The Spacelabs Healthcare AriaTele Telemetry Transmitter (96281), when used in conjunction with a Spacelabs Healthcare Ultraview patient monitor and telemetry receiver, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected.

The 96281 also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary/ circulatory functions.

The 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

Device Description

The Ultraview™ Digital Telemetry System (AriaTele) are portable, battery-powered, patient-worn transmitters that monitor electrocardiography (ECG) activity and oxygen saturation (SpO2) data (96281-C only), and transmit this information to a telemetry receiver module.

There are three (3) variants of the AriaTele:

Model 96281-A: ECG; .
Model 96281-B: ECG with display; and .
. Model 96281-C: ECG and SpO2 with display.

The AriaTele is compatible with the Ultraview SL 3800-38/-39 central monitor, and the Ultraview and Ultraview SL line of bedside monitors, collectively called "monitors." The AriaTele is also compatible with the 90478 Digital Telemetry System Receiver and Receiver Housing (90479-A, 90479-B). The receiver housing is related to the central monitor. The receiver module can go in the housing or in a bedside monitor.

The AriaTele functions as part of a digital telemetry system. The digital telemetry system consists of transmitters, diversity antennas, receiver modules, and either a receiver housing or a monitor. Typically, a request comes from a monitor to obtain data from electrodes and/or remote sensors attached to a patient which are connected to the transmitter. The monitor tells a receiver what channel to begin listening on-one that matches the transmitter on the patient.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Spacelabs Healthcare AriaTele Telemetry Transmitter (96281), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (Proposed Device)
ECG Signal Reproduction	AAMI EC13	IEC 60601-2-27 (Complies)
SpO₂ Accuracy (Adult)	± 3 % over 70 - 100 % (Unspecified over 0 - 69 %)	± 2 % over 70 - 100 % (Unspecified over 0 - 69 %)
SpO₂ Accuracy (Neonate)	± 3 % over 70 - 100 % (Unspecified over 0 - 69 %)	± 3.25 % over 70 - 100 % (Unspecified over 0 - 69 %)
PR Accuracy (Adult/Neonate)	± 3 bpm over full range	± 3 bpm over full range (Same as predicate)
Electrical Safety	Not explicitly stated for predicate; implied by general standards	Complies with IEC 60601-1:2005, IEC 60529:1989 Am1:1999, UL 60601-1:2003
Electromagnetic Compatibility (EMC)	Not explicitly stated for predicate; implied by general standards	Complies with IEC 60601-1-2:2007
Software Performance	Not explicitly stated for predicate; implied by general standards	Complies with predetermined specifications and FDA guidance documents (e.g., "General principles of software validation")
Overall Performance	Not explicitly stated for predicate; implied by general standards	Complies with internal documentation and standards: IEC 60601-2-27:2011, IEC 60601-2-49:2011, IEC 80601-2-61:2011, IEC 62366:2007

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set in the context of clinical performance or data provenance (e.g., country of origin, retrospective/prospective). The performance testing described primarily relies on engineering and regulatory compliance standards rather than clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The device's performance is evaluated against established technical standards (e.g., IEC, AAMI) rather than through expert-adjudicated clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As there's no mention of a clinical test set requiring expert ground truth, an adjudication method is not applicable in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or reported in this document. This device is a physiological monitoring system, not an AI-driven diagnostic or interpretative tool that would typically involve human reader performance comparisons.

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

The performance testing described is essentially a standalone evaluation of the device's adherence to various engineering and safety standards. The device itself (the AriaTele Telemetry Transmitter) is the "algorithm only" in the sense that its readings and functions are validated against these technical benchmarks. There's no mention of a separate "algorithm" being evaluated beyond the integrated device.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing is based on established industry standards and regulatory guidance documents. For physiological parameters like SpO2 and PR accuracy, these standards define acceptable levels of deviation from a true reference. For electrical safety, EMC, and software, the "ground truth" is compliance with the specified test procedures and limits outlined in the relevant IEC, UL, and FDA guidance documents.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The AriaTele Telemetry Transmitter is a physiological monitoring device, not an AI/ML model that would typically use a "training set" of data in the conventional sense. Its functionality is based on hardware and embedded software designed to meet specific physiological measurement and transmission standards.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided, as there is no "training set" for this type of device.

