(308 days)
The ers2 – ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate calculation, displayed for visual QRS complex assessment and to control the training load for a patient´s rehabilitation or preventive training activities.
The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp).
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare Institutions for inpatient and outpatient care.
The Ergoline Rehabilitation System 2 consists of a) software (ers2) and b) hardware (ers2 1CH ECG Telemetry system).
a) The software system runs on a PC and is used by therapists to monitor, control and document the training sessions of rehabilitation patients (e.g. in endurance and strength training), whereby the patient can train on different devices or free without the support of devices. Free training can, for example, be performed on strength training equipment or through gymnastic exercises.
The central component of the ers2 system is a PC with an MS Windows operating system and special software which runs the training programs. The training ergometers are connected to the PC system via control lines or a WiFi interface. All data are shown on one to three 22-inch TFT monitors; up to eight patients can be displayed and supervised on each monitor. The ers2 software receives the patient's physiological parameters from the ers2 1CH ECG Telemetry System and uses them for display on the monitor as well as to control the training devices.
Data are transferred between the wireless ergoline ECG transmitter and PC via Bluetooth©.
b) Via the applied part, the ers2 1CH ECG Transmitter acquires a single-channel, bipolar raw ECG signal and sends it to a medical application software or other ME equipment by radio transmission.
The ers2 1CH ECG transmitter is an ME device powered from integrated, exchangeable, rechargeable batteries
These are the components of the ers2 1CH ECG Telemetry system:
. ers2 1CH ECG Transmitter consisting of enclosure, ECG amplifier, radio transmission module, micro-controller with firmware and device connection of the ECG adapter, is worn on the body near the heart and affixed to the ETS1 adapter no skin contact, accessible part, type CF.
. The ers2 1CH ECG adapter (applied part, ECG patient connection) with device socket for connection to the ECG transmitter and device socket for connection to the patient connection (ECG electrode), is worn on the body near the heart, type CF.
. ers2 ECG receiver, receives the ECG signals transmitted by radio. Permanently connected to USB port of a Windows PC. Operated outside patient environment, accessible part, protection class II.
The provided document is a 510(k) summary for the ers2 - ergoline Rehabilitation System. It details the device's intended use, comparison with a predicate device, and compliance with various standards. However, it does not contain information about the performance evaluation of the device in terms of clinical accuracy or a comparative effectiveness study with human readers (MRMC study). The "Performance Testing" section primarily focuses on:
- Electrical Safety and Electromagnetic Compatibility: Compliance with recognized standards.
- Software and System Validation: Verification and validation of firmware and software according to IEC 62304.
- Usability Validation: Confirmation that the device meets its intended use, considering human factors.
Therefore, many of the specific details requested regarding acceptance criteria for clinical performance, sample sizes for test and training sets, expert involvement, and ground truth establishment are not present in this document. The document describes compliance with engineering standards rather than a clinical performance study measuring diagnostic or therapeutic accuracy.
Given the available information, I can only provide details based on the engineering and regulatory compliance aspects described:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for clinical performance (e.g., accuracy of heart rate calculation, QRS complex assessment). Instead, it lists technical specifications and compliance with standards.
| Acceptance Criteria (related to technical specifications/standards) | Reported Device Performance (from "Predicate Device Comparison" section) |
|---|---|
| Regulation Number: 890.2910 | In compliance |
| Product Code: DRG | In compliance |
| Transmission Signal: Radiofrequency | Radiofrequency (similar to predicate) |
| Transmission Equipment: Telemetry transmitter and receiver | Telemetry transmitter and receiver (similar to predicate) |
| Frequency response: within range | 0.05 – 125 Hz (similar to predicate, 0.05 – 100 Hz) |
| Dynamic Range: within range | ± 6 mV (similar to predicate, ± 5 mV) |
| Rejection Ratio: > 80 dB | > 80 dB (similar to predicate, 80 dB) |
| Defibrillation Recovery: Within 8 seconds | Within 5 seconds (similar to predicate) |
| Max distance: at least 100 feet | 164 feet (different from predicate, 100 feet) |
| Compliance with 21 CFR 898 (Mandatory since May 9, 2000) | Yes (similar to predicate) |
| Electrical Safety | Tested and in compliance with recognized standards |
| Electromagnetic Compatibility (EMC) | Tested and in compliance with recognized standards |
| Software Validation (IEC 62304) | Verified and validated, met software system requirements |
| Usability Validation | Validated to confirm device meets intended use |
2. Sample size used for the test set and the data provenance
Not applicable/Not mentioned. The document primarily discusses technical compliance and usability validation, not the performance against a clinical test set of ECGs. No specific data provenance (country, retrospective/prospective) for a clinical performance test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not mentioned. The device's purpose is for heart rate calculation and visual QRS complex assessment, not for interpreting complex cardiac conditions or diagnoses. Therefore, the concept of "ground truth" derived from expert consensus for diagnostic purposes is not addressed in this filing. The "ground truth" implicitly refers to the accuracy of the physiological signal acquisition and heart rate calculation as validated through engineering and software testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not mentioned. This typically relates to studies involving human interpretation or complex image analysis, which is not the focus of the performance testing described here.
