ers2 - ergoline Rehabilitation System

K212883 · Ergoline GmbH · DRG · Jul 15, 2022 · Cardiovascular

Device Facts

• Record ID: K212883
• Device Name: ers2 - ergoline Rehabilitation System
• Applicant: Ergoline GmbH
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

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 for inpatient and outpatient care.

Device Story

System records single-channel bipolar surface ECG via two electrodes; transmits signal via Bluetooth to PC-based software. Software processes ECG for heart rate calculation; displays QRS complex for visual assessment; controls training load on ergometers or during free exercise. Used in professional healthcare (inpatient/outpatient) by therapists to monitor/document training sessions. Up to eight patients monitored per 22-inch monitor. Transmitter is body-worn, battery-powered; receiver connects to PC USB port. Output assists clinicians in adjusting exercise intensity; benefits patients by enabling safe, monitored rehabilitation training.

Clinical Evidence

Bench testing only. System validated for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance (IEC 60601-2-27). Software verified and validated per IEC 62304. Usability validated per IEC 62366-1. Biocompatibility testing performed per ISO 10993 series.

Technological Characteristics

Single-channel bipolar ECG telemetry. Transmitter: ABS enclosure, rechargeable NiMH battery. Adapter: TPE (THERMOLAST M). Connectivity: Bluetooth (2402–2483.5 MHz). Software: Windows-based PC application. Standards: IEC 60601-1, IEC 60601-2-27, ISO 10993, IEC 62304. Type CF applied part, defibrillation protected.

Indications for Use

Indicated for adult patients requiring ECG monitoring during cardiac or pulmonary rehabilitation or preventive training activities in professional healthcare settings. Not for detection or diagnosis of cardiac conditions.

Regulatory Classification

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.

Predicate Devices

• TeleRehab 2004 Cardiopulmonary Rehabilitation System (K050778)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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#### 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)

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#### 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 [e-mail] [phone]
- 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.

