The device implements wireless communication vireless technology or wired with USB communication. With both connection modes, HD+ sends the data to the receiver device without performing any analysis or filtering. HD+ is not intended for monitoring of the cardiac function or to diagnose the patient's health condition. Display, print and analysis applications on the receiver device are separate products. HD+ is not able to permanently store the acquired data, therefore it does not work unless a connection has been established with a receiver application. Furthermore, HD+ does not collect any of the patient's name, age, previous health conditions etc.).

HD+ detects the QRS complexes and transmit the receiving device. The QRS detection function is intended for patients aged 12 years or older.

*HD+ is indicated for the acquisition of ECG signals with the patient in resting conditions, for example for diagnostic ECG's and rhythm strips

*HD+ is suitable for working at high altitudes, with restrictions.

*HD+ is intended for use on patients, with no limits of age or gender, except for the HR detector function which is intended for patients 12 years or older

HD+ is intended for use in medical facilities (hospitals, clinics), at home or emergency settings (ambulances).

*HD+ is intended for use by a physician, nurse or other healthcare professional (e.g., ECG technician) who acts following orders by a physician or authorized nurse, including when operated in home environments

*HD+ is not intended for real-time monitoring of vital physiological parameters.

Device Description

HD+12 and HD+15 are the new revisions of Cardioline's HD+ wireless acquisition module. The HD+ is a digital portable acquisition device which can acquire the electrocardiographic signal of 12 and 15 standard leads. Connected with a receiver via Bluetooth or USB (with the optional USB connector), the HD+ performs no analysis or filtering but sends acquired data to a host application where the User Interface is implemented. By default, the device includes a demo compatible software "HD+ Display" whose purpose is providing a UI for viewing the traces acquired by HD+. HD+ Display provides a simple UI, sufficient to configure the application to connect to an HD+ device via Bluetooth (the application automatically detects if an HD+ device is connected via USB and does not require additional configuration) and sufficient to display the ECG traces as received by HD+. HD+ Display does not provide any clinical functionality; therefore, it does not provide any capability to store, print or analyze the acquired ECG.

lt is the host (PC or Tablet separated by HD+) which performs the analysis. HD+ is not intended to control or analysis heart function and/or to diagnose the patient's health status. The analysis program on the host is a separate product not marketed with the HD+.

HD+ is a wireless acquisition device, to be primarily used as ECG front-end acquisition device for PC/tablet (Windows/MAC OS/Android/iOS/others) standard platforms for Resting ECG applications. Depending on performance/price ratio, HD+ could be also used with selected embedded electrocardiographs. HD+ allows the patient to be ambulatory.

HD+ uses a standard Bluetooth data transmission technology to transmit 12-lead and 15-lead ECG data over a proximity range, providing electrical insulation and freedom of movement for the patient. The device implements the wireless communication via Bluetooth wireless technology. The Bluetooth radio protocol is implemented by a dedicated module, FCC compliant. In order to support the data transmission speed of the application, the device implements the BLE 5 protocol with DLE (Data Length Extension) and 2M PHY (bandwidth up to 2 Mbit/s). The minimum specifications of the device connected to HD+ is BLE 4.2 to support the band required by acquisitions at 500 s/s. In order to operate at 1000 s/s, the connected device must be BLE 5.0 (or higher) and have a compatible 2M PHY radio (2 Mbit/s). Alternatively, in addition to Bluetooth connectivity described above, the HD+ has an optional USB interface that can be used to transmit data. The USB interface provides an electrical insulation offering two means of patient protection (2MPP), allowing HD+ to be connected to any IT equipment conforming to IEC 62368-1.

The HD+ function consists of acquiring and transmitting ECG signals for display processing ECG signals for the purpose of supporting the diagnosis of patient conditions. The device does not store nor does it associate patient identification data to the acquired signal, nor does it perform analysis on such signal. The HD+ is used solely for transmission of ECG signals from patient to a host analysis platform.

The HD+ transmits a continuous stream of ECG samples at a rate of 500 s/s or 1000 s/s, with a resolution of 0.817 uV/LSB or 2.495 uV/LSB, selectable by the calling application of the host analysis platform. The average required transmission throughput for sending 15 leads at 1000 s/s is approximately 155kbit/s, while to send 12 leads at 500 s/s the required throughput is approximately 54 kbit/s. BLE 5 2M PHY provides the bandwidth needed to support the maximum required throughput.

