(85 days)
Not Found
No
The summary describes a standard vital signs monitor with arrhythmia and ST analysis, which are common signal processing techniques, not necessarily AI/ML. There is no mention of AI, ML, deep learning, or any related concepts in the text.
No
The device is described as a monitor that measures and displays physiological parameters, provides alarms, and stores trends for review, which are functions of a diagnostic or monitoring device, not a therapeutic one.
No
The device monitors physiological parameters and provides alarms, but the interpretation of this data for diagnosis is left to the professional healthcare provider. The device itself does not provide a diagnosis.
No
The device description explicitly states it "measures and displays real time physiological data" and is a "modular system" that monitors various physiological parameters. This indicates the device includes hardware components for data acquisition (sensors, etc.) in addition to any software for processing and display.
Based on the provided text, 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 measuring vital signs directly from the patient's body.
- Device Description: The device measures and displays "real time physiological data of the patient." The parameters listed (ECG, NIBP, IBP, Temperature, Respiratory Gases, Anesthetic Agent Gases, Respiratory Rate, SpO2, Arrhythmia and ST Analysis) are all measured in vivo (within the living body).
- Definition of IVD: An In Vitro Diagnostic device is used to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not process such specimens.
The device described is a patient monitor, which is a type of medical device used for in vivo monitoring of physiological functions.
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 alarms and patient data analysis will be available to the care provider from the monitor.
The monitored parameters are:
-
- ECG
-
- Noninvasive Blood Pressure (NIBP)
-
- Invasive Blood Pressure (IBP)
-
- Temperature
-
- Respiratory Gases
-
- Anesthetic Agent Gases
-
- Respiratory Rate
-
- Pulse Oximetry (SpO2)
-
- Arrhythmia and ST Analysis of the ECG waveforms
Product codes
MLD, MHX
Device Description
The 9100 monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 9100 is a modular system and can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. Arrhythmia and ST Segment analysis of the ECG waveforms is also offered. For all these vital parameters, the 9100 will be capable of limit alarms and alerts, printing of strip chart recordings and storing 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 9100 complies with applicable safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed. The patient monitoring technologies present in the 9100 monitor have been in clinical use for at least six years in the 8100 monitor and it's predicates. CSI's field experience with these modalities in the predicate devices has been satisfactory.
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
26 July 2010
510(k) Summary
Model 9100 Family Vital Signs Monitor
Contact:
Alex Kaplan Director QA & RA Criticare Systems, Inc. 20925 Crossroads Circle Waukesha, WI 53186 USA 262-798-8282 Voice 262-798-8290 FAX
Trade Name:
9100 Family Vital Signs Monitor
Vital Signs Monitor Common Name:
Classification Name: ST Segment Monitor with Alarm (MLD); Physiological Monitor (with Arrhythmia Detection or Alarms) (MHX) {CFR 870.1025}
Substantial Equivalence is claimed to : 8100/8500 Vital Signs Monitor (K012059). 8100 w/Arrhythmia & ST Analysis Vital Signs Monitor (K030613). 9100 Vital Signs Monitor (K091050).
Device Description:
The 9100 monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 9100 is a modular system and can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. Arrhythmia and ST Segment analysis of the ECG waveforms is also offered. For all these vital parameters, the 9100 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.
Comparison with predicate device:
Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 9100 monitor utilizes existing core technologies from the predicate 8100 monitor for patient monitoring of ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. The patient data collected by the 9100 monitor is displayed for the user on a graphic LCD equivalent to the predicate device. Key panels and a touchscreen provide a user interface equivalent to the predicate device. The packaging design of the
1 2010 SEP
1
9100 monitor is molded plastic and allows for it to be either a stationary monitor or to be used during patient translocation within the healthcare facility, as did the predicate 8100.
Determination of Substantial Equivalence:
The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 9100 complies with applicable safety and performance standards (detailed below) for each monitoring modality and verification of compliance has been completed. The patient monitoring technologies present in the 9100 monitor have been in clinical use for at least six years in the 8100 monitor and it's predicates. 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 9100 monitor.
Therefore, the 9100 monitor is substantially equivalent to the predicate devices.
Compliance to standards and regulations:
The 9100 Vital Signs Monitor complies with the following national and international standards:
Safety
IEC 60601-1 Medical Electrical Safety IEC 60601-1-2 EMC Compliance IEC 60601-1-8 Alarıs IEC 60601-2-49 Multi-parameter Monitor Safety ISO 10993-5,10-11 Biocompatibility
Performance
IEC 60601-2-30 NIBP Safety EN 1060-1 NIBP Performance EN 1060-3 NIBP Performance AAMI SP-10 NIBP Performance ISO 9919 Oximetry Performance IEC 60601-2-27 ECG Safety AAMI EC-13 Basic ECG Performance AAMI EC-57 Performance of Cardiac Rhythm and ST Segment Measurement Algorithms
IEC 60601-2-34 Invasive Blood Pressure Safety · ISO 21647 Gas Monitor Performance EN 12470-4 Temperature Performance
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the left side of the logo. The text is in all caps and is smaller than the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Criticare Systems, Inc. c/o Mr. Alex Kaplan Director QA & RA 20925 Crossroads Circle Waukesha, WI 53186
: _ _ !!. ﺎﺕ
Re: K101602
Trade/Device Name: 9100 Family Vital Signs Monitor Regulatory Number: 21 CFR 870.1025 Regulation Name: ST Segment Monitor with Alarm Regulatory Class: II (two) Product Code: MLD, MHX Dated: June 30, 2010 Received: August 2, 2010
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 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. 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); 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/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 yours.
M. J. Weele
ﻣﻬﻢ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
1 2010 SEP
510(k) Number (if known): KIO 160 Z
9100 Family Vital Signs Monitor Device Name:
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 alarms and patient data analysis will be available to the care provider from the monitor.
The monitored parameters are:
-
- ECG
-
- Noninvasive Blood Pressure (NIBP)
-
- Invasive Blood Pressure (IBP)
-
- Temperature
-
- Respiratory Gases
-
- Anesthetic Agent Gases
-
- Respiratory Rate
-
- Pulse Oximetry (SpO2)
-
- Arrhythmia and ST Analysis of the ECG waveforms
Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Williem
Division Sign Off
Division Sign-Off Office of Device Evaluation Evaluation and Safety 510(K) K101602
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