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

Device Description

The Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd. (Spacelabs) élance Vital Signs Monitoring System (élance) 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. See the following Product Configuration List for the identified models and Spacelabs defined monitoring features.

AI/ML Overview

The provided document (K090556) is a 510(k) summary for the Spacelabs élance Vital Signs Monitoring System. This summary primarily focuses on establishing substantial equivalence to predicate devices and describes the general types of testing performed rather than detailed performance study results with specific acceptance criteria and outcome metrics.

Therefore, many of the requested details about acceptance criteria, specific performance results, and clinical study methodologies (like sample size, ground truth establishment, expert adjudication, MRMC studies) are not available in this document. The document explicitly states that "Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Spacelabs élance."

Here's a breakdown of the available information:

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

The document does not provide a table of explicit acceptance criteria or reported device performance metrics in terms of quantitative values. It states:

Software Testing: "Test results indicated that the Spacelabs élance complies with its predetermined specification."
Electrical Safety: "Test results indicated that the Spacelabs élance complies with its predetermined specification."
Electromagnetic Compatibility Testing: "Test results indicated that the Spacelabs élance complies with its predetermined specification."
Performance Testing – Bench: "Test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional, environmental, and shipping and transportation testing."

These statements confirm that internal testing was conducted and passed "predetermined specifications" or "requirements," but the specific numerical acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) and the measured performance are not disclosed in this summary.

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

Test Set Sample Size: Not specified for any of the performance tests mentioned (software, electrical safety, EMC, bench).
Data Provenance: Not specified.

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)

Not applicable as no clinical studies are mentioned. For bench and engineering tests, ground truth would typically be established by calibrated reference devices or known input signals. The document does not provide details on this.

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

Not applicable as no clinical studies with expert adjudication are mentioned.

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 study was done. The device described is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" or an MRMC study.

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

The device itself is a standalone monitor. Bench testing and engineering verification and validation (V&V) were performed to assess its performance against specifications. However, specific standalone performance metrics (e.g., accuracy of arrhythmia detection) are not detailed in this summary. The device's function involves inherent "algorithms" for processing physiological signals.

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

For the technical and bench performance testing, the ground truth would have been established through known input signals, calibrated measurement equipment, and industry standards. For example, electrical safety tests would use international safety standards, and EMC tests would use electromagnetic compatibility standards. No clinical ground truth (like pathology or outcomes data) was used, as clinical testing was not performed or deemed necessary.

8. The sample size for the training set

Not applicable. This device is a physiological monitor, not a machine learning or AI algorithm that requires a "training set" in the typical sense. Its functionality is based on established signal processing and measurement principles.

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

Not applicable, as there is no "training set" for this type of device.

In summary, the 510(k) K090556 document for the Spacelabs élance Vital Signs Monitoring System indicates that the device underwent rigorous engineering and bench testing to ensure compliance with its predetermined specifications and applicable standards. However, it explicitly states that clinical performance testing was not performed or necessary for its clearance. Therefore, detailed information regarding clinical acceptance criteria, study sizes, expert involvement, or AI-specific performance metrics is not found in this summary. The basis for clearance was substantial equivalence to predicate devices and adherence to internal and external technical standards.

Summary

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K090556

510(k) Summary

APR 3 0 2009

Submission Date:	23 February 2009
Submitter:	Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd.Building 30, West WingChuang Tou Industrial Square, Yang Xian Road
Submitter Contact:	Jennifer CuiPhone: 011-086-0512-87178286Fax: 011-086-0512-87178278Email: Jennifer.Cui@spacelabs.com
Official Contact:	Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232
Trade Name:	Spacelabs élance Vital Signs Monitoring System
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

