(88 days)
Not Found
No
The description focuses on hardware components and standard physiological monitoring parameters without mentioning AI/ML algorithms or capabilities.
No.
The device is a monitoring system that provides visual and audible alarms for vital signs; it does not directly treat or alleviate a medical condition.
No
The device is described as a monitoring system that provides visual and audible alarms for various physiological parameters, which are used to assess a patient's current state, not to make a diagnosis.
No
The device description explicitly lists hardware components such as a PC workstation, CRT displays, keyboard, mouse/trackball, laser printer, CPU/receiver, antenna system, transmitter programming port, radio frequency transmitters, and a strip chart recorder.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description of the MultiView (SC3000) Workstation Infinity Telemetry System clearly indicates it is used for monitoring physiological parameters directly from the patient (Heart rate, ECG, Pulse rate, Arterial oxygen saturation). This is done in vivo (within the body) via sensors and transmitters.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
Therefore, the device's function aligns with patient monitoring, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use statement for the Infinity Telemetry System Enhancement is to condition and transmit via radiofrequency physiological signals for display and/or measurement.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
74DRT, 74BWS, 74DQA, 74DRG, 74DSI, 74DXJ, 74MLD
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.
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 (Physician, Nurse, Technician)
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: See Exhibit J
Assessment of clinical performance data for equivalence: See Exhibit Q
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
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 physiological | |||
| signal transmitter and receiver | 74DRG | II | 21 CFR 870.2910 |
| Arrhythmia detector & alarm | 74DSI | III | 21 CFR 870.1025 |
| Medical Cathode-Ray Tube | |||
| Display | 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.
1
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 Workstation
with Infinity Telemetry
Enhancement | Explanation of the
differences between the
predicate and Infinity
Telemetry System |
|--------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Manufacture | Siemens | Same | |
| 510(k) Number | K951371 | New | |
| Intended Population | Adult | Adult, Pediatric | The Infinity system's
improved ECG
performance allows it to be
used with a pediatric
population. |
| 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 minute
events/patient | 1000 2 ch. 20 second
events/patient | Infinity increases # of
events 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 range
and improves HR accuracy. |
| Accuracy | + / -10% or 5 BPM | + / -5% or 5 BPM | |
| Tabular trends | No | Yes | Infinity adds tabular trends
for customer preference. |
| Graphic Trends | Yes | Same | |
| Radiofrequency | | | |
| Transmission Parameters | | | |
| Transmission Scheme | FSK | GMSK | Infinity uses more
sophisticated modulation
technique for reduced
channel spacing. |
2
усын | шы
: -
| The Infinity RF system is | ||||||||
|---|---|---|---|---|---|---|---|---|
| Tuning ranges of | ||||||||
| transmitter | 174 – 216 MHz. | |||||||
| Transmitter tunable over | ||||||||
| entire 42 MHz range. | 174 – 216 MHz, | |||||||
| 400 – 460 MHz, | ||||||||
| 430 – 480 MHz or | ||||||||
| 512 – 566 MHz | ||||||||
| Transmitter tunable over | ||||||||
| entire individual range. | offered in three new | |||||||
| operating bands to provide | ||||||||
| more operating frequencies. | ||||||||
| Operator Tuning of Radio | ||||||||
| Operating Frequency | Externally programmable | Same | ||||||
| Channel spacing | 40 or 50 Khz, even spacing | Same | ||||||
| Bit rate | 10.416 kbits/sec | Same | ||||||
| Receiver Type | Dual conversion | |||||||
| superhetrodyne | Same | |||||||
| Transmission | RA,LA,LL,RL, V lead wire | |||||||
| shields | Same | |||||||
| Transmitter EKG | ||||||||
| Parameters | ||||||||
| 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 | 25 Mohm at 10 Hz, | |||||||
| differential |
10 Mohm at 50 Hz,
differential | Same | | | | | | |
| EKG Analog Output | Yes | Same | | | | | | |
| EKG leads with pacer spike
detectors | I, II | Same | | | | | | |
| Transmitter Electrical & Mechanical Parameters | | | | | | | | |
| Dimensions | 116 x 65 x 30 mm | Same | | | | | | |
| Weight | 160 grams with lithium
battery | Same | | | | | | |
| Controls | Recorder start: timed &
continuous, staff alert | Same | | | | | | |
| Indicators | Lead off, low battery | Same | | | | | | |
| Water resistant | Yes | Same | | | | | | |
| Battery type | 9V alkaline or lithium
8.4 V mercury or Zinc Air | Same | | | | | | |
| Battery life | 2 days minimum with
Duracell MN1604 | Same | | | | | | |
| 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 | Same | Same | | | |
3
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:
4
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.
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/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
6
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