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.

Device Description

The 8100 / 8500 monitor measures and displays real time physiological data of the patient, including waveforms and numerical data. The 8100 / 8500 can be configured to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP (IBP), SpO2, Temperature, Respiration, CO2, N2O, O2 and Halogenated Anesthetic Agents. For all these vital parameters, the 8100 / 8500 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.

AI/ML Overview

The provided text is a 510(k) summary for the Criticare Systems, Inc. Model 8100/8500 Vital Signs Monitor. This document is a premarket notification for a medical device seeking clearance from the FDA, claiming substantial equivalence to previously cleared predicate devices. It describes the device's function, intended use, and its compliance with relevant standards. However, it does not contain the detailed study results, acceptance criteria, or specific performance metrics in the way that would typically be presented for a standalone AI/software-as-a-medical-device (SaMD) study.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states that the device's performance for each monitoring modality "has been confirmed to be equivalent to the predicate devices" and that it "complies with applicable safety and performance standards." It lists numerous specific standards (e.g., EN 60601-2-30 NIBP Safety, AAMI SP-10 NIBP Performance, EN 865 Oximetry Performance).
Reported Device Performance: The document generally states that the performance has been confirmed and complied with standards, but it does not provide numerical results or specific performance metrics against those standards. For example, it doesn't say "NIBP accuracy was within X mmHg, meeting the AAMI SP-10 requirement of Y mmHg."

Parameter/Modality	Acceptance Criteria (Implicit)	Reported Device Performance (General)
ECG	Compliance with IEC 60601-2-27 and AAMI EC-13	Confirmed equivalent to predicate, complies with standards.
NIBP	Compliance with EN 60601-2-30, EN1060-1, EN 1060-3, AAMI SP-10 (including EN 475 alarms)	Confirmed equivalent to predicate, complies with standards.
IBP	Compliance with EN 60601-2-34	Confirmed equivalent to predicate, complies with standards.
SpO2	Compliance with EN 865 (Equivalent to ASTM F 1415)	Confirmed equivalent to predicate, complies with standards.
Temperature	(Not explicitly listed, but implied under general physiological monitoring equivalence)	Confirmed equivalent to predicate, complies with standards.
Respiration	(Not explicitly listed, but implied under general physiological monitoring equivalence)	Confirmed equivalent to predicate, complies with standards.
CO2	Compliance with EN 864 Capnometry Performance (Equivalent to ASTM F 1456)	Confirmed equivalent to predicate, complies with standards.
N2O	Compliance with EN ISO 11196 Anesthetic Gas Monitor Performance (Equivalent to ASTM F 1452)	Confirmed equivalent to predicate, complies with standards.
O2	Compliance with EN 12598 Oxygen Analyzer Performance (Equivalent to ASTM F 1462)	Confirmed equivalent to predicate, complies with standards.
Halogenated Agents	Compliance with EN ISO 11196 Anesthetic Gas Monitor Performance (Equivalent to ASTM F 1452)	Confirmed equivalent to predicate, complies with standards.
Safety	Compliance with EN 60601-1, IEC 601-1-2, ISO 10993-5,10-11	Complies with applicable safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document refers to "equivalence testing" and "field experience" but does not detail the methodology, sample sizes, or data provenance of any specific tests or studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This document describes a vital signs monitor, not a diagnostic AI device requiring expert ground truth for interpretation of images or complex data. The "ground truth" for vital signs monitoring typically comes from established reference methods (e.g., a known SpO2 calibration, a reference NIBP cuff, or an invasive arterial line for IBP comparison). The document mentions "CSI's field experience with these modalities in the predicate devices has been satisfactory," suggesting real-world data, but no specific expert panel for ground truth generation is indicated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No adjudication method is mentioned as this is not a study involving expert interpretation of data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a vital signs monitor, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance effect size is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Applicable in a different context. The device is a standalone monitoring system that measures physiological parameters. Its performance, in comparison to predicate devices and standards, would be considered its "standalone" performance for each parameter. However, the document doesn't detail the specifics of such testing beyond stating compliance. The "user... will be a professional health care provider," indicating that human interpretation is part of the overall clinical use, but the device itself performs the measurements independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implied by standards. For vital signs monitors, ground truth typically involves reference devices or established physiological measurement techniques. For instance:
- NIBP: Likely compared against invasive arterial blood pressure measurements or a highly accurate reference NIBP device.
- SpO2: Likely compared against co-oximetry blood gas analysis or a reference oximeter in controlled desaturation studies.
- ECG: Compared against a reference ECG device/system that accurately captures cardiac electrical activity.
- Gas analysis (CO2, O2, N2O, Anesthetics): Likely compared against calibrated gas analyzers.
The document implies that the ground truth for its "equivalence testing" and "compliance to standards" would have been established according to the methodologies prescribed by the relevant performance standards (e.g., AAMI SP-10 for NIBP, EN 865 for Oximetry).

