(90 days)
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.
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.
The Siemens MultiView WorkStation™ Enhanced with Diagnostic Statements (Rest ECG) is a modified version of the MultiView (SC3000) WorkStation, which was previously cleared under 510(k) # K955059. This enhancement allows the MultiView WorkStation to interpret diagnostic statements (Rest ECG) and reports of multi-lead ST deviations. The device collects preprocessed ECG data from SC9000/SC9015 bedside monitors, analyzes it, and produces reports and potential patient diagnoses for physician review.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific quantifiable acceptance criteria for the diagnostic statements and reports. Instead, it relies on demonstrating equivalence to a predicate device and testing against a standard clinical database as per AAMI recommendations.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: The device should perform comparably to the Siemens MEGACART™ (K915225) in terms of ECG processing, ST segment analysis, interpretation, and reporting for resting ECGs. This includes analyzing data and providing output with interpretation. | The device is a modified version of a previously cleared device (K955059) and is enhanced to interpret diagnostic statements (Rest ECG) and reports of multi-lead ST deviations. The table of similarities and differences highlights that the new device shares the same intended use (analyzing data and providing output with interpretation for resting ECGs), intended population, intended environment, ST analysis capabilities (up to 12 ST complexes, performed on all available leads at 500 s/s), ECG processing algorithm (Megacart Algorithm), number of leads (up to 12), and reporting features (12 leads ST measurements, interpretation, proposed diagnosis, resting ECG, annotations) as the predicate device. The primary difference noted is that ST segment data is processed in the bedside monitor, not the MVWS itself, indicating a system integration rather than a fundamental change in ST analysis methodology. |
| Performance Qualified by Testing vs. Standard Clinical Database: The device's performance for diagnostic statements and reports (Rest ECG) should be qualified by testing against a standard clinical database. | "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." |
2. Sample size used for the test set and the data provenance
The document states, "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." However, it does not provide specific details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the clinical database.
4. Adjudication method for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating the device's ability to provide interpretive diagnostic statements and reports, and its equivalence to a predicate device, rather than on quantifying human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire premise of the device – "The device is suitable for use in resting ECGs and is capable of analyzing the data and providing output with interpretation" and "produce reports and possible patient diagnosis for review by the physician" – indicates that the algorithm does perform in a standalone capacity by generating interpretive diagnostic statements and reports before physician review. The qualification "Performance was qualified by testing versus a standard clinical database per AAMI recommendations" would inherently relate to the standalone performance of the algorithm in interpreting the ECG data.
7. The type of ground truth used
The ground truth for the performance qualification was established through a "standard clinical database per AAMI recommendations." While the exact nature of this ground truth (e.g., expert consensus, pathology, outcomes data) is not explicitly detailed, "standard clinical database" suggests a collection of cases with established diagnoses or interpretations, likely based on expert consensus or established clinical practice/guidelines that the AAMI standard would dictate.
8. The sample size for the training set
The document does not provide information on the sample size used for the training set. It primarily discusses performance qualification rather than the development or training of the underlying ECG interpretation algorithm. Given the K980623 filing in 1998, and the use of the "Megacart Algorithm" which is also present in the 1991 predicate device (K915225), it's highly probable that the core algorithm was developed and trained much earlier.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set was established. As mentioned, the core "Megacart Algorithm" predates this submission, so details regarding its original training and ground truth establishment would not be expected in this 510(k) summary.
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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 | ClassificationNumber | 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 EquivalentDeviceSiemens Megacart | ApplicantSiemens Medical SystemsMultiView WorkStation enhanced withDiagnostic Statements (Rest ECG) | Explanation ofDifferences | |
|---|---|---|---|
| Manufacturer | Siemens-Elema | Siemens Medical Systems | |
| 510(k) Number | K915225 | To be assigned | |
| Intended Use | The device determines theST Segment of the ECGsignal and computes thedeviation of this STSegment from the iso-electric point (baseline).The device is suitable forcapable of analyzing thedata and providing outputwith interpretation. | The device is suitable for use inresting ECGs and is capable ofanalyzing the data and providingoutput with interpretation. | ST Segment data isprocessed in thebedside monitor,not the MVWS |
| IntendedPopulation | Adult, Pediatric | Same | |
| IntendedEnvironment | In the medical clinic orhospital environment foruse by physicians, nursesand ECG technicians. | In an environment where healthcare isprovided by healthcare professionals,i.e. doctors, nurses, technicians. | |
| ST Analysis | Up to 12 ST complexes | Same | |
| ST analysis performed onall available leads at 500s/s | Same | ||
| ECGProcessing | Megacart Algorithm | Same | |
| Up to 12 leadsI, II, III, aVR, aVL, aVF,V1, V2, V3, V4, V5, V6 | Same | ||
| Reporting | 12 leads STmeasurements | Same | |
| Interpretation andproposed 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.
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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
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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
§ 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.