The BLE communication link ensures that data is either received correctly or not received at all. It is up to the host application to detect packet losses, handling the data gaps appropriately (e.g. by filling the stream with invalid dummy samples, signaling transmission errors etc...). This approach has been preferred over enabling the data retransmission (supported by the module) to reduce the data iitter and transmission delay.

HD+ uses standard 12 lead or 15 lead ECG cables to acquire the physiological signal from the patient. HD+ is light and compact, comfortable to wear, minimizing motion artifacts caused by traditional electrodes and patient cables.

HD+ offers full ECG acquisition - meeting the standards used in clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). HD+ uses a LED indicator to comfortably monitor the link status (off when unit is powered down, blinking when unit is attempting to connect with the receiver, steady when unit is connected with the receiver). HD+ uses a programmable key to send macro commands to the receiving system (i.e. acquire and print an ECG). Low-power technology allows continuous usage of the device for more than 10 hours (from full battery charge).

The HD+ continuously transmits the acquired data to a computer platform where compatible software, a Host Application authorized by Cardioline, is installed that acts as its User Interface. As an example of such Host Application, the device includes a compatible demo Windows application "HD+ display" from Cardioline to visualize the ECG traces and check the functionality of the results of the analysis must always be validated by qualified, trained medical personnel and the HD+ is intended for use in a medical environment. HD+ is intended to be used on adult and all pediatric patients. The device must be handled with care by taking all the necessary precautions in order to prevent and avoid shocks, vibrations, heat sources, liquids and anything else that may damage it.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Cardioline HD+12, HD+15), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than proving a device meets specific acceptance criteria through a clinical study in the way an AI/ML algorithm might.

Therefore, the document does not contain details about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML algorithm's performance. The device described in the document is an ECG signal acquisition and transmission device, explicitly stating that it "sends the data to the receiver device without performing any analysis or filtering" and "is not intended for monitoring or analysis of the cardiac function or to diagnose the patient's health condition." It also mentions that "clinical evaluation is not required" because it's an acquisition device without analysis, diagnosis, or monitoring features.

However, I can extract information related to performance testing conducted to support the substantial equivalence claim, which serves a similar purpose to meeting acceptance criteria for a non-AI/ML device.

Here's an analysis based on the provided text, while acknowledging that it doesn't align with the detailed AI/ML study requirements in the prompt:

Acceptance Criteria and Device Performance (for a non-AI/ML acquisition device)

The document primarily focuses on demonstrating that the new devices (HD+12, HD+15) are substantially equivalent to a predicate device (HD+) by showing adherence to relevant standards and similar performance characteristics. The "acceptance criteria" here are essentially compliance with safety and performance standards for a physiological signal acquisition device.

