MOBINEURO Alita Intraoperative MRI System

K223875 · Sino Canada Health Engineering Research Institute (Hefei) · LNH · Mar 20, 2023 · Radiology

Device Facts

• Record ID: K223875
• Device Name: MOBINEURO Alita Intraoperative MRI System
• Applicant: Sino Canada Health Engineering Research Institute (Hefei)
• Product Code: LNH · Radiology
• Decision Date: Mar 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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: 1. Correspond to the distribution of protons exhibiting MR characteristics; 2. Depend on NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and 3. 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.

Device Story

MOBINEURO Alita is an intraoperative MRI system for head and whole-body diagnostic imaging. It acquires proton density, flow velocity, T1, and T2 NMR parameters to generate tomographic cross-sectional images of soft tissue. Operated by trained physicians in intraoperative suites or multi-room configurations, it functions alongside MR-compatible anesthesia and patient monitoring equipment. Physicians interpret the resulting images to assist in clinical diagnosis and intraoperative decision-making. The system provides real-time or near-real-time imaging capabilities during surgical procedures, potentially improving surgical precision and patient outcomes by allowing intraoperative assessment of anatomical structures.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Magnetic resonance diagnostic device (21 CFR 892.1000). Operates via NMR parameters (proton density, flow velocity, T1, T2). Designed for intraoperative use in multi-room suites; compatible with MR-safe anesthesia and monitoring equipment.

Indications for Use

Indicated for head and whole-body diagnostic imaging in patients requiring tomographic cross-sectional soft tissue visualization. Used in intraoperative settings with MR-compatible monitoring/anesthesia equipment.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

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 ([e-mail]) or phone [phone] 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:

1. Correspond to the distribution of protons exhibiting MR characteristics;

2. Depend on NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and

3. 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) |
|--------------------------------------------------------------------------------------|
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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