(111 days)
The Family of Crystal 20 Monitors are intended for 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 Family of Crystal 20 Monitors® are designed to monitor physiological signals such as cardiovascular, neurological, and muscular for the purpose of research and diagnostic purposes. The Crystal 20 Monitor is a device that is programmable to the type of physiological signals being monitored such as EEG, EOG, EMG, ENG, ECG, PSG, airflow, pulse oximetry, respiratory effort, temperature, blood pressure, etc. The signals are communicated between the patient module and the computer unit using wireless technology based on frequencies such as but not limited to 902-928 MHz, 2.4 - 2.484 GHZ, Wireless Medical Telemetry Bands (WMTS), 608-614 MHz, 1395-1400 MHz, or 1429-1432 MHz. The communication between the patient module and computer unit can also be wired (instead of wireless). The Family of Crystal 20 Monitors® will consist of three major components:
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Patient Module;
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Computer Unit; and
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Interface Software
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The Patient Module can have up to 32 channels and the ability to either transmit only (one-way) or transmit and receive (two-way). The basic functional feature of the component is to acquire signals from commercially available electrodes / sensors that are attached to the subject, perform analog-to-digital conversion (when appropriate), encode, format, and transmit the signals to the Computer Unit. The Patient Unit will also have on-board memory capability that will permit the physiological data to be stored inside the patient unit. The Patient Module will contain no-touch connectors to enable connections to commercially available electrodes / sensors.
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The Computer Unit will have the ability to only receive (one-way) or receive and transmit (two-way). The basic functional feature of this component is to receive data packets, performs error detection and correction, and then sends the data to the PC Operator interface where the data can be monitored in real time or stored and analyzed at a later time.
This 510(k) summary is for the "Family of Crystal 20 Monitors" and, as such, focuses on substantial equivalence to predicate devices rather than providing detailed clinical study results with acceptance criteria. Medical device 510(k) submissions, particularly for devices like physiological signal monitors, often rely on non-clinical performance data and comparison to predicate devices to demonstrate safety and effectiveness.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not present in this document. The document describes the device, its intended use, and its classification, but does not include a performance study with acceptance criteria in the way one might find for an AI/ML-driven diagnostic device.
Here's an analysis based on the provided text, highlighting what is (and isn't) available:
Acceptance Criteria and Device Performance (Not explicitly stated for clinical performance in this document)
This document does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for clinical performance, nor does it report the device's performance against such criteria. The submission is a 510(k) for a physiological signal monitor, which typically focuses on demonstrating technical performance (e.g., signal quality, frequency range, safety) and substantial equivalence to existing predicate devices.
The "Predicate" section lists "Crystal Monitor Model 16, K013863 and Siesta System, K003175." This indicates the primary method of demonstrating effectiveness is likely through comparison to these legally marketed devices, asserting that the new device performs similarly and is at least as safe and effective.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided in this document. This document does not describe a clinical performance study with a test set of patient data to evaluate the device's diagnostic accuracy. The submission focuses on the technical specifications and intended use of a physiological signal acquisition system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided in this document. Since no clinical performance study with a test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided in this document. No clinical performance study is detailed.
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
Not applicable/Not provided in this document. The device is a physiological signal monitor, not an AI-driven diagnostic tool intended to assist human readers in interpreting images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device type and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided in this document. This device is for acquiring physiological signals; it does not contain a standalone algorithm for diagnostic interpretation in the sense of AI/ML performance. Its function is to provide raw or processed physiological data to clinicians for their interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in this document. Given the nature of the device as a physiological signal monitor, ground truth would typically refer to the accuracy of the measurement itself rather than the accuracy of a diagnostic output. The document doesn't detail specific accuracy studies, but rather focuses on overall functionality and safety in comparison to predicate devices.
8. The sample size for the training set
Not applicable/Not provided in this document. This device is not an AI/ML system that requires a "training set" of data for algorithm development.
9. How the ground truth for the training set was established
Not applicable/Not provided in this document. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided text.
Summary of what the document DOES provide:
- Device Description: The Family of Crystal 20 Monitors® is designed to monitor physiological signals (e.g., EEG, EOG, EMG, ECG, PSG, airflow, pulse oximetry, respiratory effort, temperature, blood pressure) for research and diagnostic purposes.
- Components: Patient Module, Computer Unit, and Interface Software.
- Key Features: Up to 32 channels, one-way or two-way transmission, analog-to-digital conversion, encoding, formatting, wireless (various MHz and GHz bands, including WMTS and ISM) or wired communication, on-board memory in the Patient Module, error detection/correction in the Computer Unit.
