(203 days)
Not Found
No
The description focuses on signal acquisition, storage, and transmission, with no mention of algorithmic analysis or interpretation using AI/ML. The analysis is stated to be performed by a trained physician.
No.
The device records and transmits ECG signals for analysis by a physician, but it does not directly treat or provide therapy to the patient.
Yes
Explanation: The device is intended for recording ECG signals to be analyzed by a trained physician, which aids in the diagnosis of medical conditions. The "Intended Use / Indications for Use" section states that recordings are made "to be analyzed by a trained physician," implying the data collected will be used for diagnostic purposes.
No
The device description explicitly mentions hardware components such as "two built-in 'thumb electrodes'", an "external auxiliary electrode", an "LCD display", and an "RS232 serial digital port". It also describes "Internal battery operation". These are all physical components, indicating the device is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- ecg@home Function: The ecg@home device records electrical signals directly from the patient's body (via thumb electrodes or an external electrode). It does not analyze specimens derived from the body.
- Intended Use: The intended use is to record an electrocardiogram (ECG) signal from the patient for analysis by a trained physician. This is a direct physiological measurement, not an in vitro test.
Therefore, based on the provided information and the definition of an IVD, the ecg@home device is not an In Vitro Diagnostic. It is a medical device that performs a direct physiological measurement.
N/A
Intended Use / Indications for Use
The device is intended for use by patients who might experience transient The donos that may suggest cardiac arrythmia, conduction ECG abnormalities or other ECG abnormalities visibles on lead D1 or lead D2.
The device is not intended for the simultaneous recording and transmission of the patient's ECG signal.
ECG acquisition and transmission is voluntary and manually activated by the patient.
Product codes
DXH
Device Description
Ecg@home is a personal single lead ECG transtelephonic transmitter characterized by the following features:
- · Internal battery operation
- Patient activated acquisition of Standard lead D1 (lead D2 by means of an external auxiliary electrode)
- Storage of 10 seconds of acquired ecg signal
- · Use of two built-in "thumb electrodes" (US Pat. Nº 5,928,141)
- · LCD display featuring the following characteristics:
- Indication of the battery charge status A
- Indication that signal acquisition is active A
-
Indication that a noisy acquisition has been performed
-
Indication that data transmission is active
-
Indication that the recording is stored in memory
-
Indication of the istantaneous and of the mean heart rate frequency
- · Digital ecg transfer via RS232 serial digital port to a computer
- · Acustic transtelephonic ecg transfer via common phone line
The use of two built-in patented electrodes allows the patient to record the electrocardiogram lead D1 by simply placing his thumbs on the electrodes. The two patented electrodes are designed in such a way to minimize noise and base-line shifts due to relative movements at the electrode/skin interface.
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
Not Found
Intended User / Care Setting
Not Found
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)
A set of in vivo clinical tests have been performed in order to asses the performances of the device. Tests were performed at the Medical University School of Brescia (Italy). Tests results have shown that the recordings performed on the patients using the device where highly satisfactory and comparable to those obtained with a common electrocardiograph recorder.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
H&C Medical Devices
FDA DOCUMENT NUMBER:
012012
p.119
JAN 1 7 2002
Summary of Safety and Effectiveness 5.
| 5.1 Date of application: | 06/26/2001 |
|---|---|
| 5.2 Applicant's name and address: H&C Medical Devices spa | Via Pisa 250 |
| 20099 Sesto San Giovanni | |
| (Milan) ITALY |
| 5.3 Contact person: | Mr. Attilio Castelli |
|---|---|
| Tel: | (+39) 0222476861 |
| Fax: | (+39) 0222476872 |
| E-mail: | attilio@hcmed.com |
- Device Trade Name 5.4 ecg@home
Device Common Name 5.5
ECG Transmitter, Electrocardiograph
Device Classification Name 5.6
CFR 870.2920 Transmitters and Receivers, Electrocardiograph, telephone 74 DXH Class II
Predicate Device 5.7 -
The legally marketed device to which equivalence is being claimed is:
| Manufacturer Name | Applicant Name | Predicate Device | 510(k) Number |
|---|---|---|---|
| Card Guard | |||
| Scientific Survival | |||
| LTD | Card Guard LTD | CG-2206 Personal | |
| ECG Transmitter | K963725 |
Table 5.7.1 reports a tchnical comparison between ecg@home device and CG-2206 Predicate device.
