(112 days)
Unknown
The summary describes an "analysis system" and an "Algorithm" that determines sleep states, but it does not explicitly mention AI or ML. While an algorithm could potentially be ML-based, there is no definitive evidence provided in this summary.
No
The device is intended for monitoring and diagnosis, not for treating or preventing a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended "as an adjunct to their diagnosis of sleep disorders."
No
The device description explicitly states that the system includes hardware components such as the Zmachine device, disposable EEG sensors, sensor cable, and a wall charger, in addition to the software for acquisition and analysis.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- CRI Zmachine function: The CRI Zmachine acquires and analyzes EEG signals directly from the patient's body (in vivo) through sensors placed on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor wake and sleep states and assist in the diagnosis of sleep disorders based on electrical activity in the brain, not on the analysis of bodily fluids or tissues.
Therefore, based on the provided information, the CRI Zmachine is a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CRI Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.
Product codes
OLZ, OLV, OMC
Device Description
The CRI Zmachine is a battery-operated, single-channel, EEG acquisition and analysis system. The Zmachine system includes the Zmachine device, disposable EEG sensors, sensor cable, and a wall charger. The device operates on data from the differential-mastoid EEG channel to determine the wake and sleep states (wake, light sleep, deep sleep and REM) of the patient every 30 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mastoid
Indicated Patient Age Range
Adults
Intended User / Care Setting
Qualified healthcare practitioners / home or clinical environments.
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
A clinical study was conducted in which overnight laboratory polysomnographic (PSG) data, and data from the differential-mastoids (A1-A2), were acquired from 99 subjects (52F/47M, 18-60 years, median age 32.7 years), including those reporting normal sleep and those reporting complaints consistent with various sleep disorders.
The standard PSG channels were scored independently by two to four certified polysomnographic technologists, using the Rechtschaffen and Kales (R&K) visual sleep staging guidelines. The individual score files were then combined, on a 30-second epoch basis, using a majority voting rule, to generate a single score file per subject ("Human Scores"). EEG data acquired from A1-A2 was processed by the Zmachine Algorithm which determines wake, light sleep (N1&N2), deep sleep (N3) and REM on a 30-second epoch basis.
Summary of Performance Studies
Study Type: Clinical Study
Sample Size: 99 subjects
Standalone Performance: Overall, kappa agreement between Zmachine Algorithm and Human Scores for 85,206 epochs is 0.716.
Key Results:
Zmachine DT-200 performance:
Wake: P1=0.908, P2=0.843
Light Sleep: P1=0.835, P2=0.848
Deep Sleep: P1=0.738, P2=0.782
REM: P1=0.721, P2=0.732
Predicate Sleep Profiler algorithm performance (from K120450, 44 subject study):
Wake: P1=0.789, P2=0.831
Light Sleep: P1=0.855, P2=0.812
Deep Sleep: P1=0.757, P2=0.787
REM: P1=0.719, P2=0.782
The P1 and P2 values obtained during clinical validation of the Zmachine Algorithm are similar to those obtained by the predicate Sleep Profiler algorithm, which was validated using its own data set.
Key Metrics
Kappa agreement, P1 (the probability that Zmachine will correctly assign an epoch when the PSG Consensus assigns the epoch to a particular stage), P2 (when the Zmachine assigns an epoch to a particular stage, the probability of such assignment is correct).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure with three overlapping profiles, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2015
Consolidated Research Of Richmond, Inc % Richard Kaplan President 26250 Euclid Ave Suite 709 Euclid. Ohio 44132
K142825 Re:
Trade/Device Name: Zmachine DT-200 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ, OLV, OMC Dated: December 15, 2014 Received: December 19, 2014
Dear Dr. Kaplan,
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 (reporting of medical device
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -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) K142825
Device Name Zmachine DT-200
Indications for Use (Describe)
The CRI Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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C)
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510(k) Summary
Zmachine® 510(k) Notification Consolidated Research of Richmond, Inc.
| 510(k) Owner | Consolidated Research of Richmond, Inc. |
|---|---|
| Address | 26250 Euclid Avenue, Suite 709 |
| Euclid, Ohio 44132 | |
| Phone: (216) 289-2331 | |
| Fax: (216) 393-0079 | |
| Contact Person | Richard F. Kaplan, Ph.D., President |
| Phone: (216) 289-2331 Extension 1001 | |
| E-mail: kaplan@cri-systems.com | |
| Date Prepared | December 16, 2014 |
| Trade Name | Zmachine® DT-200 |
| Common Name | Sleep monitoring system |
| Classification Name | Electroencephalograph |
| 21 CFR 882.1400 | |
| Product Codes | OLZ, OLV and OMC |
| Indications for Use | The CRI Zmachine is a single-channel, EEG acquisition and analysis |
| system, designed for use in the home or clinical environments. This | |
| device is intended to be used by qualified healthcare practitioners to | |
| monitor the wake and sleep states of adult patients and as an adjunct to | |
| their diagnosis of sleep disorders. |
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| Device
Description | The CRI Zmachine is a battery-operated, single-channel, EEG
acquisition and analysis system. The Zmachine system includes the
Zmachine device, disposable EEG sensors, sensor cable, and a wall
charger. The device operates on data from the differential-mastoid
EEG channel to determine the wake and sleep states (wake, light sleep,
deep sleep and REM) of the patient every 30 seconds. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The Zmachine DT-200 is substantially equivalent to the Zmachine DT-
100 (K101830) by Consolidated Research of Richmond, Inc., sharing
the same indications for use, the same primary wake/sleep detection
algorithm, and the same hardware platform. The firmware of
Zmachine DT-200 has been upgraded to further subdivide epochs
detected as sleep by the primary wake/sleep detection algorithm into
light sleep (stages N1 and N2), deep sleep (N3) and REM. The further
subdivision of sleep stages are substantially equivalent to the Sleep
Profiler algorithm (K120450) by Advanced Brain Monitoring, Inc. |
The table below summarizes the technological characteristics of the Zmachine DT-200 in comparison to the predicate devices.
