The Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.

The Visor System is an adjunct to standard methodologies for clinical evaluation.

Device Description

The Visor System is a bioimpedance spectroscopy device used to monitor patients who have conditions that predispose them to fluid volume changes. The device uses Volumetric Integral Phase-Shift Spectroscopy (VIPS) technology. Changes in the volume of fluids in the human skull can be detected by monitoring changes in electrical properties. VIPS technology measures the frequency response of the phase angle shift between an emitter antenna and a detector antenna, when placed on opposite sides of the head. The device is intended to be used as an aid to clinical assessment in conjunction with current standards of care.

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Cerebrotech Visor System, detailing its substantial equivalence to a predicate device (CMS-5000) based on modifications to its physical dimensions, user interface software platform, and power source.

The document discusses:

Indications for Use: To measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment, as an adjunct to standard methodologies.
Technological Characteristics: Multi-frequency Bioimpedance Spectroscopy using low-power radio frequency current.
Comparison to Predicate: The Visor System is essentially the CMS-5000 with a smaller profile due to a change from a MacBook laptop to an Android tablet for the user interface, and a removable rechargeable battery.

It explicitly states, "The Visor System is the same device as the predicate with some modifications. It provides adjunct information about tissue fluid differences derived from bioimpedance ratios and does not replace standard diagnostic techniques, which may include physical examination, medical imaging, and professional judgment. The systems are therefore substantially equivalent."

This means the submission focuses on demonstrating that the modified device (Visor System) is as safe and effective as the previously cleared predicate device (CMS-5000), rather than providing new performance criteria and a study to meet those criteria. The verification of the CerebroScan software in the Android Tablet is mentioned as being provided in the 510(k) submission, but the details of this verification, including specific acceptance criteria, sample size, or study design, are not included in this summary.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

November 23, 2018

Cerebrotech Medical Systems, Inc. Dawnel Scott Director. RA/OA 1048 Serpentine Lane, Suite 301 Pleasanton, California 94566

Re: K182967

Trade/Device Name: Visor System Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: QAF Dated: October 25, 2018 Received: October 26, 2018

Dear Dawnel Scott:

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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Xiaolin Zheng -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182967

Device Name Visor System

Indications for Use (Describe)

The Visor System is an adjunct to standard methodologies for clinical evaluation.

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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510(K) SUMMARY K182967

1. General Information

Submission
Sponsor:	Cerebrotech Medical Systems, Inc.1048 Serpentine Lane, Suite 301Pleasanton, CA 94566

Submission
Contact:	Dawnel ScottT 510-501-6571F 925-399-5827

Date Prepared: November 20, 2018

2. Device Identification

Device Name:	Visor™ System
Classification Name	Impedance Plethysmograph
ClassificationRegulation:	21 CFR Part 870.2770
Classification Panel:	Neurology
Product Code:	QAF
Device Class:	Class II

3. Predicate Device

K171186, Cerebrotech CMS-5000, Impedance Plethysmograph, Cranial

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4. Device Description

5. Indications for Use

The Visor System is an adjunct to standard methodologies for clinical evaluation.

6. Comparison of Technological Characteristics

The Visor System is the same device as the predicate with some modifications: smaller overall size and changing from a MacBook laptop to an Android tablet for the user interface.

7. Substantial Equivalence

The Visor System is the same device as the predicate with some modifications. The devices are substantially equivalent.

