The C1 Series Patient Monitor series are multi-parameter patient monitors that are used to monitor ECG waveforms, heart rate, noninvasive blood pressure (systolic, dialstolic), functional atterial oxygen saturation and temperature for adult and pediatric patients in all hospital areas and health care facilities.

Device Description

The C1 Series Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five physiological measurements: Electrocardiogram (ECG), Pulse Oximetry (SpO2), Temperature, Non-invasive Blood Pressure (NIBP), and an external optional thermal printer. It is powered by internal sealed lead-acid batteries.

AI/ML Overview

This document refers to the Analogic Corporation C1 Series Patient Monitor, which measures and displays physiological data. The information provided heavily emphasizes non-clinical testing for substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the types of tests conducted rather than specific quantitative acceptance criteria or reported performance values. The primary acceptance criterion is that the device "meets all elements of its Requirements Specification" and is "substantially equivalent to the predicate device." The performance is reported through compliance with various recognized national and international standards.

Acceptance Criteria (General)	Reported Device Performance (Compliance)
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2: 2001 (Group 1, Class B emissions limits), CISPR 11, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11
General Safety of Medical Electrical Equipment	Complies with IEC 60601-1:1988 +A1:1991 +A2:1995
ECG Performance	Complies with ANSI/AAMI EC-13 Cardiac Monitors, Heart Rate Meters, and Alarms
Sphygmomanometer Performance (NIBP)	Complies with ANSI/AAMI SP10 Manual, Electronic, or Automated Sphygmomanometers
Specific Safety for Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment	Complies with IEC 60601-2-30
Specific Safety for Electrocardiographic Monitoring Equipment	Complies with IEC 60601-2-27
Specific Safety for Multifunction Patient Monitoring Equipment	Complies with IEC 60601-2-49
General Requirements for Alarm Systems	Complies with IEC 60601-1-8

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on sample sizes for specific test sets (e.g., number of patients, test cases). The testing described is primarily non-clinical compliance testing against engineering standards rather than clinical performance testing with patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) related to patient data is not applicable in this context. The testing is based on engineering validation and laboratory compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Given the nature of the non-clinical, engineering, and standards compliance testing, the "ground truth" would be defined by the technical specifications of the standards themselves and the proper functioning of the measurement equipment, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the non-clinical, standards-based testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and safety compliance to standards and comparison of technological characteristics with a predicate device, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a patient monitor, which inherently provides data for human interpretation. The "algorithms" mentioned (e.g., predictive temperature algorithm, NIBP oscillometric method, SpO2 calculation) are integrated functions of the device. The testing described focuses on the device's adherence to performance and safety standards, implying standalone function of these measurement capabilities. However, a specific "standalone algorithm performance" study, as might be done for an AI diagnostic tool, is not described in these terms. The performance of the integrated algorithms is validated as part of the overall device's compliance with relevant standards.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" is established by:

International and National Standards: The specifications and requirements outlined in standards like IEC 60601 series, CISPR 11, ANSI/AAMI EC-13, and ANSI/AAMI SP10 serve as the objective criteria for what constitutes correct and safe device performance.
Predicate Device Characteristics: Substantial equivalence is largely based on the C1 Series Patient Monitor sharing similar technological characteristics and performance with the legally marketed predicate device, the NPB 3900 (A1) Patient Monitor.

8. The Sample Size for the Training Set

This information is not applicable. The Analogic C1 Series Patient Monitor is a hardware device with integrated firmware and algorithms for physiological measurements (ECG, SpO2, NIBP, temperature). It is not an AI/ML-driven diagnostic or predictive model that typically requires a "training set" of data in the modern sense. The algorithms for its functions (e.g., oscillometric NIBP, SpO2 calculation, predictive temperature) are established medical technologies.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no mention of a "training set" for AI/ML model development. The ground truth for the device's measurements would be derived from physical principles, validated medical references, and engineering specifications.

Summary

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K041376
p 1/4

510(k) Summary For Analogic Corporation C1 Series Patient Monitor

DATE THIS SUMMARY WAS PREPARED:

May 21, 2004

SUBMITTER'S NAME AND ADDRESS:

Analogic Corporation 8 Centennial Drive Peabody, MA 01960

CONTACT PERSON:

Donald J Sherratt, Regulatory Affairs Manager Telephone (978) 977-3000 extension 3049 Facsimile (978) 977-6808

DEVICE NAME:

Proprietary or Trade Name: C1 Series Patient Monitor Common Name: Multi-Function Patient Monitor Classification Name: Physiological Patient Monitoring System and Accessories

PREDICATE DEVICE:

The legally marketed device to which equivalence is being claimed is: The NPB 3900 (A1) Patient Monitor that was cleared under Premarket Notification K980411

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DEVICE DESCRIPTION:

The C1 Series 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 3900 (A1).
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 the same printed wiring board layout as well as the same microprocessor and imbedded firmware that is used in the predicate device, the NPB 3900 (A1).
The temperature is measured using thermistor probes and a "predictive" algorithm to . enable temperature measurements to be completed more quickly. The temperature subsystem uses technology licensed from the manufactures of the Welch Allyn SureTemp® Portable Thermometer, which was cleared for marketing under premarket notification K943695 and K964643.
. 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 3900 (A1) and cleared for use in the C3 Patient Monitor cleared under K030931.
. An external optional thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm wide strip chart.
. The C1 Series Patient Monitor is powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for 2.5 hours.

