The Spacelabs Medical Ultraview Digital Telemetry System, when used in conjunction with a Spacelabs Medical PCMS Patient Monitor or Ultraview Care Network, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected.

The Ultraview Digital Telemetry System also provides a means for the episodic monitoring of noninvasive blood pressure (NIBP) signals to detect abnormal events such as high and low blood pressure. The System also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary/circulatory functions.

The Spacelabs Medical Ultraview Digital Telemetry System Models 90343 and 90347 are intended for use with either adult or neonatal patient populations in a hospital environment. When the NIBP option is selected in the Model 90343 configuration, the NIBP feature is to be used with adult patient populations only.

Device Description

The Ultraview Digital Telemetry System is a multiple parameter system which provides the capability for wireless central station monitoring of patients within hospitals or medical center facilities. This telecommunications feature converts bedside monitors to telemetry operation and works with a portable monitor for the transport of telemetricallymonitored patients to allow for the remote programming and data retrieval of clinical parameters specific to patient populations, clinical protocols, or operating preferences. Physiological parameters supported by the System are the acquisition and monitoring of electrocardiographic signals (ECG), pulse oximetric oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) parameters, based upon the System configuration options selected by the clinician.

The devices subject to this submission are the Models 90343, 90347, and 90478. Each Ultraview Digital Telemetry System configuration consists of a battery-operated Telemetry Transmitter, a Receiver Module, and an antenna system. The Ultraview Digital Telemetry Multi-Parameter Transmitter Model 90343 is a wideband VHF unit that provides 5electrode ECG and continuous or episodic SpO2 monitoring capabilities, with an optional noninvasive blood pressure (NIBP) interface when connected to a Spacelabs Medical Model 90217Ambulatory Blood Pressure (ABP) Monitor (K855127). The Ultraview Digital Telemetry ECG Transmitter Model 90347 is identical to the Model 90343 with the SpO2 measurement function and ABP communications capabilities removed.

The Ultraview Digital Telemetry System interfaces to a patient using standard accessories including ECG electrodes and lead wires, NIBP hoses and cuffs, SpO2 cables and sensors, and adapter cables to connect these accessories to the Transmitter. The telemetry system sends raw ECG vectors or preprocessed SpO2 and NIBP data, based upon the capability of the selected Transmitter, to the VHF version of the Model 90478 Modular Receiver via a diversity antenna system.

The Modular Receiver collects and processes parameter specific physiologic data for alarm generation and display of numeric values and waveforms on a Spacelabs Medical Patient Care Management System (PCMS) Monitor or Ultraview Care Network via SDLC communications. The monitor provides the display, review, editing and analysis capabilities for the care provider. Hard copy records may be provided by the wide variety of Spacelabs Medical printers and recorders that can be interfaced by either Ethernet or SDLC communications.

AI/ML Overview

Here's an analysis of the provided text regarding the Spacelabs Medical Ultraview™ Digital Telemetry System, focusing on acceptance criteria and study information:

Based on the provided text, a detailed breakdown of acceptance criteria and a study proving device performance is not explicitly present in the format requested. This document is a 510(k) Safety and Effectiveness Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics against a ground truth.

However, I can extract the information that is available and highlight what is missing based on your request.

Missing Information/Why it's not present:

Detailed Acceptance Criteria Table: The document describes the intended function of the device (detecting abnormal cardiac rhythms, NIBP events, SpO2 desaturation), but it does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy percentages) that the device must meet for each function.
Reported Device Performance (Quantitative): Since quantitative acceptance criteria are not stated, reported performance metrics are also absent. The document asserts that the device will be subject to extensive testing and will meet functional requirements and specifications, but it doesn't provide the results of such tests here.
Sample Size for Test Set, Data Provenance, Ground Truth Establishment for Test Set: There is no mention of a specific test set, its size, the origin of data, or how ground truth was established for this device. The document relies on substantial equivalence to predicate devices which presumably have undergone such testing.
Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth (Test Set): These are all related to a specific clinical or performance study that is not detailed in this 510(k) summary. The document does not describe such studies for the Ultraview Digital Telemetry System.
Sample Size for Training Set, Ground Truth Establishment for Training Set: As this is a traditional medical device (not explicitly AI/ML software), the concept of a "training set" in the context of machine learning is not applicable here. Even if it involved some algorithms, the document does not elaborate on a training phase or 'training data' in the modern AI sense.