ITEM	PREDICATE DEVICEVisor System (previouslycalled CMS-5000)	SUBJECT DEVICEVisor System (as modified)	Comments
Sponsor	Cerebrotech Medical Systems, Inc.	Cerebrotech Medical Systems, Inc.
510 (k) Number	K171186	K182967
CDRHClassification	Class II	Class II	Same as Predicate
Product Code	QAF	QAF	Same as Predicate
RegulationName	Impedance Plethysmograph, Cranial	Impedance Plethysmograph, Cranial	Same as Predicate
RegulationNumber	21 CFR Part 870.2770	21 CFR Part 870.2770	Same as Predicate
ITEM	PREDICATE DEVICEVisor System (previously called CMS-5000)	SUBJECT DEVICEVisor System (as modified)	Comments
Indications for Use	The CMS-5000 is a bioimpedance spectroscopy device for use on adult human patients utilizing impedance ratios that are displayed as a B-DEX ratio as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment.The CMS-5000 is an adjunct to standard methodologies routinely used in the clinical evaluation of intracranial fluid distribution and is not intended to be a sole determinant.	The Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.The Visor System is an adjunct to standard methodologies for clinical evaluation.	ModifiedSee Note 1.
Monitoring Mode	Periodic. Baseline, then repeated as required	Periodic. Baseline, then repeated as required	Same as Predicate
Operating Principle	Multi-frequency Bioimpedance Spectroscopy	Multi-frequency Bioimpedance Spectroscopy	Same as Predicate
Software	Yes	Yes	ModifiedSee Note 2.
Type of Energy	Low-Power Radio Frequency Current	Low-Power Radio Frequency Current	Same as Predicate
Frequency Range	30-310 MHz	30-310 MHz	Same as Predicate
Displayed parameter	Bioimpedance ratio	Bioimpedance ratio	Same as Predicate
Device Configuration	Non-invasive, antenna modules and system controller	Non-invasive, antenna modules and system controller	Same as Predicate
Physical Dimensions	Weight: 1.1 lbsLength: 9.6"Width: 8.42"Height: 3.26"	Weight: 1.1 lbsLength: 9.0"Width: 9.0"Height: 2.8"	ModifiedSee Note 3.
Power Source	Rechargeable Battery	Rechargeable Battery	ModifiedSee Note 4.
Performance	Device detects and monitors bioimpedance ratios	Device detects and monitors bioimpedance ratios	Same as Predicate
ELECTRICAL REQUIREMENTS
Voltage	100-240	100-240	Same as Predicate
Frequency	50-60 Hz	50-60 Hz	Same as Predicate
Current	1A Apple MagSafe 2Power Adapter (forrecharging Console)0.2A Cell-Con plug(Scanner BatteryRecharger)	2.1A Power Adapter (forcharging the Tablet)1A for the Scanner BatteryCharger	ModifiedSee Note: 5

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Indication for Use: The indication for use statement presented for the NOTE 1: subject device is a clarified version of the predicate indication statement. No substantial changes were made to the statement.

NOTE 2: Software: User interface software (CerebroScan) is included in a MacBook laptop for the predicate, whereas the software is included in a Tablet for the subject device. Verification of the CerebroScan software in the Tablet (Android platform) is provided in the 510(k) submission.

Physical dimensions: The subject device has a smaller profile. The user NOTE 3: interface is now contained on an Android Tablet rather than a MacBook laptop.

Image /page/6/Picture/4 description: The image shows a white mannequin head wearing a Cerebrotech Visor. The visor is white and gray, with orange accents. The visor is positioned on the mannequin's head so that it covers the forehead and eyes. The mannequin's head is facing forward and is set against a white background.

Figure 1a: Predicate Device

Image /page/6/Picture/6 description: The image shows a Cerebrotech Visor device on a mannequin head. The device is white and gray with orange accents. It is positioned on the mannequin's head, covering the forehead and temples. The device has a sleek, futuristic design and appears to be a medical or technological device.

Figure 1b: Subject Device

Power Source: Both the predicate and subject devices use rechargeable NOTE 4: Li-ion batteries. The battery in the predicate device was not removable whereas the battery for the subject device is removable. Both batteries are ISO 62133 certified.

Current: Both the predicate and subject devices use chargers as provided NOTE 5: by their manufacturer.

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8. Safety and Effectiveness information

The Visor System is the same device as the predicate with some modifications. It provides adjunct information about tissue fluid differences derived from bioimpedance ratios and does not replace standard diagnostic techniques, which may include physical examination, medical imaging, and professional judgment. The systems are therefore substantially equivalent.

9. Statement of Substantial Equivalence

The Visor System is the same device as the predicate with some modifications. The devices have the same intended use and the same technological characteristics.

10.Conclusion

The Cerebrotech Visor as modified is substantially equivalent to the predicate device. It shares the same indications for use, design features and functional characteristics and thus is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.