(88 days)
Use of the MultiView (SC3000) Workstation Infinity Telemetry System is indicated for adult and pediatic patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician) when the professional determines that a device is required on moussional produce visual and audible alarms for any one or more of the following parameters:
- Heart rate .
- ECG arrhythmia analysis .
- . ECG ST segment elevation or depression
- Pulse rate .
- Arterial oxygen saturation.
The Siemens MultiView Workstation consists of a PC workstation, up to two CRT displays, keyboard, mouse/trackball input devices and a laser printer.
The Infinity Telemetry System Enhancement adds a CPU/receiver that communicates with the MultiView Workstation PC, an antenna system, a transmitter programming port, radio frequency transmitters and a strip chart recorder. The CPU/receiver can be configured for 1 - 4, 1 - 12, and 1 - 16 receiver channels for the monitoring of 1 - 16 transmitters.
The Siemens MultiView Workstation Infinity Telemetry System is intended to monitor adult and pediatric patients in a healthcare setting under the supervision of professionals. The device provides visual and audible alarms for heart rate, ECG arrhythmia analysis, ECG ST segment elevation or depression, pulse rate, and arterial oxygen saturation.
Here's an analysis of the provided information regarding acceptance criteria and performance studies:
Acceptance Criteria and Device Performance
The submission indicates that the MultiView Workstation with Infinity Telemetry Enhancement improves upon the predicate device (Siemens 1481 T Digital Telemetry system) in several aspects that can be interpreted as demonstrating meeting enhanced performance criteria.
| Acceptance Criteria / Performance Metric | Predicate Device Specification (Siemens 1481 T System) | Reported Device Performance (MultiView Workstation with Infinity Telemetry Enhancement) |
|---|---|---|
| Intended Population | Adult | Adult, Pediatric |
| Number of Waveform Traces | 8 | 16 |
| Event Recall (stored events/patient) | 100 (2 channel, 1 minute events) | 1000 (2 channel, 20 second events) |
| ECG Leads Displayed | LI, LII, LIII, V | LI, LII, LIII, aVF, aVL, AVR, V |
| Heart Rate (HR) Range | 30 - 300 BPM | 15 - 300 BPM |
| Heart Rate (HR) Accuracy | +/- 10% or 5 BPM | +/- 5% or 5 BPM |
| Tabular Trends | No | Yes |
| Tuning ranges of transmitter | 174 – 216 MHz (tunable over entire 42 MHz range) | 174 – 216 MHz, 400 – 460 MHz, 430 – 480 MHz or 512 – 566 MHz (tunable over entire individual range) |
| Shock Resistance | Defibrillator protection | Withstands twenty 5 foot drops onto tiled surface with only minor cosmetic blemishes to case (In accordance with EN 60601-2-27) |
Specifics on the Study
The provided document does not contain detailed information about specific studies that rigorously prove the device meets explicit acceptance criteria in a quantitative manner (e.g., sensitivity, specificity for arrhythmia detection). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and outlining improvements in various features and specifications.
Based on the available information:
- Sample size used for the test set and data provenance: Not explicitly stated. The submission refers to "validation results" and "clinical performance data for equivalence" in Exhibit Q, but details about the sample size, its composition, or provenance (country of origin, retrospective/prospective) are not provided in the summary.
- Number of experts used to establish the ground truth for the test set and qualifications: Not explicitly stated.
- Adjudication method for the test set: Not explicitly stated.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not indicated. The submission focuses on device features and comparison to a predicate, not on human reader performance with or without AI assistance.
- Standalone (algorithm only without human-in-the-loop performance) study: Not explicitly detailed. While the device performs automated functions like arrhythmia detection and heart rate measurement, the submission does not present standalone performance data (e.g., sensitivity/specificity for these functions) from a dedicated study. The improvements mentioned (e.g., HR accuracy, enhanced ECG performance for pediatric use) imply internal testing or validation but without specifics.
- Type of ground truth used: Not explicitly stated in this summary. For parameters like heart rate accuracy or arrhythmia detection, the ground truth would typically be established by expert review of ECG recordings or comparison to a gold standard measurement device.
- Sample size for the training set: Not applicable, as this device primarily relies on established physiological monitoring principles and hardware/software improvements rather than a machine learning model that would require a distinct training set in the modern sense.
- How the ground truth for the training set was established: Not applicable.
Summary of what is available:
The submission focuses on establishing substantial equivalence to a predicate device (Siemens 1481 T Digital Telemetry system) by highlighting similarities and demonstrating enhancements. The "Explanation of the differences" section implies that these enhancements lead to improved performance, such as:
- Improved ECG performance allowing pediatric use: This suggests that the device's ECG processing capabilities were validated to be suitable for pediatric patients, who have different heart rates and ECG characteristics than adults.
