HD+ is a physiological ECG acquisition module. HD+ transmits wireless, via Bluetooth to a PC or Tablet, the data acquired, without making any analysis or filtering on the data acquired.

HD+ acquires 12-lead ECG waveforms meeting the standards for clinical and diagnostic applications (AAMI, ANSI, AHA, ACC) and offers full ECG acquisition.

HD+ is designed to acquire and transmit a high quality ECG data allowing the patient to be free to moving (without cable connected to the processing unit).

The HD+ transmits the acquired physiological signals in real-time to a computer/device where a compatible application is installed.

All data acquired are sent via Bluetooth to a receiver that it can be a PC, tablet or device capable of receiving BT data. The ECG is transmitted verbatim to the receiving system, without LSB or sampling adjustment. It is up to the receiving system/application to perform the necessary processing such as (but not limited to) LSB scaling, signal filtering, Resting ECG analysis etc ...

The device HD+ is intended to be used on adult and on all pediatric patients.

The device is intended for use by qualified, trained nurses and physicians operating in hospitals, clinics and medical practices.

Device Description

The HD+ is a digital portable acquire which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the host but doesn't make any analysis or filtering. It's the host (PC or Tablet separated by HD+) which make the analysis. HD+ is not intended to control or analysis heart function and/or to diagnose the patient's health status. 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 common ECG front-end for PC/tablet (Windows/MAC OS/other) standard platforms (both for Resting ECG and Stress ECG applications). Depending on performance/price ratio, HD+ could be also used with selected embedded electrocardiographs.

HD+ allow the patient to be ambulatory.

HD+ uses a standard Bluetooth data transmission technology to transmit 12-lead ECG data over a proximity range, providing perfect 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 chipset developed by Bluegiga Technologies (WT-12). The device is a BT 2.1 compliant device. Its rated emission power is 3.46 dBm and uses the Bluetooth radio bandwidth (2402-2480 Hz, 79 channels).

The device function consists of acquiring and wirelessly transmitting ECG signal for displaying, processing and presenting ECG signal for the purpose of supporting the diagnose of patient conditions.

The device does not store nor does associate patient identification data to the acquired signal, nor does it perform analysis on such signal.

The device transmits a continuous stream of ECG samples at rate of 500 s/s and a resolution < 1uV/LSB. The bitrate required by the application is ~90 kbit/s at 500 s/s and ~180 kbit/s at 1000 s/s.

In order to support the application data throughput, the device implements the Bluetooth Serial Port Profile (SPP) with EDR (Enhanced Data Rate), which nominally provides a bandwidth up to 2 mbit/s.

The SPP adopted by the device ensures that data is either 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 jitter and transmission delay.

HD+ uses standard 12 lead ECG cable to acquire the physiological signal to 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+ transmits the acquired data in real-time to a computer where one of the compatible CARDIOLINE software is installed. The results of the analysis must always be validated by qualified, trained medical personnel and the device 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

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Cardioline HD+ device:

Based on the provided 510(k) summary for the Cardioline HD+ (K150289), the device is a physiological ECG acquisition module that wirelessly transmits acquired data without performing analysis or filtering. Therefore, the "acceptance criteria" discussed in the document are primarily related to technical performance standards and safety/EMC compliance, rather than clinical performance metrics often associated with AI/analysis devices (like sensitivity, specificity, or reader improvement).

1. Table of Acceptance Criteria and Reported Device Performance

Since this device is a data acquisition and transmission module without analytical capabilities, the acceptance criteria are based on adherence to established medical device standards for ECG acquisition. The document doesn't provide a direct "acceptance criteria" table with specific pass/fail values for each parameter, but it lists the standards and the performance tests carried out.

