(90 days)
Not Found
No
The document describes interpretive diagnostic statements for ECG data but does not mention AI, ML, or related terms, nor does it describe training or test sets in a way typical for AI/ML development.
No
The device is described as a monitoring workstation that provides interpretive diagnostic statements and reports from ECG data. It does not provide therapy or treatment.
Yes
The device "can provide interpretive diagnostic statements and reports when connected to a bedside monitor with ECG monitoring capability." The "enhancement enables the MultiView WorkStation to interpret diagnostic statements (Rest ECG) and reports of multi-lead ST deviations." These statements directly indicate its diagnostic function.
No
The device is described as a "WorkStation™" which implies a hardware component. While it has software capabilities (interpreting diagnostic statements), the description doesn't explicitly state it is software-only and it is an enhancement to a previously cleared hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description clearly state that this device monitors patients directly via bedside monitors and processes ECG data. It does not analyze biological specimens.
- The device's function is focused on monitoring physiological signals (ECG) and providing interpretive diagnostic statements based on that data. This falls under the category of patient monitoring and diagnostic interpretation of physiological signals, not in vitro analysis of specimens.
Therefore, this device is a patient monitoring and diagnostic interpretation system, not an IVD.
N/A
Intended Use / Indications for Use
The MultiView WorkStation (MVWS) with Rest ECG collects preprocessed ECG data derived from the SC9000/SC9015 bedside monitor. The data is analyzed by the MVWS to produce reports and possible patient diagnosis for review by the physician (this functionality is currently part of interpretive cardiographs).
This device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
This device is capable of connecting to one or more bedside monitors via a network. The device allows the user to monitor the patients connected to these monitors at a central location. The monitoring ability of the device is determined by the bedside monitors. In addition, this device can provide interpretive diagnostic statements and reports when connected to a bedside monitor with ECG monitoring capability.
This device is intended for use with adults and pediatrics in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when 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 MultiView (SC3000) WorkStation™ enhanced with Diagnostic Statements (Rest ECG) is a modified version of the MultiView (SC3000) WorkStation granted clearance under 510(k) # K955059. This enhancement enables the MultiView WorkStation to interpret diagnostic statements (Rest ECG) and reports of multi-lead ST deviations.
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, Pediatric
Intended User / Care Setting
Healthcare Professionals, i.e. Physicians, Nurses, and Technicians / In an environment where healthcare is provided by healthcare professionals, i.e. doctors, 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)
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.
Not Found
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
MAY 19 1998
510(k) SUMMARY as required per 807.92(c)
Submitters Name, Address: 1.
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 774-8342 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline Emery Date submission was prepared: February 12, 1998
Trade Name, Common Name and Classification Name: 2. A. Trade Name: Siemens MultiView WorkStation™ (MVWS) Enhanced with Diagnostic Statements (Rest ECG)
- 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 Cathode-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 |
l
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)
1
Predicate Device Identification: 3.
Siemens MEGACART™ granted SE (substantial equivalence) under 510(k) file number K915225)
4. Device Description:
The Siemens MultiView (SC3000) WorkStation™ enhanced with Diagnostic Statements (Rest ECG) is a modified version of the MultiView (SC3000) WorkStation granted clearance under 510(k) # K955059. This enhancement enables the MultiView WorkStation to interpret diagnostic statements (Rest ECG) and reports of multi-lead ST deviations.
5. Intended Use:
The MultiView WorkStation (MVWS) with Rest ECG collects preprocessed ECG data derived from the SC9000/SC9015 bedside monitor. The data is analyzed by the MVWS to produce reports and possible patient diagnosis for review by the physician (this functionality is currently part of interpretive cardiographs).
This device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
2
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) ్లో వై
2
6. Table of Device Similarities and differences to predicate device
| | Substantial Equivalent
Device
Siemens Megacart | Applicant
Siemens Medical Systems
MultiView WorkStation enhanced with
Diagnostic Statements (Rest ECG) | Explanation of
Differences |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Manufacturer | Siemens-Elema | Siemens Medical Systems | |
| 510(k) Number | K915225 | To be assigned | |
| Intended Use | The device determines the
ST Segment of the ECG
signal and computes the
deviation of this ST
Segment from the iso-
electric point (baseline).
The device is suitable forcapable of analyzing the
data and providing output
with interpretation. | The device is suitable for use in
resting ECGs and is capable of
analyzing the data and providing
output with interpretation. | ST Segment data is
processed in the
bedside monitor,
not the MVWS |
| Intended
Population | Adult, Pediatric | Same | |
| Intended
Environment | In the medical clinic or
hospital environment for
use by physicians, nurses
and ECG technicians. | In an environment where healthcare is
provided by healthcare professionals,
i.e. doctors, nurses, technicians. | |
| ST Analysis | Up to 12 ST complexes | Same | |
| | ST analysis performed on
all available leads at 500
s/s | Same | |
| ECG
Processing | Megacart Algorithm | Same | |
| | Up to 12 leads
I, II, III, aVR, aVL, aVF,
V1, V2, V3, V4, V5, V6 | Same | |
| Reporting | 12 leads ST
measurements | Same | |
| | Interpretation and
proposed diagnosis | Same | |
| | Resting ECG | Same | |
| | Annotations | Same | |
3
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronies Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
3
- Assessment of non-clinical performance data for equivalence: 7. Currently there are no FDA standards for this device.
8. Assessment of clinical performance data for equivalence: Not applicable. Performance was qualified by testing versus a standard clinical database per AAMI recommendations.
-
- Biocompatability: Not applicable
-
- Sterilization: Not applicable
-
- Standards and Guidances: Currently there are no FDA standards for this device. "American National Standard for Diagnostic Electrocardiographic Devices" ANSI/AAMI EC11-R-8-90
4
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/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1998
Ms. Jacqueline E. M. Emery Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
K980625 Re: Siemens MultiView Workstation™ Enhanced with Diagnostic Statements Requlatory Class: III (three) Product Code: 74 DSI February 12, 1998 Dated: February 18, 1998 Received:
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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as setforth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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.
5
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,
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
6
510(k) Number (if known): K980625
Siemens MultiView WorkStation Enhanced with Diagnostic Statements Device Name: (Rest ECG)
Indications for Use:
This device is capable of connecting to one or more bedside monitors via a network. The device allows the user to monitor the patients connected to these monitors at a central location. The monitoring ability of the device is determined by the bedside monitors. In addition, this device can provide interpretive diagnostic statements and reports when connected to a bedside monitor with ECG monitoring capability.
This device is intended for use with adults and pediatrics in an environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
MRI Compatibility Statement:
The Siemens MultiView WorkStation Enhanced with Diagnostic Statements (Rest ECG) 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)
Mr. Piny
(Division Sign Division of Cardic and Neurological De 510(k) Number