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.

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
- Indication that signal acquisition is active
- 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the ecg@home device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a structured table or qualitative descriptions. However, it implicitly suggests that the device's performance should be "satisfactory" and "comparable" to a common electrocardiograph recorder.

Acceptance Criteria (Implied)	Reported Device Performance
Recordings are "highly satisfactory"	"Tests results have shown that the recordings performed on the patients using the device where highly satisfactory"
Recordings are "comparable to those obtained with a common electrocardiograph recorder"	"...and comparable to those obtained with a common electrocardiograph recorder."
No adverse working conditions claimed or filed (safety)	"No adverse working conditions have been claimed and filed up to date."
Conformance to EN60601-1 Standard (safety)	"Full safety tests according to EN60601-1 Standard... have been performed..."
Conformance to IEC 601-2 47 draft Standard (performance)	"...and performances tests according to IEC 601-2 47 draft Standard have been performed..."
Conformance to EN60601-1-2 Standard (EMC)	"The equipment have been subject to Electromagnetic Compatibility testing procedures according to EN60601-1-2 standard."
CE marked according to 93/42/CEE Medical Device Directive	"A similar version of the device is CE marked according to 93/42/CEE Medical Device Directive."

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

Sample Size: Not explicitly stated. The document mentions "a set of in vivo clinical tests have been performed in order to asses the performances of the device." but does not quantify the number of patients or recordings.
Data Provenance: Prospective (in vivo clinical tests).
Country of Origin: Italy (Tests were performed at the Medical University School of Brescia, Italy).

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: The document mentions that the recordings are to be "analyzed by a trained physician" for the intended use, and the tests were performed at a "Medical University School." This implies that the ground truth was established by medical professionals, likely physicians with expertise in ECG interpretation, but specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The document only states that the recordings were "highly satisfactory and comparable to those obtained with a common electrocardiograph recorder," implying a qualitative assessment, but no details on how discrepancies (if any) between the device's recordings and the common recorder's were resolved or how multiple expert opinions were combined.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance was not performed or described. The document pertains to a medical device's performance, not an AI-assisted diagnostic workflow.
Effect Size of Human Readers with/without AI: Not applicable, as this was not an MRMC study involving AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes, in essence, the "in vivo clinical tests" can be considered a standalone performance study for the device itself.
- The device's recordings (ecg@home) were directly compared against the recordings from a "common electrocardiograph recorder" to assess its inherent performance (i.e., the quality and comparability of the ECG signal generated by the device).

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth was established by comparing the device's ECG recordings to those obtained from a "common electrocardiograph recorder" (a widely accepted and presumably gold-standard clinical device for ECG recording) and assessed by medical professionals. This can be considered a form of expert assessment against a reference standard.

8. Sample Size for the Training Set

Sample Size: Not applicable. The ecg@home device described in the document is a hardware device for recording ECGs, not a machine learning or AI algorithm that requires a training set.

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

Ground Truth Establishment: Not applicable, as there is no training set for this device.

Summary

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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 25020099 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 GuardScientific SurvivalLTD	Card Guard LTD	CG-2206 PersonalECG Transmitter	K963725

Table 5.7.1 reports a tchnical comparison between ecg@home device and CG-2206 Predicate device.

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Summary of Safety and Effectiveness (con't)

Table 5.7.1

Parameter	ecg@home	CG 2206
ECG INPUT ANDPROCESSING
Input dynamic range	+/-300mV @ DC+/-5 mV within the bandpass	+/-300mV @ DC+/-2.5 mV within thebandpass
Input Impedance	10 Mohm	100 Mohm
CMRR	> 100 dB	60 dB
Frequency response	0.5 - 30 Hz (-3dB) (linearphase)	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)

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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

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.

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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.

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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.

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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

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KO12012

Indications for Use Statement 4.

Device Name: ecg@home

Indication for Use:

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

Regulation Number and Section

§ 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).