(270 days)
Not Found
No
The summary describes automated analysis of ECG data but does not mention AI or ML. The analysis appears to be based on standard algorithms and specifications (ANSVAAMI EC38-1994).
No.
This device is an analysis workstation that processes pre-recorded ECG data; it does not provide any therapy or treatment.
Yes
The device is explicitly described as analyzing ambulatory ECG data, producing reports summarizing activity, and highlighting significant clinical events. It aids in the review and editing of automated analysis, which are all diagnostic functions.
No
The device description explicitly states that the "Workstation consists of a generally-available The Pentium® based personal computer system with an SVGA monitor, laser printer and keyboard, with optional mouse and CD-ROM drive, running Windows NT or Windows 95 and SpaceLabs Medical proprietary software." This indicates the device includes significant hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The SpaceLabs Medical Cardiology Workstation analyzes electrocardiographic (ECG) data, which is a measurement of the electrical activity of the heart. This data is collected externally from the patient's body using electrodes placed on the skin.
- Lack of biological sample analysis: The description clearly states the device analyzes "ECG waveform data" and "patient cardiac waveform data." There is no mention of analyzing biological samples.
Therefore, since the device analyzes electrical signals from the body rather than biological samples, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SpaceLabs Medical Cardiology Workstation is intended for use with the SpaceLabs Medical ECG Recorder to provide for the analysis of ambulatory ECG data. After the recording is made on the ECG Recorder. the Cardiology Workstation analyzes the ECG waveform data for the duration of the recording and produces a series of reports summarizing the overall activity on the recording and highlighting significant clinical events. The system provides for review of the automated analysis and for a qualified user to make editing changes to the automated results.
The Cardiology Workstation can also receive input from an analog-based cassette tape ambulatory recorder and an infrared serial link, as well as from the SpaceLabs PCMS monitoring network to provide for the collection. review, editing, printing and archiving of waveform data records.
Product codes
DQK, MLO
Device Description
The SpaceLabs Medical ECG Analysis System provides the means via a lightweight, portable recording device to ambulatory patient continuously continuously record electrocardioaraphic (ECG) data over a 24-hour period through a digital solid-state flash memory card for subsequent review and processing on an analysis workstation. Workstation consists of a generally-available The Pentium® based personal computer system with an SVGA monitor, laser printer and keyboard, with optional mouse and CD-ROM drive, running Windows NT or Windows 95 and SpaceLabs Medical proprietary software. The Workstation is designed to accept input from a digital flash memory card, an analog cassette tape, or via an IR Serial Link to a portable recorder. The workstation also has the capability to interface via an Ethernet link with the SpaceLabs Medical Patient Care Management System (PCMS) to offer support for the collection, review, editing, archiving and printing of patient cardiac waveform data available from a clinical network.
Workstation software provides the capability for the processing of waveform data for display, editing, and analysis, the printing of reports, and the management of patient information. 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
qualified user
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 ECG Analysis System 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. The ECG Analysis system meets the specified clinical output data requirements of the ANSVAAMI EC38-1994 specification for ambulatory electrocardiography. Standard databases have been used for automated ECG algorithm verification testing. 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
APR 25 1997
510(k) SUMMARY
SpaceLabs Medical ECG Analysis System
- SpaceLabs Medical Inc. 1. Submitter's Name 15220 N.E. 40th Street Redmond, WA 98073 Contact Person: Russ Garrison Director, Regulatory Affairs (206) 882-3913 Telephone: Facsimile: (206) 867-3550
- SpaceLabs Medical ECG Analysis System 2. Name of Device
Class II Device Classification:
Primary Classification: Programmable Diagnostic Computer: 74DQK, 21 CFR 870.1425
Secondary Classification: Ambulatory Electrocardiograph with Analysis Algorithm: 74MLO, 21 CFR 870.2800
- We consider the SpaceLabs Medical ECG Analysis Predicate Device(s) 3. System to be substantially equivalent to a combination of features offered by predicate devices, with identical intended uses.
