(99 days)
Not Found
No
The description focuses on the device's function as a passive display, data communication, and alarm notification system. There is no mention of algorithms that learn or make predictions based on data, which are characteristic of AI/ML. The changes described are hardware and operating system updates.
No
The device is described as a monitor that passively displays patient data and sounds alarms, not one that delivers therapy.
No
Explanation: The device passively displays data generated from other modules and functions as a generic display or computer terminal to monitor patient parameters. It does not generate a diagnosis itself; rather, it presents information to a clinician.
No
The device description explicitly states that different microcomputer processor hardware was incorporated into the modified design, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is a patient monitor for displaying patient parameters in a hospital environment. It passively displays data generated from other medical devices.
- Device Description: The device description reinforces that it's a patient monitor that displays data and can function as a generic display or computer terminal.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests or analyze biological samples. It simply displays data from other devices that may be measuring physiological parameters.
The device is a patient monitor, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
PC1 Monitor - The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
Universal Clinical Workstation (UCW) - The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
PC Scout Monitor - The PC Scout is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
General Spacelabs Medical PCIS Patient Monitor Intended Use Statement
Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow networkbased applications to open windows and display information on other networked monitors.
PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules.
In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission .. Through this network, a patient's data may be displayed at the bedside monitor, central station or a clinical information system.
Product codes (comma separated list FDA assigned to the subject device)
74DSI
Device Description
Spacelabs Medical PCIS patient monitors (code name "Viper") passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network- based applications to open windows and display information on other networked monitors.
The modifications to the Spacelabs Medical PCIS patient monitor design specified in this submission incorporate performance and functional enhancements. More specifically, different microcomputer processor hardware was incorporated into the modified design. In addition, the executive software has been changed to VxWorks, thereby requiring a significant change/conversion from the existing platform.
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
hospital environment
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 modified Spacelabs Medical PCIS Patient Monitors shall be subject to extensive safety and performance testing prior to release. Final testing for the system shall includes various performance tests designed to ensure that the device will meet all of its functional requirements and performance specifications. Safety and standards testing are to be performed by third party agencies 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
§ 870.1025 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.
0
K972282
SEP 2 5 1997
510(k) SUMMARY
Modified Spacelabs Medical PCIS Patient Monitors
| 1. Submitter's Name
Telephone:
Facsimile: | Russ Garrison
Spacelabs Medical Inc.
15220 N.E. 40th Street
Redmond, WA 98073
(425) 882-3913
(425) 867-3550 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device | Spacelabs Medical PCIS Patient Monitors |
| Classification: | Arrhythmia Detector and Alarm, 74DSI; 870.1025 (Class III) |
| 3. Predicate Device(s) | The Spacelabs Medical PCIS Patient Monitors are substantially equivalent to the PCIS patient monitors marketed by Spacelabs Medical, Inc. |
| | The PC1 Patient Monitor is marketed under K842616B. The Universal Clinical Workstation (UCW) is marketed under K932734. The PC Scout is a portable bedside monitor marketed under K930095. |
| 4. Device Description | Spacelabs Medical PCIS patient monitors (code name "Viper") passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network- based applications to open windows and display information on other networked monitors. |
| | The modifications to the Spacelabs Medical PCIS patient monitor design specified in this submission incorporate performance and functional enhancements. More specifically, different microcomputer processor hardware was incorporated into the modified design. In addition, the executive software has been changed to VxWorks, thereby requiring a significant change/conversion from the existing platform. |
| 5. Intended Use | The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical. |
| | The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters |
1
currently available through Spacelabs Medical.
The PC Scout Monitor is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
General Spacelabs Medical PCIS Patient Monitor Intended Uses
Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network-based applications to open windows and display information on other networked monitors.
- · PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated: (b) the alarm priority (i.e. high, medium or low); (c) alarm limits: and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules.
In all applications. Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission.. Through this network, a patient's data may be displayed at the bedside monitor, central station or a clinical information system.
- Comparison of We consider the devices to be substantially equivalent to the ర్. Spacelabs Medical PCIS Patient Monitors currently marketed by Technological Spacelabs Medical Inc. The design, components used in the modified Characteristics Spacelabs Medical PCIS Patient Monitors, and energy source are similar to its predicate devices.
- The modified Spacelabs Medical PCIS Patient Monitors shall be 7. Testing subject to extensive safety and performance testing prior to release. Final testing for the system shall includes various performance tests designed to ensure that the device will meet all of its functional requirements and performance specifications. Safety and standards testing are to be performed by third party agencies to ensure the system complies to applicable industry and safety standards.
In conclusion, the modified Spacelabs Medical PCIS Patient Monitors are as safe and effective as the predicate devices and raises no new issues.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 1997
Mr. Russ Garrison Spacelabs Medical, Inc. 15220 N.E. 40th Street P.O. Box 97013 Redmond, Washington 98073-9713
Re: K972282 Spacelabs Medical PCIS Patient Monitors Regulatory Class: III (three) Product Code: 74 DSI Dated: September 15, 1997 Received: September 17, 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 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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.
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 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, "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. 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
4
PREMARKET NOTIFICATION
Spacelabs Medical PCIS Patient Monitors
INDICATIONS FOR USE
510(k) Number: Pending
Spacelabs Medical PCIS Patient Monitors Device Name:
Indications for Use:
PC1 Monitor - The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
Universal Clinical Workstation (UCW) - The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
PC Scout Monitor - The PC Scout is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical.
General Spacelabs Medical PCIS Patient Monitor Intended Use Statement
Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow networkbased applications to open windows and display information on other networked monitors.
PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules.
In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission .. Through this network, a patient's data may be displayed at the bedside monitor, central station or a clinical information system.
Arth A. Codd
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K972282