(189 days)
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.
The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module which produces three outputs which mav be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.
The provided text is a 510(k) summary and an FDA clearance letter for the Olympic Medical Lectromed Cerebral Function Monitor System. It does not contain details about specific acceptance criteria or dedicated studies proving the device meets them, in the sense of a performance study with metrics like sensitivity or specificity.
Instead, the documentation focuses on:
- Classification and Intended Use: Defining what the device is and what it's for.
- Predicate Device Comparison: Establishing substantial equivalence to previously cleared devices (Aspect Medical Systems A-2000 EEG Monitor with BIS and SpaceLabs 90482 EEG BIS Module). The implication is that if the predicate devices meet safety and effectiveness, then a substantially equivalent new device also meets them.
- Device Description: What the device consists of.
- Safety and Standards: Listing general electrical safety and EMC standards (BS EN 60601-1-1 and BS EN 60601-1-2: 1993) that the device meets. These are general product safety standards, not performance criteria specific to EEG monitoring accuracy.
To answer your request, I will extract the information that is present and note when specific details (like clinical study results, expert qualifications, or sample sizes for performance evaluations) are not found in this document.
Acceptance Criteria and Device Performance Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (as implied or stated through standards compliance) | Reported Device Performance (as implied by predicate equivalence and safety standards) |
|---|---|
| Electrical Safety: Compliance with BS EN 60601-1-1 | The device "meets" this standard. |
| Electromagnetic Compatibility (EMC): Compliance with BS EN 60601-1-2: 1993 | The device "meets" this standard. |
| Functional Equivalence: Ability to monitor the state of the brain by acquisition of EEG signals in specified environments (ICU, OR, clinical research). | Demonstrated through "substantial equivalence" to predicate devices (Aspect Medical Systems A-2000 EEG Monitor with BIS and SpaceLabs 90482 EEG BIS Module), which are legally marketed for similar functions. |
Note: The document does not provide quantitative performance metrics such as sensitivity, specificity, accuracy, or any other objective measure against a clinical ground truth for the device's ability to 'monitor the state of the brain'. The "performance" is primarily established through its substantial equivalence to predicate devices and adherence to general safety standards.
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not describe a specific "test set" or a clinical study with a defined sample size for evaluating the device's performance against clinical outcomes or a ground truth.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not mention a test set with expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. The document does not mention a test set or an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. The device is an EEG monitor, not an AI-assisted diagnostic tool for human readers. This document focuses on the device's ability to acquire EEG signals, not to interpret them with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable in the context of an algorithm's diagnostic performance. The device is a monitor that acquires and outputs EEG signals, not an algorithm that interprets them in a standalone capacity for diagnosis.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
No specific clinical ground truth (e.g., pathology, outcomes data, or expert consensus on EEG interpretation) is mentioned as being used to assess the performance of the Olympic Medical Lectromed Cerebral Function Monitor System within this document. The assessment relies on substantial equivalence to existing devices and compliance with safety standards.
8. The Sample Size for the Training Set
Not applicable. The document does not describe a training set for a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The document does not describe a training set or its ground truth establishment.
Summary of what the document implies about "proving" the device meets acceptance criteria:
The primary method of demonstrating that the Olympic Medical Lectromed Cerebral Function Monitor System meets its purpose and is safe is through its substantial equivalence to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as the predicate devices, which would have undergone their own review processes (though not detailed in this specific document). Compliance with general electrical safety and EMC standards (BS EN 60601-1-1 and BS EN 60601-1-2) is also cited as proof of basic safety. No specific clinical performance studies with quantitative metrics, ground truth, or expert review are described within this 510(k) summary.
{0}------------------------------------------------
3/23/99
K 983229
Section 2 - Summary & Certification
A. 510(k) Summary of Safety and Effectiveness
Classification
Electroencephalograph, 21 CFR 882.1400, Class II, OMA, OMA, Neurology
Device Name
Proprietary: Olympic Medical Lectromed Cerebral Function Monitor System Common Name: EEG Monitor
Company
Olympic Medical 5900 First Ave. S. Seattle, WA 98108
Contact
Edward B. (Ted) Weiler, Ph.D. Director of Special Projects Phone (206) 767-3500; Fax (206) 762-4200
Intended Use
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.
Predicate Device
Aspect Medical Systems A-2000 EEG Monitor with BIS. (K974496) SpaceLabs 90482 EEG BIS Module (K973596)
Device Description
The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module which produces three outputs which mav be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.
Safety and Standards
The device meets the following safety standards:
- . BS EN 60601-1-1
- BS EN 60601-1-2: 1993 Medical Electrical Equipment . Part 1. General requirements for safety Section 1.2 Collateral Standard for EMC
{1}------------------------------------------------
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 stylized eagle or bird symbol, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 9 2012
Edward B. Weiler, Ph.D. Engineering Manager Olympic Medical Corporation 5900 First Avenue South Seattle, Washington 98108
Re: K983229
Trade/Device Name: Olympic Medical Lectromed Cerebral Function Monitor System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMA, OMA, OMC Dated (Date on orig SE ltr): December 29, 1998 Received (Date on orig SE ltr): December 30, 1998
Dear Mr. Weiler:
This letter corrects our substantially equivalent letter of March 23, 1999.
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.
{2}------------------------------------------------
Page 2 - Mr. Edward B. Weiler
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. N Director
Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page 1 of 1
INDICATION FOR USE
510(k) NUMBER (IF KNOWN): K 983229 DEVICE NAME: Olympic Medical Lectromed Cerebral Function Monitor System
INDICATIONS FOR USE:
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use OR (Optional Format 1-2-96)
BocceDs
(Divis on Sign-Off) Division of General Restorative Devices 1983229 510(k) Number
Olympic LCFM 510(k)
§ 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).