This device is capable of monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arthythmia (adult only), temperature, cardiac output (adult only), arterial oxygen saturation, pulse rate, end-tidal carbon dioxide and (central) apnea and ST Segment Analysis (adult only). This device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

Device Description

The Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with ST Segment Analysis is an updated software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the iso-electric point (baseline). This is the same algorithm that is used in the Siemens 1481(T) Digital Telemetry System with S-T Segment Analysis Option (K951371). The hardware of the SC9000/SC9015 is unchanged.

The ST Segment Analysis is not active when the Siemens SC9000/SC9015 Monitor is in the neonatal functionality

The modified software (version VB2) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions. There are no hardware changes required for the upgrade.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Siemens SC9000/SC9015 Bedside Monitoring System enhanced with ST Segment Analysis:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the stated accuracy improvements.

Acceptance Criteria (Predicate Device)	Reported Device Performance (Applicant Device)
ST segment deviation measurement accuracy: +/- 1 mm	ST segment deviation measurement accuracy: +/- 0.5 mm
Leads processed: I, II, III, aVR, aVL, aVF, V	Leads processed: I, II, III, aVR, aVL, aVF, V, V+, V1 - V6
Iso point default: QRS onset - 30 msec	Iso point default: QRS onset - 28 msec
Sample rate: 100 samples/ second	Sample rate: 250 samples/sec.
Update interval: 20 seconds	Update interval: 15 seconds

Study Proving Acceptance Criteria:

The submission states: "Performance was qualified by testing versus a standard clinical patient database per AAMI recommendations."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document only mentions "a standard clinical patient database."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is referred to as a "standard clinical patient database."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not explicitly stated. The document refers to "standard clinical patient database per AAMI recommendations," implying a pre-existing, validated dataset where ground truth would have been established, but the details of its establishment are not part of this submission.

4. Adjudication Method for the Test Set

Not explicitly stated.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on the standalone performance of the device and its comparison to a predicate device based on technical specifications and database testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The document states, "Performance was qualified by testing versus a standard clinical patient database." This implies evaluating the algorithm's output against the ground truth derived from the database, without a human in the loop interpretating the device's results.

7. The Type of Ground Truth Used

The ground truth was established by a "standard clinical patient database per AAMI recommendations." This suggests that the database contains reference ST segment measurements and related ECG annotations established through expert consensus or other validated methods that align with AAMI (Association for the Advancement of Medical Instrumentation) guidelines for ECG analysis.

8. The Sample Size for the Training Set

Not explicitly stated. The 510(k) summary focuses on the performance of the algorithm (which was previously cleared in K951371) in a new monitoring system, rather than the development of the algorithm itself. Therefore, training set details are not provided here.

9. How the Ground Truth for the Training Set Was Established

Not explicitly stated. As mentioned above, the submission pertains to the application of an existing algorithm to a new device, not the development of the algorithm.

Summary

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K970920

2 9 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: David Simard, Director Quality Assurance and Regulatory Affairs. Contact person for this submission: Jacqueline E. M. Emery Date submission was prepared: February 12, 1997

3: Trade Name, Common Name and Classification Number:

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-indwellingbloodpressure 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

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

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4: Predicate Device Identification:

K946306 Siemens SC9000/SC9015 Monitor (Original Submission)

K954632 Siemens SC9000/SC9015 Monitor with etCO2 Functionality

K962291 Siemens SC9000/SC9015 Monitor modified with Neonatal Functionality

K964624 Siemens SC9000/SC9015 Monitor with modified Arrhythmia Monitoring (Pending)

The software for the ST Segment Analysis was granted 510(K) clearance under:

K951371 Siemens 1481 (T) Digital Telemetry with ST Segment Analysis Option

5. Device Description

The ST Segment Analysis is not active when the Siemens SC9000/SC9015 Monitor is in the neonatal functionality

6. Intended Use:

The intended use of the Siemens SC900/ SC9015 Bedside Monitoring System is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, temperature, arrhythmia (adult only), cardiac output (adult only), arterial oxygen saturation, pulse rate, end-tidal carbon dioxide, (central) apnea, and ST segment analysis (adult only). This device will produce visual and audible alarns if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET or Infinity (Olympus) network.

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.

ST Segment Analysis	Substantially Equivalent DeviceSiemens Medical Systems1481T Digital Telemetry Option withST segment analysis optionK951371	ApplicantSiemens Medical SystemsSC9000/SC9015 enhanced withST analysis	Explanation of themodified version
Manufacturer	Siemens Medical Systems	Same
510K number	K951371	To be assigned
Intended patientpopulation	Adult only	Same
ST segment deviationmeasurement accuracy	+/- 1 mm	+/- 0.5 mm	+/- 0.1 mV = 1 mmImprovements made inbeat classification(K964624) enable higheraccuracy.
Leads processed	I, II, III, aVR, aVL, aVF, V	I, II, III, aVR, aVL, aVF, V, V+,V1 - V6	Depends on cable typeconnected
Iso point adjustmentrange	complex start to fiducial point	Same
Iso point default	QRS onset - 30 msec	QRS onset - 28 msec	Sample rate changenecessitated QRS onsetpoint to be changed to bea multiple of 4 msec.
ST measurement pointadjustment range	fiducial point to complex end	Same
measurement pointdefault	QRS offset + 80 msec	Same
ST complex length	900 msec.	Same
Sample rate	100 samples/ second	250 samples/sec.	Higher sample rate resultsin higher fidelity signalswith finer resolution foralignment.
Update interval	20 seconds	15 seconds	Improved update rate
Alarms	Yes	Same

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

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Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device.

1. Assessment of clinical performance data for equivalence:
  NA

Performance was qualified by testing versus a standard clinical patient database per AAMI recommendations

Biocompatability Data: Not applicable

1. Sterilization data: Not applicable

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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

JUL 29 1997

Re : K970920 Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with ST Segment Analysis (SW Version VB2) Regulatory Class: III (three) Product Code: 74 DSI Dated: May 31, 1997 Received: June 4, 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 aqainst 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 GMF 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 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. Callahon

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): K970920

Device Name: Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with ST Segment Analysis

Indications for Use:

MRI Compatibility Statement:

The Siemens SC9000/SC9015 Series is not compatible for use in a 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)

-M. Puzic
21.01.2023

-ision 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.