(45 days)
Not Found
No
The document describes a standard patient monitor with physiological measurement capabilities and explicitly states that the design of key subsystems is derived directly from or is an enhanced version of the predicate device, which is a traditional patient monitor. There is no mention of AI, ML, or related concepts.
No
The device is described as a "patient monitor" which measures, processes, stores, and displays physiological information. It does not provide any treatment or therapy.
Yes
The device is described as a "patient monitor" that measures and displays physiological information (ECG, heart rate, NIBP, SpO2, respiration rate, temperature, CO2). These measurements provide data that can be used by clinicians to assess a patient's health status and aid in diagnosis. While it doesn't provide a definitive diagnosis on its own, it provides diagnostic information.
No
The device description clearly outlines multiple hardware components for acquiring physiological measurements (ECG leads, SpO2 sensor, temperature probe, NIBP cuff, CO2 sensor) and displaying/recording data (LCD screen, optical strip chart recorder, thermal printer). It also mentions internal batteries for power. This is a hardware-based patient monitor with integrated software, not a software-only device.
Based on the provided information, the C3 patient monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
- C3 Patient Monitor Function: The C3 patient monitor directly measures physiological parameters from the patient's body (ECG, heart rate, blood pressure, SpO2, respiration rate, temperature, CO2). It does not analyze specimens taken from the patient.
The device description and intended use clearly indicate that it's a patient monitoring system that gathers data directly from the patient's body to assess their vital signs. This falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for 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 areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport.
Product codes (comma separated list FDA assigned to the subject device)
MHX
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.
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
Clinical users / hospital areas and hospital-type facilities, such as clinics; hospital transport
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)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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 .
3
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.
4
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
5
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
6
K030931
510(k) Number (K030931):
Device Name: C3 Patient Monitor
Indications For 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 areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport.
(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