1
Summary of Safety and Effectiveness (con't)
Table 5.7.1
| Parameter | ecg@home | CG 2206 |
|---|---|---|
| ECG INPUT AND | ||
| PROCESSING | ||
| Input dynamic range | +/-300mV @ DC | |
| +/-5 mV within the bandpass | +/-300mV @ DC | |
| +/-2.5 mV within the | ||
| bandpass | ||
| Input Impedance | 10 Mohm | 100 Mohm |
| CMRR | > 100 dB | 60 dB |
| Frequency response | 0.5 - 30 Hz (-3dB) (linear | |
| phase) | 0.5 - 40 Hz (-3dB) | |
| A/D conversion | 11 bits | 8 bits |
| Sampling frequency | 500 samples/s | 250 samples/s |
| Leads | 1 Standard lead D1 or D2 | 1 non Standard chest lead |
| Mode of operation | Patient activated recording | Patient activated recording |
| Memory | 10 s (200 s optional) | 192 s |
| Display | LCD | N/a |
| Clock | Yes (optional) | N/a |
| ACUSTIC TRANSMISSION | ||
| Type | Frequency Modulation | Frequency Modulation |
| Carrier frequency | 1900 Hz | 1700 Hz |
| Modulation factor | 100 Hz/mV | 170 Hz/mV |
| DIGITAL INTERFACE | ||
| RS 232 serial digital port | N/a | |
| POWER SUPPLY | ||
| Battery type | 2 x 1.5V AAA (IEC LR03) | 2 x 3V lithium |
| Autonomy | 2400 recordings | 2000 recordings |
| MECHANICAL | ||
| Size | 4.13 x 3.15 x 0.59 in | 4.13 X 2.16 X 0.39 in |
| Weight | 100 gr | 42 gr |
| Operating temperature | +50...+113 °F | 32...+113 °F |
| Storage temperature | +32...+122 °F | -4...+122 °F |
5.8 Device description
Ecg@home is a personal single lead ECG transtelephonic transmitter characterized by the following features:
- · Internal battery operation
- Patient activated acquisition of Standard lead D1 (lead D2 by means of an external auxiliary electrode)
- Storage of 10 seconds of acquired ecg signal
- · Use of two built-in "thumb electrodes" (US Pat. Nº 5,928,141)
2
K012012 p 3/4
Summary of Safety and Effectiveness (con't)
- · LCD display featuring the following characteristics:
- Indication of the battery charge status A
- Indication that signal acquisition is active A
-
Indication that a noisy acquisition has been performed
-
Indication that data transmission is active
-
Indication that the recording is stored in memory
-
Indication of the istantaneous and of the mean heart rate frequency
- · Digital ecg transfer via RS232 serial digital port to a computer
- · Acustic transtelephonic ecg transfer via common phone line
The use of two built-in patented electrodes allows the patient to record the electrocardiogram lead D1 by simply placing his thumbs on the electrodes. The two patented electrodes are designed in such a way to minimize noise and base-line shifts due to relative movements at the electrode/skin interface.
5.9 Intended use
The device is intended for use by patients who might experience transient The donos that may suggest cardiac arrythmia, conduction ECG abnormalities or other ECG abnormalities visibles on lead D1 or lead D2.
The device is not intended for the simultaneous recording and transmission of the patient's ECG signal.
ECG acquisition and transmission is voluntary and manually activated by the patient.
5.10 Comparison of technological characteristics
ecg@home personal electrocardiogram transmitter is based on technological characteristics similar to the predicate device CG - 2206.
5.11 Non clinical tests used for Substantial Equivalence Determination
Full safety tests according to EN60601-1 Standard and performances tests according to IEC 601-2 47 draft Standard have been performed on ecg@home. The equipment have been subject to Electromagnetic Compatibility testing procedures according to EN60601-1-2 standard.
No adverse working conditions have been claimed and filed up to date.
3
Summary of Safety and Effectiveness (con't)
A similar version of the device is CE marked according to 93/42/CEE Medical Device Directive.
5.12 Clinical tests performed
A set of in vivo clinical tests have been performed in order to asses the performances of the device. Tests were performed at the Medical University School of Brescia (Italy). Tests results have shown that the recordings performed on the patients using the device where highly satisfactory and comparable to those obtained with a common electrocardiograph recorder.
5.13 Conclusions
Based on the above, H&C Medical Devices belives that ecg@home personal electrocardiogram transmitter is substantially equivalent to Predicate device CG -2206.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Mr. Attilio Castelli Managing Director H&C Medical Devices spa Via Pisa 250 20099 Sesto San Giovanni (Milan) ITALY
Re: K012012 Trade Name: ecg @ home Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DXH Dated: October 22, 2001 Received: October 25, 2001
Dear Mr. Castelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rovious your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sualou in the encreations) it itgenactment 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 such 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. Attilio Castelli
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toast of advised that I Dris issualite or our device complies with other requirements of the Act that I Dr has Intact and regulations administered by other Federal agencies. You must of any I cacal statutes and regerments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 607); adomig (DF CFR Part 820); and if applicable, the electronic forth in the quinty by see provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms icter will anow you to ocgan maing of substantial equivalence of your device to a legally promatics notification: The Pro Pressification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 - 11 - 1646. Additionally, for questions on the promotion and advertising of Compliance at (301) 597 1010. Finance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Redeith
am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
KO12012
Indications for Use Statement 4.
Device Name: ecg@home
Indication for Use:
ecg@home is a personal single lead ECG transtelephonic transmitter. The device is intended for self-testing by patients by recording ten seconds of the first standard lead (D1) or of the second standard lead (D2) of the electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician.
The patient is normally not required to apply electrodes on the body. Two electrodes integrated within the device are provided. The patient has to place his thumbs on the two integrated electrodes in order to record the ECG signal.
In case of very low amplitude of lead D1 caused by heart orientation (mainly experienced by women), an external auxiliary electrode is provided in order to record lead D2.
The recorded data can be directly trasmitted to a receiving station via a common phone line or can be downloaded via RS 232 serial digital port to a Personal Computer for subsequent connection to a Service Provider using Internet facilities.
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) number K012022