(151 days)
The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Ultraview™ Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring network. The Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The Spacelabs Medical Ultraview™ Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor.
The Spacelabs Medical Ultraview™ Waveform Pager System provides caregivers within a clinical environment the ability to remain mobile and be notified when an alarm event occurs. Typically, alarm notification by the pager occurs within 4-8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The administration module allows convenient assignment of patients to caregivers from any location on the network, including WinDNA-enabled Universal Clinical Workstations. Patient status updates can also be scheduled for dispatch to the pager on a repeating basis if desired.
This system is not a replacement for the primary alarm notification system. The delivery of pages cannot be guaranteed or verified. The Waveform Paging System is intended to augment alarm notification. It is not intended or designed to replace monitoring personnel, good clinical judgment, or to be used in place of bedside and remote alarm notification, or the Alarm Watch function of the monitor.
The device subject to this submission is Model 91841. Each Spacelabs Medical Ultraview™ Waveform Pager System consists of a Server which collects and formats data from the monitoring network, a Transmitter which broadcasts the information to the mobile caregiver, and a Receiver which receives the broadcast and displays the formatted information.
The provided document, K992749, is a 510(k) Safety and Effectiveness Summary for the Spacelabs Medical Ultraview™ Waveform Pager System. It does not contain detailed information about specific acceptance criteria or an explicit study proving device performance against those criteria in the way a modern clinical validation study would be presented for an AI/ML device.
Instead, it relies on a comparison to predicate devices and general performance claims. Here's a breakdown of the available information based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a formal table of acceptance criteria with specific quantifiable metrics. However, key performance characteristics are mentioned as a comparison to predicate devices and as functional requirements.
| Acceptance Criterion (Implied or Stated) | Reported Device Performance |
|---|---|
| Alarm Notification Time | "Typically, alarm notification by the pager occurs within 4-8 seconds of an alarm event on the patient monitor." (Page 1) |
| Information Displayed on Pager | Pager provides: "audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot." (Page 1, 2) |
| Paging Technology | Uses "standard paging technology to deliver this information to mobile caregivers." (Page 1) |
| Equivalence to Predicate Devices (Functional) | "The underlying technological characteristics... are similar to and functionally equivalent to those of the predicate devices. The systems collect substantially the same information. The collected data is transmitted to the mobile caregiver(s) using standard technologies." (Page 2) |
| Safety and Effectiveness | "The Spacelabs Medical Ultraview™ Waveform Pager System is as safe and effective as its predicate devices and raises no new issues." (Page 2) |
| Display Resolution (Improvement over predicate) | "The Spacelabs Medical Ultraview™™ Waveform Pager System has a higher resolution display than the predicate devices." (Page 2) |
| Waveform Snapshot Length (Improvement over predicate) | "The Spacelabs Medical Ultraview™M Waveform Pager System provides a longer snapshot of waveform data for the alarming parameter than the predicate devices." (Page 2) |
| Role (Secondary Alarm, not replacement) | "This system is not a replacement for the primary alarm notification system. The delivery of pages cannot be guaranteed or verified. The Waveform Paging System is intended to augment alarm notification. It is not intended or designed to replace monitoring personnel, good clinical judgment, or to be used in place of bedside and remote alarm notification, or the Alarm Watch function of the monitor." (Page 1) "The Spacelabs Medical Ultraview™M Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor." (Page 2) |
| Interoperability (Spacelabs monitoring network) | "interfacerace with the Spacelabs monitoring network" (Page 2) |
2. Sample size used for the test set and the data provenance
The document does not specify a scientific study with a defined test set sample size or data provenance in the way a modern clinical validation for AI/ML would.
Instead, it states: "The Spacelabs Medical Ultraview™ Waveform Pager System will be subject to extensive safety and performance Final testing for the system testing prior to release includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." (Page 2)
This suggests internal engineering and functional testing rather than a clinical study with patients or a specific dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no external "test set" and corresponding "ground truth" established by experts for performance evaluation are described. The testing described is internal and functional.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. The device is a secondary alarm notification system, not an AI-assisted diagnostic tool that would involve human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a system for relaying information, not an algorithm that performs analysis. Its core function is to transmit data, and its performance would be judged on the speed and accuracy of that transmission, effectively a "standalone" system in terms of its notification function. However, this is not in the context of an AI/ML algorithm.
7. The type of ground truth used
For functional performance related to alarm notification time and data display, the "ground truth" would likely be derived from:
- System logs/measurements: Actual time taken for a page to be sent and received following an alarm event on a patient monitor.
- Visual inspection: Verification that the correct patient ID, alarm parameters, and waveform snapshot are accurately displayed on the pager device.
- Predicate device comparison: Functional equivalence to the legally marketed predicate devices (K973527 Data Critical Corporation's Cardio-Pager System and K971868 Marquette Medical Systems Impact Pager System) formed the primary basis for regulatory clearance.