Page 1 of 4

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SubstantiallyEquivalent Devices:	Spacelabs élance Vital SignsMonitoring System	Predicate 510(k)Number	PredicateManufacturer / Model
	ECG component	K001775	Zoe Medical NightingaleMonitoring System
	Respiration component
	Non-invasive blood pressurescomponent
	Invasive blood pressurescomponent
	Temperature component
	Expired and/or inspired CO2component	K060065	Oridion Capnostream 20
	Functional arterial oxygensaturation component	K033296	Masimo Corporation SETRad 5 MS-11 board
	Arrhythmia detection andinvasive pressure monitoring(IBP)	K062144	Invivo Escort M8 VitalSigns Patient MonitorModel 3810
	Functional arterial oxygensaturation component	K012891	Nellcor Oximax N-595pulse oximeter
Device Description:	The Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd.(Spacelabs) élance Vital Signs Monitoring System (élance) is a familyof portable patient monitors intended to be used by clinicians andmedical 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. See the following ProductConfiguration List for the identified models and Spacelabs definedmonitoring features.
Central Station:	A software package (93900) is available for use with customer acquiredcomputer based on specifications provided by Spacelabs Medical. Thispackage allows monitoring of the élance at a central workstation.
TechnologyComparison:	The élance utilizes the same or similar technology for each parameteras utilized by the predicate devices.

. . .

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Intended Use:

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

Adult
Pediatric

The Spacelabs élance Vital Signs Monitor facilitates the monitoring of:

ECG with arrhythmia detection
Respiration
Non-invasive blood pressures
Invasive blood pressures
Body temperature
Functional arterial oxygen saturation, and
Expired and/or inspired CO2.

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

Performance Testing:

SterilizationValidation	The Spacelabs élance is not sterilized or sterilizable, and therefore thissection does not apply to the monitor itself.
Shelf Life Testing	The Spacelabs élance is not sterilized or sterilizable, and therefore thissection does not apply to the monitor itself.
BiocompatibilityTesting	The Spacelabs élance has no patient contact materials, and thereforethis section does not apply to the monitor itself.
Software Testing	Software for the Spacelabs élance was designed and developed accordingto a robust software development process, and was rigorously verifiedand validated. Test results indicated that the Spacelabs élance complieswith its predetermined specification.
Electrical Safety	The Spacelabs élance was tested for patient safety in accordance withapplicable Standards. Test results indicated that the Spacelabs élancecomplies with its predetermined specification.
ElectromagneticCompatibility Testing	The Spacelabs élance was tested for EMC in accordance withapplicable Standards. Test results indicated that the Spacelabs élancecomplies with its predetermined specification.
Performance Testing– Bench	The Spacelabs élance was tested in accordance with internal requirementsand procedures, and test results indicated that the device complies withthe predetermined requirements. This testing includes performance andfunctional, environmental, and shipping and transportation testing.
Performance Testing— Animal:	Animal performance testing was not performed and is not necessary todemonstrate safety and effectiveness of the Spacelabs élance.

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Performance Testing	Clinical performance testing was not performed and is not necessary to
– Clinical:	demonstrate safety and effectiveness of the Spacelabs élance.
Conclusion	Based upon a comparison of devices and performance testing results,the Spacelabs élance is substantially equivalent to the predicate devices.

. . . .

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Public Health Service

Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, resembling an eagle or a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the design.

MAY 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd. c/o Mr. Thomas Kroenke Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466

Re: K090556

Trade/Device Name: élance Vital Signs Monitoring System; and, élance Central Monitor 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: February 23, 2009 Received: March 2, 2009

Dear Mr. Kroenke:

This letter corrects our substantially equivalent letter of April 30, 2009.

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 (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. 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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

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):	K
Device Name:	Spacelabs Healthcare, Inc. (Spacelabs) élance Vital SignsMonitoring System
Indications for Use:	The Spacelabs élance Vital Signs Monitor is indicated for use inpatient populations for:- Adult- Pediatric
	The Spacelabs élance Vital Signs Monitor facilitates themonitoring of:- ECG with arrhythmia detection- Respiration- Non-invasive blood pressures- Invasive blood pressures- Body temperature- Functional arterial oxygen saturation, and- End title CO2.
	The Spacelabs élance Vital Signs Monitor is a prescriptiondevice intended to be used by healthcare professionals in allareas of a healthcare facility.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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 Division of Caraloversealar Bo
510(k) Number_Ko G0 53 G

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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.