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

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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a study detailing the device's numerical performance against such criteria. The document is a 510(k) summary for the Criticare Systems Inc. Model 9100 Family Vital Signs Monitor, which primarily asserts substantial equivalence to predicate devices and compliance with various performance and safety standards.

Therefore, many of the requested details, such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not present in this document.

Here's an overview of what can be extracted and what is missing:

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

The document does not provide a table with specific numerical acceptance criteria and reported device performance. Instead, it broadly states: "The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device." It also lists various performance standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria.

Parameter	Acceptance Criteria	Reported Device Performance
Overall Device	Equivalent to predicate device (8100/8500 Vital Signs Monitor K012059; 8100 w/Arrhythmia & ST Analysis Vital Signs Monitor K030613; 9100 Vital Signs Monitor K091050)	Confirmed to be equivalent to the predicate device.
Specific Modalities	Compliance with relevant performance standards:	Compliance confirmed for all listed standards.
NIBP	`- IEC 60601-2-30 NIBP Safety` `- EN 1060-1 NIBP Performance` `- EN 1060-3 NIBP Performance` `- AAMI SP-10 NIBP Performance`	Implicitly meets the performance standards by stating compliance.
Oximetry (SpO2)	`- ISO 9919 Oximetry Performance`	Implicitly meets the performance standards by stating compliance.
ECG	`- IEC 60601-2-27 ECG Safety` `- AAMI EC-13 Basic ECG Performance` `- AAMI EC-57 Performance of Cardiac Rhythm and ST Segment Measurement Algorithms`	Implicitly meets the performance standards by stating compliance.
Invasive BP	`- IEC 60601-2-34 Invasive Blood Pressure Safety`	Implicitly meets the performance standards by stating compliance.
Gas Monitor	`- ISO 21647 Gas Monitor Performance`	Implicitly meets the performance standards by stating compliance.
Temperature	`- EN 12470-4 Temperature Performance`	Implicitly meets the performance standards by stating compliance.
Safety	`- IEC 60601-1 Medical Electrical Safety` `- IEC 60601-1-2 EMC Compliance` `- IEC 60601-1-8 Alarms` `- IEC 60601-2-49 Multi-parameter Monitor Safety` `- ISO 10993-5,10-11 Biocompatibility`	Compliance confirmed for all listed standards.

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

This information is not provided in the document. The filing focuses on substantial equivalence and standard compliance rather than detailed study results.

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)

This information is not provided in the document. Given that the main claim is equivalence to predicate devices and compliance with engineering standards, direct human interpretation of a test set with expert ground truth establishment is not described.

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

This information is not provided in the document.

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

An MRMC comparative effectiveness study is not mentioned in the document. The device is a vital signs monitor, and the filing describes its standalone performance and equivalence, not its role in assisting human interpretation or diagnostic efficacy in a reader study. There is no AI component mentioned.

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

Yes, the filing implicitly describes a standalone performance evaluation by stating "The 9100 monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device" and listing compliance with various performance standards (e.g., for NIBP, oximetry, ECG, etc.). These standards typically involve objective testing of the device's accuracy and functionality without human intervention in the loop of the measurement and display process.

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

For the performance evaluations mentioned (compliance with standards like AAMI SP-10 for NIBP or ISO 9919 for Oximetry), the ground truth would typically be established through scientific reference methods, calibrated instruments, and standardized test protocols as defined by those specific engineering and performance standards. It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather "technical ground truth" established by the standards themselves.

8. The sample size for the training set

This information is not provided in the document. The document references "existing core technologies from the predicate 8100 monitor" and "CSI's field experience with these modalities in the predicate devices has been satisfactory." This suggests that the development likely leveraged historical data and experience from previous products, but specific training set sizes are not disclosed.

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

This information is not explicitly provided. Given the reliance on "existing core technologies" and "field experience," the ground truth for any underlying algorithms (e.g., for arrhythmia detection or ST segment analysis) would have been established during the development and validation of those predicate technologies, likely through a combination of clinical data and expert review, but the specifics are not detailed here.

Summary

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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:

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

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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

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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

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Indications for Use

1 2010 SEP

510(k) Number (if known): KIO 160 Z

9100 Family Vital Signs Monitor Device Name:

Indications For Use:

The monitored parameters are:

1. ECG
1. Noninvasive Blood Pressure (NIBP)
1. Invasive Blood Pressure (IBP)
1. Temperature
1. Respiratory Gases
1. Anesthetic Agent Gases
1. Respiratory Rate
1. Pulse Oximetry (SpO2)
1. 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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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.