The purpose and function of the C3 patient monitor continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration rate, temperature and carbon dioxide (CO2) for single patient use on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport.

Device Description

The C3 Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five physiological measurements:

Electrocardiogram (ECG). A three lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optical strip chart recorder. The design of the ECG function is derived directly from the predicate device, the NPB-4000.
Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses a similar printed wiring board, software and firmware that is used in the predicate device, the NPB-4000.
The temperature is measured using thermistor probes for continuous temperature measurements.
Blood pressure is measured non-invasively (NIBP) by the oscillometric method. The design of the NIBP subsystem is an enhanced version of the NIBP subsystem used in the predicate device, the NPB-4000.
End-tidal CO2. This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system.
An optional thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm wide strip chart.
The C3 monitor is powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for four hours.

AI/ML Overview

Here's an analysis of the provided text regarding the Analogic C3 Patient Monitor, focusing on acceptance criteria and supporting studies:

Assessment of the Provided Information:

The provided document (K030931) is a 510(k) summary for a patient monitor. It primarily discusses the device description, intended use, comparison to a predicate device, and non-clinical tests conducted for substantial equivalence. It is important to note that this document is a 510(k) summary for a patient monitor, not a device related to AI/ML or image analysis. As such, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details, ground truth for training set) are not applicable to this type of device and submission.

The "acceptance criteria" discussed are largely related to compliance with recognized standards for medical electrical equipment and functional performance of physiological measurements, rather than diagnostic accuracy or AI model performance. The "study" refers to the non-clinical testing performed to demonstrate that the device meets these standards and functions as intended.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Category	Specific Standard/Test	Reported Device Performance
Safety	IEC 60601-1	All tests passed the stated criteria.
Electromagnetic Compatibility	EN 55011, Group 1, Class B emissions limits	All tests passed the stated criteria.
	IEC 60601-1-2	All tests passed the stated criteria.
Power/Line Stability	FDA Reviewer Guidance for PreMarket Notification Submissions, November 1993 (Anesthesiology and Respiratory Devices Branch) for Line Dropout and Variation Susceptibility	All tests passed the stated criteria.
Battery Performance	Battery Cycle Testing	All tests passed the stated criteria.
Environmental Performance	Operational Temperature Test	All tests passed the stated criteria.
	Altitude Tests	All tests passed the stated criteria.
Physical/Mechanical	Alarm Volume Tests	All tests passed the stated criteria.
	Cleanability Tests	All tests passed the stated criteria.
	Mechanical Shock and Vibration Tests	All tests passed the stated criteria.
	Shipping Container Transportation Test	All tests passed the stated criteria.
	Measure of External Temperature Rise	All tests passed the stated criteria.
ECG Performance	AAMI/ANSI EC-13	All tests passed the stated criteria.
EtCO2 Performance	EN 864/1996	All tests passed the stated criteria.
SpO2 Performance	EN865, Pulse Oximeters Particular requirements: 1997	All tests passed the stated criteria.
NIBP Performance	AAMI/ANSI SP10, Electronic or Automated Sphygmomanometers, 2nd Ed.: 1992	All tests passed the stated criteria.

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

Not Applicable. This document describes non-clinical engineering and functional testing of a patient monitor, not a study involving patient data or a "test set" in the context of AI/ML or diagnostic performance evaluation. The tests are performed on the device itself under controlled conditions.

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. As above, there is no "test set" requiring expert ground truth in the diagnostic sense for this type of device submission. The "ground truth" for these tests are the established parameters and performance limits defined by the referenced industry standards.

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

Not Applicable. No adjudication method is necessary or mentioned, as the evaluation involves meeting predefined engineering and performance standards, not resolving disagreements in diagnostic interpretations.

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 device is a patient monitor, not an AI-powered diagnostic tool. Therefore, no MRMC study testing human reader improvement with AI assistance was performed or would be relevant.

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

Not Applicable. This device measures and displays physiological parameters. It does not employ an "algorithm" in the sense of an AI model that performs a diagnostic task independently. Its performance is inherent in its hardware and embedded firmware/software, which are tested for functional accuracy against established standards.

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

The ground truth for the non-clinical tests performed is the specified performance criteria and limits defined within the referenced consensus standards (e.g., IEC 60601-1, AAMI/ANSI EC-13, EN865). For example, if a standard specifies a blood pressure accuracy of +/- 5 mmHg, then a measurement within that range is considered "ground truth" for compliance.

