The SpaceLabs Medical Multi-Disclosure Workstation is intended for use with the SpaceLabs PCMS monitoring network to provide for the collection, review, editing, printing and archiving of waveform data records (full disclosure and strips), 12-lead ECG diagnostic reports, and alarm recordings collected by monitors on the network.

Indications for Use:

Data Access Provides the user with the means to collect multiple patient data directly from a hardwired or telemetry Patient Care Management System (PCMS) monitoring network.
Data Storage Allows the user to retain up to 48 patient waveforms for up to 48 hours.
Data Display - Allows the user to pull data from storage or during continuous monitoring by patient and parameter.
Data Editing Provides the user with the means to edit 12-lead ECG waveform data and interpretation text from SpaceLabs Medical 12-lead modules connected to the Patient Care Management System (PCMS) monitoring network.
Data Printing Allows the user to print time annotated waveforms and patient data on paper for review or archive history.

Device Description

The SpaceLabs Medical Multi-Disclosure Workstation is a personal computer accessory with an Ethernet link to the SpaceLabs Medical PCMS network. The Workstation is a software application for a generally available Pentium® based computer system with an SVGA monitor, laser printer and keyboard, with optional mouse and CD-ROM drive, running Windows NT. The SpaceLabs Medical proprietary software consists of modules for monitoring census information on the PCMS network, collecting waveform, 12-lead and alarm data from the network, processing waveform data for display, printing reports, and managing patient information. The system provides full-disclosure waveform data, which provides a means to review continuous waveform data from a patient for one or more channels of data. Strips or disclosure print-outs of the data may be reviewed on-screen, printed, or saved for archival purposes and later side-by-side comparisons of previously stored data. The user may select from a variety of viewing and printing formats.

AI/ML Overview

The provided text describes the SpaceLabs Medical Multi-Disclosure Workstation, an accessory to the SpaceLabs Medical PCMS network. The document is a 510(k) submission to the FDA, indicating it focuses on demonstrating substantial equivalence to predicate devices rather than proving novel performance.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific, quantitative acceptance criteria for its own performance in a medical diagnosis context. The "performance" described is largely functional equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Devices:	The SpaceLabs Medical Multi-Disclosure Workstation provides support for the collection, review, editing, archiving, and printing of patient waveform data available from the PCMS network. It is stated to be "substantially equivalent to workstations currently marketed by Hewlett-Packard Company and Marquette Electronics, Inc."
- Collection of waveform data	Collects waveform, 12-lead, and alarm data from the network.
- Review of waveform data	Provides full-disclosure waveform data for review, on-screen.
- Editing of waveform data	Provides means to edit 12-lead ECG waveform data and interpretation text.
- Archival of waveform data	Saves data for archival purposes and later side-by-side comparisons. Allows printing for archive history.
- Printing of waveform data	Prints strips or disclosure print-outs. Allows printing of time annotated waveforms and patient data on paper.
- Data Storage	Allows the user to retain up to 48 patient waveforms for up to 48 hours.
- Data Display	Allows the user to pull data from storage or during continuous monitoring by patient and parameter, with a variety of viewing and printing formats.
Safety and Regulatory Compliance:	"The SpaceLabs Medical Multi-Disclosure Workstation has been 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 tests have further been performed by the various manufacturers of the required hardware components to ensure the system complies to applicable industry and safety standards." The FDA also states it "assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices"

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a test set sample size in terms of patient data or cases. The "testing" mentioned refers to functional and performance tests of the device itself and its compliance with standards, rather than a clinical study evaluating its diagnostic accuracy or impact on patient care using a specific dataset.

The data provenance (country of origin, retrospective/prospective) related to a specific test set is not mentioned, as such a test set for clinical performance is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document does not describe a clinical study where expert ground truth would be established for a test set.

4. Adjudication Method for the Test Set

This information is not provided. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. The submission is focused on demonstrating substantial equivalence, not on comparing human reader performance with and without AI assistance. The device is a workstation for data management, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

No "standalone" algorithm performance study is described in the context of an AI or diagnostic algorithm. The device itself is a "software application" that processes and displays data, but it explicitly states: "the SpaceLabs Medical Workstation does not support non-network applications and provides no analysis of physiological data." This suggests it does not contain a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The document does not describe the use of ground truth in the context of diagnostic performance (e.g., expert consensus, pathology, outcomes data). The "performance tests" mentioned are about the device's functional requirements and specifications.

8. The Sample Size for the Training Set

This information is not provided. The device is a workstation for data management and display; it is not described as an AI system that undergoes training on a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not provided, as the device is not described as an AI system requiring a training set with established ground truth.

Summary

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K962811

Image /page/0/Picture/1 description: The image shows the logo for SpaceLabs Medical. The logo consists of the letters "SL" in a stylized font, with horizontal lines above and below the letters. To the right of the letters is the text "SpaceLabs Medical" in a simple, sans-serif font. The logo is black and white and is surrounded by a thin black border.

