Who is the manufacturer of Orion LifeSpan MEG?

Compumedics Limited filed the 510(k) submission for Orion LifeSpan MEG (K191785).

What is the FDA product code for Orion LifeSpan MEG?

OLY. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Orion LifeSpan MEG?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Orion LifeSpan MEG?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Orion LifeSpan MEG

K191785 · Compumedics Limited · OLY · Feb 14, 2020 · Neurology

Device Facts

Record ID	K191785
Device Name	Orion LifeSpan MEG
Applicant	Compumedics Limited
Product Code	OLY · Neurology
Decision Date	Feb 14, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Orion LifeSpan MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning. It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas: Hospital procedures; Physiological monitoring of patients; Training relevant to the specific discipline or disorder under investigation. Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.

Device Story

Orion LifeSpan™ MEG records magnetic signals from human brain using superconducting magnetometry; optionally records EEG via integrated SynAmps2 hardware. System uses CURRY software platform for acquisition, processing, and display. Operated by trained physicians/technicians in clinical settings. Input signals transformed into localized active brain areas; output displayed for physician interpretation. Localization data correlated with anatomical brain information to aid neurosurgical planning. Benefits include non-invasive identification of epileptic regions and sensory cortex locations, supporting surgical decision-making.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including empty-room noise performance, phantom dipole localization accuracy, device compatibility, and software verification/validation. Phantom testing showed average localization error of 2.3mm (Orion) vs 1.9mm (Elekta).

Technological Characteristics

Superconducting magnetometry; DROS SQUID architecture; flux-locked loop readout. 186 (adult) or 138 (pediatric) axial gradiometer pickup coils. Fiberglass composite dewar/helmet. Mains power. Connectivity via CURRY software. Standards: IEC 60601-1, IEC 60601-1-2, IEC 80601-2-26, IEC 62304, ISO 14971.

Indications for Use

Indicated for non-invasive measurement of MEG and optional EEG signals from electrically active brain tissue to localize active areas for neurosurgical planning. Used to identify visual, auditory, and somatosensory locations and epileptic activity. For use by trained physicians or neurology technicians. Excludes life support/vital signs monitoring.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

Elekta Neuromag (K041264)

Reference Devices

CURRY software platform (K001781)
SynAmps2 hardware system (K023771)
Elekta Neuromag TRIUX MEG

