(204 days)
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 system, the 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 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 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.
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. 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 SC9000 unit. To enable 12-lead ST processing, the new, optional processing board must be installed in the SC9000 unit. In addition, the SC9000 must have the new software version VC0 installed. The SC9000 unit receives the 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 to generate ST vector magnitude (STVM) and an ST change magnitude (STCVM) vector. The SC9000 may be connected to a central station, the MultiView WorkStation (K955059). If connected to a commercially available LaserPrinter™, ECG reports can be printed. VC0 software needs to be installed in the MultiView WorkStation to enable printing of 12-lead reports. This requires no hardware modifications. The Cardiology Review Station (CRS), a derivative of a MVWS, receives all available ST data from the SC9000, and collects and archives the trend data for review by the user.
The provided 510(k) summary for the Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis includes limited information regarding acceptance criteria and study details. Based on the document, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states: "Currently there are no FDA standards for this device." and "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." However, it does not list specific quantitative acceptance criteria for ST segment analysis or the reported performance metrics against those criteria. It only mentions that the device uses "the same algorithm as the predicate device" for 12-lead ST analysis.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "a standard clinical database per AAMI recommendations," but the size of this database is not provided.
- Data Provenance: Not explicitly stated. It refers to "a standard clinical database," which implies a collection of existing data, likely retrospective. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The document mentions "testing versus a standard clinical database," but it does not describe how the ground truth within this database was established or the number and qualifications of experts involved.
4. Adjudication Method for the Test Set
Not explicitly stated. Given the reference to a "standard clinical database," it's possible that the ground truth within that database was already established through some form of expert consensus or adjudication, but the method is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or indicated in the document. The study described focuses on the device's performance against a clinical database, not on its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation of the algorithm appears to have been done. The document states, "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." This implies the algorithm's output was compared directly against the ground truth of the database, without human intervention in the analysis process being explicitly mentioned as part of this qualification.
7. The Type of Ground Truth Used
The ground truth used was based on a "standard clinical database per AAMI recommendations." This suggests that the ground truth for ST segment analysis within this database would typically be derived from expert consensus by cardiologists or other qualified medical professionals, often using established criteria for ST segment evaluation. However, the exact nature (e.g., pathology, outcomes data) is not specified beyond "standard clinical database."
8. The Sample Size for the Training Set
Not applicable. This device is an updated version of a previously cleared device (Siemens MEGACART™ K915225 and SC9000/SC9015 K946306). The document mentions the new device uses "the same algorithm as the predicate device" for ST analysis. This suggests that the algorithm was developed and validated prior to this submission, likely using training data, but the details of that training set and its size are not provided in this 510(k) summary. The current submission focuses on demonstrating substantial equivalence, not re-training a new algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as details about a training set for this specific submission are not provided. The algorithm is stated to be the "same as the predicate device," implying its ground truth establishment would have occurred during the development of the original algorithm, which is not described here.
{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 | 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 |
| 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 DeviceSiemens Megacart | ApplicantSiemens Medical SystemsSC9000/SC9015 enhanced with12 Lead ST Segment Analysis | ||
|---|---|---|---|
| Manufacturer | Siemens-Elema | Siemens Medical Systems | |
| 510(k) Number | K915225 | To be assigned | |
| Intended Use | To determine the ST Segmentof the ECG signal and tocompute the deviation of thisST Segment from the iso-electric point (baseline). | Same | |
| IntendedPopulation | Adult, Pediatric | Same | |
| IntendedEnvironment | In the medical clinic or hospitalenvironment for use byphysicians, nurses and ECGtechnicians. | Same | |
| ST Analysis | Up to 12 ST complexes | Same | |
| ST analysis performed on allavailable leads at 500 s/s | Same | ||
| Computes ST VectorMagnitude ( $STCVM$ ) | Same | ||
| Computes Change in STVector Magnitude( $STCVM$ ) | A mathematical equationthat involves no signalprocessing | ||
| ECGProcessing | Megacart Algorithm | Same | |
| Analog Devices ADSP2101 | SC9000 with new processorBoard 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 |
|---|---|
| --------------- | --------- |
§ 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.