(90 days)
The Crystal Monitor® Model 16 is intended for wireless monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.
The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Crystal Monitor Model 16 is an eight-channel, programmable, wireless data acquisition system intended to monitor and record physiological signals. Any channel can be programmed to monitor any physiological signal. Harnesses connect electrodes or sensors from the patient to the patient unit. The patient unit, worn by the patient, acquires, amplifies, and digitizes physiological signals. These signals are then transmitted by radio frequency to a computer unit connected via a serial port to a personal computer (PC). The data is then displayed in real-time and can be stored on the PC.
The Crystal Monitor Model 16 incorporates state-of-the-art wireless technology for viewing and recording physiological signals such as EEG, EKG, EMG, and EOG. This 8channel monitor is the most unobtrusive, flexible, and convenient way of measuring and transmitting physiological signals. Subjects can now be untethered during studies while real time data is collected and displayed. The Crystal Monitor Model 16 wireless physiological signal monitor consists of a Transmitter (also called the Patient Unit), a Receiver Assembly (a Receiver [also called the Computer Unit], receiver cable, and power supply), accessories (Universal Differential Harness, mounting band, electrolyte gel, screwdriver, batteries, and Test Pack), and a PC Operator Interface Software program.
The Patient Unit collects signals from electrodes attached to the subject, performs analogto-digital conversion, encoding, formatting, and transmitting of all signals. The signals are transmitted via a radio transmitter. The Computer Unit receives the transmitted data packets, performs extensive error detection and correction, and then sends the data through a Receiver cable to the PC Operator interface where the data can be stored, monitored in real time, or analyzed at a later time.
The Crystal Capture program consists of several software components that allow the user to acquire, store, and view physiological data as acquired by the Crystal Monitor Transmitter. The software provides a simple graphical interface for setting up and managing data acquisition. The Crystal Configuration Wizard allows customization of the number of input channels (1-8), ranges (micro- to millivolts), and sampling rate. Configurations can be saved allowing the user to program the Crystal Monitor for numerous applications.
The provided text describes a 510(k) premarket notification for the Crystal Monitor Model 16, an 8-channel wireless data acquisition system for physiological signals. It details the device's technical characteristics, intended use, and substantial equivalence to existing devices. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or accuracy of physiological signal measurement against a ground truth.
Instead, the document focuses on regulatory compliance and technical specifications. The "acceptance criteria" discussed are primarily related to safety, electromagnetic compatibility, and adherence to voluntary standards.
Here's an analysis based on the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Safety and EMC Standards: | The device was subjected to the following voluntary standards: - FCC Part 15.109, Class B digital device - FCC Part 15.249, Intentional radiator, FCC ID#N9Y0007 - IEC 60601-1-2 Medical Electrical Equipment, Part 1 General requirements for safety - EN 61000-4-2: 1995 Electrostatic discharge immunity test - EN 61000-4-3: 1995 Radiated, radio-frequency, electromagnetic field immunity test - EN 61000-4-4: 1995 Electrical fast transient/burst immunity tests - EN 61000-4-6: 1996 Immunity to conducted disturbances induced by radio-frequency fields - EN-55011 Electromagnetic Emissions - IEC 601-2-26 (environmental conditions: 10° to 50° C, 25-95% humidity) |
| Functional Equivalence to Predicate Devices: | "The Crystal Monitor Model 16 is technically the same as the Crystal-EEG Model 15 with the exception of software, labeling, and production company." It states they have "the same hardware, board designs, drawings, and all available accessories." |
| Wireless Signal Transmission (Implicit Functionality): | Acquires, amplifies, and digitizes physiological signals, then transmits them by radio frequency to a computer for display and storage. Performs "extensive error detection and correction" upon reception. |
| Programmability (Implicit Functionality): | 8-channel, programmable (number of channels 1-8, ranges micro- to millivolts, sampling rate). |
| Real-time Display and Storage (Implicit Functionality): | Data is "displayed in real-time and can be stored on the PC." |
Missing Information: It's crucial to understand that this document does not present clinical performance acceptance criteria such as accuracy of EEG readings, signal-to-noise ratio, or agreement with a gold standard for physiological signal interpretation. The "reported device performance" above is a summary of capabilities and compliance with safety/EMC standards, not clinical efficacy.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- None provided. The document describes regulatory compliance testing (e.g., EMC, electrical safety) but does not detail human subject testing or clinical performance evaluation with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set or ground truth established by experts is described for clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication method is described.
