(127 days)
The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
The Spacelabs Healthcare (Spacelabs) Telemetry Receiver, Model 96280, (ETR) is a new version of a currently marketed Spacelabs product. The Spacelabs ETR offers receipt and analysis of patient data for those patients connected to a Spacelabs Healthcare telemetry transmitter. The Spacelabs ETR provides for data communication using the TCP/IP network protocol employed in the Xhibit Central Station, Model 96102, (Xhibit) (K122146) network of hardwired and/or ETR monitored patients. Xhibit is the primary alarming device for the ETR telemetry receiver system.
This FDA 510(k) clearance document for the Spacelabs Healthcare Telemetry Receiver, Model 96280, indicates a traditional medical device (hardware and embedded software) rather than an AI/ML-driven device. As such, the information typically associated with AI/ML device studies (such as ground truth establishment involving experts, training/test set sizes for AI, MRMC studies, or standalone algorithm performance) is not available or applicable in the provided text.
The acceptance criteria and performance summary primarily revolve around compliance with established industry standards for medical electrical equipment, software development, electrical safety, electromagnetic compatibility, and performance testing for physiological monitoring.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in a table format for specific performance metrics of the device as one might expect for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by adherence to various established medical device standards and internal requirements. The "reported device performance" is essentially that the device was tested and found to comply with these standards and its predetermined specifications.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Compliance) |
|---|---|
| Software developed to robust process (e.g., IEC 62304, FDA Guidance for software, cybersecurity) | Complies with predetermined specifications and applicable standards/guidance |
| Electrical safety (IEC 60601-1: 2005) | Complies with applicable standards |
| Electromagnetic compatibility (IEC 60601-1-2: 2007) | Complies with applicable standards |
| Performance testing (e.g., ANSI/AAMI EC-57: 2012 for cardiac rhythm/ST-segment, IEC 60601-1-8 for alarm systems, IEC 60601-2-27 for ECG monitoring, IEC 80601-2-61 for pulse oximeter, IEC 62366 for usability engineering) | Complies with predetermined specifications and applicable standards |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. Performance testing was conducted in a bench setting based on established standards. The type or size of patient data or physiological signals used for these bench tests is not detailed (e.g., how many ECG recordings, how many simulated arrhythmia events).
- Data provenance is not mentioned as this is a device clearance based on engineering and safety standards, not a clinical trial with patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML diagnostic device requiring expert-adjudicated ground truth. The "ground truth" for compliance with engineering standards is the adherence to specifications as measured by laboratory testing.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There's no human adjudication process described for establishing ground truth as it would be for an AI/ML system.
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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:
- Not applicable. This device is a telemetry receiver, not an AI/ML system designed to assist human readers in interpretation. There is no mention of an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself functions as a "standalone" physiological monitoring system, receiving and analyzing patient data. The performance tests ("Performance Testing – Bench") assess the device's inherent capabilities against technical standards. However, this is not a "standalone algorithm" in the context of an AI/ML submission where an algorithm's diagnostic performance is evaluated in isolation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of device is defined by the technical specifications and requirements outlined in the referenced standards (e.g., an arrhythmia detection algorithm must correctly identify a pre-defined set of arrhythmias from test data as per the standard). This is an engineering truth rather than a clinical ground truth established by medical experts for diagnostic accuracy.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
In summary, the provided document details the FDA clearance of a traditional telemetry receiver based on its compliance with established medical device standards for electrical safety, electromagnetic compatibility, software robustness, and performance (e.g., ECG analysis, alarm systems, pulse oximetry). It does not involve AI/ML technology, and thus the specific types of studies and criteria relevant to AI/ML devices (like training/test sets, expert adjudication, MRMC studies) are not present in this submission.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
September 9, 2014
Spacelabs Healthcare % Thomas Kroenke Speed To Market, Inc. P.O. Box 3018 Nederland, CO 80466 US
Re: K141156
Trade/Device Name: Spacelabs Healthcare Telemetry Receiver Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (with Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX, DSI, MLD, MSX Dated: June 31, 2014 Received: August 4, 2014
Dear Thomas 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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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.
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 devicerelated 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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.
Sincerelv vours.
