(314 days)
The Invivo Research Inc. The Centurion™ Central Station Arrhythmia Patient Monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor patients' cardiac arrhythmias during ECG monitoring. The need to monitor these arrhythmias is most commonly encountered in the intensive care areas of the hospital during patient monitoring. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
The Centurion™ Central Station with Arrhythmia Monitoring System is a Central Station monitor comprised of a standard VGA display, a standard Personal Computer (PC) base system, and hardware used to install the Network communications system (i.e. spreadspectrum transponders and UHF telemetry receivers). The Centurion™ Central Station with Arrhythmia Monitoring System can provide the centralized display, storage and recording (or printing) of patient vital sign and waveform data that is being monitored at the Invivo Research Inc. Millennia 3500 Series bedside monitors or spread-spectrum/UHF telemetry receivers. Data accumulated at the Millennia 3500 Series bedside monitors is sent via a proprietary spread-spectrum LAN (local area network) to the Central Station for display, storage, and/or printing. Data accumulated from any of the Invivo Research Inc. telemetry transceivers is sent directly to the Central Station on standard UHF telemetry frequencies. The Central Station oversees all communications activities, allowing each system component to pass information along without interruption of patient monitoring. The Central Station with Arrhythmia monitoring provides alarm detection and reporting for all patient parameters that are available to the Central Station, including arrhythmia monitoring for up to 8 patients. The Central Station alarm capability supplements the existing bedside monitor alarm capability (alarms at both locations). The Central Station can provide storage of patient data for 8 patients for up to 24 hours. This includes waveform and patient parameter data for all available parameter values. The waveform and parameter data that has been stored in a patient file at the Central Station can be retrieved and reviewed on the display or printed out on a thermal array recorder or laser printer.
The provided text describes a 510(k) submission for the Centurion™ Central Station with Arrhythmia Patient Monitoring System. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving device performance.
Here's what can be extracted and what is missing:
Missing Information:
- Specific Acceptance Criteria: The document states "The Invivo Research Inc. Centurion™ Central Station with Arrhythmia Monitoring System conforms with national and available international product safety standards for electrical. electromagnetic compatibility, and cardiac monitoring." and "Tests demonstrating consideration and mitigation of the identified potential hazards for this device have been developed, and will be complete before release of the device." This implies that there are acceptance criteria for safety and performance, but the actual criteria (e.g., sensitivity, specificity for arrhythmia detection, alarm accuracy thresholds) and reported device performance metrics are not provided.
- Study Details: There is no detailed description of a specific study that tested the arrhythmia detection performance of the device against predefined acceptance criteria.
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
- Number of Experts/Qualifications for Ground Truth: Not specified.
- Adjudication Method: Not specified.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, and generally not applicable for a standalone arrhythmia detection system like this.
- Standalone Performance: While the device functions as a standalone system, the specific performance metrics (like sensitivity, specificity, accuracy for arrhythmia detection) are not reported. The document only generally states it "provides alarm detection and reporting for all patient parameters... including arrhythmia monitoring for up to 8 patients."
- Type of Ground Truth: Not specified. For an arrhythmia detection system, this would typically involve expert-reviewed ECG recordings.
- Sample Size for Training Set: Not specified.
- How Ground Truth for Training Set Was Established: Not specified.
Information that can be extracted:
Here's a table based on the limited information available, with significant sections marked as "Not Provided in Document":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device should do, based on general statements) | Reported Device Performance (What the document says the device does) |
|---|---|
| Conformance with national and international product safety standards | "Conforms with national and available international product safety standards for electrical, electromagnetic compatibility, and cardiac monitoring." |
| Conformance with identified potential hazards mitigation | "Tests demonstrating consideration and mitigation of the identified potential hazards for this device have been developed, and will be complete before release of the device." |
| Accurate arrhythmia detection and alarm reporting | "The Central Station with Arrhythmia monitoring provides alarm detection and reporting for all patient parameters that are available to the Central Station, including arrhythmia monitoring for up to 8 patients." (Specific performance metrics like sensitivity/specificity for arrhythmia detection are not provided) |
2. Sample Size for Test Set and Data Provenance
Not provided in the document.
3. Number of Experts and Qualifications for Ground Truth
Not provided in the document.
4. Adjudication Method
Not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned in the document. This type of study is typically for image-based AI systems where human readers are interpreting data. This device is a monitoring system that directly detects arrhythmias.
6. Standalone (Algorithm only) Performance
The device itself is a standalone system for arrhythmia detection. However, specific performance metrics (e.g., sensitivity, specificity, positive predictive value, negative predictive value for different arrhythmia types) are not reported in this summary. The document only confirms its capability to perform these functions.
7. Type of Ground Truth Used
Not provided in the document. For an arrhythmia detector, ground truth would typically be established by expert cardiologists reviewing ECG recordings.
8. Sample Size for Training Set
Not provided in the document.
