(273 days)
Not Found
Yes
The document explicitly states that the device uses a "Proprietary artificial neural network-based algorithm".
No
The device is described as an EEG acquisition and analysis system intended to monitor wake and sleep states and serve as an adjunct to diagnosis. It does not exert any direct therapeutic effect on the patient.
Yes
Explanation: The "Intended Use / Indications for Use" section 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: "The Zmachine system includes the Zmachine device, disposable EEG sensor cable, and a wall charger."
Based on the provided information, the CRI Zmachine is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- CRI Zmachine Function: The CRI Zmachine directly acquires and analyzes physiological signals (EEG) from the patient's body (specifically, the mastoid). It does not analyze specimens taken from the body.
Therefore, the CRI Zmachine falls under the category of a medical device that monitors physiological parameters, rather than an In Vitro Diagnostic device.
No
The input letter does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is blank.
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
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 sensor cable, and a wall charger. The device operates on data from the differential-mastoid EEG channel to determine the wake and sleep states of the patient every 30 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Proprietary artificial neural network-based algorithm
Input Imaging Modality
EEG
Anatomical Site
Mastoid
Indicated Patient Age Range
Adults
Intended User / Care Setting
qualified healthcare practitioners in the 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 ninety-nine subject (99) clinical study was conducted in which polysomnographic (PSG) data was acquired and analyzed by human scorers, and simultaneously data from the mastoid was acquired and processed by the Zmachine wake/sleep algorithm. Each PSG record was scored independently by at least two (2) certified polysomnographic technologists (3 records scored by 2 technologists, 16 records scored by 3 technologists, and 80 records scored by 4 technologists) using the Rechtschaffen & Kales (R&K, 1968) visual sleep scoring rules.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study, 99 subjects. The performance of the Zmachine was evaluated by comparing wake/sleep as determined by the Zmachine algorithm to the consensus of human scorers. The analysis demonstrates substantial agreement for wake/sleep determination, on an epoch-by-epoch basis, between the Zmachine algorithm and the consensus of human scorers. The overall Kappa agreement between the consensus of human scorers and the Zmachine algorithm is 0.8275, exceeding the 0.75 threshold for "high association". In conclusion, the Zmachine algorithm demonstrates accurate performance in detecting wake and sleep from a single channel (mastoid) of EEG data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Of the 16,908 epochs indicated by the consensus of human scorers as wake, the Zmachine algorithm correctly identified 91.6% as wake (Zmachine specificity). Similarly, of the 65.873 epochs indicated by the consensus of human scorers as sleep, the Zmachine algorithm correctly identified 95.8% as sleep (Zmachine sensitivity). The overall Kappa agreement between the consensus of human scorers and the Zmachine algorithm is 0.8275.
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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Zmachine® 510(k) Summary
| Submitter | Consolidated Research of Richmond, Inc. | |
|---|---|---|
| Address | 26250 Euclid Avenue, Suite 024 | |
| Euclid, Ohio 44132 | ||
| Contact Person | Richard F. Kaplan, Ph.D., President | |
| Phone: (216) 289-2331 | ||
| Fax: (216) 393-0079 | ||
| E-mail: kaplan@cri-systems.com | ||
| Date Prepared | March 28, 2011 | |
| Trade Name | Zmachine® | |
| Common Name | Sleep monitoring system | |
| Classification | ||
| Name | Electroencephalograph | |
| Classification | 21 CFR (882.1400) | |
| Product Codes | OLV and OMC | |
| 510(k) Number | K101830 | |
| Indications | ||
| for Use | The CRI Zmachine is a single-channel, EEG acquisition | |
| designed for use in the home or clinical environment | ||
| intended to be used by qualified healthcare practitioners |
ition and analysis system, ts. This device is ners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.
MAR 3 1 20i1
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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 sensor cable, and a wall charger. The device operates on data from the differential-mastoid EEG channel to determine the wake and sleep states of the patient every 30 seconds.
