SPACELABS MULTI-PARAMETER MODULE by SPACELABS HEALTHCARE, INC.

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.

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.

The Spacelabs Multi-parameter Module utilizes the same technology for each parameter as utilized by the predicate device.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:

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

Acceptance Criteria Category	Reported Device Performance	Comments
Sterilization & Shelf-Life	Not applicable	Device is not sterilized or sterilizable by the user. Software modifications did not affect accessories that are.
Biocompatibility	Not applicable	Device is not intended for direct or indirect patient contact. Software modifications did not affect accessories that are.
Software Testing	Complies with predetermined specifications	Designed and developed according to a robust software development process; rigorously verified and validated. Complies with FDA guidance for software in medical devices.
Electrical Safety & Electromagnetic Compatibility	Not applicable	Software modifications did not affect these aspects; no hardware modifications were made.
Performance Testing - Bench	Performance equal to or better than the predicate device	Tested in accordance with ANSI/AAMI EC57: 1998 / (R) 2003, in addition to software verification and validation.
Performance Testing - Animal	Not applicable	Not necessary to demonstrate safety and effectiveness.
Performance Testing - Clinical	Not applicable	Not necessary to demonstrate safety and effectiveness.

2. Sample size used for the test set and the data provenance:

The document does not specify a numerical sample size for a dedicated "test set" in the context of clinical or large-scale data evaluation.
The performance testing primarily focuses on software verification and validation and bench testing against a standard (ANSI/AAMI EC57: 1998 / (R) 2003) and comparison to a predicate device. This suggests internal testing and adherence to engineering standards rather than external data-driven validation.
Data provenance is not explicitly mentioned as no clinical or animal performance testing was deemed necessary. The evaluation seems to be based on engineering benchmarks and comparisons to the predicate device's established performance.

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 submission. Given that clinical and animal testing were deemed not applicable, and the focus was on software and bench testing, expert review for ground truth on patient data (such as for arrhythmia detection accuracy) is not described.

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

This information is not provided. As clinical and animal testing were not performed, and no external expert review of patient cases is described, an adjudication method for a test set is not detailed.

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:

No MRMC comparative effectiveness study was performed or described. The device is a multi-parameter module that includes arrhythmia detection, which is typically an algorithmic function, not a human-in-the-loop AI assistance tool that would necessitate an MRMC study. The comparison is between the modified device and its predicate, based on technical performance.

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

Yes, in essence. The "Software Testing" and "Performance Testing - Bench" sections evaluate the device's inherent performance. The arrhythmia detection component would inherently be a standalone algorithmic function within the module. The document states:
- "Test results indicate that the Spacelabs Multi-parameter Module complies with its predetermined specification." (Software Testing)
- "Test results demonstrate performance equal to or better than the predicate device." (Performance Testing - Bench, which includes testing in accordance with ANSI/AAMI EC57 for ECG/arrhythmia).
These statements imply that the algorithm's performance was evaluated in isolation to ensure it met its defined specifications and performed comparably to the predicate device.

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

For the software and bench testing, the "ground truth" would be the expected output or reference standard defined by the product's specifications and the requirements of standards like ANSI/AAMI EC57. For instance, in arrhythmia detection, this would involve synthetic ECG signals with known arrhythmias, or recorded physiological data where arrhythmias have been definitively identified by established methods (though specifics of how this ground truth was established for the test data are not detailed in this summary). The comparison to the predicate device also implies its established performance serves as a benchmark for "ground truth."

8. The sample size for the training set:

This information is not provided. The submission details modifications to an existing device rather than the development of a novel algorithm that would typically involve a distinct "training set." The software development process mentioned implies iterative testing and refinement, but specifics of data used for internal training are not disclosed.

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

As a "training set" is not explicitly mentioned, the method for establishing its ground truth is not described. For an algorithmic component like arrhythmia detection, initial development (training) would likely involve a combination of expert-annotated ECG waveforms (synthetic or recorded) and adherence to physiological principles. However, the 510(k) focuses on the modifications' verification and validation against existing standards and the predicate, not the original algorithm's development.

Summary

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510(k) Summary

K103142
MAR - 3 2011

Submission Date:	17 December 2010
SubmitterCorrespondent:	Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029Mr. David J. GeraghtySpacelabs HealthcarePhone: +1 (425) 657-7200, ext 5889Fax: +1 (425) 657-7210Email: david.geraghty@spacelabs.com
ApplicationCorrespondent:	Speed To Market, Inc.PO Box 3018Nederland, CO 80466Mr. Thomas KroenkePhone: +1 (303) 956-4232Fax: +1 (303) 642-3141Email: tkroenke@speedtomarket.net
Trade Name:	Spacelabs Multi-parameter Module
Common Name:	Arrhythmia Detector and Alarm
Classification Name:	Detector and Alarm, Arrhythmia
ClassificationRegulation:	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
SubstantiallyEquivalent Devices:	New Spacelabs Model	Predicate 510(k)Number	PredicateManufacturer / Model
	Spacelabs Multi-parameterModule	K050605	Spacelabs Medical Inc. /Spacelabs Medical Multi-parameter, Module 91496

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The Spacelabs Multi-parameter Module utilizes the same technology for each parameter as utilized by the predicate device.

K103142 Page 2 of 4

Technology Comparison:

Intended Use:

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Performance Testing:

Sterilization andShelf-Life	The Spacelabs Multi-parameter Module is not sterilized or sterilizableby the user.Accessories which may be sterilized or sterilizable by the user were notaffected by the software device modifications made to the SpacelabsMulti-parameter Module. Therefore, this section is not applicable.
Biocompatibility	The Spacelabs Multi-parameter Module is not intended to directly orindirectly contact the patient.Accessories which may directly or indirectly contact the patient werenot affected by the software device modifications made to theSpacelabs Multi-parameter Module. Therefore, this section is notapplicable.
Software Testing	The software device modifications made to the Spacelabs Multi-parameter Module were designed and developed according to a robustsoftware development process, and were rigorously verified andvalidated.Software information is provided in accordance with:FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05; and FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02. Test results indicate that the Spacelabs Multi-parameter Modulecomplies with its predetermined specification.
Electrical Safety andElectromagneticCompatibility Testing	The software device modifications made to the Spacelabs Multi-parameter Module did not affect the electrical safety or electromagneticcompatibility performance of the device. No hardware modificationswere made to the device; therefore this section is not applicable.
Performance Testing- Bench	In addition to the software verification and validation performed, thesoftware device modifications made to the Spacelabs Multi-parameterModule were testing in accordance with ANSI/AAMI EC57: 1998 / (R)2003. Test results demonstrate performance equal to or better than thepredicate device.
Performance Testing– Animal:	Animal performance testing is not necessary to demonstrate safety andeffectiveness of the Spacelabs Multi-parameter Module. Therefore, thissection is not applicable.
Performance Testing- Clinical:	Clinical performance testing is not necessary to demonstrate safety andeffectiveness of the Spacelabs Multi-parameter Module. Therefore, thissection is not applicable.

K103142 Page 3 of 4

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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.

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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.

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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

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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.

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

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.