8. The sample size for the training set:

Not Applicable. This device does not use machine learning or AI that requires a "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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K030931
page 1 of 4

510(k) Summary For Analogic Corporation C3 Patient Monitor

DATE THIS SUMMARY WAS PREPARED: March 3, 2003 SUBMITTER'S NAME AND ADDRESS:

Analogic Corporation 8 Centennial Drive Peabody, MA 01960

CONTACT PERSON:

Marvin Rosenbaum, Regulatory Affairs Manager Telephone (978) 977-3000 extension 3049 Facsimile (978) 977-6808

DEVICE NAME:

Proprietary or Trade Name: C3 Patient Monitor Common Name: Multi-Function Patient Monitor Classification Name: Physiological Patient Monitoring System and Accessories

PREDICATE DEVICE:

The legally marketed devices to which equivalence is being claimed is:

The NPB-4000 Patient Monitor that was cleared under Premarket Notification K962424.

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DEVICE DESCRIPTION:

The C3 Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five physiological measurements:

Electrocardiogram (ECG). A three lead ECG is acquired and a waveform ● can be displayed real-time on the LCD screen or permanently recorded on the optical strip chart recorder. The design of the ECG function is derived directly from the predicate device, the NPB-4000.
Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses a similar printed wiring board, software and firmware that is used in the predicate device, the NPB-4000.
The temperature is measured using thermistor probes for continuous temperature measurements.
Blood pressure is measured non-invasively (NIBP) by the oscillometric ● method. The design of the NIBP subsystem is an enhanced version of the NIBP subsystem used in the predicate device, the NPB-4000.
End-tidal CO2. This method pulls a constant sample flow of exhaled breath ● from the patient, and analyzes it with a remote CO2 sensor built into the measurement system.
An optional thermal printer records waveforms, digital vital signs, and . tabular trends on a 50-mm wide strip chart.

The C3 monitor is powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for four hours.

INTENDED USE:

The purpose and function of the C3 patient monitor continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration rate, temperature and carbon dioxide (CO2) for single patient use on adult and pediatric patients in hospital-type facilities, such as clinics, clinics. Clinical users may use the monitor during hospital transport.

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K030931
page 3 of 4

COMPARISION OF TECHNOLIGICAL CHARACTERISTICS:

The design of the C3 Patient Monitor is derived from the design of the NPB-4000 Patient Monitor

The C3 monitor is smaller and lighter than the predicate.

NONCLINICAL TEST USED IN DETERMINATION OF SUBSTANIAL EQUIVALENCE:

The design of the C3 Patient Monitor has been thoroughly validated at the unit and system level and meets all element of its Requirements Specification. This included the following non-clinical tests:

IEC 60601-1, an FDA recognized consensus standard for safety of medical . electrical equipment.
Electromagnetic Emissions Tests to determine if it was in compliance with . the EN 55011, Group 1, and Class B emissions limits.
IEC 60601-1-2, an FDA recognized consensus standard for . electromagnetic compatibility.
. Line Dropout and Variation Susceptibility were tested according to the FDA Reviewer Guidance for PreMarket Notification Submissions, November 1993 (Anesthesiology and Respiratory Devices Branch).
Battery Cycle Testing .
Operational Temperature Test ●
Altitude Tests ●
Alarm Volume Tests ●
Cleanability Tests
Mechanical Shock and Vibration Tests ●
Shipping Container Transportation Test .
Measure of External Temperature Rise .

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K030931
page 4 of 4

ECG Performance Testing According to AAMI/ANSI EC-13 ●
. EtCO2 Function Test According to EN 864/1996
SpO2 Tested According to EN865, Pulse Oximeters Particular ● requirements: 1997.
. NIBP Functional Testing to AAMI/ANSI SP10, Electronic or Automated Sphygmomanometers, 2nd Ed.: 1992.

All tests passed the stated criteria.

CONCLUSIONS FROM NONCLINCAL TESTING

The testing of the C3 Patient Monitor demonstrates that the performance is substantially equivalent to the predicate devices cited above.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2003

Analogic Corporation c/o Mr. Marvin Rosenbaum Regulatory Affairs Manager 360 Audubon Road Wakefield, MA 01880

Re: K030931

Trade Name: C3 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: April 30, 2003 Received: May 1, 2003

Dear Mr. Rosenbaum:

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.

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

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Page 2 - Mr. Marvin Rosenbaum

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,

W. Odel N. Tule

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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K030931

510(k) Number (K030931):

Device Name: C3 Patient Monitor

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	X OR Over-The-Counter Use ______
(Per 21 CFR 801.109)
(Division Sign-Off)Division of Cardiovascular Devices
510(k) Number	K03093/

Analogic Corporation C3 Patient Monitor 510(k) March 3, 2003 Page vii of x

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.