Substantial Equivalence
The Zmachine is substantially equivalent to the Oxford Biosomnia device, manufactured by Oxford Biosignals Limited (K021485). The table below summarizes the technological characteristics of the Zmachine in comparison to the predicate device.
| Device | Zmachine | BioSomnia |
|---|---|---|
| Classification | 21 CFR (882.1400) | 21 CFR (882.1400) |
| Product Code(s) | OLV and OMC | GWQ |
| 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. | The Oxford BioSignals BioSomnia | |
| is a single channel ambulatory EEG | ||
| with a software package designed | ||
| for use as an adjunct for the | ||
| physician in their diagnosis of sleep | ||
| disorders and to quantify sleep and | ||
| wakefulness on a second by second | ||
| basis. The device is designed to be | ||
| used overnight in the patient's home | ||
| environment to assist the physician | ||
| in diagnosing sleep disorders. | ||
| Patient Population | Adults | Adults |
| Type of Device | EEG-based sleep monitor | EEG-based sleep monitor |
| No. of EEG Channels | 1 | 1 |
| Electrode Placement | Mastoid | Mastoid |
| Frontal | ||
| EOG Upper | ||
| Central | ||
| Analyzes EEG Data in | ||
| Real Time | Yes | Yes |
| Sleep Classification | Wake and Sleep | Wake and Sleep (light sleep, deep |
| sleep, and REM sleep) | ||
| EEG Analysis | ||
| Methodology | Proprietary adaptive algorithm | |
| using time and frequency domain | ||
| features | Proprietary artificial neural | |
| network-based algorithm | ||
| Can Provide | ||
| Information to Assist | ||
| the Physician in | ||
| Diagnosis of Sleep | ||
| Disorders? | Yes | Yes |
| Can Provide | ||
| Information to Assist | ||
| the Physician in the | ||
| Application of | ||
| Treatment? | Yes | Yes |
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| Device | Zmachine | BioSomnia |
|---|---|---|
| Provides Information | ||
| to Assist Physician in | ||
| the Evaluation of | ||
| Treatment Efficacy? | Yes | Yes |
| Calculates Summary | ||
| Sleep Statistics? | Yes | Yes |
| Battery Powered? | Yes | Yes |
Performance Testing - Nonclinical
The Zmachine system has been assessed against the following standards:
Electrical safety in accordance with IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety: Safety Requirements for Medical Electrical Systems;
Electromagnetic compatibility in accordance with IEC 60601-1-2, Medical Electrical Equipment -Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility --Requirements and Tests. (General).
In addition, software testing was performed in accordance with FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices- Document issued on: May 11, 2005" regarding a moderate level of concern device:
Performance Testing - Clinical
A ninety-nine subject (99) clinical study was conducted in which polysomnographic (PSG) data was acquired and analyzed by human scorers, and simultaneously data from the mastoid was acquired and processed by the Zmachine wake/sleep algorithm. Each PSG record was scored independently by at least two (2) certified polysomnographic technologists (3 records scored by 2 technologists, 16 records scored by 3 technologists, and 80 records scored by 4 technologists) using the Rechtschaffen & Kales (R&K, 1968) visual sleep scoring rules. The performance of the Zmachine was evaluated by comparing wake/sleep as determined by the Zmachine algorithm to the consensus of human scorers. The analysis demonstrates substantial agreement for wake/sleep determination, on an epoch-by-epoch basis, between the Zmachine algorithm and the consensus of human scorers. Of the 16,908 epochs indicated by the consensus of human scorers as wake, the Zmachine algorithm correctly identified 91.6% as wake (Zmachine specificity). Similarly, of the 65.873 epochs indicated by the consensus of human scorers as sleep, the Zmachine algorithm correctly identified 95.8% as sleep (Zmachine sensitivity). The overall Kappa agreement between the consensus of human scorers and the Zmachine algorithm is 0.8275, exceeding the 0.75 threshold for "high association". In conclusion, the Zmachine algorithm demonstrates accurate performance in detecting wake and sleep from a single channel (mastoid) of EEG data.
3
Conclusion
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This submission demonstrates that the Zmachine is substantially equivalent to the predicate device based on descriptive information, non-clinical and clinical performance testing.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Consolidated Research of Richmond, Inc. President % Richard Kaplan, Ph.D. 26250 Euclid Ave. Suite 024 Euclid, OH 44132
Re: K101830
MAR 3 1 2011
Trade/Device Name: ZMachine, Model DT-100 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV and OMC Dated: February 1, 2011 Received: February 4, 2011
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.
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Page 2 - Richard Kaplan, Ph.D.
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/ucm117800 html fou 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
6
Indications for Use Statement
510(k) Number: K101830
Device Name: Zmachine
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.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KRISTEN BOWSHER
(Division Sign-Off) (Division Sign-Orr)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KIO| 830 510(k) Number,