(129 days)
No
The summary describes a standard multi-parameter patient monitoring module and does not mention any AI or ML capabilities. The analysis and processing described appear to be based on traditional algorithms.
No.
The device is described as acquiring, monitoring, and processing various clinical parameters; it does not provide any therapy or treatment.
No
Explanation: The device monitors, acquires, and processes various clinical parameters and physiological data, displaying and recording them for healthcare providers. While it aids in patient monitoring, it does not interpret or diagnose conditions, which is characteristic of a diagnostic device. The analysis mentioned is for "waveform data and numeric values," not for creating a diagnosis.
No
The device is described as a "plug-in" module that connects to a monitoring station and receives physiological data via cables/sensors, indicating it is a hardware component. The summary also mentions electrical safety and electromagnetic compatibility testing, which are typically associated with hardware devices.
Based on the provided information, the Spacelabs Multi-parameter Module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations." It lists physiological parameters like ECG, respiration, blood pressure, temperature, SpO2, and cardiac output. These are all measurements taken directly from the patient's body.
- Device Description: The description reinforces that the device connects to the patient via "parameter-specific cables/sensors" to acquire "the patient's physiological data."
- Lack of In Vitro Activity: An IVD device is designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on such specimens. It directly monitors physiological signals from the living patient.
Therefore, the Spacelabs Multi-parameter Module is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
Product codes
DSI, DPZ, DQA, DSK, DXG, DXN, FLL, LOS
Device Description
The Spacelabs Multi-parameter Module provides monitoring capability for the following parameters: ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. It is a "plug-in" module that is used in conjunction with a Spacelabs Monitoring Station such as the Model 91387.
The patient is connected to the Spacelabs Multi-parameter Module via parameter-specific cables/sensors which provide the monitor with the patient's physiological data. The physiological data for each active parameter is accumulated by the Spacelabs Multi-parameter Module, and sent to the monitor which performs any necessary analysis and provides both waveform data and numeric values for display on the monitor screen. The monitor provides the display and printing capabilities for the care provider.
Setting of alarm limits, enabling or disabling alarm monitoring, and definition of alarm responses are determined on a parameter-byparameter basis, and can be defined by the user for each parameter. In general, alarm limits can be set to provide the user with both audible and visible indications of the alarm condition. Each parameter provides a hierarchy of menu structures and keys that are activated through controls of the monitor by touching the monitor screen.
Each parameter provides the capability to output recordings of selected information to a variety of recording devices. Recordings are available using the Spacelabs Monitor internal printer, network printers, and the Intesys Clinical Suite Print Manager Model 91881. Recordings can be automatically generated by each of the parameter's alarm managers or manually generated.
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
adult or neonate/infant populations
Intended User / Care Setting
any type of clinical environment other than home use.
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 Testing: The software device modifications made to the Spacelabs Multi-parameter Module were designed and developed according to a robust software development process, and were rigorously verified and validated. Test results indicate that the Spacelabs Multi-parameter Module complies with its predetermined specification.
Performance Testing - Bench: In addition to the software verification and validation performed, the software device modifications made to the Spacelabs Multi-parameter Module were testing in accordance with ANSI/AAMI EC57: 1998 / (R) 2003. Test results demonstrate performance equal to or better than the predicate device.
Clinical performance testing is not necessary to demonstrate safety and effectiveness of the Spacelabs Multi-parameter Module.
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
§ 870.1025 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
510(k) Summary
K103142
MAR - 3 2011
| Submission Date: | 17 December 2010 | ||
|---|---|---|---|
| Submitter | |||
| Correspondent: | Spacelabs Healthcare | ||
| 5150 220th Avenue SE | |||
| Issaquah, WA 98029 | |||
| Mr. David J. Geraghty | |||
| Spacelabs Healthcare | |||
| Phone: +1 (425) 657-7200, ext 5889 | |||
| Fax: +1 (425) 657-7210 | |||
| Email: david.geraghty@spacelabs.com | |||
| Application | |||
| Correspondent: | Speed To Market, Inc. | ||
| PO Box 3018 | |||
| Nederland, CO 80466 | |||
| Mr. Thomas Kroenke | |||
| Phone: +1 (303) 956-4232 | |||
| Fax: +1 (303) 642-3141 | |||
| Email: tkroenke@speedtomarket.net | |||
| Trade Name: | Spacelabs Multi-parameter Module | ||
| Common Name: | Arrhythmia Detector and Alarm | ||
| Classification Name: | Detector and Alarm, Arrhythmia | ||
| Classification | |||
| Regulation: | 21 CFR §870.1025, 21 CFR §870.2710, 21 CFR §870.2700, | ||
| 21 CFR §870.1110, 21 CFR §870.1435, 21 CFR §870.1130, | |||
| 21 CFR §880.2910, 21 CFR | |||
| Product Code: | DSI, DPZ, DQA, | ||
| DSK, DXG, DXN, | |||
| FLL, LOS | |||
| Substantially | |||
| Equivalent Devices: | New Spacelabs Model | Predicate 510(k) | |
| Number | Predicate | ||
| Manufacturer / Model | |||
| Spacelabs Multi-parameter | |||
| Module | K050605 | Spacelabs Medical Inc. / | |
| Spacelabs Medical Multi- | |||
| parameter, Module 91496 |
1
The Spacelabs Multi-parameter Module provides monitoring capability for the following parameters: ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. It is a "plug-in" module that is used in conjunction with a Spacelabs Monitoring Station such as the Model 91387.