- Increased number of events stored: A practical improvement for clinicians.
- Added ECG leads: Provides more comprehensive diagnostic information.
- Extended HR range and improved HR accuracy: Directly addresses a performance metric by offering a wider measurement range and better accuracy.
- Sophisticated modulation technique: Implies improved signal integrity and reduced channel spacing, contributing to overall reliability.
- Enhanced shock resistance: A physical durability improvement compliant with EN 60601-2-27.
The document states, "The comparison of intended use and technological features of these devices to other legally marketed devices taken together with the validation results and other information in this submission indicate that these devices are substantially equivalent to legally marketed predicated devices in safety, effectiveness and intended use."
The "Assessment of non-clinical performance data for equivalence" (Exhibit J) and "Assessment of clinical performance data for equivalence" (Exhibit Q) are referenced but not detailed in the provided summary. These exhibits would ostensibly contain the specific studies and data used to support the claims of equivalence and improved performance.
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510(k) SUMMARY as required per 807.92(c)
OCT 17 1997
Submitters Name, Address 2.
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923
Tel: (508) 750-7500 Fax: (508) 750-6879
Official Correspondent: David Simard, Director, Quality Assurance & Regulatory Affairs Contact Person for this submission: Mark Kolnsberg, Senior Clinical Product Manager Date submission was prepared: July 11, 1997
Trade Name, Common Name and Classification Name 3. _
A. Trade Name: Siemens MultiView Workstation Infinity Telemetry System
Common Name, Classification Number, Class and Regulation Number: B.
| 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 |
| Radiofrequency physiologicalsignal transmitter and receiver | 74DRG | II | 21 CFR 870.2910 |
| Arrhythmia detector & alarm | 74DSI | III | 21 CFR 870.1025 |
| Medical Cathode-Ray TubeDisplay | 74DXJ | II | 21 CFR 870.2450 |
| ST Segment monitor w/alarm | 74MLD | III | 21 CFR 870.1025 |
Predicate Device Information 4.
Siemens 1481 T Digital Telemetry system granted premarket clearance under 510(k) file number K951371.
న. Device Description
The Siemens MultiView Workstation consists of a PC workstation, up to two CRT displays, keyboard, mouse/trackball input devices and a laser printer.
The Infinity Telemetry System Enhancement adds a CPU/receiver that communicates with the MultiView Workstation PC, an antenna system, a transmitter programming port, radio frequency transmitters and a strip chart recorder. The CPU/receiver can be configured for 1 - 4, 1 - 12, and 1 - 16 receiver channels for the monitoring of 1 - 16 transmitters. For a more detailed device description refer to Exhibit G, Device Description in this submittal.
Intended Use of the Device 6.
The intended use statement for the Infinity Telemetry System Enhancement is to condition and transmit via radiofrequency physiological signals for display and/or measurement.
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ECG Ectopic beat detection, arrhythmic rhythm detection and alarm. Measure and alarm audibly and visually for heart rate. Measure and alarm audibly and visually for ECG ST segment elevations or depressions. Measure and alarm audibly and visually for heart arterial oxygen saturation and pulse rate. The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.
The device is also intended to provide telemetered physiological signals and measurements to the Siemens Infinity (Olympus) Communication Network.
- Table of device similarities and differences to predicate device 7.
The comparison of intended use and technological features of these devices to other legally marketed devices taken together with the validation results and other information in this submission indicate that these devices are substantially equivalent to legally marketed predicated devices in safety, effectiveness and intended use.
