Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states that the device "does not include ecg interpretation tools and/or analysis programs" and that any analysis program on a PC is a separate product. There is no mention of AI or ML in the device description or performance studies.

Therapeutic

No

This device is an ECG acquirer, transmitting electrical heart activity rather than directly providing therapy.

Diagnostic

Yes

The device is an ECG acquirer that detects and transmits electrical heart activity, which is a diagnostic function even though it doesn't include interpretation tools itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a 12 lead ECG acquirer "fitted with a display and keyboard" and mentions "standard and/or rechargeable internal AA batteries," "10 wire cable," "5 wire cable," "USB port," and "graphic LCD display," all of which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the cardiette microtei is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Cardiette Microtei Function: The cardiette microtei directly measures electrical activity of the heart using electrodes placed on the body. It acquires and transmits this electrical signal (ECG trace). It does not analyze or process biological specimens.
Intended Use: The intended use is for "routine ecg recording" and transmitting the ECG trace. It explicitly states it "does not include ecg interpretation tools and/or analysis programs."

Therefore, the cardiette microtei falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

cardiette microtei is a 12 lead ECG acquirer fitted with a display and keyboard. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and the device can acquire and transmit an ECG trace in analogue (via sound coupling) or digital formal (USB port or via the wireless Bluetooth channel) to a remote PC.

The equipments are intended for use in routine ecg recording in physician practice and/or hospital. Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The equipment is intended to be used by trained medical personnel or physicians.

cardiette microtel does not include ecg interpretation tools and/or analysis programs. The device is intended to transmit ECG waveforms to a PC. Analysis program on a PC is a separate product not marketed with the Cardiette Microtel.

The hardware and the software of the equipment, except for the paper recorder routines and interpretation program, are the same of the predicated device.

Indication for use of cardiette microtel has not been changed, except for the ecg interpretation program not present on this device, with respect to the predicate device CARDIOLINE AR600, AR1200, AR2100 (ref. K051534 CARDIOLINE AR600, AR1200, AR2100).

Product codes (comma separated list FDA assigned to the subject device)

DPS

Device Description

cardiette microtel is an electrocardiograph providing the following characteristics:

· standard and/or rechargeable internal AA batteries
· simultaneous acquisition and storage of the 12 standard leads acquired from a 10 wire cable, or 7 leads (6 peripheral + 1 precordial) acquired from a 5 wire cable.
· storege of 10 second ECG of acquired ECG signals (in 12 and 7 lead formats)
· storage of up to 40 ecg recordings (optional)
· digital filters for AC interference suppression and base-line drift
· transmition of the ECG in an analogue format via sound coupling or in digital format (SCP format) via the USB port and also via the wireless Bluetooth channel
· graphic LCD display for user interface and ECG visualisation (the ecg trace may be used only to evaluate the quality of the acquired ecq)
· functional keyboard for patient identification input data (disabled in the basic product), ECG recording and ECG sending operations

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

full range of patient population with no limitations with respect to age

Intended User / Care Setting

trained medical personnel or physicians / physician practice and/or hospital.

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)

Non clinical tests used for Substantial Equivalence Determination:
Full safety tests according to EN60601-1. IEC 601-2 25 and IEC 601-2-51 have been performed on the device, on both version of CARDIETTE WICROTEL (Standard and Bluetooth versions). Tests have shown full compliance with these standards.

The equipment has been subject to Electromagnetic Compatibility testing procedures according to EN60601-1-2 standard. Tests have shown full compliance with this standard.

The Bluetooth version complies with ETSI EN 301 489-17 v 1.2.1 (2002-08) and ETSI EN 300 328 v 1.7.1 (2006-10) Standard concerning the radio equipment and telecommunications terminal equipment. Tests have shown full compliance with these 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.

K051534

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

Regulation Number and Section

§ 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).

Summary

0

et medical devices spa

FDA DOCUMENT NUMBER:_ 608212

P3 1 of 6

5. Summary of Safety and Effectiveness FEB 1 9 2009 cardiette microtel Date of application 5.1 10/07/2008 Applicant's name and address 5.2 et medical devices spa Via De Zinis 6 . 38011 Cavareno (Trento) ITALY 5.3 Contact person Mr. Luigi Bucchi (+39) 02 95051854 Tel: Fax: (+39) 02 9566013 E-mail: I.bucchi@etmed.biz 5.4 Device Trade Name cardiette microtel Device Common Name 5.5 Electrocardiograph . 3.6 Device Classification ' Sme CFR 870.2340 Electrocardiograph Class II 74DPS

cardiette microtel special 510(K) SUBMISSION DOCUMENT Page 9 of 37

1

P3.2.of 6

5.7 -Unmodified (Predicate) Device

The legally marketed device which has been modified is:

| Manufacturer

Name	Applicant Name	Predicate Device
et medical devices SpA	et medical devices SpA	CARDIOLINE
AR 600, AR 1200
and AR 2100	K051534

The safety features of the cardiette microtel are identical to those of the predicate CARDIOLINE AR 600, AR 1200 and AR 2100. The performance of cardiette microtel are basically similar to the predicate CARDIOLINE AR 600, AR 1200 and AR 2.100 and are summarized in table 5.7.1. The cardiette microtel is not equipped with the Parameters computation and Interpretation Program implemented in CARDIOLINE AR 600 and AR 1200 and AR 2100.