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
Not applicable/Not mentioned. The device is a "Radiofrequency Physiological Signal Transmitter and Receiver" intended for heart rate calculation and visual QRS complex assessment to control training load. It is explicitly stated: "The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp)." Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's intended use and is not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies "standalone" performance in terms of the technical capabilities and software validation. The "ers2 software" processes the ECG for heart rate calculation and display. The "Software and System validation" section states that the software "met the software system requirements." This indicates an assessment of the algorithm's functionality, but no quantitative performance metric (e.g., accuracy against a true heart rate benchmark) is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance aspects (e.g., software validation, heart rate calculation), the implied "ground truth" would be engineering benchmarks, known physiological signals, or predefined system requirements for the software's functionality. It does not involve expert consensus, pathology, or outcomes data, as those are typically for diagnostic or prognostic devices.
8. The sample size for the training set
Not applicable/Not mentioned. This document pertains to regulatory submission for a medical device (transmitting and receiving physiological signals), not the development or training of an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable/Not mentioned for the same reason as #8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2022
ergoline GmbH Alexandra Lertz Quality Manager Lindenstrasse 5 Bitz, Hessen 72475 Germany
Re: K212883
Trade/Device Name: ers2 - ergoline Rehabilitation System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: Mav 30, 2022 Received: June 3, 2022
Dear Alexandra Lertz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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.
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212883
Device Name
ers2 - ergoline Rehabilitation System
The ers2 – ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate calculation, displayed for visual QRS complex assessment and to control the training load for a patient's rehabilitation or preventive training activities.
The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp).
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare for inpatient and outpatient care.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary for ers2 - ergoline Rehabilitation System
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirement of 21 CFR 807.92
Sponsor
- Sponsor: ergoline GmbH Lindenstrasse 5 72475 Bitz Germany
- Contact Person: Mr. Andreas Maurer amaurer@ergoline.com +49 7431 9894 138
- May 31, 2022 Date Prepared:
510(k) number: K212883
Device Name and Classification
- Proprietary Name: ers2 - ergoline Rehabilitation System
Common/Usual Name: Transmitters and receivers, physiological signal, radiofrequency
Classification Name: Cardiovascular Monitoring Devices (21 CFR 870.2910, Product Code DRG)
Predicate Device
TeleRehab 2004 Cardiopulmonary Rehabilitation System, K050778 Predicate Device:
Intended Use
The ers2 – ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate calculation, displayed for visual QRS complex assessment and to control the training load for a patient´s rehabilitation or preventive training activities.
The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp).
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare Institutions for inpatient and outpatient care.
{4}------------------------------------------------
Device Description and Function
The Ergoline Rehabilitation System 2 consists of a) software (ers2) and b) hardware (ers2 1CH ECG Telemetry system).
- a) The software system runs on a PC and is used by therapists to monitor, control and document the training sessions of rehabilitation patients (e.g. in endurance and strength training), whereby the patient can train on different devices or free without the support of devices. Free training can, for example, be performed on strength training equipment or through gymnastic exercises.
The central component of the ers2 system is a PC with an MS Windows operating system and special software which runs the training programs. The training ergometers are connected to the PC system via control lines or a WiFi interface. All data are shown on one to three 22-inch TFT monitors; up to eight patients can be displayed and supervised on each monitor. The ers2 software receives the patient's physiological parameters from the ers2 1CH ECG Telemetry System and uses them for display on the monitor as well as to control the training devices.
Data are transferred between the wireless ergoline ECG transmitter and PC via Bluetooth©.
- b) Via the applied part, the ers2 1CH ECG Transmitter acquires a single-channel, bipolar raw ECG signal and sends it to a medical application software or other ME equipment by radio transmission.