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
- No such study was done or described. This device is a physiological signal monitor, not an AI-based diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm" as typically referred to in AI/diagnostic studies. The device's primary function is data acquisition and display, not automated interpretation or standalone diagnostic decision-making beyond what an electroencephalograph intrinsically does (i.e., record signals). The "software components" described are for acquiring, storing, and viewing, not for AI-driven standalone analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the safety and EMC standards, the "ground truth" is compliance with the specifications of those standards (e.g., does it emit below a certain level, does it withstand a certain electrostatic discharge).
- For functional equivalence, the "ground truth" is the established performance and design of the predicate device (Crystal EEG Model 15).
- No clinical ground truth (expert consensus on EEG readings, etc.) is mentioned.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no described training set, there is no discussion of how its ground truth was established.
Conclusion:
The provided 510(k) summary for the Crystal Monitor Model 16 focuses on technical specifications, regulatory compliance with safety and EMC standards, and substantial equivalence to a predicate device. It does not present a clinical study with acceptance criteria related to physiological signal accuracy, diagnostic performance, or a "ground truth" derived from patient data interpreted by experts. The "study" referenced in the prompt's question is essentially the device's submission to and compliance with various engineering and safety standards, and its comparison to a previously cleared predicate device.
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FEB 1 9 2002
K 013863 1/3
510k Summary
The Summary of Safety and Effectiveness of the Crystal Monitor Model 16 reflects data available and represented at the time the submission was prepared, but caution should be exercise in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
As required by section 807.92(a), the following summary is included for the Crystal Monitor Model 16 by Cleveland Medical Devices, Inc.
Applicant: Robert N. Schmidt Cleveland Medical Devices 11000 Cedar Avenue, Suite 130 Cleveland, Ohio 44106
216-791-6720 Telephone: 216-791-6744 Fax:
Submission Date: 11/20/01
Trade Name: Crystal Monitor Model 16 Common Name: Electroencephalograph Classification: Class II per regulations 882.1400 Product Codes: OMC, OLV
Equivalent Devices: Crystal EEG Model 15, 510(k) No. K001110 Compumedics Siesta System, 510(k) No. K003175
Description: The Crystal Monitor Model 16 is an eight-channel, programmable, wireless data acquisition system intended to monitor and record physiological signals. Anv channel can be programmed to monitor any physiological signal. Harnesses connect electrodes or sensors from the patient to the patient unit. The patient unit, worn by the patient, acquires, amplifies, and digitizes physiological signals. These signals are then transmitted by radio frequency to a computer unit connected via a serial port to a personal computer (PC). The data is then displayed in real-time and can be stored on the PC.
The Crystal Monitor Model 16 incorporates state-of-the-art wireless technology for viewing and recording physiological signals such as EEG, EKG, EMG, and EOG. This 8channel monitor is the most unobtrusive, flexible, and convenient way of measuring and transmitting physiological signals. Subjects can now be untethered during studies while real time data is collected and displayed. The Crystal Monitor Model 16 wireless physiological signal monitor consists of a Transmitter (also called the Patient Unit), a Receiver Assembly (a Receiver [also called the Computer Unit], receiver cable, and power supply), accessories (Universal Differential Harness, mounting band, electrolyte gel, screwdriver, batteries, and Test Pack), and a PC Operator Interface Software program.