Intended use of cardiette microtel is identical to that of CARDIOLINE AR 600 and AR 1200 and AR 2100 excluding the Parameters computation and Interpretation Program.

cardiette microtel special 510(K) SUBMISSION DOCUMENT Page 10 of 37

2

1

:

彩票

:、

5.7.1. Table - Cardiette Microtel in comparison with AR600 (Predicate Device)

...

| Parameter

RECORDER	MICROTEL	AR 600	AR 1200	AR 2100
ECG Signals
Input dynamic
range	+/-300mV @ DC
+/- 5.0 mV within the
bandpass	+/-300mV @ DC
+/- 5.0 mV within the
bandpass	+/-300mV @ DC
+/- 10.0 mV within
the bandpass	+/-300mV @ DC
+/- 10.0 mV within
the bandpass
Frequency
response	0.05 - 150 Hz (-3dB)	0.05 - 150 Hz (-3dB)	0.05 - 150 Hz (-3dB)	0.05 - 150 Hz (-3dB)
A/D conversion	11 bits	11 bits	12 bits	12 bits
Leads	12 Standard / 12
Cabrera	12 Standard / 12
Cabrera	12 Standard / 12
Cabrera	12 Standard / 12
Cabrera
Sensitivity (LSB)	5 µvolts (microvolt)	5 µvolts (microvolt)	5 µvolts (microvolt)	5 µvolts (microvolt)
Writing system
Writing system	Not present	Thermal head 48
mm 8 dots/mm	Thermal head 108
mm 8 dots/mm	Thermal head 210
mm 8 dots/mm
Printed channels	Not applicable	1/2/3	3/4/6	3/4/6/12
Paper speed	Not applicable	25 50mm/s +/-5%	5 mm/s +/-10% 25
50mm/s +/-5%	5 mm/s +/-10% 25
50mm/s +/-5%
Thermal paper	Not applicable	DOTCARD 65 mm	DOTCARD 120 mm	DOTCARD 210 mm
Mode of
operation	Not applicable	Manual and
Automatic recording	Manual and
Automatic recording	Manual and
Automatic recording
Interfaces
Input/output	> Sound couple
transmission

USB (optional)
Blue Tooth (only for
microtel bt version). | Infrared digital
interface | Infrared digital
interface | Infrared digital
interface |
| DISPLAY | | | | |
| Size | Backlit single-colour
LCD 128x64 pixels | None/120 x 32 pixels | 120 x 32 pixels / 240
x 320 pixels | 120 x 32 pixels / 240
x 320 pixels |
| Nº of displayed
channels | 1 | none | 3/6 | 3/6/12 |
| Traces speed | 12,5 mm/s | N/a | 12.5 25 50 mm/s | 12.5 25 50 mm/s |
| Sensitivity | 5 mm/mV | N/a | 5 10 20 mm/mV | 5 10 20 mm/mV |
| Keyboard | | | | |
| Type i keys | Silicon rubber
20 functional keys | Membrane
21 functional keys | Membrane
46 functional keys | Membrane
49 functional keys |
| SW options | | | | |
| ECG
Interpretation | No | Interpretation
Program HES EKG
developed by the
Medizinische
Hochschule
Hannover (Germany) | Interpretation
Program HES EKG
developed by the
Medizinische
Hochschule
Hannover (Germany) | Interpretation
Program HES EKG
developed by the
Medizinische
Hochschule
Hannover (Germany) |

cardiette microtel special 510(K) SUBMISSION DOCUMENT Page 11 of 37

3

et medical devices spa

5.8 Device description

cardiette microtel is an electrocardiograph providing the following characteristics:

· standard and/or rechargeable internal AA batteries
· simultaneous acquisition and storage of the 12 standard leads acquired from a 10 wire cable, or 7 leads (6 peripheral + 1 precordial) acquired from a 5 wire cable.

FDA DOCUMENT NUMBER:

· storege of 10 second ECG of acquired ECG signals (in 12 and 7 lead formats)
· storage of up to 40 ecg recordings (optional)
· digital filters for AC interference suppression and base-line drift
· transmition of the ECG in an analogue format via sound coupling or in digital format (SCP format) via the USB port and also via the wireless Bluetooth channel
· graphic LCD display for user interface and ECG visualisation (the ecg trace may be used only to evaluate the quality of the acquired ecq)
· functional keyboard for patient identification input data (disabled in the basic product), ECG recording and ECG sending operations

More information about the cardiette microtel device is available in the Attachment A "Hardware and Software description".