8. The sample size for the training set

Not applicable/Not provided. This is a hardware-based vital signs monitor, not an AI/machine learning model that undergoes "training." Its performance is based on established physiological measurement principles embedded in its design.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no "training set" in the context of an AI/ML algorithm, this question is not relevant to the information provided.

Summary

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AUG 1 2001

17
K01205-9

16 April 2001

510K Summary

Model 8100 / 8500 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: 8100 / 8500 Vital Signs Monitor

Common Name: Vital Signs Monitor

Classification Name: Monitor, Physiological, Patient (74 MWI)

Substantial Equivalence is claimed to : CSI Model 2200 Scholar Vital Signs Monitor (K944860) and CSI POET IQ 5-Agent Monitor (K942737)

Device Description:

Intended Use:

Comparison with predicate device:

Criticare Systems Inc. has developed and distributed physiological monitoring devices worldwide since its inception in 1984. The 8100 / 8500 monitor utilizes existing core

@2000 Criticare Systems, Inc All Rights Reserved

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technologies from the predicate Scholar 2200 and POET IQ monitors for patient monitoring of ECG, NIBP, IBP, Resp, SpO2, Temp, CO2, N2O, O2 and Halogenated Anesthetic Agents. The patient data collected by the 8100 / 8500 monitor is displayed for the user on a flat panel display as on the predicate devices. The 8100 / 8500 monitor utilizes Passive LCD or Active TFT LCD color display technologies. Membrane key panels and rotary push button navigation provides a user interface equivalent to the predicate devices. The packaging design of the 8100 /8500 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 Scholar 2200.

Determination of Substantial Equivalence:

The 8100 / 8500 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate devices. Additionally, the 8100 / 8500 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 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 / 8500 monitor.

Therefore, the 8100 / 8500 monitor is substantially equivalent to the predicate devices.

Compliance to standards and regulations:

The 8100 / 8500 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 EN1060-1 NIBP Performance EN 1060-3 NIBP Performance {including EN 475 Alarm Performance} AAMI SP-10 NIBP Performance IEC 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 ISO 11196 Anesthetic Gas Monitor Performance (Equivalent to ASTM F 1452) EN 12598 Oxygen Analyzer Performance (Equivalent to ASTM F 1462)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other. The profiles are connected and form a single, flowing shape.

1 2001 AUG

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alex Kaplan Criticare Systems, Inc. 20925 Crossroads Circle Waukesha, WI 53186

Re: K012059

Trade Name: 8100/8500 Vital Signs Monitor Regulatory Number: 21 CFR 870.2300 Regulatory Class: II (two) Product Code: 74 MWI Dated: June 29, 2001 Received: July 2, 2001

Dear Mr. Kaplan:

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 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). 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 Regulation (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 regulation may result in regulatory 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

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Page 2 - Mr. Alex Kaplan

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR 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,

Oak Telle

lames E. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): K012059

DEVICE NAME: Vital Signs Monitor

Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)

Prescription Use √
(Per 21 CFR 801.109)

Over - the - Counter - Use (Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012059

Regulation Number and Section

§ 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).