(54 days)
Not Found
No
The document describes a standard multiparameter patient monitoring module that acquires and processes physiological data. There is no mention of AI, ML, or any advanced analytical techniques beyond basic signal processing and data communication. The validation focuses on compliance with standards and software development processes, not on performance metrics typically associated with AI/ML algorithms.
No
The device is intended for acquiring, monitoring, and processing various clinical parameters, which are diagnostic and monitoring functions, not therapeutic interventions.
No
The device is described as a multiparameter module intended to acquire, monitor, and process various clinical parameters, and communicate that data to a network or display for analysis. While it provides "data of interest" and highlights "abnormalities," it acts as a data acquisition and monitoring system, not a device that directly provides a diagnosis or interprets the data for diagnostic purposes. The statement "Acquired data may then be communicated to an information network for display, recording, editing and analysis" further supports its role as a data provider rather than a diagnostic tool.
No
The device description explicitly states it is a "slim, lightweight singular modular unit" and the "primary interface to the patient being monitored," indicating it is a physical hardware device that acquires and processes physiological data.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). The description clearly states the device acquires and processes physiological data from the patient, either externally or invasively into the bloodstream. This is in vivo monitoring (within the living body).
- The parameters monitored are physiological measurements. ECG, respiration, blood pressure, temperature, SpO2, and cardiac output are all direct measurements of bodily functions, not analyses of samples like blood, urine, or tissue.
- The intended use is monitoring. The primary function is to acquire, monitor, and process these physiological parameters for display and analysis, not to perform diagnostic tests on samples.
Therefore, the Spacelabs Medical Multiparameter Module 91496 is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Spacelabs Medical Multiparameter Module 91496 is intended for use with the PCMS to acquire, monitor and process various clinical parameters from adult or neonatal/infant populations in any type of clinical environment other than home use. Physiologic parameters that may be monitored include cardiac activity, 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.
Indications for Use: Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (SpO2) readings. Prescription use only. Yes. Caution statement is provided in the introductory page of the Patient Care Management System which includes the operating instructions for this Module.
Physiological purpose. In conjunction with clinical findings, a screening and diagnostic tool for use in: assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations; monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea; continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure; episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure; continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature; monitoring of the patient’s pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.
Product codes
DQA, DPZ, DSI, LOS, DXN, DSK, DXG and FLL
Device Description
The Spacelabs Medical Multiparameter Module 91496 with Option M is a slim, lightweight singular modular unit that, when used in conjunction with a Spacelabs Medical Patient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting.
The Module 91496 is the primary interface to the patient being monitored. The Module 91496 is capable of acquiring and processing ECG, respiration, invasive and noninvasive blood pressure, temperature, cardiac output and SpO2 parameters for a single patient. The Module 91496 accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical PCMS monitor via SDLC communications. The PCMS monitor will provide the display capabilities for the care provider.
Option M utilizes Masimo SET oximetry and sensors and SET-compatible adapter cables.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Specific to the physiologic parameter being monitored, accessories may be applied externally to the chest and limbs or invasively into the blood stream.
Indicated Patient Age Range
adult or neonatal/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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Module 91496 was validated through rigorous testing that, in part, supports the compliance of the Module 91496 to applicable standards. Additionally, the software for the Module 91496 was developed following a robust software development process and was fully specified and validated. Safety testing has been performed by third party agencies to ensure the device complies with applicable industry and safety standards.
The Module 91496 is substantially equivalent to its predicate devices in design concepts, technologies, materials and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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KO50605
Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496 with SpO₂ Option M 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.
