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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Criticare Systems Inc. 8100 Vital Signs Monitor with Arrhythmia Detection and ST Analysis. It describes the device, its intended use, and claims substantial equivalence to a predicate device.

However, the document does NOT contain specific acceptance criteria, detailed study design, or reported device performance metrics in the format requested. It mentions that AAMI EC-57 testing was performed by Brentwood Medical for a previous submittal (K013717) and that the device was tested with "a representative group of prerecorded ECG waveforms with abnormal beats" to document the performance of the integrated Brentwood algorithms. There is no table of acceptance criteria or reported device performance against such criteria in this document.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the information available:

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

Not provided in the document. The document states "AAMI EC-57 testing was performed by Brentwood Medical in their previous submittal (K013717)", which is a standard for ambulatory electrocardiographs. While this implies performance against AAMI EC-57 standards, the specific acceptance criteria or how the 8100 monitor performed against them are not detailed here.

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

Test Set Sample Size: "a representative group of prerecorded ECG waveforms with abnormal beats." No specific number is given.
Data Provenance: Not specified.
Retrospective or Prospective: "prerecorded ECG waveforms" suggests retrospective data.

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 specified. The document does not describe how the ground truth for the "abnormal beats" in the prerecorded ECG waveforms was established or by whom.

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

Not specified.

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:

No, an MRMC study is not mentioned. This device is a vital signs monitor with arrhythmia and ST analysis, not an "AI" device as typically conceived for MRMC studies involving human readers' diagnostic performance. The document describes the integration of software algorithms into existing hardware.

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

Yes, implicitly. The testing described: "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." This refers to evaluating the algorithms' performance on predefined ECG data, which is a form of standalone testing.

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

Implied ground truth: "abnormal beats" in prerecorded ECG waveforms. The basis for declaring these beats "abnormal" (e.g., expert interpretation, pre-labeled dataset) is not explicitly stated but is typically derived from expert-annotated databases for arrhythmia analysis.

8. The sample size for the training set:

Not specified. The document mentions the integration of Brentwood Medical's software, which implies these algorithms were pre-developed. The training set size for those algorithms is not discussed.

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

Not specified. This information would pertain to the development of Brentwood Medical's algorithms, which is not detailed in this 510(k) summary.

Summary

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K030613
page 1 of 2

17 February 2003

APR 1 7 2003

510(k) Summary

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:

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.

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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.

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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.

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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); 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

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510(k) NUMBER (IF KNOWN) : _ KQ 306/3

DEVICE NAME: Vital Signs Monitor

Indications for Use

(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)

Regulation Number and Section

§ 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.