Related Devices

K041264 — ELEKTA OY · Elekta Neuromag OY · Aug 10, 2004
K081430 — ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING · Elekta Neuromag OY · Jul 28, 2008
K210199 — RICOH MEG · Ricoh Company, Ltd. · Jul 2, 2021
K971329 — CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) · Ctf Systems, Inc. · Nov 20, 1997
K030737 — OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 · Ctf Systems (2001), Inc. · Oct 10, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ February 14, 2020 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Compumedics Limited William Alam Quality Engineering Manager 30-40 Flockhart Street Abbotsford, 3067 Au ### Re: K191785 Trade/Device Name: Orion LifeSpan™ MEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLY, GWQ, OLX Dated: January 10, 2020 Received: January 13, 2020 #### Dear William Alam: 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 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 {1}------------------------------------------------ 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, for Jay Gupta, M.S.E. Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191785 Device Name Orion LifeSpan MEG #### Indications for Use (Describe) The Orion LifeSpan MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning. It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas: #### • Hospital procedures - · Physiological monitoring of patients - · Training relevant to the specific discipline or disorder under investigation Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> \[X] Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> \[] Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary The following 510(k) summary is being submitted in accordance with 21CFR807.92. | Device Information: Submitter: | Compumedics Limited | |-----------------------------------|---------------------------------------------------------------------------------| | Address: | 30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia | | Phone number: | +61 (0) 3 8420 7300 | | Fax number: | +61 (0) 3 8420 7399 | | Contact person: | William Alam 30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia | | Phone number: | +61 (0) 3 8420 7300 | | Fax number: | +61 (0) 3 8420 7399 | | Date prepared: | June 28, 2019 | | Trade name: | Orion LifeSpan™ MEG | | Common name: | Magnetoencephalograph (MEG) | | Primary product code: | OLY | | Secondary product code: | GWQ, OLX | | Device class: | II | | Regulation numbers: | 21 CFR 882.1400 | # Predicate Device Information: | Trade Name: | Elekta Neuromag | |---------------------|--------------------| | Manufacturer: | Elekta Neuromag Oy | | 510(k) number: | K041264 | | Product code: | OLY, GWQ, OLX | | Device class: | II | | Regulation numbers: | 21 CFR 882.1400 | {4}------------------------------------------------ ### Device Description The Orion LifeSpan™ MEG is a magnetoencephalograph (MEG) which records magnetic signals from the human brain. The Orion LifeSpan™ MEG uses the CURRY software platform (K001781) to acquire, process and display these signals. Optionally EEG can be recorded simultaneously with the MEG using an integrated SynAmps2 (K023771) hardware system. The Orion LifeSpan™ MEG can optionally be provided with adult, child or both sized helmets. The Orion LifeSpan™ MEG is used by skilled operators or physicians trained in the acquisition and interpretation of such signals. It is used as an adjunct as part of a range of measurements performed, such as imaging and other studies, to form a more complete picture of the patient's pathology alongside a standard clinical workup. ### Indications for Use The Orion LifeSpan™ MEG non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning. It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas: *Hospital procedures *Physiological monitoring of patients *Training relevant to the specific discipline or disorder under investigation Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units. {5}------------------------------------------------ # Substantial Equivalence Discussion The following technological differences exist between the Orion LifeSpan™ MEG and Elekta Neuromag. | Orion LifeSpan™ MEG (K191785) | Elekta Neuromag (K041264) | Differences (if any) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | | | | | The Orion LifeSpan™ MEG non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response stimulators. MEG is also used to non- invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning. It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas: *Hospital procedures *Physiological monitoring of patients *Training relevant to the specific discipline or disorder under investigation Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units. | The Elekta Neuromag non-invasively measures the magnetoencephalographic (meg) signals (and, optionally, electroencephalographic eeg signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. Meg is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain. Meg is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by meg may be used, in conjunction with other diagnostic data, in neurosurgical planning. | No significant difference, except the Orion LifeSpan™ MEG is not recommended for use with motor evoked response stimulators. Assumptions regarding evoked response stimulators, the types of users permitted, and use case exclusions are made more explicitly clear to further ensure safe usage. | | | Features | Orion LifeSpan™ MEG (K191785) | Elekta Neuromag (K041264) | Differences (if any) | | Technology | | | | | Site of patient | Head and Scalp | Head and Scalp | No difference. | | Patient Position | Supine | Supine and upright | No significant difference. Upright position is available mostly for research purposes. Supine position is common for MEG study. | | Underlying Technology | Superconducting magnetometry | Superconducting magnetometry | No difference. | | Overall Sensitivity | 10fT/ $√$ Hz | 10fT/ $√$ Hz | No difference. See Non- Clinical Performance Data. | | MEG Sensing Locations | 186 (adult) 138 (pediatric) | 102 | No significant difference. | | SQUID Readout | Flux locked loop | Flux locked loop | No difference. | | Features | Orion LifeSpan™ MEG (K191785) | Elekta Neuromag (K041264) | Differences (if any) | | Pickup Coil Design | Axial gradiometer | Mix of planar gradiometers and magnetometers | Despite difference in orientation, each pickup coil type measures components of the magnetic field generated from the same brain sources. During source estimation these signals are converted to (for example) equivalent current dipole locations, orientations and strengths. Therefore, there is no significant difference arising from the pickup coil designs. | | Average Coil-to-Coil Spacing | 27.3 mm (Adult), 25 mm (Pediatric) average distance b/w centers of each sensing loc. | 34 mm average distance between centers of each sensing location. | No difference. See Non- Clinical Performance Data for discussion of localization accuracy testing. | | Detector Architecture | DROS SQUID | dc SQUID | No significant difference. DROS SQUID is a type of dc SQUID. | | Interference Elimination (i.e., SSS, SPS) | SSP, DSSP | SSP, tSSS (which has superseded SSS) | Note that DSSP is conceptually equivalent to tSSS in that it uses temporal information to separate interference from signal.1 Therefore, no significant difference. | | Head Position Indicator (Y/N) | Y | Y | No difference. | | Features | Orion LifeSpan™ MEG (K191785) | Elekta Neuromag (K041264) | Differences (if any) | | Offline Average Function to Process Raw Data | Y | Y | No difference. | | Number of SQUID Sensor Elements | 186 (adult) 138 (pediatric) Each at a unique location | 306 at 102 unique locations | Phantom dipole localization accuracy has shown that sampling density is sufficient in the Orion. Therefore, no functionally significant difference is noted due to the number of SQUID elements. | | Number of Auxiliary Channels for Other Types of Data (i.e., EEG) | Up to 256 unipolar and 16 bipolar EEG channels Up to 8 ADC channels. | Up to 124 unipolar and 4 bipolar EEG channels. Up to 8 ADC channels. | No significant difference, provided that 128 EEG channels are included with the Orion, instead of the maximum (256). | | Method of Calculation (i.e., idealized v. individual head model)…