(21 days)
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/5TM 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.
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 provided text describes modifications to an existing patient monitor, the Datex-Ohmeda S/5™ Compact Anesthesia Monitor, with new software versions L-CANE03 and L-CANE03A. The primary focus of the submission is to demonstrate substantial equivalence to the predicate device and ensure continued safety and effectiveness after the modifications.
Here's an analysis of the acceptance criteria and supporting study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the device's monitoring functions, nor does it report specific numerical performance data against such criteria.
Instead, the acceptance criteria are implicitly linked to compliance with recognized medical device standards and demonstrating substantial equivalence to the predicate device. The performance is indirectly "reported" by affirming compliance with these standards and stating that the device is "safe and effective for the intended use."
The key modifications that would typically have performance implications are:
- Improvement in QRS detection with low QRS amplitude ECG, to avoid false Asystole alarms.
- Modification of Ventricular Tachycardia definition: now 6 beats at a heart rate of 120 bpm (previously 5 beats at 100 bpm).
- L-CANE03A equipped with extended arrhythmia analysis capability (though stated to be substantially equivalent to the predicate's arrhythmia analysis).
However, specific quantitative acceptance criteria or performance metrics for these changes are not provided in the summary. The document states: "Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for validating the device's performance after modifications. The evaluation seems to be focused on nonclinical testing and compliance with industry standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention using experts to establish ground truth for a test set. This type of detail is typically found in clinical validation studies, which are not explicitly detailed here.
4. Adjudication Method
Since there's no mention of experts or a test set requiring ground truth adjudication, there is no information about an adjudication method (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not described or mentioned in the provided summary. The submission focuses on substantial equivalence through design and software changes, and compliance with standards, rather than a clinical human-in-the-loop comparison.
6. Standalone Performance Study
The document implies a standalone (algorithm only) performance evaluation through "validation and verification of specifications" and compliance with standards like "FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm." However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are not quantitatively presented. The focus is on the process of testing against standards rather than reporting the results of such tests in a summarized form.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given the context of nonclinical testing and compliance with standards for a patient monitor, the ground truth would likely be established by:
- Reference measurements/simulations: Using calibrated equipment to generate known physiological signals (e.g., ECG waveforms with specific arrhythmias, varying QRS amplitudes) to test the device's ability to accurately detect and classify them.
- Expert consensus (implied for standards): The standards themselves (e.g., IEC 60601-2-27 for ECG monitoring) are often built upon expert consensus regarding acceptable performance limits.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This type of information is usually relevant for machine learning algorithms, which are not explicitly detailed as a core component of this submission beyond general "data processing" and "arrhythmia analysis capability."
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth might have been established.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through description of modifications, affirmation of similar intended use and indications, and compliance with a comprehensive list of nonclinical safety and performance standards. It does not contain detailed quantitative performance data or descriptions of clinical validation studies often associated with diagnostic AI devices.
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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).
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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).
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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.
<041790
Page 3 of 4
The S/5TM 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.
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software ($/5TM CAM) is substantially equivalent to the predicate Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (K022485). The new device with different software options, S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A, is compared to predicate as outlined below. The basic model of the monitor is the S/5TM Compact Anesthesia Monitor with L-CANE03, which is a new revision of the predicate devices, S/5TM Compact Anesthesia Monitor with L-CANE02 software (K022485). The S/5™ Compact Anesthesia Monitor with L-CANE03 may be equipped with extended bedside arrhythmia analysis capability and in this case the monitor is called S/5TM Compact Anesthesia Monitor with L-CANE03A. The arrhythmia analysis functionality of the S/5TM Compact Anesthesia Monitor with L-CANE03A is substantially equivalent to the functionality of the predicate device S/5TM Compact Anesthesia Monitor with L-CANE02A software (K022485).
The S/5™ CAM is a modular multiparameter patient monitor providing connections to measurement modules. The general construction, indications for use and intended use of the S/5™ CAM are the same as for the predicate S/5TM Compact Anesthesia Monitor with L-CANE02, L-CANE02A software (K022485). Based on the above and other documentation included in this 510(k) notification and attachments, it is evident that the main features and indications for use of the 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.
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SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software complies with the safety standards below and is therefore safe and effective for the intended use. 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:
The summary above shows that 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.
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Datex-Ohmeda c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492
Re: K041790
K041790
Trade Name: Datex-Ohmeda S/5 ™ Compact Anesthesia Monitor L-CANE03 and L-CANE 03A Software Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: July 1, 2004 Received: July 2, 2004
Dear Mr. Kent:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to togally and exament date of the Medical Device Amendments, or to Conninered pror to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been recuse in quire approval of a premarket approval application (PMA). and Cosmeter For (110) that the device, subject to the general controls provisions of the Act. The I ou may, dierelove, mains of the Act include requirements for annual registration, listing of general controls provisions 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 may be subject to back adderal 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. Joel C. Kent
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drivisation that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I ederal states and states and submited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fat 607); accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic for the quality by tool provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of the rest free resimmarketing your device as described in your Section 510(k) I mis letter will and w you'ls cognified of substantial equivalence of your device to a legally prematics notification "The 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) 594-4648. 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 other general intermational 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,
Neil Rx Ogden
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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Indications for Use
510(k) Number (if known): _KD41790
Device Name: Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software
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 (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.
Over-The-Counter Use_ Prescription Use _ × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden
(Division Sian-Division of Cardiovascular Devic
510(k) Number_
Page | of |
§ 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.