)
The MOBINEURO Alita Intraoperative MRI System is indicated for use for the head and whole body.
The MOBINEURO Alita Intraoperative MRI System 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 on 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 MOBINEURO Alita Intraoperative MRI System will also be used during intraoperative procedures when performed in an intraoperative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
The MOBINEURO Alita Intraoperative MRI System will also be used in a multi-room suite.
Not Found
There is no information present in the provided document about the acceptance criteria and the study that proves the device meets them.
The document is an FDA 510(k) clearance letter for the MOBINEURO Alita Intraoperative MRI System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain any details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts used to establish ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or associated effect sizes.
- Whether a standalone (algorithm only) performance study was conducted.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on the regulatory clearance of the device based on substantial equivalence, and lists its Indications for Use. It does not delve into the specific performance studies and criteria that would typically be described in a clinical study report or a more detailed section of the 510(k) submission.
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March 20, 2023
Sino Canada Health Engineering Research Institute (Hefei) % Danijela Domljanovic Regulatory Affairs Consultant Clinical Development Solutions 4-1250 Waverley Street Winnipeg, Manitoba R3T 6C6 CANADA
Re: K223875
Trade/Device Name: MOBINEURO Alita Intraoperative MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: March 2, 2023 Received: March 2, 2023
Dear Danijela Domljanovic:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
D. X
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223875
Device Name
MOBINEURO Alita Intraoperative MRI System
Indications for Use (Describe) The MOBINEURO Alita Intraoperative MRI System is indicated for use for the head and whole body.
The MOBINEURO Alita Intraoperative MRI System 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 on 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 MOBINEURO Alita Intraoperative MRI System will also be used during intraoperative procedures when performed in an intraoperative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
The MOBINEURO Alita Intraoperative MRI System will also be used in a multi-room suite.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 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.