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# 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 predicate<br>device | Similar / Different |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212883 | K050778 | - |
| Device Name, Model | | | |
| | ers2 - ergoline<br>Rehabilitation System | TeleRehab 2004<br>Cardiopulmonary<br>Rehabilitation System | - |
| Manufacturer | ergoline GmbH | ScottCare | - |
| Regulation Number | 890.2910 | 890.2910 | Similar |
| Product code | DRG | DRG | Similar |
| Indications for Use | The ers2 – ergoline<br>Rehabilitation System<br>is a device for<br>recording of a single-<br>channel, bipolar<br>surface ECG (frontal<br>plane) acquired with<br>two ECG electrodes.<br>The ECG is<br>transmitted to the<br>ers2 software where it<br>is processed for<br>heartrate calculation,<br>displayed for visual<br>QRS complex<br>assessment and to<br>control the training<br>load for a patient´s<br>rehabilitation or<br>preventive training<br>activities.<br>The ers2 system is not<br>intended to be used<br>to detect or diagnose<br>cardiac conditions<br>(e.g. arrhythmias, ST-<br>elevation, etc. pp).<br>The signal is acquired<br>on the intact skin of<br>adult patients.<br>The medical device is<br>intended for use in<br>professional<br>healthcare Institutions<br>for inpatient and<br>outpatient care. | This device is intended<br>to acquire and<br>condition the ECG<br>signal from a patient<br>so that it can be<br>transmitted via radio<br>frequency (WMTF)<br>with a Stickman<br>telemetry transmitter<br>to a workstation in a<br>hospital or clinical<br>setting where the ECG<br>is displayed and<br>analyzed. This device<br>is for use with<br>ambulatory adult<br>patients, which need<br>monitoring while<br>undergoing cardiac or<br>pulmonary<br>rehabilitation. The<br>data output from<br>monitoring is viewed<br>and stored on a<br>workstation for<br>tracking of the<br>patients' progress<br>through rehabilitation.<br>Patient demographics,<br>exercise protocol and<br>medical information<br>can be entered via a<br>variety of<br>commercially available<br>wireless input devices<br>or automatically<br>through an HL-7<br>hospital network<br>interface. A database<br>can be created for use<br>with an Outcomes<br>program. | Similar besides<br>different frequency<br>bands and a different<br>proprietary protocol<br>to encode the<br>transmitted data |
| Transmission signal | Radiofrequency | Radiofrequency | Similar |
| Transmission<br>equipment | Telemetry transmitter<br>and receiver | Telemetry transmitter<br>and 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, defibrillation<br>protected | CF, defibrillation<br>protected | Similar |
| Defibrillation<br>Recovery | Within 5 seconds | Within 8 seconds | Similar |
| Maximum distance | 164 feet | 100 feet | Different |
| Displayed parameters | ECG, HR, Thr; Load<br>and RPM, Slope and<br>speed, BP, CAL, METS | ECG, HR, SpO2, BP,<br>THR, CAL, METS,<br>RHR, RBP | Similar for the<br>intended use |
| Connection of the<br>device to electrodes | Electrodes are<br>connected via cables<br>to the adapter and<br>thus to the<br>transmitter. | Electrodes are<br>connected via cables<br>directly to the<br>transmitter | Different |
| Electrodes | 2 standard 510(k)<br>cleared sticking<br>electrodes | 3 or 5 standard 510(k)<br>cleared sticking<br>electrodes | Similar |
| Power Source(s) | Transmitter: 1 x<br>HR03/AAA NiMH<br>rechargeable battery,<br>1.2 V | Transmitter: 3x AAA,<br>alkaline batteries, 1.5<br>V | Different |
| Battery life | 6 hours, rechargeable | 60 hours | Different |
| - Method of Line<br>Current Isolation | Power Supply in<br>accordance with IEC<br>60601-1 | Power Supply in<br>accordance with IEC<br>60601-1 | Similar |
| Operator | Professional user in a<br>clinical setting | Professional user in a<br>clinical setting | Similar |
| Compliance with 21<br>CFR 898?<br>(Mandatory since<br>May 9, 2000) | Yes | Yes | Similar |
| Lead wires – cables | M-PUR: Compliant<br>with protected lead<br>wire and patient cable<br>safety requirements | DIN: Compliant with<br>protected lead wire<br>and patient cable<br>safety requirements | Different |
| Patient contact<br>material | Cord:<br>Silicone, ELASTOSIL® R<br>Plus 4001/60 MH<br>(WACKER) | Cord:<br>DIN style shielded lead<br>wire<br>ECG leadwires with<br>electrode clips: | Different |

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| | electrode clips:<br>M-PUR<br>Electrodes:<br>Standard 510(k)<br>cleared sticking<br>electrodes, not<br>included with the<br>device<br>Adapter base:<br>TPE, THERMOLAST® M<br>TM9MED (TPE<br>Kraiburg)<br>Colorant: Masterbatch<br>Blau (Pantone 7451 U)<br>Transmitter:<br>SINKRAL L 322 - ABS | M-PUR<br>Electrodes:<br>Standard 510(k)<br>cleared sticking<br>electrodes, not<br>included with the<br>device<br>Transmitter:<br>Polymer | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Environmental<br>conditions: | Temperature:<br>-20 – 65 °C<br>Relative Humidity:<br>10 – 95 % | Temperature:<br>10 – 40 °C<br>Relative Humidity:<br>10 – 90 % | Similar |
| Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-27<br>ANSI/AAMI EC53<br>EN 61000-4-2<br>EN 61000-4-3<br>EN 61000-4-6<br>EN 61000-4-8<br>EN 55011<br>EN 55032<br>ISO 14971<br>IEC 62366-1<br>IEC 62304<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-12 | IEC 60601-1<br>IEC 60601-1-2<br>ANSI/AAMI EC-13<br>EN 61000-3-2<br>EN 61000-3-3<br>EN 61000-4-2<br>EN 61000-4-3<br>EN 61000-4-4<br>EN 61000-4-5<br>EN 61000-4-6<br>EN 61000-4-8<br>EN 55011 | Similar |

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# 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

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- 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.