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 506CN monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 506CN can be used to monitor one or more of the following parameters: Noninvasive BP (NIBP) and SpO2. For all these vital parameters, the 506CN 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 describes a 510(k) premarket notification for the 506CN Patient Monitor. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials to establish acceptance criteria and device performance from scratch. Therefore, the information typically requested in a detailed AI device study report (like sample sizes, expert qualifications, and specific performance metrics vs. acceptance criteria tables) is not present in this document.

However, I can extract the information that is available and explain the context of why certain details are missing for this type of submission.

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

Since this is a 510(k) submission based on substantial equivalence, specific numerical acceptance criteria and a table directly reporting performance against those criteria are not provided in the same way as a de novo clinical study. Instead, the "acceptance criteria" are implied by compliance with recognized standards and equivalence to the predicate device.

Acceptance Criteria Category	Reported Device Performance (as described)
Overall Equivalence	"The 506CN monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device."
"Therefore, the 506CN monitor is substantially equivalent to the predicate devices."
Safety Standards	Complies with: IEC 60601-1 (Medical Electrical Safety), IEC 60601-1-2 (EMC Compliance), ISO 10993-5.10-11 (Biocompatibility), IEC 60601-1-8 (Alarms)
Performance Standards	Complies with: ISO 9919 (Oximetry Performance), IEC 60601-2-30 (NIBP Safety), EN 1060-1 (NIBP Performance), EN 1060-3 (NIBP Performance), AAMI SP-10 (NIBP Performance)
Clinical Use/Field Experience	"The patient monitoring technologies present in the 506CN monitor have been in clinical use for at least six years in the 506 monitor and it's predicates. CSI's field experience with these modalities in the predicate devices has been satisfactory."

2. Sample sized 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 510(k) summary. For a 510(k) based on substantial equivalence to a predicate device and compliance with standards, detailed clinical test set data (including sample size, provenance, or retrospective/prospective nature) is generally not required to be submitted or summarized. The equivalence is often demonstrated through bench testing, engineering comparisons, and adherence to established performance standards. The document mentions "equivalence testing" but does not detail its methodology or sample size.

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 510(k) summary, as it is not a study requiring expert-established ground truth in the typical sense of AI/diagnostic device validation.

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

This information is not provided in the 510(k) summary.

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 was not conducted or reported in this 510(k) summary. This device is a patient monitor, not an AI-assisted diagnostic tool, and the focus of the submission is on demonstrating equivalence to an existing monitor, not on improving human reader performance with AI.

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

This device is a patient monitor that displays data for a healthcare professional to interpret ("The user, responsible to interpret the monitored data made available, will be a professional health care provider."). It is not an "algorithm only" device in the AI sense. Its "standalone" performance is assessed by its ability to accurately measure and display physiological parameters, which is affirmed by its compliance with performance standards and equivalence to the predicate device. However, a specific "standalone" study report in the context of AI performance validation is not provided.

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

For this type of device, "ground truth" for NIBP and SpO2 measurements typically refers to reference measurements from established, highly accurate (often invasive) methods against which the device's measurements are validated during standard compliance testing (e.g., AAMI SP-10 for NIBP, ISO 9919 for SpO2). However, the specific methods and sources of this ground truth are not detailed in this 510(k) summary. It only states compliance with the standards that prescribe how such ground truth is established and used for testing.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physiological monitor, not an AI system that undergoes "training" in the machine learning sense. Its functionality is based on established signal processing and measurement algorithms, not learned from a training dataset.

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

This information is not applicable and not provided, as there is no "training set" for this device in the context of AI/machine learning.

Summary

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10 April 2009

K091050

510K Summary

MAY 2 7 2009

Model 506CN Patient 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: 506CN Patient Monitor

Vital Signs Monitor Common Name:

Classification Name: Monitor, Physiological, Patient (74D-RT)

Substantial Equivalence is claimed to : 506 Vital Signs Monitoring System (K051038).

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 506CN monitor utilizes existing core technologies from the predicate 506 monitor for patient monitoring of NIBP and SpO2. The patient data collected by the 506CN monitor is displayed for the user on a graphic

@2009 Criticare Systems, Inc All Rights Reserved

page 1 of 2

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LCD equivalent to the predicate device. Membrane key panels provide a user interface equivalent to the predicate device. The packaging design of the 506CN 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 506.

Determination of Substantial Equivalence:

The 506CN monitor performance for each monitoring modality has been confirmed to be equivalent to the predicate device. Additionally, the 506CN 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 506CN monitor have been in clinical use for at least six years in the 506 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 506CN monitor.

Therefore, the 506CN monitor is substantially equivalent to the predicate devices.

Compliance to standards and regulations:

The 506CN Vital Signs Monitor complies with the following national and international standards:

Safety

IEC 60601-1 Medical Electrical Safety IEC 60601-1-2 EMC Compliance ISO 10993-5.10-11 Biocompatibility IEC 60601-1-8 Alarms

Performance

ISO 9919 Oximetry Performance IEC 60601-2-30 NIBP Safety EN 1060-1 NIBP Performance EN 1060-3 NIBP Performance AAMI SP-10 NIBP Performance

@2009 Criticare Systems, Inc All Rights Reserved

Page 2 of 2

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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 eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Public Health Service

MAY 2 7 2009

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Criticare Systems, Inc. c/o Mr. Alex Kaplan Director of QA & QC 20925 Crossroads Circle Waukesha, WI 53186

Re: K091050

506CN Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: DRT, DQA Dated: May 12, 2009 Received: May 12, 2009

Dear Mr. Kaplan:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave roviewed your co determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the energy of 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

510(k) Number (if known):

Device Name: 506CN Vital Signs Monitor

Indications For Use:

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

(Division/Sign-Off)
Division of Cardiovascular Devices
510(k) Number K091050

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).