SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS

• K Number: K974492
• Device Name: SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 1998-02-26 ( 90 days)
• Product Code: MLD
• Regulation Number: 870.1025

Intended Use

The SC6000/SC6000P enhanced with ST Segment Analysis is intended to be used in the environment where patient care is provided by Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition. ST Segment Analysis is intended for use in the adult population. The SC6000/SC6000P is not for home use.

Device Description

The SC 6000 / SC 6000P Bedside Monitoring Series Enhanced with ST Segment Analysis is an updated software version of the SC 6000 / SC 6000P Bedside Monitoring Series. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the isoelectric point (baseline). This is the same algorithm that is used in the Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371). The hardware of the SC 6000 / SC 6000P (510(k) K944350) is unchanged. The ST Segment Analysis is not active when the SC 6000/SC 6000P is in the neonatal mode. The modified software (version VC0) is not compatible with all previously sold versions of the monitor. Therefore, a software upgrade will be offered to the owners of units with previous software revisions. No hardware changes are required for the upgrade.

Predicate Devices

K951371

Reference Devices

K944350

AI/ML (Artificial Intelligence / Machine Learning)

No
The description explicitly states the software uses the "same algorithm" as a predicate device from 1995, and there is no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as a "Bedside Monitoring Series" that determines and computes the ST Segment of an ECG signal, indicating it is for diagnostic or monitoring purposes, not therapeutic treatment.

Diagnostic

Yes

Explanation: The device performs ST Segment Analysis of the ECG signal to compute deviations, which is a diagnostic function used by healthcare professionals to assess a patient's medical condition.

SaMD (Software as a Medical Device)

No

The device is described as an "updated software version" of an existing bedside monitoring series (SC 6000 / SC 6000P). While the modification is software-only, the device itself is the bedside monitor, which is a hardware device. The software is an enhancement to this existing hardware.

IVD (In Vitro Diagnostic)

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.
• Device function: The SC6000/SC6000P with ST Segment Analysis is a bedside patient monitor that analyzes the electrical activity of the heart (ECG signal) to determine the ST segment deviation. This is a measurement taken directly from the patient's body, not from a sample taken from the body.
• Intended Use: The intended use describes monitoring the patient's condition in a healthcare setting, not performing laboratory tests on samples.

Therefore, this device falls under the category of a patient monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the SC 6000/SC 6000P Bedside Monitoring Series is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult) temperature, arterial oxygen saturation, pulse rate, central apnea, and ST Segment Analysis (adult). The device will produce visual and audible alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.
The SC6000/SC6000P enhanced with ST Segment Analysis is intended to be used in the environment where patient care is provided by Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition.
ST Segment Analysis is intended for use in the adult population.
The SC6000/SC6000P is not for home use.

Product codes (comma separated list FDA assigned to the subject device)

74MLD

Device Description

The SC 6000 / SC 6000P Bedside Monitoring Series Enhanced with ST Segment Analysis is an updated software version of the SC 6000 / SC 6000P Bedside Monitoring Series. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the isoelectric point (baseline). This is the same algorithm that is used in the Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371). The hardware of the SC 6000 / SC 6000P (510(k) K944350) is unchanged.
The ST Segment Analysis is not active when the SC 6000/SC 6000P is in the neonatal mode.
The modified software (version VC0) is not compatible with all previously sold versions of the monitor. Therefore, a software upgrade will be offered to the owners of units with previous software revisions. No hardware changes are required for the upgrade.

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

Intended User / Care Setting

Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition.
Where patient care is provided by healthcare professionals

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)

Not Found

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.

K951371

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.

K944350

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

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.

Summary

0

K974492

FEB 2 6 1998

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

• 2. Submitters Name, Address:
     Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline Emery Date submission was prepared: November 14, 1997
• 3. Trade Name. Common Name and Classification Name:

A. Trade Name:

Siemens SC6000/ SC6000P Bedside Monitoring Series enhanced with ST Segment Analysis

| Common Name | Classification
Number | Class | Regulation Number |
|---------------------------------------------|--------------------------|-------|-------------------|
| Cardiac Monitor | 74DRT | II | 21 CFR 870.2300 |
| Pulse Rate Monitor | 74BWS | II | 21 CFR 870.2300 |
| Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 |
| Breathing Frequency Monitor | 73BZQ | II | 21 CFR 868.2375 |
| Clinical Electronic Thermometer | 80BWX | II | 21 CFR 880.2910 |
| Indwelling Blood Pressure Monitor | 74CAA | II | 21 CFR 870.1110 |
| Noninvasive Blood Pressure Monitor | 74DXN | II | 21 CFR 870.1130 |
| 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 |
| ST Segment Monitor with Alarm | 74 MLD | III | 21 CFR 870.1025 |
| Arrhythmia Detector & Alarm System | 74DSI | III | 21 CFR 870.1025 |

• B. Common Name, Classification Name, Class and Regulation Number:
• 2. Predicate Device Identification:
     The Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371)

1

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

1

Siemens SC6000/SC6000P Portable Bedside Monitoring Series with ST Segment Analysis

3. Device Description:

The SC 6000 / SC 6000P Bedside Monitoring Series Enhanced with ST Segment Analysis is an updated software version of the SC 6000 / SC 6000P Bedside Monitoring Series. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the isoelectric point (baseline). This is the same algorithm that is used in the Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371). The hardware of the SC 6000 / SC 6000P (510(k) K944350) is unchanged.