1. Table of Acceptance Criteria (based on standards compliance and comparative features):

Category / "Acceptance Criteria" (Standard/Feature)	Reported Device Performance (HD+12, HD+15)	Notes on "Acceptance" / Compliance
Safety Standards
IEC 60601-1 (General medical electrical equipment)	Full compliance demonstrated	Met
IEC 60601-2-25 (ECG Specific)	Full compliance demonstrated	Met
IEC 60601-1-11 (Home healthcare environment)	Full compliance demonstrated	Met (Additional for home use compared to predicate)
Electromagnetic Compatibility (EMC)
IEC 60601-1-2	Full compliance demonstrated	Met
Radio Equipment Standards
ETSI EN 300 328	Full compliance demonstrated	Met
ETSI EN 301 489-1	Full compliance demonstrated	Met
ETSI EN 301 489-17	Full compliance demonstrated	Met
ETSI EN 300 440-2	Full compliance demonstrated	Met
FCC CFR 47 Part 15 (US)	Full compliance demonstrated	Met
Specific ECG Performance Parameters (based on IEC 60601-2-25)
Patient Derivation Polarity	Tested	Implicitly meeting expected performance for substantial equivalence.
Minimum System Switch Leads	Tested	Implicitly meeting expected performance for substantial equivalence.
Goldberger and Wilson Derivations	Tested	Implicitly meeting expected performance for substantial equivalence.
Input Impedance and Circuit Lead	Tested	Implicitly meeting expected performance for substantial equivalence.
Common Mode Rejection (CMRR)	≥100dB (Predicate: 115 dB)	Equivalent performance (considered acceptable).
Noise Level	Tested	Implicitly meeting expected performance for substantial equivalence.
Writing Speed and Trace Width	Tested	Implicitly meeting expected performance for substantial equivalence.
Channels Interaction	Tested	Implicitly meeting expected performance for substantial equivalence.
High Frequency Response	Performances equivalent to 0.05-150 Hz (@ 500 c/s); 0.05-300 Hz (@ 1000 c/s) (Predicate: 0.05-300 Hz)	Same performance where applicable.
Low Frequency Response	Tested	Implicitly meeting expected performance for substantial equivalence.
Linearity and Dynamic Range	HiRES mode: +/- 330mV; StdRES mode: +/- 500 mV (Predicate: +/- 400mV @ < 1uV/LSB)	HIRES equivalent; StdRES offers higher dynamic range with reduced resolution. Considered acceptable.
Minimal Signal Response	Tested	Implicitly meeting expected performance for substantial equivalence.
Sampling and Resolution	500 and 1000 samples/second/channel (analysis); 24 bit A/D; HiRES: <1 µV/LSB; StdRES: ~2.5 µV/LSB (Predicate: 1000 samples/s; 24 bit; 20 bit, <1uV/LSB)	Allows for downgrading if bandwidth is insufficient; HIRES equivalent; StdRES offers option. Considered acceptable.
Recording Speed	Tested	Implicitly meeting expected performance for substantial equivalence.
ECG Distortion	Tested	Implicitly meeting expected performance for substantial equivalence.
Impulse Visibility of Pace-Maker	Software on 128K c/s simultaneous on lead pairs; Impulse duration: 0.2-2ms; Impulse width: 2-250mV (Predicate: Hardware detection + digital filtering)	Increased detection sensitivity, IEC 60601-2-25 requirements met. Considered acceptable.
Internal Electrical Source Requirements	Tested	Implicitly meeting expected performance for substantial equivalence.
Functional Features
ECG Leads	12 and 15 Leads (Predicate: 12 Leads)	Additional 3 optional leads.
Wireless System	BLE 5 or higher with DLE and 2M PHY support (Predicate: Bluetooth 2.1 + EDR)	Updated to most current Bluetooth version.
USB Communication	USB Communication Device Class (RS-232 port emulation) (Predicate: None)	Addition of USB option.
Patient Cable	10 wire replaceable wire patient lead; 13 wire replaceable patient cable (Predicate: 10 wire single connector)	Additional cable for HD+15.
Target Population	Adults and pediatric patients (same as predicate)	Same.
Use Environment	Hospitals, Clinics, Home, Ambulance (Predicate: Hospitals, Clinics)	Expanded.
User	Physician, nurse, other healthcare professional (e.g., ECG technician) (Predicate: Nurse, Physician and trained medical personnel)	Expanded.

Regarding the AI/ML-specific criteria from your prompt:

The provided document does not include information for most of these categories because the device is a data acquisition and transmission device, not an AI/ML diagnostic or analysis tool. The key statement is: "HD+ is only an acquisition device without an analysis, diagnosis and monitoring features, so clinical evaluation is not required."

Here's an assessment based on the document's content:

Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to specific performance tests on the device's hardware and software (e.g., electrical signal accuracy, EMC), not a clinical dataset for an AI algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an ECG acquisition device relates to physical and electrical properties, not expert interpretation of ECGs (as the device itself performs no analysis).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the "performance tests" mentioned (e.g., noise level, frequency response), the ground truth is established by engineering standards, calibrated measurement equipment, and known electrical signals, not clinical outcomes or expert consensus on patient data.
The sample size for the training set: Not applicable (not an AI/ML device).
How the ground truth for the training set was established: Not applicable (not an AI/ML device).

In summary, the provided FDA 510(k) summary is for a traditional medical device (ECG signal acquisition system) and thus does not contain the specific AI/ML-related study and acceptance criteria details requested in your prompt.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 15, 2023

Cardioline S.P.A % Brian Brenegan Regulatory Correspondent CYA Medical Device Consulting, LLC 34340 Venice Beach Road Oconomowoc, Wisconsin 53066

Re: K220526

Trade/Device Name: HD+12, HD+15 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: April 14, 2023 Received: April 14, 2023

Dear Brian Brenegan:

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.

