The Neuromag Vectorview system is intended for use as a magneto encephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

Device Description

This device integrates 306 sensor elements, including planar gradiometers and magnetometers, with medical super-computers and data acquisition software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.

AI/ML Overview

Here's an analysis of the provided text regarding the Neuromag Vectorview device, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for the Neuromag Vectorview, which asserts substantial equivalence to a predicate device, the Neuromag-122 (K962764). In such submissions, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for specific performance metrics in the way one might see in a clinical trial. Instead, the acceptance criterion is met if the new device (Vectorview) is demonstrated to be substantially equivalent to the predicate device (Neuromag-122) in terms of safety and effectiveness.

The "study" conducted to prove this involves a direct comparison of the technical specifications and intended use of the Neuromag Vectorview against the legally marketed predicate device, Neuromag-122. The reported device performance is presented as a side-by-side comparison of features, rather than quantitative performance data from a clinical study.

Parameter	Acceptance Criteria (Substantially Equivalent to Predicate)	Reported Device Performance (Neuromag Vectorview)
Safety and Effectiveness (Overall)	Must be substantially equivalent in safety and effectiveness to Neuromag-122.	Stated as "substantially equivalent to the Neuromag-122 in safety and effectiveness."
Intended Use & Indications for Use	Same as Neuromag-122.	"The Neuromag Vectorview system does not change the existing intended use and indications for use for the Neuromag-122..." and listed identically.
Number of SQUID Sensor Elements	No explicit 'criteria', but compared to predicate.	102 (Predicate: 61)
Number of Channels for MEG Data	No explicit 'criteria', but compared to predicate.	306 (Predicate: 122)
Number of Auxiliary Channels	No explicit 'criteria', but compared to predicate.	144 (typically 64 for EEG) (Predicate: 134, typically 32 for EEG)
Coil Configuration	No explicit 'criteria', but compared to predicate.	Two orthogonal planar-first-order gradiometers and one magnetometer per location (Predicate: Two orthogonal planar-first-order gradiometers per location)
Intersensor Spacing	No explicit 'criteria', but compared to predicate.	34-35 mm (Predicate: 43-44 mm)
Sensor Element Placement / Geometry	No explicit 'criteria', but compared to predicate.	102 locations distributed across helmet-shaped lower tip of dewar, shape based on anatomy (standard EN960:1994). Inside dimensions 222 mm (length) x 181 mm (width) x 209 mm (depth).
Cryogen Used	Same as Neuromag-122.	"Same." (Predicate: Liquid Helium)
Coverage	Same as Neuromag-122.	"Same." (Predicate: One acquisition to cover entire head)
Gantry	No explicit 'criteria', but compared to predicate.	Floor mounted. Dewar helmet is either tilted 30° for seated position or horizontal (180°) for supine position. (Predicate: Floor mounted, standard gantry tilts up to 30°. Optional gantry tilts to 45°.)
Patient Position	Same as Neuromag-122.	"Same." (Predicate: Seated or Supine. Optional chair insert for children.)
Head Position Indicator	Same as Neuromag-122.	"Same." (Predicate: Available)
Computer	Same as Neuromag-122.	"Same." (Predicate: Hewlett Packard workstation with UNIX environment.)
Networking Capabilities	Same as Neuromag-122.	"Same." (Predicate: Ethernet connections to other workstations available)
Software	Same as Neuromag-122.	"Same." (Predicate: Data Acquisition, Display plotting and Signal processor for continuous data.)
Magnetic Shielded Room Accessories	Same as Neuromag-122.	"Same." (Predicate: Video monitor and two-way intercom for monitoring patients.)

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of a clinical performance study with patient data. This is a 510(k) submission based on substantial equivalence, not a clinical trial. The comparison is against the specifications of a predicate device. Therefore, no patient sample size or data provenance (country of origin, retrospective/prospective) is provided for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no test set of patient data requiring expert ground truth establishment. The "ground truth" here is the prior FDA clearance of the predicate device (Neuromag-122) and its established safety and effectiveness.

4. Adjudication method for the test set

Not applicable. There is no test set of patient data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a study involving AI or human reader performance. It is a comparison of hardware and basic software specifications to demonstrate substantial equivalence to a predecessor device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm that performs a diagnostic task in a standalone manner. It is a medical device for acquiring biomagnetic signals, which are then interpreted by a trained clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the regulatory status and established safety/effectiveness profile of the predicate device (Neuromag-122), which was previously cleared by the FDA (K962764). The new device (Vectorview) claims substantial equivalence to this established "ground truth" through a comparison of physical and functional specifications.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device undergoing a machine learning training process.

