K Number
K171186
Device Name
Cerebrotech CMS-5000
Date Cleared
2017-12-08

(228 days)

Product Code
Regulation Number
870.2770
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
The CMS-5000 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.
More Information

Not Found

No
The summary describes a bioimpedance spectroscopy device that measures electrical properties and displays a ratio. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The technology described is based on measuring physical properties, not on learning from data.

No.
The device is used for assessment and monitoring of fluid volume differences, not for treatment or therapy.

Yes
The device is described as an "aid in the assessment of fluid volume differences" and "an adjunct to standard methodologies routinely used in the clinical evaluation of intracranial fluid distribution," indicating its role in diagnosis.

No

The device description explicitly states it is a "bioimpedance spectroscopy device" that uses "VIPS technology" and involves "an emitter antenna and a detector antenna." This indicates the presence of hardware components for measuring electrical properties, not just software.

Based on the provided information, the CMS-5000 is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • CMS-5000 Function: The CMS-5000 is a bioimpedance spectroscopy device that measures electrical properties directly on the patient's head to assess fluid volume differences. It does not analyze specimens taken from the body.

The device description and intended use clearly indicate it's a non-invasive device applied externally to the patient.

N/A

Intended Use / 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.

Product codes

OAF

Device Description

The CMS-5000 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cerebral hemispheres; human skull; head

Indicated Patient Age Range

adult human patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance:
The performance of the CMS-5000 was validated in a series of bench tests, including the use of standardized, validated bioimpedance human head phantoms. In addition, all required standardized testing was completed, including IEC 60601 tests. The results of all performance, verification and validation testing showed no new issues of safety or efficacy.

Summary of Performance Data:
The bioimpedance index, or B-DEX, is a proprietary index derived from the electrical signals received by the CMS-5000 across the range of device frequencies. B-DEX asymmetry is the percent difference in B-DEX between the two hemispheres (right minus left, divided by the average). A series of studies were conducted to establish device performance.

  • Normative human bioimpedance measurements: study with 79 healthy adult volunteers established normative human bioimpedance and person-to-person variability.
  • Detection of bioimpedance asymmetry: study using Human head phantom with a septum dividing the right and left halves was used to measure bioimpedance asymmetry between the two hemispheres.
  • Mathematical model: A mathematical model validated the accuracy of the bioimpedance asymmetry readings.
  • Measurement of bioimpedance asymmetry during head tilt: Demonstrated the ability to detect a bioimpedance asymmetry induced by gravity.
  • Measurement Stability (human): Demonstrated day-to-day measurement stability in human subjects.
  • Measurement Stability (human head phantom): Demonstrated day-to-day measurement stability of the device, independent of human day-to-day variability.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K130338

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Cerebrotech Medical Systems % Pamela Buckman Consultant Pamela M. Buckman, Msn 2800 Pleasant Hill Rd. #175 Pleasant Hill, California 94523 December 8, 2017

Re: K171186

Trade/Device Name: Cerebrotech CMS-5000 Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: OAF Dated: November 7, 2017 Received: November 8, 2017

Dear Ms. Buckman:

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.

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 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);

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Page 2 - Pamela Buckman

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for 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) K171186

Device Name Cerebrotech CMS-5000

Indications for Use (Describe)

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.

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

K171186

General Information 1.

Submission
Sponsor:Cerebrotech Medical Systems, Inc.
1048 Serpentine Lane, Suite 301
Pleasanton, CA 94566
T 510-501-6571
F 925 399 5827
Contact Person: Dawnel Scott

Submission Contact:

Pamela M. Buckman, MSN 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523 T 925 980 7007 F 925 705 7381

Date Prepared: December 8, 2017

2. Device Identification

Device Name:Cerebrotech™ CMS-5000™
Classification Name:Impedance Plethysmograph
Classification
Regulation:21 CFR Part 870.2770
Classification Panel:Neurology
Product Code:QAF
Device Class:Class II

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3. Predicate Device

K130338, Impedimed L-Dex U400, Impedance Plethysmograph

    1. Device Description
      The CMS-5000 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.
    1. 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.
    1. Comparison of Technological Characteristics
      The technological characteristics of the CMS-5000 are substantially equivalent to those of the predicate device.

