(204 days)
No
The document describes standard signal processing and analysis techniques for physiological data, without mentioning AI or ML. The analysis of ST segments uses an algorithm from a predicate device, suggesting a rule-based or traditional signal processing approach.
No.
The device is described as a "Bedside Monitoring System" capable of monitoring various physiological parameters and performing analyses like ST segment analysis. Its primary function is to collect and display patient data, not to deliver therapy. While it connects to therapeutic devices like ventilators, it does not provide therapy itself.
Yes
This device monitors various physiological parameters (heart rate, respiration, pressures, etc.) and performs specific analyses like arrhythmia detection and ST segment analysis, which are used by healthcare professionals to assess a patient's medical condition. This process of assessing a patient's medical condition based on gathered data falls under the definition of diagnosis.
No
The device description explicitly states that the system is comprised of hardware components including the MultiMed-12™ ECG pod, the SC9000 unit with an optional processing board, and a new 12-lead ECG patient cable. While software is enhanced, it is part of a larger hardware system.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The description of this device clearly indicates it monitors physiological parameters directly from the patient's body (in vivo), such as heart rate, respiration rate, blood pressure, and ECG signals.
- The device description focuses on sensors, cables, and processing of electrical and physiological signals. There is no mention of analyzing biological samples.
- The intended use describes monitoring patient vital signs and physiological functions. This is characteristic of a patient monitoring system, not an IVD.
Therefore, the Siemens SC9000/SC9015 Bedside Monitoring System is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
To determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the iso-electric point (baseline) in a health care environment by health care professionals, i.e. Physicians, Nurses, Technicians.
This device is capable of monitoring
- Heart rate
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Arrhythmia
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate
- End-tidal carbon dioxide
- (central) apnea
- ST segment analysis
With the MultiGas™ and MultiGas+™ modules the SC9000/SC9015 is capable of measuring:
- Respiration rate
- Inspired and expired Carbon Dioxide (CO2)
- Inspired and expired Oxygen (MultiGas+TM only)
- Average inspired Oxygen (MultiGas™ only)
- Inspired and Expired concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.
The SC9000/SC9015 is capable of performing 12-lead ST Segment analysis.
This device can be connected to third party devices: Siemens SV 300™ ventilator, the Baxter Vigilance™ blood gas monitoring system, Puritan Bennett 7200™. Draeger Evita IV™, & Babylog™, and Siemens SV900™ ventilators.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals and where use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Product codes (comma separated list FDA assigned to the subject device)
74DRT, 74BWS, 74DQA, 73BZQ, 80BWX, 74CAA, 74FLO, 73FLS, 74FLP, 74DSI, 74DXJ, 74MLD, 74DXN, 73CCK
Device Description
The Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis is an updated version of the Siemens SC9000/SC9015 Bedside Monitoring System (original configurations appeared in the 510(k) file number K946306 (primary submission)).
The system is comprised of the following components:
- MultiMed-12™ ECG pod .
- SC9000 with a new, optional processing board and enhanced software .
- MultiView WorkStation with enhanced software •
- Cardiology Review Station (optional) .
A new 12-lead ECG patient cable, the MultiMed-12™ "pod', collects data from the patient and transmits it to the MultiMed-12™ unit (code named ARIES).
To enable 12-lead ST processing, the new, optional processing hoard must be installed in the SC9000 unit. In addition, the SC9000 must have the new software version VC0 installed. The SC9000 unit screens 12-lead ECG signals from the MultiMed-12™ ECG pod, downsamples them to 500 samples/s and performs QRS detection. The SC9000 then performs 12-lead ST analysis on the ECG leads provided, using the same algorithm as the predicate device (Siemens Megacart ™, K915225) with minor modifications. The SC9000 with VC0 software also computes an ST vector magnitude (STVM) and an ST change magnitude (STCVM) vector.
The SC9000 may be connected to a central station, the MultiView WorkStation (K955059). The SC9000 can be connected to a commercially available LaserPrinter™, therefore, full-disclosure ECG reports can be printed. VC0 software needs to be installed in the MultiView WorkStation to support the MultiMed-12™ pod; this requires no hardware modifications.
The Cardiology Review Station (CRS), a derivative of a MVWS, receives all available ST Segment data from the SC9000, and collects and archives the trend data for review by the user.