| Date: | March 10, 2005 |
|---|---|
| Submitter: | Spacelabs Medical, Inc. |
| 5150 220 th Avenue SE | |
| Issaquah, WA 98029 | |
| Mr. Al Van Houdt | |
| 1 425 657 7200, x5970 | |
| 1 425 657 7210 (FAX) | |
| Al.VanHoudt@slmd.com | |
| Proprietary | |
| Name: | Spacelabs Medical Multiparameter Module 91496 (with SpO2 Option M) |
| Common Name | |
| and | |
| Classification: | Arrhythmia Detector and Alarm |
| 74DSI, §870.1025, Class II | |
| Noninvasive Blood Pressure Measurement System | |
| 74DXN, §870.1130, Class II | |
| Oximeter | |
| 74DQA, §870.2700, Class II | |
| Blood Pressure Computer | |
| 74DSK, §870.1110, Class II | |
| Clinical Electronic Thermometer | |
| 80BWX, §880.2910, Class II | |
| Thermal Cardiac Output Monitor | |
| 74KFN, §870.1435, Class II | |
| Predicate | |
| Devices: | K051175: Spacelabs Medical Integrated Multiparameter Module 91496 with Option N |
| (Nellcor SpO2 oximetry) | |
| K972502: Spacelabs Medical Integrated Multiparameter Module 90496 | |
| K033296: Masimo Corp. SET Rad-5 Pulse Oximeter |
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Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496 with SpO₂ Option M 510(k) Summary
| Device
Description: | The Spacelabs Medical Multiparameter Module 91496 with Option M is a slim,
lightweight singular modular unit that, when used in conjunction with a Spacelabs
Medical Patient Care Management System (PCMS), provides the capability to acquire
various common physiologic data in a clinical setting. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Module 91496 is the primary interface to the patient being monitored. The Module
91496 is capable of acquiring and processing ECG, respiration, invasive and
noninvasive blood pressure, temperature, cardiac output and SpO2 parameters for a
single patient. The Module 91496 accumulates the patient physiological data of
interest and provides both waveform and digital data to a Spacelabs Medical PCMS
monitor via SDLC communications. The PCMS monitor will provide the display
capabilities for the care provider. |
| | Option M utilizes Masimo SET oximetry and sensors and SET-compatible adapter
cables. |
| Intended Use: | The Spacelabs Medical Multiparameter Module 91496 is intended for use with the
PCMS to acquire, monitor and process various clinical parameters from adult or
neonatal/infant populations in any type of clinical environment other than home use.
Physiologic parameters that may be monitored include cardiac activity, 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. |
| Comparison of
Technological
Characteristics: | The Spacelabs Medical Multiparameter Module 91496 with Option M is substantially
equivalent to the Spacelabs Medical Multiparameter Module 90496 (with Option U)
and Module 91496 (with Option N) in design concepts, technologies, materials and
intended use, and to the Masimo SET Rad-5 Oximeter with regard to SpO2 analysis. |
| Test Discussion: | The Module 91496 was validated through rigorous testing that, in part, supports the
compliance of the Module 91496 to applicable standards. Additionally, the software for
the Module 91496 was developed following a robust software development process
and was fully specified and validated. Safety testing has been performed by third
party agencies to ensure the device complies with applicable industry and safety
standards. |
| Testing
Conclusion: | The Module 91496 is substantially equivalent to its predicate devices in design
concepts, technologies, materials and intended use. |
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird with three stylized wing-like shapes.
MAY - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Al Van Houdt Director, Regulatory Affairs and Quality Spacelabs Medical, Incorporated 5150 220th Avenue Street P.O. Box 7018 Issaquah, Washington 98027-7018
Re: K050605
Trade/Device Name: Spacelabs Medical Multiparameter Module 91496 with Option M Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ, DSI, LOS, DXN, DSK, DXG and FLL Dated: April 14, 2005 Received: April 15, 2005
Dear Mr. Houdt:
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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls 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 such additional controls. Existing major regulations affecting (1 Writ), it may of basyse 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.
3
Page 2 - Mr. Houdt
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylvie H. McMain Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496, SpO2 Option M
1.4 Indications for Use
K 050605 510(k) Number (if known): Spacelabs Medical Multiparameter Module 91496 with Option M Device Name: Conditions to be screened, monitored, treated or diagnosed. Indications for Use: Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (SpO2) readings. Prescription use only. Yes. Caution statement is provided in the introductory page of the Patient Care Management System which includes the operating instructions for this Module. Parts of body applied to. Specific to the physiologic parameter being monitored, accessories may be applied externally to the chest and limbs or invasively into the blood stream. Frequency of use. Frequency as directed by physician. Physiological purpose. In conjunction with clinical findings, a screening and diagnostic tool for use in: assessing electrical activity of the heart in order to detect abnormal . cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations; monitoring respiratory effort to detect abnormal respiration events . such as high and low respiration rates and episodes of apnea; continuous monitoring of invasive pressure signals to detect . abnormal events such as high and low pressure; episodic monitoring of noninvasive pressure signals to detect . abnormal events such as high and low pressure; continuous monitoring of temperature signals to detect abnormal . events such as high and low body temperature; monitoring of the patient's pumping ability of the heart and various . hemodynamic values to detect abnormal flow volumes; and
noninvasive, continuous monitoring of pulse oxygen saturation . signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.
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Spacelabs Medical, Inc. Special 510(k) Multiparameter Module 91496, SpO2 Option M
X Prescription Use (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)
Ruuysion
(Division Sign-Off) (Division Sign-Om)
Division of Anesthesiology, General Hospital, Infaction Control. Dental
510(k) Number. K0506
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