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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) 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 (OS) 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.

Aneesh S. Deoras -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220526

Device Name HD+12, HD+15

Indications for Use (Describe)

The function of the device is the acquisition and transmission of the ECG signal in order to support diagnosis of the patient's conditions.

HD+ detects the QRS complexes and transmit the receiving device. The QRS detection function is intended for patients aged 12 years or older.

*HD+ is indicated for the acquisition of ECG signals with the patient in resting conditions, for example for diagnostic ECG's and rhythm strips

*HD+ is suitable for working at high altitudes, with restrictions.

*HD+ is intended for use on patients, with no limits of age or gender, except for the HR detector function which is intended for patients 12 years or older

HD+ is intended for use in medical facilities (hospitals, clinics), at home or emergency settings (ambulances).

*HD+ is not intended for real-time monitoring of vital physiological parameters.

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.

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510(k) SUMMARY HD+12, HD+15

1. SUBMITTER

CARDIOLINE S.p.A Via Linz, 151 3838121 Trento Italy T +39 0461 96821

Contact Person: David Lombardi Date prepared: 05 May 2023

2. DEVICE

Name of Device: Cardioline HD+12, HD+15 Common or Usual Name: HD+ Classification Name: Physiological Signal Acquisition Device Regulatory Class: II Product Code: DRG CFR 870.2910 Transmitter and Receivers, Physiological Signal, Radiofrequency

3. PREDICATE DEVICE

Manufacturer name	Applicant Name	Predicate Device	510(k) Number
Cardioline S.p.A.	Cardioline S.p.A.	HD+	K150289

4. DEVICE DESCRIPTION

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5. INDICATION FOR USE

The function of the device is the acquisition and transmission of the ECG signal in order to support diagnosis of the patient's conditions.

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HD+ is a wireless or USB (with appropriate option) ECG acquisition device, to be used primarily as common front-end for standard PC/tablet platforms (Windows/MAC OS/others), for resting ECG applications. The device implements wireless communication via Bluetooth wireless technology or wired with USB communication. With both connection modes, HD+ sends the receiver device without performing any analysis or filtering.

HD+ is not intended for monitoring or analysis of the cardiac function or to diagnose the patient's health condition. Display, print and analysis applications on the receiver device are separate products. HD+ is not able to permanently store the acquired data, therefore it does not work unless a connection has been established with a receiver application. Furthermore, HD+ does not collect any of the patient's sensitive data (patient's name, age, previous health conditions etc.).

HD+ detects the QRS complexes and transmit the receiving device. The QRS detection function is intended for patients aged 12 years or older.

. HD+ is indicated for the acquisition of ECG signals with the patient in resting conditions, for example for diagnostic ECG's and rhythm strips
트 HD+ is suitable for working at high altitudes, with restrictions.
트 HD+ is intended for use on patients, with no limits of age or gender, except for the HR detector function which is intended for patients 12 years or older
. HD+ is intended for use in medical facilities (hospitals, clinics), at home or emergency settings (ambulances).
HD+ is intended for use by a physician, nurse or other healthcare professional (e.g., ECG technician) who acts following orders by a physician or authorized nurse, including when operated in home environments
. HD+ is not intended for real-time monitoring of vital physiological parameters.