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
The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the 12-Lead ST Segment Analysis which are intended for use in the adult and pediatric populations only: and Arrhythmia which is intended for use in the adult population only.
Intended User / Care Setting
health care environment by health care professionals, i.e. Physicians, Nurses, Technicians.
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)
Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device.
Assessment of clinical performance data for equivalence: Not applicable. Performance was qualified by testing versus a standard clinical database per AAMI recommendations.
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.
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.
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
§ 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
JUL - 8 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: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline Emery Date submission was prepared: December 5, 1997
Trade Name, Common Name and Classification Name: 3.
A. Trade Name: Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classificatio
n 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 |
| 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 |
| Arrhythmia detector & Alarm | 74DSI | III | 21 CFR 870.1025 |
| Medical Cathodc-Ray Tube Display | 74DXJ | II | 21 CFR 870.2450 |
| ST Segment Monitor with Alarm | 74MLD | III | 21 CFR 870.1025 |
| Non-indwelling Blood Pressure Monitor | 74DXN | II | 21 CFR 870.1130 |
| End-tidal Carbon-Dioxide Monitor | 73CCK | II | 21 CFR 868.1400 |
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers. MA 01923 ાડત
Tcl: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
1
-
- Predicate Device Identification:
Siemens MEGACART™ granted SE (substantial equivalence) under 510(k) file number K915225)
- Predicate Device Identification:
5. Device Description:
The Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST The Siement SC9000/SC9015 Bedside Montoning SC900/SC9015 Bedside Monitoring
Segment Analysis is an updated version of the Siemens of Child (arigures System Analysis is an apared version in the 510(k) file number K946306 (primary submission).
The system is comprised of the following components:
- MultiMed-12™ ECG pod .
- SC9000 with a new, optional processing board and enhanced software .
- MultiView WorkStation with enhanced software •
- Cardiology Review Station (optional) .
A new 12-lead ECG patient cable, the MultiMed-12™ "pod', collects data from the patient and A fiew 12-lead LCG patient cable, the works one would (code named ARIES).
To enable 12-lead ST processing, the new, optional processing hoard must be installed in the SC9000 unit. In addition, the SC9000 must have the new software version VC0 installed. The SC9000 unn. "In addition, the SC7000 mact 7.0 signals from the MultiMed-12™ ECG pod, downsamples them to 500 samples/s and performs QRS detection. The SC9000 then performs 12-lead ST analysis on the ECG leads provided, using the same algorithm as the predicate device ST analysis on the LCG feast provided, and and only and one of the SC9000 with YCU software and (STEMS Megacan "", RY13225) With Minor meanerate ST vector magnitude (STVM) and an ST change magnitude (STCVM) vector.
The SC9000 may be connected to a central station, the MultiView WorkStation (K955059). The SC 7000 may be comments to a commercially available LaserPinter™, ECG reports can be printed. VC0 software needs to be installed in the MultiView WorkStation to reports can be printed. VCo software need to requires no hardware modifications.
The Cardiology Review Station (CRS), a derivative of a MVWS, receives all available ST The Cardiology Neview Station (CRD), a Gorrith of SC9000, and collects and archives the trend data for review by the user.
6. Intended Use:
To determine the ST Segment of the ECG signal and to compute the deviation of this ST For delections the iso-electric point (baseline) in a health care environment by health care professionals, i.e. Physicians, Nurses, Technicians.
1
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PC'S
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
2
7. Table of Device Similarities and differences to predicate device
| | Substantial Equivalent Device
Siemens Megacart | Applicant
Siemens Medical Systems
SC9000/SC9015 enhanced with
12 Lead ST Segment Analysis | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Manufacturer | Siemens-Elema | Siemens Medical Systems | |
| 510(k) Number | K915225 | To be assigned | |
| Intended Use | To determine the ST Segment
of the ECG signal and to
compute the deviation of this
ST Segment from the iso-
electric point (baseline). | Same | |
| Intended
Population | Adult, Pediatric | Same | |
| Intended
Environment | In the medical clinic or hospital
environment for use by
physicians, nurses and ECG
technicians. | Same | |
| ST Analysis | Up to 12 ST complexes | Same | |
| | ST analysis performed on all
available leads at 500 s/s | Same | |
| | Computes ST Vector
Magnitude ( $STCVM$ ) | Same | |
| | | Computes Change in ST
Vector Magnitude
( $STCVM$ ) | A mathematical equation
that involves no signal
processing |
| ECG
Processing | Megacart Algorithm | Same | |
| | Analog Devices ADSP2101 | SC9000 with new processor
Board installed | |
| | 12 leads | Same | |
- Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device.