8. The sample size for the training set
Not applicable. The device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
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510(K) SAFETY AND EFFECTIVENESS SUMMARY
Spacelabs Medical Ultraview™M Waveform Pager System
| 1. Submitter's Name | Irene JaworskiDirector, Regulatory Affairs and Quality |
|---|---|
| Company | Spacelabs Medical, Inc.15220 NE 40th StreetRedmond, WA 98073 |
| Telephone | (425) 882-3913 |
| Facsimile | (425) 867-3550 |
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Spacelabs Medical Ultraview™ Waveform Pager System 2. Name of the Device
System, Network and Communication, Physiological Classification Monitors 74MSX, 870.2910 Class III -
The Spacelabs Medical Waveform Pager System is 3. Predicate Device(s) substantially equivalent to the K973527 Data Critical Corporation's Cardio-Pager System and the K971868 Marquette Medical Systems Impact Pager System. (Note: Data Critical Corporation's Cardio-Pager System is the same device as the Marquette Medical System's Impact Pager System.) The Spacelabs Medical Waveform Pager System and its predicate devices serve as secondary alarm notification systems that forward patient data (text and waveforms) from the patient monitoring devices to a graphics pager(s). The Waveform Pager System and its predicate devices passively gather alarm event information (including waveforms) from the patient monitoring devices to a graphics pager(s). The Waveform Pager System and its predicate devices passively gather alarm event information (including waveforms) from the patient monitoring network and use standard paging technology to deliver this information to mobile caregivers.
-
The Spacelabs Medical Ultraview™M Waveform Pager 4. Device Description System provides caregivers within a clinical environment the ability to remain mobile and be notified when an alarm event occurs. Typically, alarm notification by the pager occurs within 4-8 seconds of an alarm event on the patient
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L 49 2749
monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The administration module allows convenient assignment of patients to caregivers from any location on the network, including WinDNA-enabled Universal Clinical Workstations. Patient status updates can also be scheduled for dispatch to the pager on a repeating basis if desired.
This system is not a replacement for the primary alarm notification system. The delivery of pages cannot be guaranteed or verified. The Waveform Paging System is intended to augment alarm notification. It is not intended or designed to replace monitoring personnel, good clinical judgment, or to be used in place of bedside and remote alarm notification, or the Alarm Watch function of the monitor
The device subject to this submission is Model 91841. Each Spacelabs Medical Ultraview™™ Waveform Pager System consists of a Server which collects and formats data from the monitoring network, a Transmitter which broadcasts the information to the mobile caregiver, and a Receiver which receives the broadcast and displays the formatted information.
The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient The Ultraview™ Waveform Pager System is events. intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring network The Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8
- ત્ત્વ Intended Use
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seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The Spacelabs Medical Ultraview™M Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor.
-
The underlying technological characteristics of the Comparison of 6. Spacelabs Medical Ultraview™ Waveform Pager System Technological are similar to and functionally equivalent to those of the Characteristics The systems collect substantially the predicate devices. same information. The collected data is transmitted to the mobile caregiver(s) using standard technologies. The Receivers are lightweight graphical pagers. The transmitted information is displayed on the pagers as a sequence of message displays that can be saved for later The systems can be configured to forward reference. patient vital sign updates to caregivers at defined intervals.
The differences between the Spacelabs Medical Ultravicw™ Waveform Pager System and its predicate devices are minor and do not raise new issues of safety and/or effectiveness in comparison with the predicate devices. The Spacelabs Medical Ultraview™™ Waveform Pager System has a higher resolution display than the predicate devices The Spacclabs Medical Ultraview™M Waveform Pager System provides a longer snapshot of waveform data for the alarming parameter than the predicate devices. -
The Spacelabs Medical Ultraview™M Waveform Pager 7 Testing System will be subject to extensive safety and performance Final testing for the system testing prior to release includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications.
In conclusion, the Spacelabs Medical Ultraview™™ Waveform Pager System is as safe and effective as its predicate devices and raises no new issues.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2000
Irene Jaworski Director Regulatory Affairs and Quality Spacelabs Medical 15220 N.E. 40th Street P.O. Box 97013 Redmond, Washington 98073-9713
Re: K992749 Trade Name: Ultraview Waveform Pager System Regulatory Class: III (three) Product Code: MSX Dated: November 29, 1999 Received: November 30, 1999
Dear Ms. Jaworski:
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 legally marketed predicate 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 regulation 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. Irene Jaworski
This letter will allow you to begin marketing your device as described inis receed will area you tification. The FDA finding of substantial in your 310 m, prom device to a legally marketed predicate device equivalence or your donion 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 reguration (Er CFF), please contact the Office of Compliance at draghostic devices), productions on the promotion and (301) 39 4040. Addressarif, as a contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. (301) 394 4037. HIBO) premarket notification" (21CFR 807.97). MISDIanding by reference to promains on your responsibilities under the Act may Other general Information of your responant of Small Manufacturers at its be obtained from the broises: 41 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Page 1 of 1
510(k) Number (if known): K992749
Device Name: Spacelabs Medical Ultraview™ Waveform Pager System
Indications for Use:
The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Ultraview™™ Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring ar onvironment Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The Spacelabs Medical Ultravicw™ Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K992749 |
| Prescription Use | Over-The-Counter Use |
(Per 21 CFR 801 109) (Optional format 1-2-96)
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).