(57 days)
No
The summary describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities, algorithms, or related performance metrics.
No
The device is described as a "multi-parameter patient monitor" used to "monitor" various physiological parameters, which indicates it is a diagnostic or monitoring device, not one that treats or provides therapy directly.
No
Explanation: The device is described as a multi-parameter patient monitor that measures and displays physiological data (ECG, heart rate, blood pressure, SpO2, temperature). While these parameters can be used by a clinician for diagnostic purposes, the device itself is not stated to perform diagnosis or interpret the data to reach a diagnostic conclusion. It simply presents the raw physiological information.
No
The device description explicitly states it is a "compact, lightweight monitor" that measures, processes, stores, and displays information, and is powered by internal batteries. This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The C1 Series Patient Monitor measures physiological parameters directly from the patient's body (ECG, blood pressure, SpO2, temperature). It does not analyze samples taken from the body.
Therefore, the device falls under the category of a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospital areas and hospital-type facilities, such as clinics. (from Intended Use section)
all hospital areas and health care facilities. (from Indications for Use Form)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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).
0
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
1
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.
2
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