The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Device Description

The Spacelabs Medical, Inc. (Spacelabs) élance Vital Signs Monitor is a family of portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, respiration, NIBP, temperature, SPO2, invasive blood pressure and EtCO2. Models within the Spacelabs élance family come in two different sized viewing areas (10.2" and 12.1"), two different housing colors (white and black) and offer selected monitoring features.

The Spacelabs Medical, Inc. élance Central Station software package is available for use with a customer acquired computer based on specifications provided by Spacelabs Medical. This package allows monitoring of the élance Vital Signs Monitor at a central workstation.

AI/ML Overview

The provided text describes a 510(k) submission for the Spacelabs Medical élance Vital Signs Monitor and élance Central Station. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial data with specific acceptance criteria and performance metrics typically seen in studies for novel technologies.

Therefore, for many of your requested points, the information is not available in the provided document, as it is not a study report designed to evaluate the device's performance against specific clinical acceptance criteria. Instead, it highlights verification that modifications were implemented correctly and that the device complies with predetermined specifications.

Here's an analysis based on the available information:

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

This information is not provided in the document. The document states that "Verification results indicated that the élance Vital Signs Monitor and élance Central Station complies with predetermined specifications," but it does not list those specifications or report numerical performance data against them.

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

This information is not provided. The submission refers to "verification results" but does not detail a specific test set, its size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As it's a 510(k) for a monitoring device, ground truth for patient physiological parameters would typically involve highly accurate reference measurements from other medical devices, not expert human agreement in the same way it would for image interpretation. However, the document does not specify any details about how reference data was obtained or validated.

4. Adjudication method for the test set

This information is not provided.

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

There is no indication of an MRMC comparative effectiveness study in the provided text. This device is a physiological monitor, not an AI-assisted diagnostic tool for human readers, so such a study would not typically be applicable in this context.

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

The document states, "The élance Vital Signs Monitor and élance Central Station utilize the same technology for each parameter as utilized by the predicate device." While there's a "central station," the primary function is monitoring, and the "arrhythmia detection" is likely an algorithmic function. However, the document does not detail specific standalone algorithm performance metrics or any studies conducted on the algorithm alone without considering the human user. The focus is on the device as a whole and its substantial equivalence to a predicate.

7. The type of ground truth used

This information is not explicitly stated. For a vital signs monitor, the ground truth for parameters like ECG, respiration, blood pressure, temperature, SpO2, and EtCO2 would typically be established by highly accurate reference devices or invasive measurements (e.g., arterial line for invasive blood pressure, capnography for EtCO2). However, the document does not elaborate on how ground truth was established for the "predetermined specifications" against which the device was verified.

8. The sample size for the training set

This information is not provided. The submission is not for a device developed using machine learning that would typically involve a "training set" in the sense of AI model development. The verification is against "predetermined specifications," suggesting a more traditional engineering validation approach.

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

This information is not provided, as the concept of a "training set" in the context of AI model development does not appear to apply to this submission.

Summary

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510(k) Summary

くし

Submission Date:	03 November 2009		NOV 2 4 2009
Submitter:	Spacelabs Medical, Inc.5150 220th Avenue SEIssaquah, WA 98029 USA
Submitter Contact:	David J. GeraghtyPhone: +1 (425) 657-7200, ext 5889Fax: +1 (425) 657-7210Email: david.geraghty@spacelabs.com
Trade Name:	élance Vital Signs Monitor and élance Central Station
Common Name:	Patient Physiological Monitor (with arrhythmia detection or alarms)
Classification Name:	Monitor, physiological, patient (with arrhythmia detection or alarms)
ClassificationRegulation:	21 CFR §870.1025
Product Code:	MHX
SubstantiallyEquivalent Devices:	New Spacelabs Model	Predicate 510(k) Number	PredicateManufacturer / Model
	élance Vital Signs Monitor andélance Central Station	K090556	Spacelabs HealthcareMedical Equipment(Suzhou) Co., Ltd. /élance Vital SignsMonitoring System; and,élance Central Monitor
Device Description:	The Spacelabs Medical, Inc. (Spacelabs) élance Vital Signs Monitor isa family of portable patient monitors intended to be used by cliniciansand medical qualified personnel for monitoring ECG, respiration,NIBP, temperature, SPO2, invasive blood pressure and EtCO2. Modelswithin the Spacelabs élance family come in two different sized viewingareas (10.2" and 12.1"), two different housing colors (white and black)and offer selected monitoring features.
Central Station:	The Spacelabs Medical, Inc. élance Central Station software package isavailable for use with a customer acquired computer based on

specifications provided by Spacelabs Medical. This package allows monitoring of the élance Vital Signs Monitor at a central workstation. .

" ·

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Technology Comparison:

Intended Use:

The élance Vital Signs Monitor and élance Central Station utilize the same technology for each parameter as utilized by the predicate device.

The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:

Adult
Pediatric

The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of:

ECG with arrhythmia detection
Respiration
Non-invasive blood pressures
Invasive blood pressures
Body temperature
Functional arterial oxygen saturation, and
End tidal CO2.

The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Performance Testing:

Device modifications made to the élance Vital Signs Monitor and élance Central Station were appropriately verified to ensure that each modification was implemented correctly.

Verification results indicated that the élance Vital Signs Monitor and élance Central Station complies with predetermined specifications.

Conclusion

Based upon a comparison of devices and verification results, the Spacelabs élance Vital Signs Monitor and élance Central Station are substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

NOV 2 4 2009

Mr. David J. Geraghty Manager, Regulatory & Quality Spacelabs Medical, Inc. 5150 220th Ave SE P.O. Box 7018 Issaquah, WA 98027-7018

Re: K093501

Device Name: élance Vital Signs Monitor and élance Central Station 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: MHX Dated: November 3, 2009 Received: November 12, 2009

Dear Mr. Geraghty:

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.

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Page 2 - Mr. David J. Geraghty

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

W.M.S. Jr.

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:

K 09 350 1

Spacelabs Medical, Inc. (Spacelabs) élance Vital Signs Monitor and élance Central Station

The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:

Adult
Pediatric

The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of:

ECG with arrhythmia detection
Respiration
Non-invasive blood pressures
Invasive blood pressures
Body temperature
Functional arterial oxygen saturation, and
End tidal CO2.

The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K093501

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.