This device can be connected to third party devices. Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac ourput monitor. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will devermine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The device is intended to be used on Adult, Pediatric and Noonatal populations, with the exception of the parameter Cardiac Output which is intended for use in the adult and pediaric populations only; and Arrhythmia which is intended for use in the adult population only.

Device Description

The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC900/ SC9015 Bedside Monitoring System. The modification improves the detection and monitoring of arrhythmia. The hardware of the SC9000/SC9015 is unchanged.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the arrhythmia monitoring functionality:

Acceptance Criteria and Reported Device Performance

The device's performance is compared against the predicate device through software modifications designed to improve arrhythmia detection. The key performance metrics are related to the accuracy and range of the ECG and QRS detection.

Metric	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Modified Algorithm)
Measuring range	15 - 300 bpm	15 - 300 bpm
Accuracy	±5 bpm /min. or ± 5% (whichever is greater)	±5 bpm /min. or ± 5% (whichever is greater)
QRS detection: amplitude	0.5 - 5.0 mV	0.5 - 5.0 mV
QRS detection: duration	70 - 120 msec	40-120 msec (extended for neonatal)
Frequency ranges: filter setting = Monitor (0.5 to 40 Hz)	0.5 to 40 Hz	0.5 to 40 Hz
Frequency ranges: filter setting = ESU (0.5 to 20 Hz)	0.5 to 20 Hz	0.5 to 20 Hz
Frequency ranges: filter setting = Off (0.05 to 40 Hz)	0.05 to 40 Hz	0.05 to 40 Hz
Samples/Sec	100 Samples/Sec	250 Samples/Second (Improved QRS processing)

Note: The primary "acceptance criteria" here are implied by the claim that the "Clinical performance is equal to, or surpasses that of the predicate device" and compliance with specific AAMI and FDA guidelines. The table highlights where the modified device directly matches or improves upon the predicate.

Study Details

Sample size used for the test set and the data provenance:
- The document states that the "assessment of clinical performance is attached in appendix V," but Appendix V is not provided. Therefore, the specific sample size, country of origin, and whether the data was retrospective or prospective for the clinical performance assessment cannot be determined from the provided text.
- However, the device's design and testing comply with AAMI (ECAR - D-94) "Draft: Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' March 1994," and FDA "Guidelines for Submitting Data in Support of Pre-market Notification (510(K)) Applications for Arrhythmia Detectors (1990)." These guidelines typically specify protocols for test data and datasets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not explicitly stated in the provided text. The document refers to "assessment of clinical performance" but does not detail how ground truth was established or the number/qualifications of experts involved.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not explicitly stated in the provided text.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned. The device described appears to be a standalone monitoring system, not primarily an AI-assisted diagnostic tool for human readers in the context of image interpretation or similar. The "AI" would be the arrhythmia detection algorithm itself, which is integrated into the monitoring system.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Yes, a standalone assessment of the algorithm's performance was done. The entire submission focuses on the "modified arrhythmia algorithm" in the Siemens SC9000/SC9015 Bedside Monitoring System. The device directly processes physiological signals (ECG) to detect and monitor arrhythmia. The compliance with AAMI (ECAR - D-94) guidelines specifically for "Ventricular Arrhythmia Detection Algorithms" indicates a standalone algorithmic evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- While not explicitly stated for the clinical assessment, for arrhythmia detection algorithms complying with standards like AAMI, ground truth is typically established through expert annotation of ECG waveforms. This involves cardiologists or trained technicians meticulously marking arrhythmia events on reference ECG databases.
The sample size for the training set:
- This information is not explicitly stated in the provided text. The document describes an "updated software version" and "modified arrhythmia algorithm," implying a development and potentially a training phase, but details of the training set are absent.
How the ground truth for the training set was established:
- This information is not explicitly stated in the provided text. Similar to the test set, it would typically involve expert annotation of ECG waveforms, but the specifics are not provided.

Summary

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K964624

SEP | | 1997

510(k) SUMMARY as required per 807.92(c)

2: Submitter's Name, Address:

Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: Robert W. Becker Contact person for this submission: Jacqueline E. M. Emery or Fred Geheb Date submission was prepared: October 24, 1996

3: Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens SC9000/ SC9015 Bedside Monitoring System

B. Common Name, Classification Number, Class and Regulation Number:

Common Name	Classification Number	Class	Regulation Number
Cardiac monitor	74DRT	II	21 CFR 870.2300
Arrhythmia detector& Alarm System	74DSI	III	21 CFR 870.1025
Breathing frequencymonitor	73BZQ	II	21 CFR 868.2375
Pulse rate monitor	74BWS	II	21 CFR 870.2300
Non-indwelling bloodpressure monitor	74DXN	II	21 CFR 870.1130
Clinical electronic thermometer	80BWX	II	21 CFR 880.2910
Pulse Oximeter	74DQA	II	21 CFR 870.2700
Cardiac Output Monitor	74KFN	II	21 CFR 870.1435
end-tidal Carbon-Dioxide Monitor	73CCK	II	21 CFR 868.1400
Indwelling Blood Pressure Monitor	74CAA	II	21 CFR 870.1110
Indwelling bloodpressure monitor	74CAA	II	21 CFR 870.1110
Heart Rate Monitor, Neonatal *	74FLO	II	21 CFR 870.2300
Ventilatory Effort Monitor *(Apnea Detector)	73FLS	II	21 CFR 868.2375
Monitor Blood Pressure, Neonatal, *Invasive	74FLP	II	21 CFR 870.1110

Pending FDA clearance of 510(K) K962291

Siemens Medical Systems, Inc.