FEATURES	CARDIOLINE HD+12, HD+15	CARDIOLINE HD+	Comparison
Intended use	The function of the device is theacquisition and transmission of theECG signal in order to supportdiagnosis of the patient'sconditions.HD+ is a wireless or USB (withappropriate option) ECG acquisitiondevice, to be used primarily ascommon front-end for standardPC/tablet platforms(Windows/MAC OS/others), forresting ECG applications.	HD+ is a physiological ECGacquisition module. HD+transmits wireless, via Bluetoothto a PC or Tablet, the dataacquired, without making anyanalysis or filtering on the dataacquired. HD+ acquires 12-leadECG waveforms meeting thestandards for clinical anddiagnostic applications (AAMI,ANSI, AHA, ACC) and offers fullECG acquisition. HD+ is designedto acquire and transmit a high-quality ECG data allowing the	Similar function of the deviceremains the same, addition ofuse environment s (home andambulance), addition of use by aphysician, nurse or
The device implements wirelesscommunication via Bluetoothwireless technology or wired withUSB communication. With bothconnection modes, HD+ sends thedata to the receiver device withoutperforming any analysis or filtering.HD+ is not intended for monitoringor analysis of the cardiac functionor to diagnose the patient's healthcondition. Display, print andanalysis applications on thereceiver device are separateproducts. HD+ is not able topermanently store the acquireddata, therefore it does not workunless a connection has beenestablished with a receiverapplication. Furthermore, HD+does not collect any of thepatient's sensitive data (patient'sname, age, previous healthconditions etc.).HD+ detects the QRS complexesand transmit the results to thereceiving device. The QRS detectionfunction is intended for patientsaged 12 years or older.	patient to be free to moving(without cable connected to theprocessing unit).The HD+ transmits the acquiredphysiological signals in real-timeto a computer/device where acompatible application isinstalled. All data acquired aresent via Bluetooth to a receiverthat it can be a PC, tablet ordevice capable of receiving BTdata. The ECG is transmittedverbatim to the receiving system,without LSB or samplingadjustment. It is up to thereceiving system/application toperform the necessary processingsuch as (but not limited to) LSBscaling, signal filtering, RestingECG analysis etc...The device HD+ is intended to beused on adult and on all pediatricpatients.The device is intended for use byqualified, trained nurses andphysicians operating in hospitals,clinics and medical practices.	otherhealthcareprofessional(e.g., ECGtechnician)who actsfollowingorders by aphysician orauthorizednurse,addition ofwiredconnectionoption
HD+ is indicated for theacquisition of ECG signalswith the patient in restingconditions, for example fordiagnostic ECG's andrhythm strips
HD+ is suitable for workingat high altitudes, withrestrictions.
HD+ is intended for use onpatients, with no limits ofage or gender, except forthe HR detector functionwhich is intended forpatients 12 years or older
HD+ is intended for use inmedical facilities (hospitals
	clinics), at home oremergency settings(ambulances).HD+ is intended for use by aphysician, nurse or otherhealthcare professional(e.g., ECG technician) whoacts following orders by aphysician or authorizednurse, including whenoperated in homeenvironmentsHD+ is not intended forreal-time monitoring ofvital physiologicalparameters.
Targetpopulation	Adults and pediatric patients	Adults and pediatric patients	Same
Safetystandards	IEC 60601-1IEC 60601-2-25IEC 60601-1-11	IEC 60601-1IEC 60601-2-25CB scheme	Additionalstandard forhome use
EMC standards	IEC 60601-1-2	IEC 60601-1-2	Same
RADIO standards	ETSI EN 300 328ETSI EN 301 489 -1ETSI EN 301 489 -17ETSI EN 300 440 -2FCC CFR47 Part 15 (US)	ETSI EN 300 328ETSI EN 301 489 -1ETSI EN 301 489 -17ETSI EN 300 440 -2FCC CFR47 Part 15 (US)	Same
ECG Leads	12 and 15 Leads	12 Leads	Optional 3additionalleads
Sampling Rate	500 and 1000samples/second/channel foranalysis	1000samples/second/channel foranalysis	Allows fordowngradingif theBluetooth linkdoes notprovidesufficientbandwidth
Leads Connector	Single connector	Single connector	Same
Standard LeadsAcquired	12-leads (I, II, III, aVR-L-F, V1-6)15-leads (I, II, III, aVR-L-F, V1-6, E1-2-3)	I, II, III, aVR-L-F, V1-6	Optional 3additionalleads
A/D Conversion	24 bit	24 bit	Same
Data Resolution	HiRES mode: <1 µV/LSB (@500 c/s)StdRES mode: ~2.5 µV/LSB	20 bit, < 1uV/LSB	HIRESoperatingmodeequivalent topredicatedevice.StdRES modereduces theresolution inexchange forhigherdynamicrange
Input Range	HiRES mode: +/- 330mVStdRES mode: +/- 500 mV	+/-400mV @ < 1uV/LSB	HIRESoperatingmodeequivalent topredicatedevice.StdRES modereduces theresolution inexchange forhigherdynamicrange
Bandwidth	Performances equivalent to 0.05-150 Hz (@ 500 c/s)Performances equivalent to 0.05-300 Hz (@ 1000 c/s)	0.05 — 300 Hz	Same
CMRR	≥100dB	115 dB	Equivalentperformance
DefibrillatorProtection	AAMI/IEC standards	AAMI/IEC standards	Same
Pacemakerdetection	Software on 128K c/ssimultaneous on lead pairs (I, II),(V4, V5) and(E1, E2) (for 13 wire cable).Impulse duration range: 0.2 ms - 2msImpulse width range: 2mV -250mVEstimate of pacemaker spikeduration and amplitude	Hardware detection coupledwith convolution digital filtering	Increaseddetectionsensitivity,requirementsof IEC 60601-2-25 met.
WirelessSystem	BLE 5 or higher with DLE (DataLength Extension) and radio with2M PHY support (for 1000 c / s)BLE 4.2 or higher with DLE (for 500c / s)	Bluetooth 2.1 + EDR	Updated tomost currentBluetoothversion
USBCommunication	USB Communication Device Class(RS-232 port emulation)	None	Addition ofUSB option
Patient Cable	10 wire replaceable wire patientlead13 wire replaceable patient cable	10 wire single connector	Additionalcable forHD+15enabling theacquisition oftheadditionalleads
Batteries	2 x 1,5 standard AAA.Battery life 10 hours	2 x 1,5 standard AAA.Battery life 10 hours	Same
IP Degree	IP 40 / IP 42 with silicon cover	IP 40 / IP 42 with silicon cover	Same
Environmental	Temperature: 0 to 40 °CRelative humidity: 15 to 95 %(without condensation)Atmospheric pressure: 540 mbar -1060 mbar (Bluetooth); 700 mbar -1060 mbar (USB)	Temperature: 10 to 40 °CRelative humidity: 25 to 95 %(without condensation)Atmospheric pressure: 700 to1060 mbar	Similar
Storageenvironmentalconditions	Temperature and humidity: -40 °Cto +5 °C without relative humiditycontrol ; +5 °C to +40 °C, up to 90% relative humidity, withoutcondensation ; 40 °C to 70 °C withwater vapour pressure up to 50hPa;Atmospheric pressure: 540 mbar;1060 mbar	Temperature: -10 to +40 °CRelative humidity: 25 to 95 %(without condensation)Atmospheric pressure: 500 to1060 mbar	Similar
Where usedBy	Hospitals, Clinics, Home,Ambulance by aphysician, nurse or otherhealthcare professional (e.g., ECGtechnician) who acts followingorders by a physician or authorizednurse	Hospitals, Clinicsby Nurse, Physician and trainedmedical personnel	Similar –addition ofhome andambulanceand use by aphysician,nurse orotherhealthcareprofessional(e.g., ECGtechnician)who acts