Mitchell Stein
for 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): | K141156 |
|---|---|
| Device Name: | Spacelabs Healthcare Telemetry Receiver, Model 96280 |
| Indications for Use: | The Spacelabs Healthcare Telemetry Receiver, Model 96280, isintended to provide the Spacelabs Healthcare monitoring systemwith adult, pediatric and neonatal patient data of patientsconnected to Spacelabs Healthcare telemetry transmitters. Dataincludes physiological waveforms and calculations, cardiacarrhythmia and ST data, and patient demographic information tomonitor adequacy of treatment or to exclude causes ofsymptoms. |
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)
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| Submission Date: | 02 May 2014 |
|---|---|
| Submitter: | Spacelabs Healthcare35301 SE Center StSnoqualmie, WA 98065 |
| Submitter Contact: | Mr. Al Van HoudtSpacelabs HealthcarePhone: +1 (425) 363- 5970Fax: +1 (425) 363-5762Email: al.vanhoudt@spacelabs.com |
| ApplicationCorrespondent: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 |
| Manufacturing Site: | Spacelabs Healthcare35301 SE Center StSnoqualmie, WA 98065 |
| Trade Name: | Spacelabs Healthcare Telemetry Receiver, Model 96280 |
| Common Name: | Telemetry Receiver |
| Classification Name: | Monitor, Physiological, Patient (With Arrhythmia Detection orAlarms); |
| PrimaryClassificationRegulation: | 21 CFR §870.1025 |
| Primary ProductCode: | MHX |
| SecondaryClassificationRegulation: | 21 CFR §870.1025; 21 CFR §870.2300 |
| Secondary ProductCode: | DSI; MLD; MSX |
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| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate510(k) Number | PredicateManufacturer / Model |
|---|---|---|---|
| Spacelabs HealthcareTelemetry Receiver,Model 96280 | K925510 | Spacelabs Medical, Inc.Model 90478 and 90479Telemetry ReceiverModule and Housing | |
| Device Description: | The Spacelabs Healthcare (Spacelabs) Telemetry Receiver, Model96280, (ETR) is a new version of a currently marketed Spacelabsproduct. The Spacelabs ETR offers receipt and analysis of patient datafor those patients connected to a Spacelabs Healthcare telemetrytransmitter. | ||
| The Spacelabs ETR provides for data communication using the TCP/IPnetwork protocol employed in the Xhibit Central Station, Model96102, (Xhibit) (K122146) network of hardwired and/or ETRmonitored patients. | |||
| Xhibit is the primary alarming device for the ETR telemetry receiversystem. | |||
| Intended Use: | The Spacelabs Healthcare Telemetry Receiver, Model 96280, isintended to provide the Spacelabs Healthcare monitoring system withadult, pediatric and neonatal patient data of patients connected toSpacelabs Healthcare telemetry transmitters. Data includesphysiological waveforms and calculations, cardiac arrhythmia and STdata, and patient demographic information to monitor adequacy oftreatment or to exclude causes of symptoms. | ||
| TechnologyComparison: | The Spacelabs ETR employs the same technological characteristics asthe predicate device. | ||
| Characteristic | Predicate Device | Proposed Device | |
| Number of Patients perReceiver Channel | 1 | Same | |
| Patients per ReceiverHousing | Up to 8 | Up to 16 | |
| Receivers Connected toCentral Station | Two (2)(Ultraview can display 16patients) | Three (3)(Xhibit can display 48 patients) | |
| Number of Displays /Patients per Display | One (1) display / 16 patientsper display | Three (3) displays / 16 patientsper display | |
| Receiver Capability | ECG, SpO2, NIBP | Same | |
| ECG Analysis in Receiver | Yes | Same |
Same
Yes
Prioritized Alarms
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Summary of Performance Testing:
| Software | The Spacelabs ETR contains MAJOR level of concern software.Software was designed and developed according to a robust softwaredevelopment process, and was rigorously verified and validated.Software information is provided in accordance with internalrequirements and the following standards and guidance documents: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; FDA guidance: Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, 28 October 2003; FDA guidance: Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 January 2005; and IEC 62304: 2006, Medical device software – Software life cycle processes. Test results indicate that the Spacelabs ETR complies with its predetermined specifications and the applicable standards and guidance documents. |
|---|---|
| Electrical Safety | The Spacelabs ETR was tested for performance in accordance with the following standard: IEC 60601-1: 2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Test results indicate that the Spacelabs ETR complies with the applicable standards. |
| ElectromagneticCompatibility | The Spacelabs ETR was tested for performance in accordance with the following standard: IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. Test results indicate that the Spacelabs ETR complies with the applicable standards. |
| Performance Testing– Bench | The Spacelabs ETR was tested for performance in accordance withinternal requirements and the following standards:ANSI/AAMI EC-57: 2012, Testing and reporting performanceresults of cardiac rhythm and ST-segment measurement algorithms. IEC 60601-1-8 2006, Am1: 2012, Medical electrical equipment –General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems. IEC 60601-2-27: 2011, Medical electrical equipment – Part 2-27:Particular requirements for the basic safety and essentialperformance of electrocardiographic monitoring equipment. IEC 80601-2-61: 2011, Medical electrical equipment – Part 2-61:Particular requirements for basic safety and essential performanceof pulse oximeter equipment. IEC 62366: 2007, Medical devices – Application of usabilityengineering to medical devices. Test results indicate that the Spacelabs ETR complies with itspredetermined specifications and the applicable standards. |
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the Spacelabs ETR. Theresults of these activities demonstrate that the Spacelabs ETR is safeand effective when used in accordance with its intended use andlabeling. |
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Therefore, the Spacelabs ETR is considered substantially equivalent to the predicate device.
§ 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.