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.

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.

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.

AI/ML Overview

This 510(k) summary does not contain the level of detail necessary to answer all sections of your request comprehensively. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a new clinical study with specific acceptance criteria, sample sizes, and expert adjudications.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. The "Test Discussion" states that the device was "validated through rigorous testing that, in part, supports the compliance of the Module 91496 to applicable standards." However, it does not specify what those standards are or what performance thresholds were met.

For the SpO2 component, it claims "The Spacelabs Medical Multiparameter Module 91496 with Option M is...substantially equivalent...to the Masimo SET Rad-5 Oximeter with regard to SpO2 analysis." This implies that the performance of the SpO2 Option M is considered acceptable if it matches that of the predicate Masimo SET Rad-5 Oximeter.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The general statement "validated through rigorous testing" does not include details on sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. Given that this is a hardware device for monitoring physiological parameters, the "ground truth" would likely come from established medical testing methods or reference devices, not necessarily expert consensus on interpretations of images/signals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this submission. The device is a "Multiparameter Module 91496 with SpO₂ Option M" which is a physiological monitoring device, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance for human readers would not be performed for this type of medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A "standalone" performance study in the context of an algorithm's classification or diagnostic ability is not directly applicable here. The device itself is a standalone monitoring unit that acquires and processes physiological data. Its performance would be evaluated based on the accuracy and reliability of its measurements compared to reference standards. The document states it was "validated through rigorous testing" and that "the software for the Module 91496 was developed following a robust software development process and was fully specified and validated," suggesting that the device's inherent performance was tested. However, specific details of this "standalone" performance (in terms of metrics like sensitivity, specificity, accuracy for a classification task) are not provided, as its function is primarily measurement rather than a diagnostic classification by an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the specific type of ground truth used. For physiological monitoring devices like this, ground truth would typically be established by:

Reference standard devices: Comparing the device's measurements (ECG, NIBP, SpO2, etc.) to highly accurate, calibrated reference instruments.
Physical simulators/phantoms: For some tests, artificial signals or physical models simulating human physiology might be used.
Clinical observation/measurements: For some parameters, direct clinical measurements might serve as a reference.

8. The sample size for the training set

This information is not provided. As this is a hardware device with embedded software for signal processing and measurement, it's unlikely to have a "training set" in the sense of modern machine learning algorithms that learn from vast datasets. The software development process likely involved traditional engineering validation and verification using test data, not a "training set" for an AI model.

9. How the ground truth for the training set was established

This information is not provided and is likely not applicable given the nature of the device (see point 8).

Summary

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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 SEIssaquah, WA 98029
	Mr. Al Van Houdt1 425 657 7200, x59701 425 657 7210 (FAX)Al.VanHoudt@slmd.com
ProprietaryName:	Spacelabs Medical Multiparameter Module 91496 (with SpO2 Option M)
Common NameandClassification:	Arrhythmia Detector and Alarm74DSI, §870.1025, Class II
	Noninvasive Blood Pressure Measurement System74DXN, §870.1130, Class II
	Oximeter74DQA, §870.2700, Class II
	Blood Pressure Computer74DSK, §870.1110, Class II
	Clinical Electronic Thermometer80BWX, §880.2910, Class II
	Thermal Cardiac Output Monitor74KFN, §870.1435, Class II
PredicateDevices:	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

DeviceDescription:	The Spacelabs Medical Multiparameter Module 91496 with Option M is a slim,lightweight singular modular unit that, when used in conjunction with a SpacelabsMedical Patient Care Management System (PCMS), provides the capability to acquirevarious common physiologic data in a clinical setting.
	The Module 91496 is the primary interface to the patient being monitored. The Module91496 is capable of acquiring and processing ECG, respiration, invasive andnoninvasive blood pressure, temperature, cardiac output and SpO2 parameters for asingle patient. The Module 91496 accumulates the patient physiological data ofinterest and provides both waveform and digital data to a Spacelabs Medical PCMSmonitor via SDLC communications. The PCMS monitor will provide the displaycapabilities for the care provider.
	Option M utilizes Masimo SET oximetry and sensors and SET-compatible adaptercables.
Intended Use:	The Spacelabs Medical Multiparameter Module 91496 is intended for use with thePCMS to acquire, monitor and process various clinical parameters from adult orneonatal/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), andcardiac output. Acquired data may then be communicated to an information networkfor display, recording, editing and analysis.
Comparison ofTechnologicalCharacteristics:	The Spacelabs Medical Multiparameter Module 91496 with Option M is substantiallyequivalent to the Spacelabs Medical Multiparameter Module 90496 (with Option U)and Module 91496 (with Option N) in design concepts, technologies, materials andintended 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 thecompliance of the Module 91496 to applicable standards. Additionally, the software forthe Module 91496 was developed following a robust software development processand was fully specified and validated. Safety testing has been performed by thirdparty agencies to ensure the device complies with applicable industry and safetystandards.
TestingConclusion:	The Module 91496 is substantially equivalent to its predicate devices in designconcepts, 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.

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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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Regulation Number and Section

§ 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.