(8 days)
Not Found
No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a monitor measuring and displaying physiological data, primarily for diagnostic or monitoring purposes, not for treating or preventing disease.
No
The device monitors physiological parameters and displays real-time data, but the "user, responsible to interpret the monitored data made available," is a professional healthcare provider. This indicates that the device itself does not provide a diagnosis; it provides data for interpretation by a human expert. Therefore, it is a monitoring device, not a diagnostic one.
No
The device description explicitly states that the 8600 monitor "measures and displays real time physiological data," indicating it includes hardware components for data acquisition (e.g., sensors for ECG, NIBP, etc.) in addition to software for processing and display.
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 measuring vital signs directly from the patient's body.
- Device Description: The device measures and displays real-time physiological data like ECG, BP, SpO2, Temperature, Respiration, and various gases. These are all measurements taken from the patient's body or breath.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not mention analyzing any such specimens.
Therefore, the 8600 monitor is a patient monitoring device, not an in vitro diagnostic device.
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.
Product codes
MWI
Device Description
The 8600 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8600 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpOz, Temperature, Respiration, CO2, Nominvasive BP (NIDF), Invasive BP Agenta, For all the samini, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8600 will be capable of limit alams 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 8600 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 8600 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 8100 monitor have been in clinical use for at least six years in the gredicate devices. CSI's field experience with these modalities in the predicate device 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 8600 monitor.
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
K042569
page 1 of
-12-
SEP 2 9 2004
15 September 2004
510K Summary
Model 8600 Vital Signs Monitor
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: 8600 Vital Signs Monitor
Common Name: Vital Signs Monitor
Classification Name: Monitor, Physiological, Patient (74 MWI)
Substantial Equivalence is claimed to : CS1 Model 8100 / 8500 Vital Signs Monitor (K012059)
Device Description:
The 8600 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8600 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpOz, Temperature, Respiration, CO2, Nominvasive BP (NIDF), Invasive BP
Agenta, For all the samini, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8600 will be capable of limit alams and alerts, printing of strip chart recordings and storing 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.
Comparison with predicate device:
Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 8600 monitor utilizes existing core technologics from the predicate monitor for patient monitoring of ECG, NIBP, IBP,
@2000 Criticare Systems, Inc All Rights Reserved
1
-13-
K042569
page 2 of 2
Resp, SpO3, Temp, CO2, NoO, O2 and Halogenated Anesthetic Agents. The 8600 monitor is MR Compatible per it's labeling claims. The patient data collected by the 8600 monitor is displayed for the user on a flat pancl display as on the predicate device. The 8600 monitor utilizes Active TFT LCD color display technology. Membrane key pancls and rotary push button navigation provides a user interface equivalent to the predicate device. The packaging design of the 8600 monitor is molded plastic and aluminum 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 / 8500 monitor.
Determination of Substantial Equivalence:
The 8600 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 8600 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 8100 monitor have been in clinical use for at least six years in the gredicate devices. CSI's field experience with these modalities in the predicate device 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 8600 monitor.
Therefore, the 8600 monitor is substantially equivalent to the predicate device.
Compliance to standards and regulations:
The 8600 Vital Signs Monitor complies with the following national and international standards:
Safety
EN 60601-1 Medical Electrical Safety IEC 601-1-2 EMC Compliance ISO 10993-5,10-11 Biocompatibility
Performance
EN 60601-2-30 NIBP Safety EN 1060-1 NIBP Performance EN 1060-3 NIBP Performance {including EN 475 Alarm Performance} AAMI SP-10 NIBP Performance EN 60601-2-27 ECG Safety AAMI EC-13 Basic ECG Performance EN 865 Oximetry Performance (Equivalent to ASTM F 1415) EN 864 Capnometry Performance (Equivalent to ASTM F 1456) EN 60601-2-34 Invasive Blood Pressure Safety EN 13698 O EN 12598 Oxygen Analyzer Performance (Equivalent to ASTM Fo AST
@2000 Criticare Systems, Inc All Rights Reserved
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with text around the perimeter and a stylized eagle in the center. The eagle is depicted with three curved lines representing its body and wings.
SEP 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Criticare Systems, Inc. c/o Mr. Alex Kaplan Director QA & RA 20925 Crossroads Circle Suite 100 Waukesha, WI 53186-4054
Re: K042569
Trade Name: Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: September 18, 2004 Received: September 21, 2004
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,
Bhimmer for
Bran D. Zuckerman, M. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (IF KNOWN) : _
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.
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over - the - Counter - Use (Optional Format 1-2-96)
B.Brummer
Lesse sign-on
510(k) Numb
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)