(29 days)
Not Found
No
The summary describes a passive display device that receives and displays data and alarms from other modules. There is no mention of AI or ML being used for data analysis, interpretation, or decision-making within the Qube itself. The alarm conditions are determined by the parameter modules, not the Qube.
No
The device is described as a monitor that passively displays data and alerts alarms; it does not explicitly state that it provides therapy or treatment.
Yes
The device passively displays data, trends, and alarms generated by other parameter modules, which perform the actual monitoring and determination of alarm conditions. It functions as a display and alert system for information already generated by other devices.
No
The device description explicitly states it is a "component of the Spacelabs Medical Patient Monitoring System" and describes it as a "monitor" that accepts and displays data. The performance studies also include electrical safety and electromagnetic compatibility testing, which are typically associated with hardware components, not software-only devices.
Based on the provided text, the Spacelabs Healthcare Qube Compact Monitor (91390) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Qube's Function: The text clearly states the Qube's primary function is to "passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms." It displays physiological parameters measured directly from the patient (ECG, respiration, blood pressure, SpO2, temperature, cardiac output).
- No Specimen Analysis: There is no mention of the Qube analyzing any biological specimens. It receives and displays data from other devices that are performing the measurements on the patient.
Therefore, the Qube acts as a display and communication hub for patient monitoring data, not a device that performs in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.
The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.
The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.
The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
The Spacelabs Spacelabs Healthcare Qube Compact Monitor (91390) (Qube) is a component of the Spacelabs Medical Patient Monitoring System. The monitor accepts and displays parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules as its predicate, the Spacelabs Medical Model 91370 Patient Monitor.
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
intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a 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)
Software Validation: The Qube software was tested for performance in accordance with internal requirements and the following Standard: IEC 60601-1-4: 1996, Aml: 1999, Medical electrical equipment, Part 1-4 – Collateral Standard: Programmable electrical medical systems. Test results indicated that the Qube software complies with its predetermined specification and with the applicable Standards.
Electrical Safety Testing: The Qube was tested for performance in accordance with the following Standard: IEC 60601-1: 1988, Aml: 1991, and Am2: 1995, Medical electrical equipment, Part 1: Particular requirements for safety. Test results indicated that the Qube complies with the Standards.
Electromagnetic Compatibility Testing: The Qube was tested for performance in accordance with the following Standard: IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. Test results indicated that the Qube complies with the Standards.
Performance Testing: The Qube was tested for performance in accordance with internal requirements and the following Standard: IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability. IEC 60601-1-8: 2006, Medical electrical equipment – General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. IEC 62366: 2007, Medical devices - Application of usability engineering to medical devices. ISTA Procedure 1A, Non-simulation integrity performance test procedure - Packaged-products under 150 lb (68 kg). Test results indicated that the Qube complies with its predetermined specification and with the applicable Standards.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the Qube. The results of these activities demonstrate that the Qube is safe and effective when used in accordance with its intended use and labeling. Therefore, the Qube is considered substantially equivalent to the predicate device.
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
K120616
MAR 2 9 2012
510(k) Premarket Notification Spacelabs Healthcare Qube Compact Monitor (91390) 510(k) Summary
| Submission Date: | 24 February 2012 | |||
|---|---|---|---|---|
| Submitter: | Spacelabs Medical, Inc. | |||
| 5150 220th Avenue SE | ||||
| Issaquah, WA 98029 USA | ||||
| Submitter Contact: | Mr. Al Van Houdt | |||
| Spacelabs Medical, Inc. | ||||
| Phone: +1 (425) 657-7200, ext 5970 | ||||
| Fax: +1 (425) 657-7210 | ||||
| Email: al.vanhoudt@spacelabs.com | ||||
| Official Contact: | Thomas Kroenke | |||
| Principal Consultant | ||||
| Speed To Market, Inc. | ||||
| PO Box 3018 | ||||
| Nederland, CO 80466 USA | ||||
| tkroenke@speedtomarket.net | ||||
| 303 956 4232 | ||||
| Manufacturing Site: | Spacelabs Medical, Inc. | |||
| 5150 220th Avenue SE | ||||
| Issaquah, WA 98029 USA | ||||
| Trade Name: | Spacelabs Healthcare Qube Compact Monitor (91390) | |||
| Common Name: | Monitor, physiological, patient (with arrhythmia detection or alarms) | |||
| Classification Name: | Monitor, physiological, patient (with arrhythmia detection or alarms) | |||
| Classification | ||||
| Regulation: | 21 CFR §870.1025 | |||
| Product Code: | MHX | |||
| Substantially | ||||
| Equivalent Devices: | New Spacelabs Model | Predicate | ||
| 510(k) Number | Predicate | |||
| Manufacturer / Model | ||||
| Spacelabs Healthcare | ||||
| Qube Compact Monitor | ||||
| (91390) | K102422 | Spacelabs Medical | ||
| Patient Monitors, | ||||
| Models 91367, 91369, | ||||
| 91370, 91388 |
Page 1 of 4
1
510(k) Premarket Notification Spacelabs Healthcare Qube Compact Monitor (91390) 510(k) Summarv
Device Description: The Spacelabs Spacelabs Healthcare Qube Compact Monitor (91390) (Qube) is a component of the Spacelabs Medical Patient Monitoring System. The monitor accepts and displays parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules as its predicate, the Spacelabs Medical Model 91370 Patient Monitor.