The ers2 1CH ECG transmitter is an ME device powered from integrated, exchangeable, rechargeable batteries
These are the components of the ers2 1CH ECG Telemetry system:
- . ers2 1CH ECG Transmitter consisting of enclosure, ECG amplifier, radio transmission module, micro-controller with firmware and device connection of the ECG adapter, is worn on the body near the heart and affixed to the ETS1 adapter no skin contact, accessible part, type CF.
- . The ers2 1CH ECG adapter (applied part, ECG patient connection) with device socket for connection to the ECG transmitter and device socket for connection to the patient connection (ECG electrode), is worn on the body near the heart, type CF.
- . ers2 ECG receiver, receives the ECG signals transmitted by radio. Permanently connected to USB port of a Windows PC. Operated outside patient environment, accessible part, protection class II.
Predicate Device Comparison
General
Table 1: Basic Device Characteristics – Comparison with Predicate Device
| Characteristic | New Device | Primary predicatedevice | Similar / Different |
|---|---|---|---|
| 510(k) Number | K212883 | K050778 | - |
| Device Name, Model | |||
| ers2 - ergolineRehabilitation System | TeleRehab 2004CardiopulmonaryRehabilitation System | - | |
| Manufacturer | ergoline GmbH | ScottCare | - |
| Regulation Number | 890.2910 | 890.2910 | Similar |
| Product code | DRG | DRG | Similar |
| Indications for Use | The ers2 – ergolineRehabilitation Systemis a device forrecording of a single-channel, bipolarsurface ECG (frontalplane) acquired withtwo ECG electrodes.The ECG istransmitted to theers2 software where itis processed forheartrate calculation,displayed for visualQRS complexassessment and tocontrol the trainingload for a patient´srehabilitation orpreventive trainingactivities.The ers2 system is notintended to be usedto detect or diagnosecardiac conditions(e.g. arrhythmias, ST-elevation, etc. pp).The signal is acquiredon the intact skin ofadult patients.The medical device isintended for use inprofessionalhealthcare Institutionsfor inpatient andoutpatient care. | This device is intendedto acquire andcondition the ECGsignal from a patientso that it can betransmitted via radiofrequency (WMTF)with a Stickmantelemetry transmitterto a workstation in ahospital or clinicalsetting where the ECGis displayed andanalyzed. This deviceis for use withambulatory adultpatients, which needmonitoring whileundergoing cardiac orpulmonaryrehabilitation. Thedata output frommonitoring is viewedand stored on aworkstation fortracking of thepatients' progressthrough rehabilitation.Patient demographics,exercise protocol andmedical informationcan be entered via avariety ofcommercially availablewireless input devicesor automaticallythrough an HL-7hospital networkinterface. A databasecan be created for usewith an Outcomesprogram. | Similar besidesdifferent frequencybands and a differentproprietary protocolto encode thetransmitted data |
| Transmission signal | Radiofrequency | Radiofrequency | Similar |
| Transmissionequipment | Telemetry transmitterand receiver | Telemetry transmitterand receiver | Similar |
| Frequency band | 2402 – 2483,5 MHz | 608-614MHz | Different |
| Frequency response | 0.05 – 125 Hz | 0.05 – 100 Hz | Similar |
| Dynamic Range | ± 6 mV | ± 5 mV | Similar |
| Rejection Ratio | > 80 dB | 80 dB | Similar |
| Type | CF, defibrillationprotected | CF, defibrillationprotected | Similar |
| DefibrillationRecovery | Within 5 seconds | Within 8 seconds | Similar |
| Maximum distance | 164 feet | 100 feet | Different |
| Displayed parameters | ECG, HR, Thr; Loadand RPM, Slope andspeed, BP, CAL, METS | ECG, HR, SpO2, BP,THR, CAL, METS,RHR, RBP | Similar for theintended use |
| Connection of thedevice to electrodes | Electrodes areconnected via cablesto the adapter andthus to thetransmitter. | Electrodes areconnected via cablesdirectly to thetransmitter | Different |
| Electrodes | 2 standard 510(k)cleared stickingelectrodes | 3 or 5 standard 510(k)cleared stickingelectrodes | Similar |
| Power Source(s) | Transmitter: 1 xHR03/AAA NiMHrechargeable battery,1.2 V | Transmitter: 3x AAA,alkaline batteries, 1.5V | Different |
| Battery life | 6 hours, rechargeable | 60 hours | Different |
| - Method of LineCurrent Isolation | Power Supply inaccordance with IEC60601-1 | Power Supply inaccordance with IEC60601-1 | Similar |
| Operator | Professional user in aclinical setting | Professional user in aclinical setting | Similar |
| Compliance with 21CFR 898?(Mandatory sinceMay 9, 2000) | Yes | Yes | Similar |
| Lead wires – cables | M-PUR: Compliantwith protected leadwire and patient cablesafety requirements | DIN: Compliant withprotected lead wireand patient cablesafety requirements | Different |
