(14 days)
Not Found
No
The document mentions an "automatic interpretation program" (Hannover Electrocardiogram System - HES) but does not use terms like AI, ML, deep learning, or neural networks to describe its functionality. The description focuses on standard signal processing and adherence to established ECG standards.
No.
The device is an electrocardiograph designed to register, analyze, and display electrocardiograms for diagnostic purposes, not for administering therapy or drugs. The text explicitly states, "No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program."
Yes
The device is described as an electrocardiograph designed to "register, analyze and display electrocardiograms" and incorporates an "automatic interpretation program for cardiac signal analysis," which are functions consistent with diagnostic purposes.
No
The device description explicitly mentions hardware components such as a thermal printer, lithium ion battery, high resolution screen, and connectivity ports (RS-232, LAN, USB 2.0). It is a portable electrocardiograph with physical components.
Based on the provided information, the Gem Heart One/One+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Gem Heart One/One+ Function: The Gem Heart One/One+ is an electrocardiograph. It measures and records electrical activity of the heart directly from the patient's body using electrodes placed on the skin. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's designed to "register, analyze and display electrocardiograms at rest." This involves measuring physiological signals from the patient, not analyzing biological samples.
Therefore, the Gem Heart One/One+ falls under the category of a medical device that measures physiological parameters in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register, analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width.
It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the records and send them to a PC by serial communication (RS-232, USB and LAN). The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program.
For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient. It is intended for use in routine ECG recording by trained physicians in hospital environment.
- The Gem Heart One/One+ is a standard portable electrocardiograph that measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements.
- Intended use is equivalent to the intended use of the predicate Cardioline AR 1200 and CorScreen electrocardiograph.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The Gem Heart One/One+ is a portable electrocardiograph of 12 channels with simultaneous leads recording, with a high quality thermal printing of 112 mm, a lithium ion battery, high resolution screen, and connectivity through serial port (RS-232), local network LAN (10/100 Base T) and USB 2.0.
The device includes protection against defibrillation integrated. Provides the automatic interpretation based on the program Hannover Ecg System HES® developed by Biosigna GmbH under the standards IEC 60601-2-51:2003. Uses the format SCP (Standard Communications Protocol) to import and export the ECG records in the framework of the CSE (Common Standards for Quantitative Electrocardiography) of the European Union.
The Gem Heart One/One+ can operate in Spanish, Catalan and English and other languages can be implemented. It includes downloading and ECG viewing PC software gem heart viewer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program.
For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient.
Intended User / Care Setting
It is intended for use in routine ECG recording by trained physicians in hospital environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Gem Heart One/One+ has been tested under the same standards to its predicate device the Cardioline AR1200 and CorScreen, in accordance with the EN 60601-1 and IEC 60601-2-25, as well as for EMC tests EN60601-1-2 standards. The device has completely passed the tests and has shown full compliance to the standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
SEP 04 2009
6. 510(k) Summary
Date of application:
Applicant's name and address: Gem-Med S.L. Calle Cartagena 245, 5é, of. 5-6 08025, Barcelona (Spain)
Contact Person:
Mr. Wilson Tseng Tel. (+34) 935 309 650 Fax. (+34) 934 366 144 E-mail: wtseng@gem-med.com
Date of submission: December, 15th 2008
Device Trade Name: Gem Heart One/One+
Device Common Name: Electrocardiograph
Device Classification Name: CFR 870.2340 Electrocardiograph
Product Code: DPS Class II
| Predicate Device | Premarket Notification |
|---|---|
| CARDIOLINE AR1200 | K051534 |
| CORSCREEN | K070614 |
Summary of Safety and Effectiveness
| Parameter | Cardioline AR 1200 | Gem Heat One | CorScreen |
|---|---|---|---|
| Input dynamic range | +/-300mV @ DC +/-10.0mV within the bandpass | +/-300mV @ DC +/-18.0mV within the band pass | +/-300mV @ DC |
| Frequency response | 0.05-150Hz (-3dB) | 0.05-150Hz | 0.05-150Hz |
| A/D conversion | 12 bits | 16 bits | 24 bits |
| Leads | 12 Standard / 12 Cabrera | 12 Cabrera / Orthogonal | 3+3 / 12 Standard |
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SEP 0 4 2009