| Parameter | 1481 T System | MultiView Workstationwith Infinity TelemetryEnhancement | Explanation of thedifferences between thepredicate and InfinityTelemetry System |
|---|---|---|---|
| Manufacture | Siemens | Same | |
| 510(k) Number | K951371 | New | |
| Intended Population | Adult | Adult, Pediatric | The Infinity system'simproved ECGperformance allows it to beused with a pediatricpopulation. |
| Display | |||
| No. Waveform Traces | 8 | 16 | |
| Recorder | |||
| Strip Recorder | Yes | Same | |
| Physiological Parameters | |||
| Parameters | HR, VPB minute rate, %paced, % O2, Pulse rate,S-T deviation | Same | |
| Alarms | HR, VPB minute rate,arrhythmia events, %paced, % O2, Pulse rate,S-T deviation | Same | |
| Arrhythmia analysis | Yes | Same | |
| Event Recall | 100 2 ch. 1 minuteevents/patient | 1000 2 ch. 20 secondevents/patient | Infinity increases # ofevents stored per patient. |
| ECG leads displayed | LI, LII, LIII, V | LI, LII, LIII, aVF, aVL,AVR, V | Infinity adds AVF, AVL,AVR ECG leads for |
| Range | 30 - 300 BPM | 15 - 300 BPM | display, extends HR rangeand improves HR accuracy. |
| Accuracy | + / -10% or 5 BPM | + / -5% or 5 BPM | |
| Tabular trends | No | Yes | Infinity adds tabular trendsfor customer preference. |
| Graphic Trends | Yes | Same | |
| Radiofrequency | |||
| Transmission Parameters | |||
| Transmission Scheme | FSK | GMSK | Infinity uses moresophisticated modulationtechnique for reducedchannel spacing. |
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усын | шы
: -
| The Infinity RF system is | ||||||||
|---|---|---|---|---|---|---|---|---|
| Tuning ranges oftransmitter | 174 – 216 MHz.Transmitter tunable overentire 42 MHz range. | 174 – 216 MHz,400 – 460 MHz,430 – 480 MHz or512 – 566 MHzTransmitter tunable overentire individual range. | offered in three newoperating bands to providemore operating frequencies. | |||||
| Operator Tuning of RadioOperating Frequency | Externally programmable | Same | ||||||
| Channel spacing | 40 or 50 Khz, even spacing | Same | ||||||
| Bit rate | 10.416 kbits/sec | Same | ||||||
| Receiver Type | Dual conversionsuperhetrodyne | Same | ||||||
| Transmission | RA,LA,LL,RL, V lead wireshields | Same | ||||||
| Transmitter EKGParameters | ||||||||
| Input leads | I, II, V | Same | ||||||
| EKG Dynamic Range | + 5 mV | Same | ||||||
| Input Offset | + 300 mV max | Same | ||||||
| EKG sample rate | 200 Hz | Same | ||||||
| A/D resolution | 10 bits | Same | ||||||
| EKG Gain Accuracy | $\pm$ 5% | Same | ||||||
| EKG Noise | <40 uV r.t.i. | Same | ||||||
| Frequency response | 0.45 Hz (-2.4 to -3.7 dB) to40 Hz (-1 to-3dB) | Same | ||||||
| Pacemaker detectionpolarity | + or - | Same | ||||||
| Pacemaker spike width | 0.1 to 2mS | Same | ||||||
| Pacer spike detectionamplitude | $\pm$ 2.5 - $\pm$ 700m V r.t.i. | Same | ||||||
| Pacer detector 50/60 HzRejection | 700m V p-p r.t.i. | Same | ||||||
| EKG input impedance | >25 Mohm at 10 Hz,differential>10 Mohm at 50 Hz,differential | Same | ||||||
| EKG Analog Output | Yes | Same | ||||||
| EKG leads with pacer spikedetectors | I, II | Same | ||||||
| Transmitter Electrical & Mechanical Parameters | ||||||||
| Dimensions | 116 x 65 x 30 mm | Same | ||||||
| Weight | 160 grams with lithiumbattery | Same | ||||||
| Controls | Recorder start: timed &continuous, staff alert | Same | ||||||
| Indicators | Lead off, low battery | Same | ||||||
| Water resistant | Yes | Same | ||||||
| Battery type | 9V alkaline or lithium8.4 V mercury or Zinc Air | Same | ||||||
| Battery life | 2 days minimum withDuracell MN1604 | Same | ||||||
| Shock resistance | Defibrillator protection | Withstands twenty 5 footdrops onto tiled surfacewith only minor cosmetic ,blemishes to case | In accordance with EN60601-2-27 | Same | Same |
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510(k) Notification:
. . . . .
س
510(k) Notification:
MultiView Workstation Infinity Telemetry System Enhancement
| 8. | Assessment of non-clinical performance data for equivalence: | See Exhibit J |
|---|---|---|
| 9. | Assessment of clinical performance data for equivalence: | See Exhibit Q |
| 10. | Biocompatibility: Not applicable |
ﻟﻠﺘﻌﻠﻴ Not Applicable Sterilization:
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 1997
Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923
Re : K972714 Siemens MultiView Workstation Infinity Telemetry System Enhancement Regulatory Class: III (three) Product Code: 74 DSI Dated: July 16, 1997 Received: July 21, 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 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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 - 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/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
K972714 510(k) Number (if known):
Device Name: Siemens MultiView Workstation Infinity Telemetry System Enhancement
Indications for Use:
Use of the MultiView (SC3000) Workstation Infinity Telemetry System is indicated for adult and pediatic patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician) when the professional determines that a device is required on moussional produce visual and audible alarms for any one or more of the following parameters:
- Heart rate .
- ECG arrhythmia analysis .
- . ECG ST segment elevation or depression
- Pulse rate .
- Arterial oxygen saturation.
MRI Compatibility Statement:
The Multi View (SC3000) Workstation Infinity Telemetry 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 V (Per 21 CFR 801.109)
OR
Over-the-Counter Use - - -
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K972714
§ 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.