The patient is connected to the Spacelabs Multi-parameter Module via parameter-specific cables/sensors which provide the monitor with the patient's physiological data. The physiological data for each active parameter is accumulated by the Spacelabs Multi-parameter Module, and sent to the monitor which performs any necessary analysis and provides both waveform data and numeric values for display on the monitor screen. The monitor provides the display and printing capabilities for the care provider.
Setting of alarm limits, enabling or disabling alarm monitoring, and definition of alarm responses are determined on a parameter-byparameter basis, and can be defined by the user for each parameter. In general, alarm limits can be set to provide the user with both audible and visible indications of the alarm condition. Each parameter provides a hierarchy of menu structures and keys that are activated through controls of the monitor by touching the monitor screen.
Each parameter provides the capability to output recordings of selected information to a variety of recording devices. Recordings are available using the Spacelabs Monitor internal printer, network printers, and the Intesys Clinical Suite Print Manager Model 91881. Recordings can be automatically generated by each of the parameter's alarm managers or manually generated.
The Spacelabs Multi-parameter Module utilizes the same technology for each parameter as utilized by the predicate device.
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
K103142 Page 2 of 4
Technology Comparison:
Intended Use:
2
Performance Testing:
| Sterilization and
Shelf-Life | The Spacelabs Multi-parameter Module is not sterilized or sterilizable
by the user.
Accessories which may be sterilized or sterilizable by the user were not
affected by the software device modifications made to the Spacelabs
Multi-parameter Module. Therefore, this section is not applicable. |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The Spacelabs Multi-parameter Module is not intended to directly or
indirectly contact the patient.
Accessories which may directly or indirectly contact the patient were
not affected by the software device modifications made to the
Spacelabs Multi-parameter Module. Therefore, this section is not
applicable. |
| Software Testing | The software device modifications made to the Spacelabs Multi-
parameter Module were designed and developed according to a robust
software development process, and were rigorously verified and
validated.
Software information is provided in accordance with:
FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05; and FDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02. Test results indicate that the Spacelabs Multi-parameter Module
complies with its predetermined specification. |
| Electrical Safety and
Electromagnetic
Compatibility Testing | The software device modifications made to the Spacelabs Multi-
parameter Module did not affect the electrical safety or electromagnetic
compatibility performance of the device. No hardware modifications
were made to the device; therefore this section is not applicable. |
| Performance Testing
- Bench | In addition to the software verification and validation performed, the
software device modifications made to the Spacelabs Multi-parameter
Module were testing in accordance with ANSI/AAMI EC57: 1998 / (R)
- Test results demonstrate performance equal to or better than the
predicate device. |
| Performance Testing
– Animal: | Animal performance testing is not necessary to demonstrate safety and
effectiveness of the Spacelabs Multi-parameter Module. Therefore, this
section is not applicable. |
| Performance Testing
- Clinical: | Clinical performance testing is not necessary to demonstrate safety and
effectiveness of the Spacelabs Multi-parameter Module. Therefore, this
section is not applicable. |
K103142 Page 3 of 4
. . . . .
3
Conclusion
Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the Spacelabs Multi-parameter Module. The results of these activities demonstrate that the Spacelabs Multiparameter Module is safe and effective when used in accordance with its intended use and labeling.
Therefore, the Spacelabs Multi-parameter Module is considered substantially equivalent to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the circumference. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spacelabs Healthcare Inc. c/o Mr. Thomas Kroenke Speed To Market, Inc PO Box 3018 Nederland, CO 80466
MAR - 3 2011
Re: K103142
Trade/Device Name: Spacelabs Multi-parameter Module Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: DSI, DQA, DSK, DXG, DXG, DXN, FLL Dated: February 7, 2011 Received: February 10, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - Mr. Thomas Kroenke
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 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 (QS) 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,
27 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
510(k) Number (if known):
Device Name:
Indications for Use:
Spacelabs Multi-parameter Module
K 103142
The Spacelabs Multi-parameter Module is intended for use with
the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
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)
510(k) Number V
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) 3/3/204
Division of Cardiovascular Devices