Specifically, SpaceLabs Medical believes that the ECG Recorder component of the system is substantially equivalent to the predicate SpaceLabs Medical ECG Recorder Model 90205 (K844940), which utilizes an analog cassette tape storage system and the Zymed Model 3100 DigiTrak ECG/Pacer Recorder (K942781), which incorporates a solid state flash memory card for data storage.
Workstation component the The Cardiology of Analysis Medical ECG System િક SpaceLabs substantially equivalent to the Model 1610 Workstation (K895208) currently marketed by Zymed Corporation in that both products provide for the loading and analysis of up to 3-channel ECG data and for the review, analysis, editing, printing and archiving of ECG waveform data.
1
- The SpaceLabs Medical ECG Analysis System provides 4. Device Description the means via a lightweight, portable recording device to ambulatory patient continuously continuously record electrocardioaraphic (ECG) data over a 24-hour period through a digital solid-state flash memory card for subsequent review and processing on an analysis workstation.
Workstation consists of a generally-available The Pentium® based personal computer system with an SVGA monitor, laser printer and keyboard, with optional mouse and CD-ROM drive, running Windows NT or Windows 95 and SpaceLabs Medical proprietary software. The Workstation is designed to accept input from a digital flash memory card, an analog cassette tape, or via an IR Serial Link to a portable recorder. The workstation also has the capability to interface via an Ethernet link with the SpaceLabs Medical Patient Care Management System (PCMS) to offer support for the collection, review, editing, archiving and printing of patient cardiac waveform data available from a clinical network.
Workstation software provides the capability for the processing of waveform data for display, editing, and analysis, the printing of reports, and the management of patient information. 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.
- ട. Intended Use The SpaceLabs Medical Cardiology Workstation is intended for use with the SpaceLabs Medical ECG Recorder to provide for the analysis of ambulatory ECG data. After the recording is made on the ECG Recorder. the Cardiology Workstation analyzes the ECG waveform data for the duration of the recording and produces a series of reports summarizing the overall activity on the recording and highlighting significant clinical events. The system provides for review of the automated analysis and for a qualified user to make editing changes to the automated results.
The Cardiology Workstation can also receive input from an analog-based cassette tape ambulatory recorder and an infrared serial link, as well as from the SpaceLabs PCMS monitoring network to provide for the collection.
2
review, editing, printing and archiving of waveform data records.
-
ECG Analysis System to be ે. Comparison of We consider the substantially equivalent to systems currently marketed by Technological both SpaceLabs Medical and Zymed Corporation. Characteristics The design, components, storage technology and energy source are similar to its predicate devices.
All systems provide a means for the collection, display, review, editing, analysis, printing, and archival of patient ECG data. The only significant differences between the SpaceLabs Medical ECG Analysis System and the comparable Zymed systems are in some of the feature The Zymed Workstation sets of the two systems. provides additional capabilities for the collection of ambulatory blood pressure measurements and the 12lead reconstruction from 3 channel ambulatory. The SpaceLabs Medical Cardiology Workstation has the capability for receiving input from analog cassette ambulatory recording tapes and via an IR Serial Link or Ethernet interface in addition to digital memory cards. -
- Testing The SpaceLabs Medical ECG Analysis System 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. The ECG Analysis system meets the specified clinical output data requirements of the ANSVAAMI EC38-1994 specification for ambulatory electrocardiography. Standard databases have been used for automated ECG algorithm verification testing. 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 ECG Analysis System is as safe and effective as the predicate devices and raises no new issues.
- Testing The SpaceLabs Medical ECG Analysis System 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. The ECG Analysis system meets the specified clinical output data requirements of the ANSVAAMI EC38-1994 specification for ambulatory electrocardiography. Standard databases have been used for automated ECG algorithm verification testing. 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.