Summary

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510(k) Summary

JUN - 6 2012

Submission Date:	15 May 2012
Submitter:	Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029
Submitter Contact:	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
Official Contact:	Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232
Manufacturing Site:	Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029
Trade Name:	Spacelabs Healthcare AriaTele Telemetry Transmitter (96281)
Common andClassification Name:	Monitor, Physiological, Patient (With Arrhythmia Detection orAlarms); Electrocardiograph; Oximeter
ClassificationRegulation:	21 CFR §870.1025; 21 CFR §870.2340; 21 CFR §870.2700
Product Code:	MXH; DPS; DQA
SubstantiallyEquivalent Devices:	New Spacelabs Model
	Spacelabs HealthcareAriaTele TelemetryTransmitter (96281) K983996 Spacelabs Medical, IncSpacelabs MedicalUltraview™ Digital

Telemetry System

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Device Description:

There are three (3) variants of the AriaTele:

Model 96281-A: ECG; .
Model 96281-B: ECG with display; and .
. Model 96281-C: ECG and SpO2 with display.

Intended Use:

The 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

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Technology Comparison:

The AriaTele employs the same technological characteristics as the predicate device.

Characteristic	Predicate Device	Proposed Device
Parameters	Electrocardiography (ECG); OxygenSaturation (SpO2) and Pulse Rate (PR);Non-invasive Blood Pressure (NIBP)	ECG; SpO2; and PR
Accuracy of ECGSignalReproduction	AAMI EC13	IEC 60601-2-27
SpO₂ Accuracy	Adult/Neonate:$\pm$ 3 % over 70 - 100 %Unspecified over 0 - 69 %	Adult:$\pm$ 2 % over 70 - 100 %Unspecified over 0 - 69 %Neonate:$\pm$ 3.25 % over 70 - 100 %Unspecified over 0 - 69 %
PR Accuracy	Adult/Neonate:$\pm$ 3 bpm over full range	Same.
Signal QualityDisplay	No	Yes
Power Source	Battery	Same

Summary of Performance Testing:

Electrical Safety

The AriaTele was tested for performance in accordance with the following Standards:

IEC 60601-1: 2005, Medical electrical equipment Part 1. General . requirements for basic safety and essential performance;
IEC 60529: 1989, Am1: 1999, Degree of protection provided by . enclosures; and
UL 60601-1: 2003, Medical electrical equipment Part 1. General . requirements for safety.

Test results indicated that the AriaTele complies with the Standards.

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510(k) Summary

ElectromagneticCompatibility (EMC)Testing	The AriaTele was tested for performance in accordance with thefollowing Standard:
	IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2:General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirementsand tests.
	Test results indicated that the AriaTele complies with the Standards.
Software Testing	Software device modifications made to the AriaTele were designed anddeveloped according to a robust software development process, andwere rigorously verified and validated.
	Software information is provided in accordance with internaldocumentation and the following Standards and guidance documents:
	•	FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05;
	•	FDA guidance: Off-the-shelf software use in medical devices, 09Sep 99; and
	•	FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02;
	Test results indicate that the AriaTele complies with its predeterminedspecification and the Standards and guidance documents.
Performance Testing	The AriaTele was tested for performance in accordance with internaldocumentation and the following Standards:
	•	IEC 60601-2-27: 2011, Medical electrical equipment - Part 2-27:Particular requirements for the basic safety and essentialperformance of electrocardiographic monitoring equipment;
	•	IEC 60601-2-49: 2011, Medical electrical equipment - Part 2-49:Particular requirements for the safety of multifunction patientmonitoring equipment ;
	•	IEC 80601-2-61: 2011, Medical electrical equipment -- Part 2-61:Particular requirements for basic safety and essential performanceof pulse oximeter equipment; and
	•	IEC 62366: 2007; Medical devices - Application of usabilityengineering to medical devices.
	Test results indicated that the AriaTele complies with its predeterminedspecification and with the applicable Standards.

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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 AriaTele. The results of these activities demonstrate that the AriaTele is safe and effective when used in accordance with its intended use and labeling.

Therefore, the AriaTele is considered substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

JUN - 6 2012

Spacelabs Healthcare c/o Mr. Thomas Kroenke Principal Consultant Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466

Re: K121480

Trade/Device Name: Spacelabs Healthcare AriaTele Telemetry Transmitter (96281) Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX Dated: May 15, 2012

Received: May 18, 2012

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

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Page 2 - Mr. Thomas Kroenke

found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

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 (OS) 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/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,

Bram D. Zuckerman, M.D.

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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K121480

Indications for Use

510(k) Number (if known): . K

Device Name:

Indications for Use:

Spacelabs Healthcare AriaTele Telemetry Transmitter (96281)

The 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

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)

Concurrences of CDRH, Office of Device Evaluation (ODE)

Bigislon Stan-Off Division of Cardiovascular Devices

510(k) Number K121480

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.