| | Zmachine DT-200
(New) | Zmachine DT-100
(K101830) | Sleep Profiler
(K120450) |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer
Name | Consolidated
Research of
Richmond, Inc. | Consolidated
Research of
Richmond, Inc. | Advanced Brain
Monitoring, Inc. |
| 510(k) Number | This 510(k) | K101830 | K120450 |
| Classification
Regulation | 882.1400 | 882.1400 | 882.1400 |
| Product Code | OLZ, OLV and
OMC | OLV and OMC | OLZ |
| | Zmachine DT-200 | Zmachine DT-100 | Sleep Profiler |
| Indications for Use | (New)
The CRI Zmachine
is a single-channel,
EEG acquisition and
analysis system,
designed for use in
the home or clinical
environments. This
device is intended to
be used by qualified
healthcare
practitioners to
monitor the wake
and sleep states of
adult patients and as
an adjunct to their
diagnosis of sleep
disorders. | (K101830)
The CRI Zmachine
is a single-channel,
EEG acquisition and
analysis system,
designed for use in
the home or clinical
environments. This
device is intended to
be used by qualified
healthcare
practitioners to
monitor the wake
and sleep states of
adult patients and as
an adjunct to their
diagnosis of sleep
disorders. | (K120450)
Sleep Profiler is
intended for the
diagnostic
evaluation by a
physician to assess
sleep quality in
adults only. The
Sleep Profiler is a
software-only
device to be used
under the
supervision of a
clinician to analyze
physiological
signals and
automatically score
sleep study results,
including the
staging of sleep,
detection of
arousals and
snoring. |
| Patient Population | Adults | Adults | Adults |
| Type of Device | EEG-based sleep
monitor | EEG-based sleep
monitor | EEG-based sleep
staging software |
| No. of EEG
Channels | 1 | 1 | 1 |
| Electrode
Placement | Mastoid | Mastoid | Frontal |
| Analyzes EEG
Data in Real Time | Yes | Yes | Yes |
| Sleep
Classification | Wake and N1+N2
(light sleep). N3
(deep sleep), and
REM | Wake and Sleep | Wake and N1, N2,
N3, and REM |
| EEG Analysis
Methodology | Proprietary
algorithm using
time and frequency
domain features | Proprietary
algorithm using
time and frequency
domain features | Proprietary
algorithm using
time and frequency
domain features |
| | Zmachine DT-200
(New) | Zmachine DT-100
(K101830) | Sleep Profiler
(K120450) |
| Provides
Information to
Assist the
Healthcare
Provider in
Evaluation of
Treatment
Efficacy? | Yes | Yes | Yes |
| Calculates
Summary Sleep
Statistics? | Yes | Yes | Yes |
| Battery Powered? | Yes | Yes | Yes |
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Performance Testing - Clinical
A clinical study was conducted in which overnight laboratory polysomnographic (PSG) data, and data from the differential-mastoids (A1-A2), were acquired from 99 subjects (52F/47M, 18-60 years, median age 32.7 years), including those reporting normal sleep and those reporting complaints consistent with various sleep disorders.
The standard PSG channels were scored independently by two to four certified polysomnographic technologists, using the Rechtschaffen and Kales (R&K) visual sleep staging guidelines. The individual score files were then combined, on a 30-second epoch basis, using a majority voting rule, to generate a single score file per subject ("Human Scores"). EEG data acquired from A1-A2 was processed by the Zmachine Algorithm which determines wake, light sleep (N1&N2), deep sleep (N3) and REM on a 30-second epoch basis.
The performance of the Zmachine Algorithm was evaluated by comparing against the Human Scores for stages wake, light sleep (N1&N2), deep sleep (N3) and REM. Overall, kappa agreement between Zmachine Algorithm and Human Scores for 85,206 epochs is 0.716, with P1 (the probability that Zmachine will correctly assign an epoch when the PSG Consensus assigns the epoch to a particular stage) and P2 (when the Zmachine assigns an epoch to a particular stage, the probability of such assignment is correct) for each stage summarized in the table below.
| Zmachine DT-200 | ||||
|---|---|---|---|---|
| Wake | Light Sleep | Deep Sleep | REM | |
| P1 | 0.908 | 0.835 | 0.738 | 0.721 |
| P2 | 0.843 | 0.848 | 0.782 | 0.732 |
Using the performance data published in K120450 (44 subject study) of the predicate Sleep Profiler algorithm, stages N1 and N2 were combined into Light Sleep for both the
7
algorithm and scorers (to permit a direct comparison with the Zmachine Algorithm) with a resulting P1 and P2 for each stage summarized in the table below.
| Sleep Profiler | ||||
|---|---|---|---|---|
| Wake | Light Sleep | Deep Sleep | REM | |
| P1 | 0.789 | 0.855 | 0.757 | 0.719 |
| P2 | 0.831 | 0.812 | 0.787 | 0.782 |
The P1 and P2 values obtained during clinical validation of the Zmachine Algorithm are similar to those obtained by the predicate Sleep Profiler algorithm, which was validated using its own data set.
Conclusion
This submission demonstrates that the Zmachine is substantially equivalent to the predicate devices based on descriptive information and clinical performance testing.