6. TABULAR COMPARISON WITH PREDICATE DEVICES

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			followingorders by aphysician orauthorizednurse

7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Full safety test according to IEC 60601-1-11, and IEC 60601-2-25 have been performed on the device. These tests have shown full compliance with these standards.

The device has been subjected to Electromagnetic Compatibility testing procedure according to EN 60601-1-2 standard. Tests have shown full compliance with this standard.

The Bluetooth module complies with ETSI EN 300 328, ETSI EN 301 489-1 and ETSI EN 301 489-17 standards concerning the radio equipment and telecommunication terminal equipment. Tests are also carried out according to FCC CFR 47 Part 15 rules. Tests have shown full compliance with these standards.

The performance tests are carried out according to IEC 60601-2-25 and the performance tested are:

Patient Derivation Polarity
Minimum System Switch Leads
Goldberger and Wilson Derivations
Input Impedance and Circuit Lead
Common Mode Rejection
Noise Level
Writing Speed and Trace Width
Channels Interaction
High Frequency Response
Low Frequency Response
Linearity and Dynamic Range
Minimal Signal Response
Sampling and Resolution
Recording Speed
ECG Distortion
Impulse Visibility of Pace-Maker
Internal Electrical Source Requirements

8. CONCLUSION

The safety features of the CARDIOLINE HD+12 and HD+15 are identical to those of the predicate device CARDIOLINE HD+.

The fundamental function and performance of HD+12 and HD+15 are the same as the predicate with additional features and are summarized in the table above.

The conclusions drawn from the performance tests demonstrate that the device is as effective, and performs as well as the legally marketed device identified in the substantial equivalence. HD+12 and HD+15, like the predicate HD+, is only an acquisition device without an analysis, diagnosis and monitoring features, so clinical evaluation is not required.

Regulation Number and Section

§ 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).