ﻨﺎ ﻥ ﻥ 71
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The Patient Unit collects signals from electrodes attached to the subject, performs analogto-digital conversion, encoding, formatting, and transmitting of all signals. The signals to-digital conversion, chooding, colline radio transmitter. The Computer Unit receives the transmitted data packets, performs extensive error detection and correction, and then sends the data through a Receiver cable to the PC Operator interface where the data can be stored, monitored in real time, or analyzed at a later time.
The Crystal Capture program consists of several software components that allow the user to acquire, store, and view physiological data as acquired by the Crystal Monitor Transmitter. The software provides a simple graphical interface for setting wp and Transmitter. The Soltware provides to namagement. The Crystal Configuration Wizard allows customization of the number of input channels (1-8), ranges (micro- to millivolis), and sampling rate. Configurations can be saved allowing the user to program the Crystal Monitor for numerous applications.
Intended Use: The Crystal Monitor Model 16 is intended for wireless monitoring and Intended Use. "The Oryonal rives to aid in research and/or diagnostic purposes.
The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Warning: Do not use in conjunction with a defibrillator.
Contraindications:
Interference may occur in the vicinity of equipment marked with the following symbol:
| Frequency ofTransmitter | Rated Maximum OutputPower of Transmitterwatts | 150 kHz to 80MHz | 150 kHz to 800MHz | 800 MHz to 1.04GHz |
|---|---|---|---|---|
| SeparationDistancemeters | SeparationDistancemeters | SeparationDistancemeters | ||
| 0.01 | 0.4 | 7 | 14 | |
| 0.1 | 1.1 | 22 | 44 | |
| 1 | 3.5 | 70 | 140 | |
| 10 | 11.1 | 221 | 443 | |
| 100 | 35 | 700 | 1400 |
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K013863p3/3
Technological Characteristics: The Crystal Monitor Model 16 is technically the same I eculliological Chiliaeter of Crystal-EEG Model 15 with the exception of software, labeling, as the production corroo, or July have the same hardware, board designs, drawings, and allo available accessoritor. They attransmitter that contains a data acquisition board for acquiring, amplifying, and digitizing physiological signals. These signals are transmitter acquiring, and digitisms, and digitizing projected to a computer. The physiological signals are by radio nequency to e or stored on a computer for analysis by a clinician.
The device was subjected to the following voluntary standards to ensure the efficacy and safety of thee device for its intended use:
FCC Part 15.109, Class B digital device;
FCC Part 15.249, Intentional radiator, FCC ID#N9Y0007;
IEC 60601-1-2 Medical Electrical Equipment, Part 1 General requirements for safety.
EN 61000-4-2: 1995 Electrostatic discharge immunity test;
EN 61000-4-3: 1995 Radiated, radio-frequency, electromagnetic field immunity test;
EN 61000-4-4: 1995 Electrical fast transient/burst immunity tests;
EN 61000-4-6: 1996 Immunity to conducted disturbances induced by radio-frequency fields;
EN-55011 Electromagnetic Emissions;
IEC 601-2-26 only to the requirements for environmental conditions in regards to ambient temperature range (10° to 50° C) and humidity (25 to 95%, without condensation).
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and recognizable, representing the department's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Mr. Robert N. Schmidt President Cleveland Medical Devices 11000 Cedar Avenue, Suite 130 Cleveland, Ohio 44106
Re: K013863
Trade/Device Name: Crystal Monitor® Model 16 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMC, OLV Dated (Date on orig SE Itr): November 20, 2001 Received (Date on orig SE ltr): November 21, 2001
APR - 9 2012
Dear Mr. Schmidt:
This letter corrects our substantially equivalent letter of February 19, 2002.
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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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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kesia Alexander
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
for
Enclosure
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| 1 | .1 | STATISTICS AND THE FORM THE FOR THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM THE FOR THE FOR |
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510(k) Number (if known): K013863
Device Name: Crystal Monitor® Model 16
Indications For Use:
The Crystal Monitor® Model 16 is intended for wireless monitoring and recording The Crystal Monitor "Model 10 10 10 10 10 21.0 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1
The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013863
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concultience of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Formal 1-2-96)
고 ... ... ). 11 C C S
§ 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).