(203 days)
Not Found
No
The summary explicitly states that the device acquires and transmits data without making any analysis or filtering. The analysis is performed by a separate host system.
No
The device is an ECG acquisition module that transmits physiological data. It does not perform any analysis, filtering, or therapeutic intervention, but rather collects data for other systems to process.
No
The device acquires ECG data and transmits it, but it explicitly states that it "doesn't make any analysis or filtering" and "is not intended to control or analysis heart function and/or to diagnose the patient's health status." The diagnostic analysis is performed on a separate host system.
No
The device description clearly states that the HD+ is a "digital portable acquire" and a "wireless acquisition device," which are hardware components. It acquires physiological signals using standard ECG cables and transmits them wirelessly via Bluetooth. While it relies on separate software for analysis, the device itself is a physical piece of hardware.
Based on the provided text, the device HD+ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- HD+ Function: The HD+ device acquires physiological signals (ECG waveforms) directly from the patient's body. It transmits this data wirelessly to a separate device for analysis.
- Lack of Sample Analysis: The description explicitly states that the HD+ "transmits wireless... the data acquired, without making any analysis or filtering on the data acquired." It also says, "HD+ is not intended to control or analysis heart function and/or to diagnose the patient's health status." The analysis is performed by a separate application on a different device.
Therefore, since the HD+ acquires data directly from the body and does not perform analysis on samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device. It is a physiological signal acquisition device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DRG
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
§ 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).
0
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
1
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
2
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.
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.
| 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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3
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 |
4
4. 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 100 dB |
| Defibrillator
Protection | AAMI/IEC standards | Defibrillator protected
when used with Mortara
Instrument patient cable | Protection against
defibrillation with
Discharging resistance in
the patient cable |
| Pacemaker | Hardware detection | Yes | Not specified |
| detection | coupled with convolution
digital filtering | | |
| Wireless System | Bluetooth 2.1 + EDR | Digital radio transmission
using a proprietary
encoding scheme | (in Bluetooth
version)
Bluetooth 1.0 |
| Patient Cable | 10 wire single connector | Single block 10 lead | 10 wire cable with banana
end |
| Batteries | 2 x 1.5 standard AAA | 2 x AA alkaline batteries | 4 AA ultra alkaline batteries |
| | Battery life 10 hours | Battery life 30 hours | or rechargeable NiMh (at
least 2500mAh) Battery life
7 hours |
| IP Degree | IP 40 / IP 42 with silicon
cover | Not specified | IP 20 |
| Environmental | - Temperature
between +10 and
+40 °C inclusive
-
Relative humidity
between 25 and 95
% inclusive
(without
condensation)
-
Atmospheric
pressure between
700 and 1060 mbar | - Operating
temperature
between 10 to 32
°C
-
Humidity between
20 to 80 %
Atmospheric
pressure between
700 and 1060
mbar | - Temperature
between +10 and
+40 °C inclusive
-
Relative humidity
between 25 and 95
% inclusive (without
condensation)
Atmospheric
pressure between
700 and 1060 mbar |
| Storage
environmental
conditions | - Temperature
between -10 e +40
°C inclusive
-
Relative humidity
between 25 and 95
% inclusive
(without
condensation)
-
Atmospheric
pressure between
500 and 1060 mbar
inclusive | - Temperature
between 0 e +45
°C
-
Relative humidity
between 10 and
90 % inclusive
(without
condensation)
Atmospheric
pressure between
700 and 1060
mbar inclusive | - Temperature
between -10 e +40
°C inclusive
-
Relative humidity
between 25 and 95
% inclusive (without
condensation)
Atmospheric
pressure between
500 and 1060 mbar
inclusive |
| Where used
By | Hospitals, Clinics.
Nurse, Physician and
trained medical personnel | Hospitals, Clinics
Not specified | Hospitals, Clinics
Physician and trained
medical personnel |
8
9
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Full safety test according to IEC 60601-2 and IEC 60601-2-25 have been performed on the device. These test have shown full compliance with these device.
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 301 489-1 and ETSI EN 301 489-17 standards concerning the radio equipment and telecommunication terminal equipment. Test arecarried out also according FCC CFR 47 Part 15 rules. Tests have shown full compliance with this standards.
The performance test are carried out according to IEC 60601-2-51 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
10
8. CONCLUSION
The safety features of the CARDIOLINE HD+ are identical to those of the predicate device MORTARA X-12 and CARDIETTE MICROTEL.
The performance of HD+ are basically similar to the predicate and are summarized in table above. Like Cardiette Microtel, the subject device HD+, has no parameters computation and interpretation program implemented on device and uses, for the Cardiette Bluetooth version, the same transmission mode (data transmitted by Bluetooth).
Like Mortara X-12 is designed to acquire and transmit quality ECG data.
The Standards Leads Acquired are the same to both predicate devices.
The intended use of CARDIOLINE HD+ is the same of Mortara X-12 excluding the transmission protocol which is the same of Cardiette Microtel.
The conclusions drawn from the nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in the substantial equivalence. HD+ is only an acquisition device without an analysis, diagnosis and monitoring features, so is not expected clinical evaluation.