| Patient contactmaterial | Cord:Silicone, ELASTOSIL® RPlus 4001/60 MH(WACKER) | Cord:DIN style shielded leadwireECG leadwires withelectrode clips: | Different |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
| electrode clips:M-PURElectrodes:Standard 510(k)cleared stickingelectrodes, notincluded with thedeviceAdapter base:TPE, THERMOLAST® MTM9MED (TPEKraiburg)Colorant: MasterbatchBlau (Pantone 7451 U)Transmitter:SINKRAL L 322 - ABS | M-PURElectrodes:Standard 510(k)cleared stickingelectrodes, notincluded with thedeviceTransmitter:Polymer | ||
|---|---|---|---|
| Environmentalconditions: | Temperature:-20 – 65 °CRelative Humidity:10 – 95 % | Temperature:10 – 40 °CRelative Humidity:10 – 90 % | Similar |
| Standards | IEC 60601-1IEC 60601-1-2IEC 60601-2-27ANSI/AAMI EC53EN 61000-4-2EN 61000-4-3EN 61000-4-6EN 61000-4-8EN 55011EN 55032ISO 14971IEC 62366-1IEC 62304ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | IEC 60601-1IEC 60601-1-2ANSI/AAMI EC-13EN 61000-3-2EN 61000-3-3EN 61000-4-2EN 61000-4-3EN 61000-4-4EN 61000-4-5EN 61000-4-6EN 61000-4-8EN 55011 | Similar |
{8}------------------------------------------------
Performance Testing
Electrical Safety and Electromagnetic Compatibility testing: ers2 - ergoline Rehabilitation System was tested according to and is in compliance with recognized standards for electrical safety and electromagnetic compatibility.
Software and System validation: The ers2 - ergoline Rehabilitation System comprises "ETS1 Transmitter firmware" and the software "ers2 software" which were verified and validated according to IEC 62304. Software validation demonstrated that the "ETS1 Transmitter firmware" and "ers2 software" met the software system requirements.
Usability validation: The overall system was validated to confirm that the device meets its intended use, i.e. can be used as intended by the specified users within the specified use environment, taking into account human factors and usability requirements.
Performance Standards
The ers2 - ergoline Rehabilitation System complies with the applicable requirements of the following international and national standards:
- . IEC 60601-1:2005 + A1:2012 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2:2014 - Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- . IEC 60601-2-27:2011 + COR1:2012 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- IEC 62304:2006 + A1:2015 - Medical Device Software - Software Life Cycle Processes
- o ISO 14971:2019 - Medical Devices - Application Of Risk Management To Medical Devices
- IEC 62366-1:2015 + COR1:2016 - Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
- ISO 10993-1:2018 - Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
- . ISO 10993-5:2009 - Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10:2010 - Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- . ISO 10993-12:2012 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO 10993-18:2020: Biological evaluation of medical devices – Part 18: Chemical characterization of materials
{9}------------------------------------------------
- 0 ANSI AAMI EC53:2013/(R)2020 - ECG trunk cables and patient leadwires
- EN 55011:2011 - Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
- EN 55032:2016 - Electromagnetic compatibility of multimedia equipment - Emission Requirements
- . ISO 15223-1: 2016: Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
- . ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
The following FDA Guidance Documents have been applied:
- . FDA: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014
- Off-The-Shelf Software Use in Medical Devices, 2019
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", 2020
- o Radio Frequency Wireless Technology in Medical Devices, 2013
- Applying Human Factors and Usability Engineering to Medical Devices, 2016
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 2017
- . Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015
Conclusion
Both the subject and the predicate device have a similar intended use and use comparable technical features. They both fulfill the same applicable standards for Medical Electrical Equipment. However, the devices differ in terms of a different frequency band and a different protocol to encode the transmitted data as well as different patient superficial contacting material. Fulfilling all applicable FDA-recognized consensus standards for Radio Frequency Wireless Technology, Electromagnetic Compatibility and Biocompatibility, no further questions regarding safety and performance are raised. Both devices are deemed to be substantially equivalent.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).