(50 days)
Not Found
No
The description focuses on standard physiological monitoring and analysis algorithms (Arrhythmia Detection and ST Analysis) which are typically rule-based or statistical, not explicitly mentioning or implying AI/ML. The performance testing described also aligns with traditional algorithm validation.
No
The device is intended to monitor physiological parameters and display real-time data, not to provide any therapeutic intervention or treatment.
Yes
The device is designed to interpret and display real-time physiological data, including the incorporation of "Arrhythmia Detection and ST Analysis software." These features indicate that the device processes physiological signals to provide information that can lead to a diagnosis (e.g., detecting arrhythmias or ST segment changes indicative of cardiac conditions). The purpose is to monitor physiological parameters, and by detecting specific patterns or changes in these parameters, it aids healthcare providers in understanding a patient's health status, which is a key function of a diagnostic device.
No
The device description explicitly states it is a "monitor" that "interprets and displays real time physiological data" and can be "custom configured to monitor ECG, Noninvasive BP (NIBP), Invasive BP (IBP), S.O2, Temperature, Respiration, CO2, N.O. O2 and Halogenated Anesthetic Agents." It also mentions using "extant ECG hardware inputs and microprocessor." This indicates the device is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor physiological parameters of patients within any healthcare environment." This involves directly measuring and displaying vital signs from the patient's body.
- Device Description: The device monitors parameters like ECG, NIBP, IBP, S.O2, Temperature, Respiration, CO2, N.O., O2, and Halogenated Anesthetic Agents. These are all physiological measurements taken from the patient.
- Lack of In Vitro Activity: An IVD is a device intended for use in vitro for the examination of specimens, including blood, tissues, and body excretions, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures. This device does not perform any tests on specimens outside of the body.
The device is a patient monitor, which is a type of medical device used for real-time monitoring of a patient's physiological status.
N/A
Intended Use / Indications for Use
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarns and patient data analysis will be available to the care provider from the monitor.
Product codes
MHX
Device Description
The 8100 monitor interprets and displays real time physiological data of the patient including waveforms and numerical data. The 8100 can be custom configured to monitor ECG, Noninvasive BP (NIBP), Invasive BP (IBP), S.O2, Temperature, Respiration, CO2, N.O. O2 and Halogenated Anesthetic Agents. Arrhythmia Detection and ST Analysis software from Brentwood Medical has been incorporated into the 8100 system and uses the extant ECG hardware inputs and microprocessor to enable these capabilities. All user interface elements are provided by the existing 8100 monitor. For each patient vital parameter, the 8100 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional health care provider / any healthcare environment
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
To document the performance of the Brentwood algorithms when integrated into the 8100 and verify the timeliness of ECG morphology-related alarms, the 8100 was tested with a representative group of prerecorded ECG waveforms with abnormal beats.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
AAMI EC-57 testing was performed by Brentwood Medical in their previous submittal (K013717). To document the performance of the Brentwood algorithms when integrated into the 8100 and verify the timeliness of ECG morphology-related alarms, the 8100 was tested with a representative group of prerecorded ECG waveforms with abnormal beats.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K030613
page 1 of 2
17 February 2003
APR 1 7 2003
510(k) Summary
12
8100 Vital Signs Monitor w/ Arrhythmia Detection and ST Analysis
| Contact: | Alex Kaplan |
|---|---|
| Director of QA & RA | |
| Criticare Systems, Inc. | |
| 20925 Crossroads Circle | |
| Waukesha, WI 53186 USA | |
| 262-798-8282 Voice | |
| 262-798-8290 FAX | |
| Trade Name: | 8100 Vital Signs Monitor w/Arrhythmia and ST |
| Common Name: | Vital Signs Monitor |
| Classification Name: | Monitor, Physiological, Patient (74 MWI) |
| Substantial Equivalence is claimed to : | CSI Model 8100/8500 Vital Signs Monitor (K012059) |
Device Description:
The 8100 monitor interprets and displays real time physiological data of the patient including waveforms and numerical data. The 8100 can be custom configured to monitor ECG, Noninvasive BP (NIBP), Invasive BP (IBP), S.O2, Temperature, Respiration, CO2, N.O. O2 and Halogenated Anesthetic Agents. Arrhythmia Detection and ST Analysis software from Brentwood Medical has been incorporated into the 8100 system and uses the extant ECG hardware inputs and microprocessor to enable these capabilities. All user interface elements are provided by the existing 8100 monitor. For each patient vital parameter, the 8100 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review.
Intended Use:
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.
1
Comparison with predicate device:
Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 8100 Vital Signs Monitoring System w/ Arrhythmia Detection and ST Analysis (8100) has the same functions and specifications as the predicate device, the 8100 / 8500 Vital Signs Monitoring System (8100 / 8500), with the addition of Arrhythmia Detection and ST Analysis software algorithms from Brentwood Medical (Brentwood algorithms). The 8100 / 8500 Vital Signs Monitoring System was approved for distribution under the FDA 510(k) file number K012059 and Brentwood Medical's algorithms were previously listed under FDA 510(k) file number K013717. The 8100 / 8500 predicate system is capable of monitoring a number of physiological parameters including ECG, NIBP, IBP, ETCO3, N,O. O., Halogenated Anesthetic Agents, Respiration, Temperature and SpO2. The patient data collected by the 8100 monitor is displayed for the user on a flat panel display as on the predicate device. The 8100 monitor utilizes Active TFT LCD color display technology. Membrane key panels and rotary push button navigation provides a user interface equivalent to the predicate device. The packaging design of the 8100 monitor is molded plastic, as was the predicate 8100/8500 Vital Signs Monitor. It incorporates audible and visual alarm functions that are activated when set parameter limits are exceeded. The monitoring system is also capable of communicating patient data to the VitalView 24 central monitor for display and alarms as appropriate.
Determination of Substantial Equivalence:
The 8100 monitor has been confirmed to have equivalent performance to the predicate devices for each patient monitoring modality. Additionally, the 8100 complies with safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed. AAMI EC-57 testing was performed by Brentwood Medical in their previous submittal (K013717). To document the performance of the Brentwood algorithms when integrated into the 8100 and verify the timeliness of ECG morphology-related alarms, the 8100 was tested with a representative group of prerecorded ECG waveforms with abnormal beats. The patient monitoring technologies present in the 8100 monitor have been in clinical use for at least six years in the predicate 8100 / 8500 (and it's predicate devices, the Scholar 2200 and POET IQ monitors). CSI's field experience with these modalities in the predicate devices has been satisfactory. This combination of equivalence testing, applicable objective standards compliance and field experience substantiates a high level of confidence in the safety and efficacy of the 8100 monitor.
Therefore, the 8100 monitor is substantially equivalent to the predicate devices.
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 its wings spread, with the profiles of two human faces incorporated into the design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2003
Criticare Systems, Inc. c/o Mr. Alex Kaplan Director of QA & RA 20925 Crossroads Circle Suite 100 Waukesha, WI 53186-4054
Re: K030613
Trade Name: Vital Signs Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: April 3, 2003 Received: April 7, 2003
Dear Mr. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Alex Kaplan
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); 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. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
K. Walter Tull
Bi am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (IF KNOWN) : _ KQ 306/3
DEVICE NAME: Vital Signs Monitor
Indications for Use
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarns and patient data analysis will be available to the care provider from the monitor.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Prescription Use Qver - the - Counter - Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)