- Intended Use: Monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.
- Contraindication: Not intended for use as life support equipment or vital signs monitoring in intensive care units.
- Predicate Devices: Crystal Monitor Model 16 (K013863) and Siesta System (K003175). The substantial equivalence claim is based on comparison to these devices.
- Regulatory Information: Classified as an Electroencephalograph (21 CFR 882.1400), Class II.
- K Number: K042039.
In conclusion, this 510(k) summary is typical for a device primarily focused on signal acquisition and hardware, demonstrating equivalence to already cleared devices rather than presenting novel clinical performance data through a structured study with specific acceptance criteria as would be expected for a new diagnostic algorithm or AI product.
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510(k) SUMMARY
The Summary of Safety and Effectiveness information on the Family of Crystal 20 Monitors® is being submitted in accordance with the requirements of 21 C.F.R. §807.92 and reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
| Applicant | Cleveland Medical Devices Inc. | |
|---|---|---|
| 4415 Euclid Avenue | ||
| Cleveland, Ohio 44103 | ||
| Telephone | (216) 791-6720 | |
| Facsimile | (216) 791-6739 | |
| Date | July 26, 2004 | |
| Name | Robert N. Schmidt, President | |
| Classification | 882.1400 | |
| Predicate: | Crystal Monitor Model 16, K013863 and Siesta System, K003175 | |
| Description: | The Family of Crystal 20 Monitors® are designed to monitor physiologicalsignals such as cardiovascular, neurological, and muscular for the purposeof research and diagnostic purposes. The Crystal 20 Monitor is a devicethat is programmable to the type of physiological signals being monitoredsuch as EEG, EOG, EMG, ENG, ECG, PSG, airflow, pulse oximetry,respiratory effort, temperature, blood pressure, etc. The signals arecommunicated between the patient module and the computer unit usingwireless technology based on frequencies such as but not limited to 902-928 MHz, 2.4 - 2.484 GHZ, Wireless Medical Telemetry Bands (WMTS),608-614 MHz, 1395-1400 MHz, or 1429-1432 MHz. Thecommunication between the patient module and computer unit can also bewired (instead of wireless). The Family of Crystal 20 Monitors® willconsist of three major components: | |
| 1. Patient Module;2. Computer Unit; and3. Interface Software | ||
| 1. The Patient Module can have up to 32 channels and the ability toeither transmit only (one-way) or transmit and receive (two-way). Thebasic functional feature of the component is to acquire signals fromcommercially available electrodes / sensors that are attached to thesubject, perform analog-to-digital conversion (when appropriate),encode, format, and transmit the signals to the Computer Unit. ThePatient Unit will also have on-board memory capability that willpermit the physiological data to be stored inside the patient unit. ThePatient Module will contain no-touch connectors to enable connectionsto commercially available electrodes / sensors.2. The Computer Unit will have the ability to only receive (one-way) orreceive and transmit (two-way). The basic functional feature of thiscomponent is to receive data packets, performs error detection andcorrection, and then sends the data to the PC Operator interface wherethe data can be monitored in real time or stored and analyzed at a latertime. |
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Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cleveland Medical Devices, Inc. c/o Mr. Robert N. Schmidt President 4415 Euclid Avenue Cleveland, Ohio 44103
Re: K042039
Trade/Device Name: Family of Crystal 20 Monitors Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWO Dated (Date on orig SE ltr): November 5, 2004 Received (Date on orig SE ltr): November 8, 2004
APR - 9 2012
Dear Mr. Schmidt:
This letter corrects our substantially equivalent letter of November 17, 2004.
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 - Mr. Robert N. Schmidt
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/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
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1 / 009 of 1 / 009 Page _
| 510(k) Number (if known): | K042039 |
|---|---|
| Device Name: | Family of Crystal 20 Monitors |
The various types of model versions within the Family of Crystal 20 Monitors would be as follows:
| # | Wireless Model Option | Transmission Frequencies | Bands |
|---|---|---|---|
| 1 | CS20 - 600 | 608 - 614 MHz | WMTS |
| 2 | CS20 - 900 | 902 - 928 MHz | ISM |
| 3 | CS20 - 1300 | 1395 - 1400 MHz | WMTS |
| 4 | CS20 - 1400 | 1429 - 1432 MHz | WMTS |
| 5 | CS20 - 2400 | 2400 - 2484 MHz | ISM |
| Hard-Wired Model Option | Operating Voltage | ||
| 6 | CS20 - 120 | 120 VAC |
Indications For Use:
The Family of Crystal 20 Monitors are intended for 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number KU42039
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use __
(Optional Format 1-2-96)
1 / 009A
§ 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).