INTENDED USE:

The purpose and function of the C1 Series Patient Monitor is to monitor ECG, heart rate, non-invasive blood pressure (NBP), functional arterial oxygen saturation (SpO2) and temperature for single patient use on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics.

COMPARISION OF TECHNOLIGICAL CHARACTERISTICS:

The design of the C1 Series Patient Monitor is derived from the design of the NPB 3900 (A1) Patient Monitor. Clinically the two devices are nearly identical.

The C1 Series Patient Monitor uses the same base technology as the predicate and incorporates a step-bleed algorithm for NIBP licensed from SunTech that has been cleared by FDA for use in the Analogic C3 patient monitor (K030931). Software changes were made to allow the use of a color display and update the alarms to bring them in line with current technology and international standards.

The materials of construction, physical size, weight and footprint are the same as predicate.

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NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANIAL EQUIVALENCE:

The design of the C1 Patient Monitor has been thoroughly validated at the unit and system level and meets all element of its Requirements Specification. The C1 patient monitor will comply with the following recognized standards:

Electromagnetic Compatibility Tests to determine if it was in compliance with IEC . 60601-1-2: 2001 - Group 1, and Class B emissions limits.
- CISPR 11 Industrial, scientific and medical (ISM) radio-frequency equipment o Radio disturbance characteristics - Limits and methods of measurement.
- IEC 61000-3-2 Electromagnetic compatibility (EMC) Part 3-2: Limits o Limits for harmonic current emissions (equipment input current <= 16A per phase)
- IEC 61000-3-3 Electromagnetic compatibility (EMC) Part 3-3: Limits -O Limitation of voltage changes, voltage fluctuations and flicker in public lowvoltage supply systems, for equipment with rated current <= 16A per phase and not subject to conditional connection
- IEC 61000-4-2 Electromagnetic compatibility (EMC) Part 4-2: Testing and O measurement techniques - Electrostatic discharge immunity test
- IEC 61000-4-3 Electromagnetic compatibility (EMC) Part 4-3: Testing and o measurement techniques -- Radiated, radio frequency, electromagnetic field immunity test
- IEC 61000-4-4 Electromagnetic compatibility (EMC) -- Part 4-4: Testing and o measurement techniques -- Section 4: Electrical fast transient/burst immunity test. Basic EMC Publication
- IEC 61000-4-5 Electromagnetic compatibility (EMC) Part 4-5: Testing and o measurement techniques - Surge immunity test
- IEC 61000-4-6 Electromagnetic compatibility (EMC) Part 4-6: Testing and O measurement techniques - Immunity to conducted disturbances, induced by radiofrequency fields
- IEC 61000-4-8 Electromagnetic compatibility (EMC) Part 4-8: Testing and o measurement techniques – Power frequency magnetic field immunity test
IEC 61000-4-11 Electromagnetic compatibility (EMC) Part 4-11: Testing and 0 measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests

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. Safety and Performance Tests
- IEC 60601-1:1988 +A1:1991 +A2:1995, Medical Electrical Equipment-O Part 1: General Requirements for Safety
- ECG Performance Testing According to ANSVAAMI EC-13 Cardiac o Monitors, Heart Rate Meters, and Alarms
- ANSI/AAMI SP10 Manual, Electronic, or Automated o Sphygmomanometers
- IEC 60601-2-30 -- Medical electrical equipment -- Part 2-30: particular 0 requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment.
- IEC 60601-2-27 Medical electrical equipment-- Part 2: Particular O requirements for the safety of electrocardiographic monitoring equipment
- IEC 60601-2-49 -- -- Medical electrical equipment -- Part 2-49: Particular O requirements for the safety of multifunction patient monitoring equipment
- IEC 60601-1-8 Medical electrical equipment Part 1-8: General 0 requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

CONCLUSIONS FROM NONCLINCAL TESTING

The testing of the C1 Patient Monitor demonstrates that the performance is substantially equivalent to the predicate device cited above.

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2004

Mr. Donald J. Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive Centennial Industrial Park Peabody, MA 01960

Re: K041376

Trade Name: C1 Series Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia alarms) Regulatory Class: II (two) Product Code: MWI Dated: May 21, 2004 Received: May 24, 2004

Dear Mr. Sherratt:

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 for are 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. Donald J. Sherratt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be deviced that i bring that your device complies with other requirements of the Act that I Dr I has Intatutes and regulations administered by other Federal agencies. You must or any I 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 OF R Fart 6075, its ens (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. production of the realling your device as described in your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicated 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 If you deem's 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 may be obtained 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 vours.

Neil R.P. Ogden for

Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

K041376 510(k) Number (if known):

Device Name: C1 Series Patient Monitor

Indications For Use:

	Nil R. Okun

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K041376

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use _______

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).