5.9 Intended use

Intended use of cardiette microtel is equivalent to the intended use of the predicate CARDIOLINE AR 600, AR 1200 and AR 2100.

More specifically:

The equipment is intended for use in routine ecg recording in physician practice and/or hospital. The electrical heart activity is detected by means of two or more electrocardiograph electrodes. The ECG signals can be visualized on a digital display (this only to verify the quality of the signals). The acquired eog can be sendto a personal computer or other device able show it on a video and/or print the ecg signals on a printer or a paper thermal recorder.

Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The equipment is intended to be used by trained medical personnel or physicians.

cardiette microtel special 510(K) SUBMISSION DOCUMENT Page 12 of 37

4

et medical devices spa

FDA DOCUMENT NUMBER

5.10 Comparison of technological characteristics

cardiette microtel electrocardiograph is based on the same technological characteristics of the predicate device CARDIOLINE AR 600 and AR 1200 and AR 2100. The differences between cardiette microtel electrocardiograph and the predicated device is that the cardiette microtel does not include the thermal printer and it is not equipped with the measurements and interpretation software program.

5.11 Non clinical tests used for Substantial Equivalence Determination

Full safety tests according to EN60601-1. IEC 601-2 25 and IEC 601-2-51 have been performed on the device, on both version of CARDIETTE WICROTEL (Standard and Bluetooth versions). Tests have shown full compliance with these standards.

The equipment has been subject to Electromagnetic Compatibility testing procedures according to EN60601-1-2 standard. Tests have shown full compliance with this standard.

The Bluetooth version complies with ETSI EN 301 489-17 v 1.2.1 (2002-08) and ETSI EN 300 328 v 1.7.1 (2006-10) Standard concerning the radio equipment and telecommunications terminal equipment. Tests have shown full compliance with these standards.

In comparison with the predicate device CARDIOLINE AR 600 and AR 1200 and AR 21,00, cardiette microtel has not the measurements and interpretation program.

Moreover, the previous model of cardiette microtel, the equipment Microtel and Microtel 232 that used respectively the acoustic and serial interface to transfer the ecg signals to a computer, are manufactured and marketed worldwide since 2002. No adverse working conditions have been claimed and filed up to this date. The equipment is CE marked according to 93/4/2/CEE Medical Device Directive.

cardiette microtel special 510(K) SUBMISSION DOCUMENT Page 13 of 37

5

5.12 Risk Analysis

Comparative risk analysis has been performed with respect to the unmodified (predicate) device (see Attachment B) demonstrating that all means adopted for risk reduction were identical to those adopted for the unmodified equipment. The safety and the risk related to the use of the modified equipment are identical to those of the unmodified equipment.

5.13 Conclusions

Based on the above, et medical devices SpA believes that cardiette microtel electrocardiograph is substantially equivalent to CARDIOLINE AR 600, AR1200 and AR 2100.

cardiette microtel special 510(K) SUBMISSION DOCUMENT Page 14 of 37

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2009

et medical devices SpA c/o Mr. Luigi Bucchi Quality Assurance Manager Via De Zinis 6 Calvareno Italy 38011

Re: K082124

Trade/Device Name: Cardiette Microte1 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: January 16, 2009 Received: January 21, 2009

Dear Mr. Bucchi:

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 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 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.

7

Page 2 - Mr. Bucchi

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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.(24-CFR:Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (210) 216 01161 2100" (21CFR Part 807.97). For questions regarding postmarket surveillance, premailer nother of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

27 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

8

Indications for Use

510(k) Number (if known): __ K082124_

Device Name: cardiette microtel

Indications for Use:

cardiette microtei is a 12 lead ECG acquirer fitted with a display and keyboard. The electrical heart activity is detected by means of two or more electrocardiograph electrodes and the device can acquire and transmit an ECG trace in analogue (via sound coupling) or digital formal (USB port or via the wireless Bluetooth channel) to a remote PC.

The equipments are intended for use in routine ecg recording in physician practice and/or hospital. Intended use for non interpretive applications covers the full range of patient population with no limitations with respect to age, sex and race of the patient.

The equipment is intended to be used by trained medical personnel or physicians.

cardiette microtel does not include ecg interpretation tools and/or analysis programs. The device is intended to transmit ECG waveforms to a PC. Analysis program on a PC is a separate product not marketed with the Cardiette Microtel.

The hardware and the software of the equipment, except for the paper recorder routines and interpretation program, are the same of the predicated device.

Indication for use of cardiette microtel has not been changed, except for the ecg interpretation program not present on this device, with respect to the predicate device CARDIOLINE AR600, AR1200, AR2100 (ref. K051534 CARDIOLINE AR600, AR1200, AR2100).

Prescription Use (Part 21:CFR 801 Subpart D)

מטעמאל

Over The-Counter Use (21 CER 861 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
2/20/08

1Division Sian-Off) Division of Cardiovascular Devices K082124

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