The Spacelabs Healthcare Qube Compact Monitor (91390), functioning Intended Use: as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.
The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.
The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.
The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
2
510(k) Premarket Notification Spacelabs Healthcare Qube Compact Monitor (91390) 510(k) Summary
Technology Comparison:
The Qube employs the same technological characteristics as the predicate device.
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Bedside, Transport or | ||
| Central Station | Bedside/ Transport | Bedside/ Transport / |
| Central Station | ||
| Maximum Parameter | ||
| Capacity | 18 | Same |
| Number of Internal | ||
| Module Slots | 1 | Same |
| Maximum Number of | ||
| Remote Module Housings | ||
| Slots | 1 | Same |
| User Interface Methods | Touchscreen, Keyboard, | |
| Mouse, Remote Keyboard | Same | |
| Bedside Monitor (Visible | ||
| waveforms) | 4 - 6 | Same |
| Display Technology | Color TFT-LCD | Same |
Summary of Performance Testing:
| Software Validation | The Qube software was tested for performance in accordance with internal requirements and the following Standard: | |
|---|---|---|
| • | IEC 60601-1-4: 1996, Aml: 1999, Medical electrical equipment, Part 1-4 – Collateral Standard: Programmable electrical medical systems. | |
| Test results indicated that the Qube software complies with its predetermined specification and with the applicable Standards. | ||
| Electrical Safety Testing | The Qube was tested for performance in accordance with the following Standard: | |
| • | IEC 60601-1: 1988, Aml: 1991, and Am2: 1995, Medical electrical equipment, Part 1: Particular requirements for safety. | |
| Test results indicated that the Qube complies with the Standards. |
3
510(k) Premarket Notification Spacelabs Healthcare Qube Compact Monitor (91390) 510(k) Summary
| Electromagnetic
Compatibility
Testing | The Qube was tested for performance in accordance with the following
Standard: |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements
and tests. |
| | Test results indicated that the Qube complies with the Standards. |
| Performance Testing | The Qube was tested for performance in accordance with internal
requirements and the following Standard: |
| | • IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6:
General requirements for basic safety and essential performance –
Collateral standard: Usability. |
| | • IEC 60601-1-8: 2006, Medical electrical equipment – General
requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems. |
| | • IEC 62366: 2007, Medical devices - Application of usability
engineering to medical devices. |
| | • ISTA Procedure 1A, Non-simulation integrity performance test
procedure - Packaged-products under 150 lb (68 kg). |
| | Test results indicated that the Qube complies with its predetermined
specification and with the applicable Standards. |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics of the device modifications
made to the Qube. The results of these activities demonstrate that the
Qube is safe and effective when used in accordance with its intended
use and labeling. |
| | Therefore, the Qube is considered substantially equivalent to the
predicate device. |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 9 2012
Spacelabs Medical, Inc. c/o Mr. Thomas Kroenke Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466
Re: K120616
Trade/Device Name: Spacelabs Healthcare Qube Compact Monitor (91390) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement
and alarm)
Regulatory Class: Class II (two) Product Codes: MHX Dated: February 24, 2012 Received: February 29, 2012
Dear Mr. Kroenke:
We.have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
5
Page 2 - Spacelabs Medical, Inc. c/o Mr. Thomas Kroenke
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K 120616
510(k) Number (if known):
Device Name:
Indications for Use:
Spacelabs Healthcare Qube Compact Monitor (91390)
The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.
The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.
The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.
The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| ্ | and the commend of the comments of the comments of the country of the country of the country of the first of the first of the first of the first of the first of the first of |
on of Cardiovascular I
510(k) Number K120616
Page 1 of 1