(21 days)
No
The document describes standard physiological monitoring and data processing without mentioning AI or ML algorithms.
No
This device is described as a monitor that displays measurements of physiological parameters and signals alarms, not one that directly treats or provides therapy.
No
The device is a monitor that displays physiological parameters and signals alarms. It aids in monitoring patient status and the effects of anesthetic agents, but it does not diagnose conditions.
No
The device description explicitly states it is a "patient monitor" that displays measurements from "specialized measurement modules" which are "plugged into the frame". This indicates the device includes hardware components beyond just software.
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. They are used to examine specimens outside of the body.
- Device Description: The S/5™ Compact Anesthesia Monitor is described as a "patient monitor" that displays the measurement of patient physiological parameters. These measurements are taken directly from the patient using specialized measurement modules.
- Intended Use: The intended use focuses on monitoring various physiological parameters of the patient (hemodynamic, respiratory, ventilatory, etc.) and documenting patient care. It does not mention analyzing samples taken from the patient.
The device is a patient monitoring system that measures physiological signals directly from the patient's body, which is distinct from the function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A is intended for multiparameter patient monitoring with optional patient care documentation.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents.
The S/5 ™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is also indicated for documenting patient care related information.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for use by qualified medical personnel only.
Product codes
MHX
Device Description
The S/5™ Compact Anesthesia Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Compact Anesthesia Monitor: L-CANE03 and L-CANE03A. L-CANE03A is equipped with extended arthythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-CANE03.
The modifications to the device are:
- Support for M-Entropy module has been added. M-Entropy has its own 510(k) clearance 1. (K023459).
- Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false 2. Asystole alarms.
- The definition for Ventricular Tachycardia has been modified: 3. now 6 beats at a heart rate of 120 (previously 5 beats at a heart rate of 100).
-
- Invasive pressure cursor added to the InvBP waveform field. The cursor is used for marking the reference pressure levels during a monitoring period.
- న్. Invasive pressure Mean Arterial Pressure (Art mean) value has replaced FiAA value and NIBP mean value has replaced FiO2 value in the vital parameters numerical trend page.
- New catheter types added to the selection list for the Cardiac Output measurement. 6.
- Automatic case reset disabled during Cardio Pulmonary Bypass (CPB) mode. 7.
- Messages related to the communication between S/5 monitor and D-O Central have been 8. modified. "HR limit changed" and "PVC rate changed" messages have been replaced with the message "Alarm setup changed from Central".
-
- Enhancements for the iCentral communication added.
-
- ECG beep volume steps 1-5 have been modified to output less volume.
- The SpO2 error message "Poor signal" has been replaced with message "Low perfusion" 11. when M-PRESTN module is used.
- The recorder in Compact Monitor CMREC1..01 has been changed to be an option in 12. CM1.02.
- The AMD microprocessor in the S4CPU has been replaced with the Intel microprocessor. 13.
- The LCD display (LQ121S1DG31) has been replaced with LCD display 14. (LQ121S1DG41).
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
Not Found
Intended User / Care Setting
qualified medical personnel only.
hospital setting
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 device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:
- IEC 60601-1:1988+ Amdt.:1:1991 + Amdt. 2:1995
- EN 60601-1: 1990 + A1:1993+A2:1995+A13:1996
- CAN/CSA-C22.2 No.601.1-M90 +S1:1994+Amdt. 2:1998
- IEC 60601-2-27:1994/EN 60601-2-27:1994
- IEC 60601-2-30:1995/EN 60601-2-30:1995
- IEC 60601-2-34:1994/EN 60601-2-34:1994
- IEC 60601-2-40:1998
- IEC 60601-1-2(1993)/EN 60601-1-2
- IEC 60601-1-4: 1996+Amdt. 1:1999/EN 60601-1-4
- ISO 9918:1993/EN 864:1996
- ISO 9919:1992/EN865:1997
- ISO 7767:1997/EN12598:1999
- ISO 11196:1995 + Corr. 1:1997/EN ISO11196:1997
- IEC 601-2-10:1987/HD 395.2.10:1988 + Am.1:2000
- IEC 60601-2-26:1994/EN60601-2-26
- IEC 60068-2
- UL 2601-1:1997
- ANSI/AAMI ES-1:1993
- ANSI/AAMI EC57:1998
- FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Document issued on: October 28, 2003
- FDA 21 CFR 898.12
Conclusion: there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software as compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo. The logo consists of a circle with a letter "D" cut out of the center. There is a small square in the upper right corner of the circle, similar to an old camera logo.
Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software
14-796
GENERAL COMPANY INFORMATION as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344
NAME OF CONTACT:
Mr. Joel Kent
DATE:
July 1, 2004
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software
COMMON NAME:
Patient Monitor
CLASSIFICATION NAME:
The following Class II classifications appear applicable:
Monitor, Physiological,Patient (With Arrhythmia Detection or Alarm) 870.1025 MHX Monitor, ST segment with Alarm 870.1025 MLD
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)
The Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software (S/5™ CAM) is substantially equivalent to the predicate Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (K022485).
1
Page 2 of 4
DEVICE DESCRIPTION as required by 807.92(a)(4)
The intended use for the device, Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software, is identical to the predicate Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (K022485). The indications for use for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software are essentially the same as the predicate the only difference being that the new device supports the M-ENTROPY module and therefore Entropy has been added to the list of monitoring parameters. There has been no change to the fundamental scientific technology from the predicate. The S/5™ Compact Anesthesia Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Compact Anesthesia Monitor: L-CANE03 and L-CANE03A. L-CANE03A is equipped with extended arthythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-CANE03.
The modifications to the device are:
- Support for M-Entropy module has been added. M-Entropy has its own 510(k) clearance 1. (K023459).
- Improvement in the QRS detection with rather low QRS amplitude ECG, to avoid false 2. Asystole alarms.
- The definition for Ventricular Tachycardia has been modified: 3. now 6 beats at a heart rate of 120 (previously 5 beats at a heart rate of 100).
-
- Invasive pressure cursor added to the InvBP waveform field. The cursor is used for marking the reference pressure levels during a monitoring period.
- న్. Invasive pressure Mean Arterial Pressure (Art mean) value has replaced FiAA value and NIBP mean value has replaced FiO2 value in the vital parameters numerical trend page.
- New catheter types added to the selection list for the Cardiac Output measurement. 6.
- Automatic case reset disabled during Cardio Pulmonary Bypass (CPB) mode. 7.
- Messages related to the communication between S/5 monitor and D-O Central have been 8. modified. "HR limit changed" and "PVC rate changed" messages have been replaced with the message "Alarm setup changed from Central".
-
- Enhancements for the iCentral communication added.
-
- ECG beep volume steps 1-5 have been modified to output less volume.
- The SpO2 error message "Poor signal" has been replaced with message "Low perfusion" 11. when M-PRESTN module is used.
- The recorder in Compact Monitor CMREC1..01 has been changed to be an option in 12. CM1.02.
- The AMD microprocessor in the S4CPU has been replaced with the Intel microprocessor. 13.
- The LCD display (LQ121S1DG31) has been replaced with LCD display 14. (LQ121S1DG41).
2
INTENDED USE as required by 807.92(a)(5)
Intended use:
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A is intended for multiparameter patient monitoring with optional patient care documentation. Indications for use:
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy and Response entropy) and neurophysiological status of all hospital patients.