JUN 24 1997

15220 N F 40th Stree PO Box 97013 Redmond, Washington 98073-9713 206-882-3700

510(k) SUMMARY

SpaceLabs Medical Multi-Disclosure Workstation

1. Submitter's Name SpaceLabs Medical Inc. 15220 N.E. 40th Street Redmond, WA 98073 Telephone: (206) 882-3913 Facsimile: (206) 867-3550
1. Name of Device SpaceLabs Medical Multi-Disclosure Workstation

Classification: Display, Cathode-Ray Tube; 74DXJ; 21 CFR 870.2450

1. Predicate Device(s) The SpaceLabs Medical Multi-Disclosure Workstation is an accessory to the SpaceLabs Medical PCMS network to offer support for the collection, review, editing, archiving and printing of patient waveform data available from the network. This device is substantially equivalent to workstations currently marketed by Hewlett-Packard Company and Marquette Electronics, Inc. Hewlett-Packard markets the M1251A Full Disclosure Review System (K905788) which collects waveform data and provides support for the review, editing, archival and printing of this data. The Marquette Muse Cardiology Management System (K840932) includes these features for the on-line review of 12-lead ECG reports and their subsequent archival for later retrieval.
1. Device Description The SpaceLabs Medical Multi-Disclosure Workstation is a personal computer accessory with an Ethernet link to the SpaceLabs Medical PCMS network.

The Workstation is a software application for a generallyavailable Pentium® based computer system with an SVGA monitor, laser printer and keyboard, with optional mouse and CD-ROM drive, running Windows NT.

The SpaceLabs Medical proprietary software consists of modules for monitoring census information on the PCMS network, collecting waveform, 12-lead and alarm data from the network, processing waveform data for display, printing reports, and managing patient information.

The system provides full-disclosure waveform data, which provides a means to review continuous waveform data from a patient for one or more channels of data. Strips or disclosure print-outs of the data may be reviewed on-screen, printed, or saved for archival purposes and later side-by-side comparisons

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of previously stored data. The user may select from a variety of viewing and printing formats.

The SpaceLabs Multi-Disclosure Workstation is intended for 5. Intended Use use with the SpaceLabs PCMS monitoring network to provide for the collection, review, editing, printing and archiving of waveform data records (full disclosure and strips), 12-lead ECG diagnostic reports, and alarm recordings collected by monitors on the network.
We consider the device to be substantially equivalent to 6. Comparison of workstations currently marketed by Hewlett-Packard Company Technological Characteristics and Marquette Electronics, Inc. The design, components used in the workstation system, and energy source are similar to its predicate devices.

All systems provide an interface to a network system in order to provide basic collection, display, review, editing, printing, and archival capabilities for the management of patient data. The only significant difference between the Multi-Disclosure Workstation and these comparable systems is in the number of additional features provided by the Hewlett-Packard and the Marquette workstations when compared to the SpaceLabs Medical Workstation. Specifically, the SpaceLabs Medical Workstation does not support non-network applications and provides no analysis of physiological data.

Testing 7. The SpaceLabs Medical Multi-Disclosure Workstation has been 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 tests have further been performed by the various manufacturers of the required hardware components to ensure the system complies to applicable industry and safety standards.
In conclusion, the SpaceLabs Medical Multi-Disclosure Workstation is as safe and effective as the predicate devices and raises no new issues.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1997

Mr. Russ Garrison SpaceLabs Medical, Inc. 15220 N.E. 40th Street P.O. Box 97013" Redmond, Washington 98073-9713

Re: K962811 SpaceLabs Medical Multi-Disclosure Workstation Requlatory Class: II (two) Product Code: 74 DXJ Dated: March 24, 1997 Received: March 26, 1997

Dear Mr. Garrison:

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 reqistration, 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 Manufacturinq Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements requlatory action. 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. Russ Garrison

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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. 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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PREMARKET NOTIFICATION

SpaceLabs Medical Multi-Disclosure Workstation

INDICATIONS FOR USE

510(k) Number:	Pending
----------------	---------

SpaceLabs Medical Multi-Disclosure Workstation Device Name:

Indications for Use:

Data Access Provides the user with the means to collect multiple patient data directly 1. from a hardwired or telemetry Patient Care Management System (PCMS) monitoring network.
Data Storage Allows the user to retain up to 48 patient waveforms for up to 48 hours. 2.
1. Data Display - Allows the user to pull data from storage or during continuous monitoring by patient and parameter.
Data Editing Provides the user with the means to edit 12-lead ECG waveform data 4. and interpretation text from SpaceLabs Medical 12-lead modules connected to the Patient Care Management System (PCMS) monitoring network.
Data Printing Allows the user to print time annotated waveforms and patient data on 5. paper for review or archive history.

M. Pught

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

510(k) Number Y4662.911

/ Prescription Use

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).