| Sensitivity | |||
|---|---|---|---|
| 2.5.5.10.20 mm/mV | |||
| +/-5% | 2.5 5.10 20 mm/mV | 5, 10, 20 mm/mV | |
| Writing system | Thermal head 108mm | ||
| 8 dots/mm | Thermal head | ||
| 110mm 16dots/mm |
- 8dots/mm | Ink Printer US letter
and DIN-A4 size |
| Printed channels | 3/4/6 | 1/3/6 | 1/2/6/12 |
| Paper speed | 5mm/s +/-10%
50mm/s +/-5% | 25
10 25 50 mm/s | 25 50 mm/s |
| Thermal paper | DOTCARD 120mm | DOTCARD 120mm | US letter and DIN-A4 |
| Mode of operation | Manual and Automatic recording | Manual and
Automatic recording | Manual |
| Input/output | Infrared digital interface | RS 232, Ethernet,
USB | SD Memory card |
| DISPLAY | AR 1200 | Gem Heat One | CorScreen |
| Size | 120x32 pixels / 240x320 pixels | 240X320 pixels | 240X320 pixels |
| N° of displayed channels | 3/6 | 1/3/6/12 | 1/3/6/12 |
| Traces speed | 12.5 25.50 mm/s | 10.25 50 mm/s | 5 10 25 50 mm/s |
Device description
The Gem Heart One/One+ is a portable electrocardiograph of 12 channels with simultaneous leads recording, with a high quality thermal printing of 112 mm, a lithium ion battery, high `resolution screen, and connectivity through serial port (RS-232), local network LAN (10/100 Base T) and USB 2.0.
The device includes protection against defibrillation integrated. Provides the automatic interpretation based on the program Hannover Ecg System HES® developed by Biosigna GmbH under the standards IEC 60601-2-51:2003. Uses the format SCP (Standard Communications Protocol) to import and export the ECG records in the framework of the CSE (Common Standards for Quantitative Electrocardiography) of the European Union.
2
The Gem Heart One/One+ can operate in Spanish, Catalan and English and other languages can be implemented. It includes downloading and ECG viewing PC software gem heart viewer.
Intended use
Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register, analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width.
It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the records and send them to a PC by serial communication (RS-232, USB and LAN). The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program.
For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient. It is intended for use in routine ECG recording by trained physicians in hospital environment.
- The Gem Heart One/One+ is a standard portable electrocardiograph that measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements.
- Intended use is equivalent to the intended use of the predicate Cardioline AR 1200 � and CorScreen electrocardiograph.
Summary of Device Testing
The Gem Heart One/One+ has been tested under the same standards to its predicate device the Cardioline AR1200 and CorScreen, in accordance with the EN 60601-1 and IEC 60601-2-25, as well as for EMC tests EN60601-1-2 standards. The device has completely passed the tests and has shown full compliance to the standards.
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SEP 0 4 2009
Conclusions
The intended use, indication for use and principle of operation are similar to the predicate devices with some distinct features that have been previously cleared which do not raise any new types of safety and effectiveness questions. Furthermore it has been demonstrated that the Gem Heart One/One+ has shown to have passed the same safety and effectiveness standards to its predicate device, Cardioline AR1200 and the CorScreen.
Based on the performance and characteristics of the Gem Heart One/One+ described above, it is demonstrated that it is substantially equivalent to the predicate device Cardioline AR 1200 and CorScreen electrocardiographs.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP - 4 2009
Gem-Med S. L. c/o Mr. Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Road Melville, NY 11747
K092576 Re:
Trade/Device Name: Gem Heart One/One+ Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: August 19, 2009 Received: August 21, 2009
Dear Mr. Conry:
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.
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.
5
Page 2 - Mr. Casey Conry
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known):
Device Name: Gem Heart One/One+
Indications for Use:
Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register. analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width.
It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the records and send them to a PC by serial communication (RS-232, USB and LAN). The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program.
For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient. It is intended for use in routine ECG recording by trained physicians in hospital environment.
- The Gem Heart One/One+ is a standard portable electrocardiograph that � measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements.
- Intended use is equivalent to the intended use of the predicate Cardioline AR . 1200 and CorScreen electrocardiograph.
Prescription Use × (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRA Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
W.M.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092576