The ST Segment Analysis is not active when the SC 6000/SC 6000P is in the neonatal mode.

The modified software (version VC0) is not compatible with all previously sold versions of the monitor. Therefore, a software upgrade will be offered to the owners of units with previous software revisions. No hardware changes are required for the upgrade.

• 4. Intended Use:
     The intended use of the SC 6000/SC 6000P Bedside Monitoring Series is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult) temperature, arterial oxygen saturation, pulse rate, central apnea, and ST Segment Analysis (adult). The device will produce visual and audible alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.

2

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

2

SIEMENS MED SYS

Siemens SC6000/SC6000P Portable Bedside Monitoring Series with ST Segment Analysis

| | Substantial Equivalent
Device
Siemens Medical Systems
1481T Digital Telemetry
with ST Segment Analysis
Option | Applicant
Siemens Medical Systems
SC 6000/SC 6000P Series
Enhanced with ST Segment
Analysis | Explanation of the
modified version |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The intended use of this device
is to detect a patient's EKG
signals and to transmit this
data via radiofrequency to a
central monitoring station. At
the central monitoring station,
cardiac arrhythmias, ST
segment deviation values and
heart rates are determined.
The patient's pulse rate and
arterial oxygen saturation
values, heart rate values, ST
segment deviation values are
displayed and visual and aural
alarms and recordings are
initiated if these parameters
vary beyond preset limits. | The intended use of this device is to
measure heart rate, respiration rate,
invasive pressure, non-invasive
pressure, arrhythmia (adult only), ST
Segment Analysis (adult), temperature,
arterial oxygen saturation, pulse rate,
and (central) apnea. This device will
produce visual and audible alarms 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 | The intended use for
the ST Segment
Analysis is the same
for both the SC6000
and the predicate,
1481T. The devices
themselves have
different intended uses
(patient monitor vs.
telemetry system) |
| Intended
Population | Adult | Adult | |
| Intended
Environment | Where patient care is provided
by healthcare professionals | Same | |
| ST Segment
deviation
measurement
accuracy | $ \pm $ 1mm / $ \pm $ 0.1mV | Same | |
| Leads processed | Any two of I, II, III, V | Any one of I, II, III, V, aVR, aVL,
aVF | The SC6000 series
measures only one lead
and supports
augmented leads. |
| ISO point
adjustment range | Complex start to fiducial point | Same | |
| ISO point default | 30 msec before QRS onset | Same . | |
| ST measurement
point adjustment
range | Fiducial point to complex end | Same | |
| ST complex
length | 900 msec | Same | |
| Sample Rate | 100 samples per second | Same | |
| Update interval | 20 Seconds | 15 Seconds | |

3

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

3

Siemens SC6000/SC6000P Portable Bedside Monitoring Series with ST Segment Analysis

• 8. Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device
• 9. Assessment of clinical performance data for equivalence: The ST Segment Analysis of the SC6000/SC6000P series patient monitors is equivalent to the ST Segment Analysis of the predicate device.
• 10. Biocompatability: Not applicable (Same as original submission)
• 11. Sterilization: Not applicable (Same as original submission)
• 12. Standards and Guidance:

Currently there are no FDA standards for this device. The Siemens Series SC 6000/SC 6000P Bedside Monitoring Series enhanced with ST Segment Analysis complies with: "Performance Measurements for Algorithms to Detect Transient Ischemic ST Segment Changes", IEEE 1992

"ST Segment Monitor Preliminary Guidance", US Department of Health and Human Services, July 1994.

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

4

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 1998

Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

K974492 Re : Siemens SC6000/SC6000P Bedside Monitoring Series Enhanced with ST Segment Analysis III (three) Requlatory Class: Product Code: 74 MLD Dated: November 25, 1997 Received: November 28, 1997

Dear Mr. Simard:

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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 regulation 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.

5

Page 2 - Mr. David Simard

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

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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Page 1 of 1

510(k) Number (if known): K974492

Device Name: Siemens SC6000 / SC6000P Bedside Monitoring Series enhanced with ST Segment Analysis

Indications for Use:

The SC6000/SC6000P enhanced with ST Segment Analysis is intended to be used in the environment where patient care is provided by Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition.

ST Segment Analysis is intended for use in the adult population.

The SC6000/SC6000P is not for home use.

MRI Compatibility Statement:

The Siemens SC6000 / SC6000P Bedside Monitoring System 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)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

C. Carey

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

510(k) Number