-
- Assessment of clinical performance data for equivalence: Not applicable. Performance was qualified by testing versus a standard clinical database per AAMI recommendations.
درا
- Assessment of clinical performance data for equivalence: Not applicable. Performance was qualified by testing versus a standard clinical database per AAMI recommendations.
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS
16 Electronics Avenue Danvers. MA (01923 USA
Tcl: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
3
-
- Biocompatability: Not applicable
l l . Sterilization: Not applicable
- Biocompatability: Not applicable
-
- Standards and Guidances:
and the same of the same of the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the
- Standards and Guidances:
Standards and Guidances.
Currently there are no FDA standards for this device rently there are no FDA standards for this device.
"ST Segment Monitor Preliminary Guidance", US Department of Health and Human Services, July 1994.
ﻨﻨ
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers. MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic, emphasizing the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 1998
Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
K974698 Re: K974690
Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment Analysis Regulatory Class: III (three) Product Code: 74 DSI Dated: April 10, 1998 Received: April 13, 1998
Dear Mr. Simard:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosien on we have determined the device is the device fereiched above and indications for use stated in the enclosure) to legally marketed predicate devices marketed in enclosure) to regally marketed products 76, the enactment date of the Interstate Commerce proble do the have been reclassified Medical Device Amendments) of to devilose of the Federal Food, Drug, and In accordance with the provider and the device, subject to Cosmeric Act (ACC). Tourmaly) the Act. The general controls the general concroro provide requirements for annual registration, provisions of the not on manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class IT (Special II your device is crassiried (boo oproval), it may be subject to such Controls) of Class III (Frenalitions affecting your device nudicional ocheroly Code of Federal Regulations, Title 21, Parts 800 can be round in the ollualent determination assumes compliance with the Current Good Manufacturing Practice requirements, as society with the Current Cood namem Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regulation od and Drug Administration (FDA) will verify such Inspections, Ent rood and Brog muith the GMP regulation may result in assumption. In addition, FDA may publish further announcements reguratory dostronivice in the Federal Register. Please note: this concerning your device in the ification submission does not affect any response to your premater sections 531 through 542 of the Act obrigation you might 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 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/dsma/csmamain.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
6
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead Device Name: ST Segment Analysis
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 .
- End-tidal carbon dioxide .
- (central) apnea ◆
- ST segment analysis .
With the MultiGas™ and MultiGas+™ modules the SC9000/SC9015 is capable of measuring:
- Respiration rate .
- Inspired and expired Carbon Dioxide (CO2) �
- Inspired and expired Oxygen (MultiGas+TM only) .
- Average inspired Oxygen (MultiGas™ only) .
- Avelage inspired Oxygen (man Bas of Enflurane, Halothane, Isoflurane, Desflurane, . Sevoflurane, and Nitrous Oxide.
The SC9000/SC9015 is capable of performing 12-lead ST Segment analysis.
This device can be connected to third party devices: Siemens SV 300™ ventilator, the Baxter Vigilance™ blood This device can be connected to mira party devices. Stematics,
I his device can be connected formity, Puritan Bennett 7200™. Draeger Evita IV™, & Babylog™, and Siemens SV900™ ventilators.
The device is intended to be used in the environment where patient care is provided by Healthcared beard upon he I he device is intended to be used in the environment 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 Neonatal populations, with the exception of the The device Is intended to be asea on Analysis which are intended for use in the adult and pediarric purations only: and Arrhythmia which is intended for use in the adult population only
MRI Compatibility Statement:
MRT Companibility Statement.
The Siemens SC9000SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis 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) | |
|---|---|---|---|
| --------------------------------------- | -- | ---- | ----------------------------------------------- |
Mark Krame
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | K974112 |
|---|---|
| --------------- | --------- |