Information that can be extracted or inferred:

1. A Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Inferred from Intended Use)	Reported Device Performance
ECG Monitoring: Detect abnormal cardiac rhythms, including:	Device is designed to offer these capabilities and will meet its functional requirements and performance specifications.
- High and low heart rates
- Asystole
- Ventricular fibrillation
- (Optional, adult patients) Ventricular runs
- (Optional, adult patients) Tachycardia
- (Optional, adult patients) ST segment deviations
NIBP Monitoring: Detect abnormal events such as high and low blood pressure.
SpO2 Monitoring: Detect desaturation caused by abnormal pulmonary/circulatory functions (continuous and episodic).
Safety and Standards Compliance: Compliance with applicable industry & safety standards, including ANSI/AAMI EC13 and AAMI ECAR-1987.	Device will be tested to assure compliance. Safety testing has been or will be performed by third-party agencies.

Explanation: The "acceptance criteria" listed above are inferred from the stated "Indications for Use" and the "Testing" section. The document does not provide specific quantitative thresholds (e.g., "detect with 90% sensitivity"). The "Reported Device Performance" column reflects the statements made in the document about the device's design and planned testing, not actual performance data for this submission.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified.
Data Provenance: Not specified. This document emphasizes substantial equivalence to existing predicate devices rather than presenting data from a new, specific clinical trial for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. (No specific test set or ground truth establishment described for this device in the provided text).

4. Adjudication method for the test set:

Not specified.

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 mentioned. This document describes a medical device, not a diagnostic AI system for medical image interpretation or a system that "assists human readers" in an interpretable way in the context of MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a "multiple parameter system which provides the capability for wireless central station monitoring." It performs automated detection of physiological events. Its intended use implies "standalone" detection for the parameters it monitors, but no specific "standalone performance study" in the modern sense (e.g., comparing algorithm output to human interpretation) is described as part of this submission. The device itself is the "standalone" component doing the monitoring and detection.

7. The type of ground truth used:

Not explicitly stated for the new device. For predicate devices, it would typically involve clinical diagnosis, validated reference measurements, or expert clinical review for arrhythmia detection. This document implies that the device's functional integrity will ensure it aligns with the expected physiological measurements, rather than comparing its diagnostic output against a 'ground truth' in a clinical study for this 510(k).

8. The sample size for the training set:

Not applicable/Not specified. This document describes a hardware/software system for physiological monitoring, not an AI/Machine Learning model that undergoes a training phase in the typical sense.

9. How the ground truth for the training set was established:

Not applicable/Not specified. (See point 8).

Summary of the Study (Based on 510(k) statement):

The "study" described in the 510(k) summary is not a detailed clinical trial with quantified results, but rather a declaration of planned and ongoing testing.

Device Under Review: Spacelabs Medical Ultraview™ Digital Telemetry System (Models 90343, 90347, 90478).
Purpose of Testing: To ensure the device meets all its functional requirements and performance specifications, and complies with applicable industry and safety standards (e.g., ANSI/AAMI EC13 and AAMI ECAR-1987).
Nature of Testing: "Extensive safety and performance testing prior to release," including "various performance tests" and "safety testing... performed by third party agencies."
Conclusion: The submission concludes that the device "is as safe and effective as its predicate devices and raises no new issues," implying that the planned testing will confirm this.

In essence, this 510(k) submission primarily leverages the concept of substantial equivalence to predicate devices. It describes the device's functional capabilities and the commitment to conduct testing to ensure it performs as intended and meets relevant safety standards, rather than presenting the results of a specific, comprehensive clinical study.

Summary

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JUN 3 1999

510(k) SAFETY AND EFFECTIVENESS SUMMARY

Spacelabs Medical Ultraview™ Digital Telemetry System

1. Submitter's Name	Nancy J. GertlarManager, Regulatory
Company	Spacelabs Medical, Inc.15220 N.E. 40th StreetRedmond, WA 98073
Telephone	(425) 867-7315
Facsimile	(206) 867-3550
2. Name of Device	Spacelabs Medical Ultraview™ Digital Telemetry System
Classification	Arrhythmia Detector and Alarm74DSI; 21 CFR 870.1025Class III
	Noninvasive Blood Pressure Measurement System74DXN; 21 CFR 870.1130Class II
	Oximeter74DQA; 21 CFR 870.2700Class II
3. Predicate Device(s)	The Ultraview Digital Telemetry System is substantially equivalent to a combination of features offered by predicate devices, with identical intended uses, for the three (3) physiological parameters that may be telemetrically monitored within a hospital environment by the System.. Specifically, the Ultraview Digital Telemetry System is substantially equivalent to a combination of the:

Spacelabs Medical Ultraview™ K972502) in that both modules offer the capability for the monitoring of electrocardiographic signals,

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noninvasive pressure measurement and pulse oximetric oxygen saturation (SpO2);

Spacelabs Medical Ultralite™ Ambulatory Blood Pressure Monitor 90217 (510[k] reference K855127) for the monitoring of noninvasive blood pressure measurements via remote programming and digital data retrieval capabilities:

Spacelabs Medical Single Lead Digital Telemetry Transmitter Model 90339 (510[k] reference 952885), Dual Lead Digital Telemetry Transmitter Model 90341 (510[k] reference 925510) and the Quad Lead Digital Telemetry Transmitter Model 90340 (510[k] reference 781836) for the monitoring of electrocardiographic programming and digital data retrieval capabilities; and

Packard -Company's M2601A Viridia Hewlett Transmitter and M2603A Viridia Receiver, marketed under the system model number of M2600A (510[k] reference 961165) for the integration of ECG, with support for arrhythmia monitoring and ST segment analysis, and continuous and episodic SpO2 operations in a telemetric monitoring system.

Device Description 4. The Ultraview Digital Telemetry System is a multiple parameter system which provides the capability for wireless central station monitoring of patients within hospitals or medical center facilities. This telecommunications feature converts bedside monitors to telemetry operation and works with a portable monitor for the transport of telemetricallymonitored patients to allow for the remote programming and data retrieval of clinical parameters specific to patient populations, clinical protocols, or operating preferences. Physiological parameters supported by the System are the acquisition and monitoring of electrocardiographic signals (ECG), pulse oximetric oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) parameters, based upon the System configuration options selected by the clinician.

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1. Intended Use The Spacelabs Medical Ultraview Digital Telemetry System, when used in conjunction with a Spacelabs Medical PCMS Patient Monitor or Ultraview Care Network, provides a means for the continuous

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monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including lifethreatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST seqment deviations are detected.

1. Comparison of We consider the Ultraview Digital Telemetry System Technological to be substantially equivalent to a combination of Characteristics systems currently marketed by Spacelabs Medical and, for the integration of physiological parameters into a telemetry system, to the Hewlett Packard System Model Number M2600A. The design, components, storage technology and energy source are similar to its predicate devices. The comparable systems all provide a means for interfacing with a patient, collecting parameter specific physiologic data, and processing the data for alarm generation and display of numeric values and waveforms on a bedside or central monitoring system.
  The only significant differences between the Medical Ultraview Digital Telemetry Spacelabs System and the comparable systems are in the physiologic feature sets offered by each of the systems and in the hardware packaging of the multi

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parameter feature sets of the Ultraview Digital Telemetry Transmitters into one modular unit designed to be compatible with the existing Patient Care Monitoring System (PCMS) and Ultraview Care Network currently offered by Spacelabs Medical.

1. Testing The Spacelabs Medical Ultraview Digital Telemetry System will be subject to extensive safety and performance testing prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety testing has been or will be performed by third party agencies to ensure the device complies to applicable industry and safety standards. The Ultraview Digital Telemetry System will also be tested to assure compliance to the requirements of various standards, including ANSI/AAMI EC13 and AAMI ECAR-1987.
  In conclusion, the Spacelabs Medical Ultraview Digital Telemetry System is as safe and effective as its predicate devices and raises no new issues.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1999

Ms. Nancy J. Gertlar Spacelabs Medical 15220 N.E., 40th Street P.O. Box 97013 Redmond, WA 98073-9713

K983996 Re : Ultraview Digital Telemetry System Regulatory Class: III (three) Product Code: MHX Dated: March 4, 1999 Received: March 5, 1999

Dear Ms. Gertlar:

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 Requlations, 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 Requlation (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 Reqister. Please note: this

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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.

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, 2 Misbranding by reference to premarket notification? (21CFR 807.97). Other qeneral 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/dsma/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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INDICATIONS FOR USE

Page 1 of 1

510/k) Number (if known): Not Known (New Submission)

Device Name: Spacelabs Medical Ultraview™ Digital Telemetry System

Indications for Use:

(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) (Optional Format 1-2-96)

Over-The-Counter Use

(Division Sign-Off)

510(k) Number

ivision Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

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Regulation Number and Section

§ 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.