Acceptance Criteria Category / Parameter	Reported Device Performance
Safety Standards Compliance	Full compliance with IEC 60601-1 and IEC 60601-2-25.
Electromagnetic Compatibility (EMC)	Full compliance with EN 60601-1-2 standard.
Radio/Wireless Standards (Bluetooth)	Compliance with ETSI EN 301 489-1, ETSI EN 301 489-17, and FCC CFR 47 Part 15 rules.
ECG Performance (IEC 60601-2-51)	Tests performed on: 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. (All indicated as "Test have shown full compliance with this standard" implicitly for previous items, and "performance test are carried out... according to IEC 60601-2-51" implying satisfactory results for these parameters).
Sampling Rate	1000 samples/second/channel for analysis (compared to predicate device values of 500 s/s).
A/D Conversion	24 bit (compared to predicate device 11 bit and unspecified).
Data Resolution	20 bit, < 1uV/LSB (compared to unspecified for predicates).
Input Range	+/-400mV @ < 1uV/LSB (compared to ± 300 mV @ 0 Hz, ± 5 mV in the through band for one predicate, and unspecified for another).
Bandwidth	0.05 — 300 Hz (compared to 0.05 Hz — 150 Hz for one predicate, and unspecified for another).
CMRR	115 dB (compared to > 100 dB for one predicate, and unspecified for another).
Battery Life	10 hours (compared to 30 hours and > 7 hours for predicates).

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

The document explicitly states: "HD+ is only an acquisition device without an analysis, diagnosis and monitoring features, so is not expected clinical evaluation." (Page 10)

Therefore, no clinical test set (i.e., human patient data for diagnostic accuracy assessment) was used. The "test set" in this context refers to the device itself being subjected to engineering and electrical performance tests. The data provenance would be laboratory testing in an engineering environment, not from human subjects or countries of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Given that no clinical evaluation was performed, there was no ground truth established by medical experts in the traditional sense for diagnostic accuracy. The "ground truth" for the engineering performance tests is the defined specifications and limits within the cited international and national standards (e.g., IEC, EN, FCC). The "experts" involved would be qualified test engineers and technicians performing the standard compliance tests.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring medical expert adjudication. The compliance tests are objective measurements against established standard specifications.

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

No MRMC study was done. This device is a pure data acquisition and transmission module, not an AI or analysis tool. It does not provide any interpretation or diagnostic assistance to human readers.

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

No standalone algorithm performance study was done. The HD+ itself does not contain any algorithms for analysis, diagnosis, or interpretation. It merely acquires and transmits raw ECG data.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for performance validation relates to engineering standards and specifications. For instance, the ground truth for "sampling rate" is 1000 samples/second/channel, verified by direct measurement. The ground truth for "CMRR" is 115 dB, verified by testing against the definition of Common Mode Rejection Ratio under specific conditions. There is no clinical "ground truth" (like pathology or expert consensus on diagnosis) that its performance would be measured against, as it performs no diagnostic function.

8. The Sample Size for the Training Set

No training set was used. The device does not employ machine learning or AI algorithms that would require training data.

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

Not applicable, as there was no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

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

August 27, 2015

Cardioline S.p.A Mr. Emanuele Ercoli Via De Zinis, 6 38011 Cavareno (TN), Italy

Re: K150289

Trade/Device Name: Cardioline HD+ Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: March 20, 2015 Received: July 22, 2015

Dear Emanuele Ercoli:

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 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

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Sincerely yours.

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) K150289

Device Name HD+

Indications for Use (Describe)

HD+ is a physiological ECG acquisition module. HD+ transmits wireless, via Bluetooth to a PC or Tablet, the data acquired, without making any analysis or filtering on the data acquired.

HD+ acquires 12-lead ECG waveforms meeting the standards for clinical and diagnostic applications (AAMI, ANSI, AHA, ACC) and offers full ECG acquisition.

HD+ is designed to acquire and transmit a high quality ECG data allowing the patient to be free to moving (without cable connected to the processing unit).

The HD+ transmits the acquired physiological signals in real-time to a computer/device where a compatible application is installed.

The device HD+ is intended to be used on adult and on all pediatric patients.

The device is intended for use by qualified, trained nurses and physicians operating in hospitals, clinics and medical practices.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY HD+ - K150289

1. SUBMITTER

CARDIOLINE S.p.A Via De Zinis, 6 38011 Cavareno (TN), Italy

T +39 0463 850125 F +39 0463 850088

Contact Person: Mr Emanuele Ercoli Date preparated: December 12, 2014

2. DEVICE

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

3. PREDICATE DEVICE

Manufacturer name	Applicant Name	Predicate Device	510(k) Number
Cardioline S.p.A.	Cardioline S.p.A.	Mortara X-12	K974149
Cardioline S.p.A.	Cardioline S.p.A.	Et medical devices S.p.A.	K082124

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4. DEVICE DESCRIPTION