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Technological Characteristics Comparison Table
CharacteristicImpedimed L-Dex U400Cerebrotech Fluids Monitor CMS-5000
Monitoring ModePeriodic. Baseline, then repeated as requiredPeriodic. Baseline, then repeated as required
Operating PrincipleMulti-frequency Bioimpedance SpectroscopyMulti-frequency Bioimpedance Spectroscopy
Embedded SoftwareYesYes
Type of EnergyElectric CurrentLow-Power Radio Frequency
Frequency Range30-310 MHz4-1000 KHz
Displayed parameterBioimpedance ratioBioimpedance ratio
Device ConfigurationNon-invasive, antenna modules and system controllerNon-invasive; adhesive contact electrode modules, system controller
Power SourceRechargeable BatteryRechargeable Battery
PerformanceDevice detects and monitors bioimpedance ratiosDevice detects and monitors bioimpedance ratios
Voltage100-240100-240
Frequency50-60 Hz50-60 Hz
Current1A Apple MagSafe 2 Power Adapter (for recharging Console)
0.2A Cell-Con plug (Scanner Battery Recharger)Not available

7. Substantial Equivalence

The compared systems utilize the same multi-frequency bioimpedance spectroscopy technology to measure tissue fluid differences between contralateral anatomies. Bioimpedance has been used for decades to measure tissue fluids in many anatomical regions, including limbs, lungs, brain, and large portions of the body for body composition analysis. While the type of energy used for monitoring differs between the CMS-5000 (Low-Power RF) and L-Dex U400 (Current), the principles of comparison are similar. The differences between the CMS-5000 and the L-Dex U400 identified above introduce no additional risks.

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    1. Safety and Effectiveness information
      The CMS-5000 and the L-Dex U400 use the same technical principles to achieve the same goal: to provide information about tissue fluid differences derived from bioimpedance ratios. Both are intended to supply adjunct information and do not replace standard diagnostic techniques, which may include physical examination, medical imaging, and professional judgment. The systems are therefore substantially equivalent.
    1. Non-Clinical Performance
      The performance of the CMS-5000 was validated in a series of bench tests, including the use of standardized, validated bioimpedance human head phantoms. In addition, all required standardized testing was completed, including IEC 60601 tests. The results of all performance, verification and validation testing showed no new issues of safety or efficacy.

Summary of Performance Data

The bioimpedance index, or B-DEX, is a proprietary index derived from the electrical signals received by the CMS-5000 across the range of device frequencies. B-DEX asymmetry is the percent difference in B-DEX between the two hemispheres (right minus left, divided by the average). A series of studies were conducted to establish device performance.

StudyDescription
Normative human
bioimpedance measurements79 healthy adult volunteers established normative
human bioimpedance and person-to-person
variability.
Detection of bioimpedance
asymmetryHuman head phantom with a septum dividing the
right and left halves was used to measure
bioimpedance asymmetry between the two
hemispheres.
Mathematical modelA mathematical model validated the accuracy of
the bioimpedance asymmetry readings.
Measurement of
bioimpedance asymmetry
during head tiltDemonstrated the ability to detect a bioimpedance
asymmetry induced by gravity.
Measurement Stability
(human)Demonstrated day-to-day measurement stability in
human subjects.
Measurement Stability
(human head phantom)Demonstrated day-to-day measurement stability of
the device, independent of human day-to-day
variability.

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10. Clinical Performance

There was no clinical testing required to support this medical device as the indications for use and technology are equivalent to those of the predicate devices.

11.Statement of Substantial Equivalence

A device is substantially equivalent when the subject device has the same intended use and the same technological characteristics as the previously cleared predicate device(s). The CMS-5000 component change from patient contacting electrodes in the predicate device to a non-contact antenna technology does not alter either of these characteristics and does not raise any new questions of safety or efficacy as compared to the predicate.

12. Conclusion

The Cerebrotech CMS-5000 was found to be substantially equivalent to the predicate device. It shares the same indications for use, similar design features as well as functional features and thus is substantially equivalent to the predicate device.