9. How the ground truth for the training set was established

Not applicable. As there's no training set, there's no ground truth established for it.

Summary

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DEC 30 1998

K984401

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

1. General Information

Classification:	Class IIMagnetoencephalograph
Common/Usual Name:	Magnetoencephalographic (MEG) Device
Proprietary Name:	Vectorview
Establishment Registration:	Manufacturer:Neuromag Ltd.P.O. Box 35700511 Helsinki, FinlandPhone: +358-9-394 101Fax: +358-9-3941 203FDA Facility Registration: #9680891United States Representative:Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965

No applicable performance standards have been Performance Standards: issued under section 514 of the Food, Drug and Cosmetic Act.

2. Intended Uses

The Neuromag Vectorview system does not change the existing intended use and indications for use for the Neuromag-122 as defined below.

【- | PICKER INTERNATIONAL, INC. (VECTOR) 12/01/98

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Device Description 3.

Safety and Effectiveness 4.

The Neuromag Vectorview is substantially equivalent to the Neuromag-122 in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence.

Parameter	Neuromag Vectorview	Predicate DeviceNeuromag-122 (K962764)
No. of SQUID sensorelements	102	61
No. of channels for MEGdata	306	122
No. of auxiliary channelsfor other types of data (e.gEEG)	144(typically 64 for EEG)	134(typically use 32 for EEG)
Coil Configuration	Two orthogonal planar-first-order gradiometers and onemagnetometer per location	Two orthogonal planar-first-ordergradiometers per location
Intersensor spacing	34-35 mm	43-44 mm
Sensor element placement	102 locations distributedacross helmet-shaped lower tipof dewar, shape based onanatomy (standardEN960:1994). Insidedimensions 222 mm (length) x181 mm (width) x 209 mm(depth).	Sixty-one locations distributed acrosshelmet-shaped lower tip of dewar.Radius of curvature of helmet is 83mm (front-portion) and 91 mm (back-portion).
Cryogen Used	Same.	Liquid Helium
Coverage	Same.	One acquisition to cover entire head
Gantry	Floor mounted. Dewar helmetis either tilted 30° for seatedposition or horizontal (180°)for supine position.	Floor mounted, standard gantry tiltsup to 30°. Optional gantry tilts to 45°.

Substantial Equivalence Chart

PICKER INTERNATIONAL, INC. (VECTOR) 12/01/98

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Parameter	Neuromag Vectorview	Predicate DeviceNeuromag-122 (K962764)
Patient Position	Same.	Seated or Supine. Optional chairinsert for children.
Head Position Indicator	Same.	Available
Computer	Same.	Hewlett Packard workstation withUNIX environment.
Networking Capabilities	Same.	Ethernet connections to otherworkstations available
Software	Same.	Data Acquisition, Display plotting andSignal processor for continuous data.
Magnetic Shielded RoomAccessories	Same.	Video monitor and two-way intercomfor monitoring patients.
Intended Use & Indicationsfor Use	Same.	The Neuromag-122 system is intendedfor use as a magneto encephalographic(MEG) device which non-invasivelydetects and displays biomagneticsignals produced by electrically activenerve tissue in the brain. Wheninterpreted by a trained clinician, thedata enhances the diagnostic capabilityby providing useful information aboutthe location relative to brain anatomyof active nerve tissue responsible forcritical brain functions.

12/01/98

(VECTOR)

I - 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Elaine K. Keeler, Ph.D. Manager, MR Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

APR - 9 2012

Re: K984401

Trade/Device Name: Neuromag Vectorview Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY, GWQ Dated (Date on orig SE Itr): December 7, 1998 Received (Date on orig SE ltr): December 9, 1998

Dear Ms. Keeler:

This letter corrects our substantially equivalent letter of December 30, 1998.

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. 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.

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Page 2 - Ms. Elaine K. Keeler

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows a stylized, handwritten letter 'J' in black ink on a white background. The 'J' has a flowing, cursive style with a prominent loop at the bottom and a curved stroke extending from the top. The stroke at the top of the 'J' appears to form a small, connected 'or' or 'ar' shape, adding a unique flourish to the letter.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

. 2

510(k) Number (if known): K984401

Device Name: Vectorview

Indications for Use:

4-1 - 1

The Vectorview is intended for use as a magneto encephalographic (MEG) device which noninvasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by the viding useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark McMullen

for
Cyma (Division Sign-Off)
cre Division of General Restorative Devices
510(k) Number. K984401

× Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).