(341 days)
Not Found
No
The description focuses on data collection, storage, display, editing, and printing, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a workstation and software application for collecting, reviewing, editing, printing, and archiving medical data. It primarily deals with data management and display, and there is no indication that it directly treats or diagnoses a medical condition.
No
The device is primarily for the collection, review, editing, printing, and archiving of patient data from a monitoring network. While it can edit 12-lead ECG waveform data and interpretation text, its core function is data management and display, not the generation of diagnostic interpretations itself. The "12-lead ECG diagnostic reports" mentioned are collected by the monitors, implying the diagnostic process occurs upstream, and this device is for handling those reports.
No
The device is described as a "personal computer accessory" and explicitly states it 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". While the core functionality is software, it is presented as an accessory to and reliant on specific hardware components (PC, monitor, printer, etc.) which are part of the overall system being described and tested. The summary also mentions safety tests performed by "various manufacturers of the required hardware components". This indicates the device is not solely software but a system incorporating both software and hardware.
Based on the provided information, the SpaceLabs Medical Multi-Disclosure Workstation is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a system for collecting, reviewing, editing, printing, and archiving waveform data (ECG, etc.) and diagnostic reports from a patient monitoring network. This data is collected from the patient via connected monitors, not from in vitro samples (like blood, urine, tissue).
- Device Description: The description reinforces that the system processes and displays data collected from the PCMS network, which is a patient monitoring system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device is a workstation for managing and reviewing physiological data collected directly from patients through connected monitoring equipment. This falls under the category of patient monitoring and data management, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SpaceLabs 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DXJ
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 of previously stored data. The user may select from a variety of viewing and printing formats.
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
Not Found
Intended User / Care Setting
Not Found
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)
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.
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
§ 870.2450 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).
0
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
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- Submitter's Name SpaceLabs Medical Inc. 15220 N.E. 40th Street Redmond, WA 98073 Telephone: (206) 882-3913 Facsimile: (206) 867-3550
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- Name of Device SpaceLabs Medical Multi-Disclosure Workstation
Classification: Display, Cathode-Ray Tube; 74DXJ; 21 CFR 870.2450
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- 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.
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- 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
1
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.
2
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.
3
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
4
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.
-
- 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