9. How Ground Truth for Training Set Was Established
Not provided in the document.
{0}------------------------------------------------
NOV 1 6 1998
510(k) Summary of Safety and Effectiveness
Submitter Information:
Invivo Research Inc. 12601 Research Parkway Orlando, FL 32826 407-275-3220 Contact: Mr. Francis Casey
Product Name:
Centurion™ Central Station with Arrhythmia Patient Monitoring System Proprietary: Arrhythmia Detector and Alarm. Common: Classification: Class III (see 21 CFR - 870.1025).
Predicate Devices:
The predicate device(s) are the PCI/Vitalcom Inc. Central Station with Arrhythmia Monitor (510(k) numbers K962473 and K925411), the Datascope VISA Central Station with Arrhythmia Monitor(510(k) number K913676), and the Critikon Central Station with Arrhythmia Monitor (510(k) number K933404). These predicate devices have the same performance specifications as the Central Station with Arrhythmia Patient Monitoring System
Device Description:
The Centurion™ Central Station with Arrhythmia Monitoring System is a Central Station monitor comprised of a standard VGA display, a standard Personal Computer (PC) base system, and hardware used to install the Network communications system (i.e. spreadspectrum transponders and UHF telemetry receivers).
The Centurion™ Central Station with Arrhythmia Monitoring System can provide the centralized display, storage and recording (or printing) of patient vital sign and waveform data that is being monitored at the Invivo Research Inc. Millennia 3500 Series bedside monitors or spread-spectrum/UHF telemetry receivers.
Data accumulated at the Millennia 3500 Series bedside monitors is sent via a proprietary spread-spectrum LAN (local area network) to the Central Station for display, storage, and/or printing. Data accumulated from any of the Invivo Research Inc. telemetry transceivers is sent directly to the Central Station on standard UHF telemetry frequencies. The Central Station oversees all communications activities, allowing each system component to pass information along without interruption of patient monitoring.
{1}------------------------------------------------
The Central Station with Arrhythmia monitoring provides alarm detection and reporting for all patient parameters that are available to the Central Station, including arrhythmia monitoring for up to 8 patients. The Central Station alarm capability supplements the existing bedside monitor alarm capability (alarms at both locations).
The Central Station can provide storage of patient data for 8 patients for up to 24 hours. This includes waveform and patient parameter data for all available parameter values. The waveform and parameter data that has been stored in a patient file at the Central Station can be retrieved and reviewed on the display or printed out on a thermal array recorder or laser printer.
Intended Uses:
The Invivo Research Inc. The Centurion™ Central Station Arrhythmia Patient Monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor patients' cardiac arrhythmias during ECG monitoring. The need to monitor these arrhythmias is most commonly encountered in the intensive care areas of the hospital during patient monitoring. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications ..
Technological Comparison to Predicate Device(s):
The Invivo Research Inc. Centurion™ Central Station with Arrhythmia Monitoring System uses the same type of technology (i.e. personal computers and UHF analog or digital spread-spectrum transponders) that are found in the predicate devices listed above, and are enumerated in Attachment 2 of this document.
Summary of Performance Testing:
The Invivo Research Inc. Centurion™ Central Station with Arrhythmia Monitoring System conforms with national and available international product safety standards for electrical. electromagnetic compatibility, and cardiac monitoring.
Tests demonstrating consideration and mitigation of the identified potential hazards for this device have been developed, and will be complete before release of the device. Conformance to the product development procedures and plans are assured by the application of the system tests, design reviews, and product verification and validation testing performed prior to product release.
{2}------------------------------------------------
Image /page/2/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 image of an eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
Public Health Service
NOV 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Francis X. Casey Invivo Research, Inc. 12601 Research Parkway Orlando, FL 32826
K980045 Re: Centurion Central Station Arrhythmia Patient Monitoring System Regulatory Class: III (three) Product Code: 74 DSI Dated: August 31, 1998 Received: September 1, 1998
Dear Mr. Casey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Mr. Francis X. Casey
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page L of L
510 (k) NUMBER (IF KNOWN) : K 980045 DEVICE NAME: CENTRAN CENTRAL STATION WITH ARRIVATION OF MONITORING INDICATIONS FOR USE:
Intended Uses:
t .
The Invivo Research Inc. The Central Station Artistma Artistman Patient Monitoring The Invivo Kesearch Inc. The Centuries of clinical professionals whenever it is a is intended for general nospital of cancar costing ECC monitoring. The need to required to momor panents Cardies annoyinmencountered in the intensive careas of the monitor these arthythmas is nast comical can assisted only upon the only upon the onder of hospital during patient monitoring. This device is available to the many home use applications ..
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrent of CDRH, Office of Device Evaluation (ODE) |
|---|
| ------------------------------------------------------- |
Mark Kome
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter-Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ------------------------------------------ | -------------------------------------------------- |
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.