Electromedical Group

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4: Predicate Device Identification:

The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC9000/SC9015 Bedside Monitoring System. The hardware of the SC9000/SC9015 is unchanged. The modification improves the detection and monitoring of arrhythmia. The Siemens SC9000/SC9015 Bedside Monitoring Systems was granted 510(K) clearance under the following 510(K) numbers:

K946306 - Siemens SC9000/SC9015 Monitor (Original Submission) K954632 - Siemens SC9000/SC9015 Monitor with etCO2 Functionality

The following submission is currently awaiting FDA 510(K) clearance:

K962291 - Siemens SC9000/SC9015 Monitor modified with Neonatal Functionality.

5. Device Description

6. Intended Use:

The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult), temperature, cardiac output, arterial oxygen saturation, pulse rate, cardiac output, end-tidal carbon dioxide and (central) apnea. This device will produce visual and aural alarms if any of these parameters vary bevond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET or Infinity(Olympus)network.

The SC9000/SC9015 Modified Patient Monitoring System is intended to be used on Adult. Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, which is intended for use in the adult and pediatric populations only, and Arrhythmia, which is intended for use in the adult population only.

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

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7. Table of device similarities and differences to predicate device

ﺴﺴﺴﺴ

	Modified Algorithm	PredicateDeviceAlgorithm	Explanation of the modifiedversion
Manufacturer	Siemens Medical Systems EMG	same
Device name	SC9000 with modifiedarrhythmia algorithm	SC9000	2 leads improve arrhythmiadetection
510(K) Number	To be assigned	K946306
Intended Population	Adult, pediatric and neonatal *	same	Same-application areas.Arrhythmia detection is inactive inthe neonatal mode.
Software Revision	VB1.1-W	VA2-W
Display:	up to 2 leads	same
Available leads:	I, II, III, aVR, aVF, aVL, V,MCL1, MCL6(MCL1, MCL6 only with 3-leadset;V, aVR, aVF, aVL only with 5lead set)	same
Measuring range:	15 - 300 bpm	same
Accuracy:	±5 bpm /min. or ± 5%(whichever is greater)	same
QRS detection:amplitude:duration:	0.5 - 5.0 mV40-120 msec	same70 - 120 msec	extended to 40 for neonatal.
Frequency ranges:filter setting =	0.5 to 40 Hz	same
Monitor:filter setting = ESU:	0.5 to 20 Hz	same
filter setting = Off:	0.05 to 40 Hz	same
Degree of protectionagainst electrical shock	Type CF	same
Defibrillation protection	In accordance with IEC 6-1-2-27	same
Arrhythmia Detection:	Yes	same
Pacer Detection:	Yes	same
Samples/Sec	250 Samples/Second	100Samples/Sec	Increased sample rate forimproved QRS processing.

with the exception of the parameter Cardiac Output, which is intended for use in the adult and pediations only, and Arrhythmia, which is intended for use in the adult population only.

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

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8. Assessment of non-clinical performance data for equivalence:

Currently there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Monitor with modified arrhythmia detection complies with:

AAMI (ECAR - D-94) " Draft: Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' March 1994.

AAMI (EC13 - 1992) "Cardiac monitors, heart rate meters, and alarms".

FDA "Guidelines for Submitting Data in Support of Pre-market Notification (510(K)) Applications for Arrhythmia Detectors (1990)".

9. Assessment of clinical performance data for equivalence:

Clinical performance is equal to, or surpasses that of the predicate device. The assessment of clinical performance is attached in appendix V.

Bio-compatabilityData: Not applicable
Sterilization data: Not applicable

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

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Image /page/4/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 1 1 1997

Ms. Jacqueline E.M. Emery Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923

K964624 Re: Siemens SC9000/SC9015 Bedside Monitoring System with Modified Arrhythmia Monitoring Regulatory Class: III (three) Product Code: 74 DSI March 8, 1997 Dated: Received: June 10, 1997

Dear Ms. Emery:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Jacqueline E.M. Emery

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled,

"Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Cillehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Device De Siemens SC9000/SC9015 Bedside Monitoring System with Modified Arrhythmia Monitoring

Indications for Use:

This device is capable of monitoring:

� heart rate
respiration rate ●
. invasive pressure
non-invasive pressure ●
arrhythmia .
. temperature
� cardiac output
. arterial oxygen saturation
. pulse rate
. cardiac output
end-tidal carbon dioxide and (central) apnea .

MRI Compatibility Statement:

The Siemens SC9000/SC9015 Series is not compatible for use in an MRI magnetic field.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,and Neurological Devices

510(k) Number __

Regulation Number and Section

§ 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.