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).

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

AI/ML Overview

The information provided is for a 510(k) premarket notification for the "cardiette microtel" electrocardiograph. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically associated with novel devices.

Therefore, many of the requested sections below cannot be fully populated as this is not a study proving the device meets new acceptance criteria, but rather a demonstration that it is substantially equivalent to an existing device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in the typical format of a clinical study, as the submission focuses on substantial equivalence to a predicate device. Instead, performance characteristics of the "cardiette microtel" are compared directly to those of the predicate devices (CARDIOLINE AR 600, AR 1200, AR 2100) in Table 5.7.1. The "acceptance criteria" here is implicitly that the microtel's performance should be substantially similar to the predicate, with any differences not raising new questions of safety or effectiveness.

Parameter (Acceptance Criteria - Implicitly, predicate device performance)	Reported cardiette microtel Performance
ECG Signals
Input dynamic range: +/-300mV @ DC, +/- 5.0 mV within the bandpass (AR 600)	+/-300mV @ DC, +/- 5.0 mV within the bandpass
Frequency response: 0.05 - 150 Hz (-3dB)	0.05 - 150 Hz (-3dB)
A/D conversion: 11 bits (AR 600)	11 bits
Leads: 12 Standard / 12 Cabrera	12 Standard / 12 Cabrera
Sensitivity (LSB): 5 µvolts (microvolt)	5 µvolts (microvolt)
Writing system
Writing system: Thermal head 48 mm 8 dots/mm (AR 600)	Not present
Printed channels: 1/2/3 (AR 600)	Not applicable
Paper speed: 25 50mm/s +/-5% (AR 600)	Not applicable
Thermal paper: DOTCARD 65 mm (AR 600)	Not applicable
Mode of operation: Manual and Automatic recording (AR 600)	Not applicable
Interfaces
Input/output: Infrared digital interface (AR 600)	> Sound couple transmission > USB (optional) > Blue Tooth (only for microtel bt version).
DISPLAY
Size: None/120 x 32 pixels (AR 600)	Backlit single-colour LCD 128x64 pixels
Nº of displayed channels: none (AR 600)	1
Traces speed: N/a (AR 600)	12,5 mm/s
Sensitivity: N/a (AR 600)	5 mm/mV
Keyboard
Type i keys: Membrane 21 functional keys (AR 600)	Silicon rubber 20 functional keys
SW options
ECG Interpretation: Interpretation Program HES EKG (AR 600)	No

The main "performance" aspects derived from the comparison are that the microtel (the new device) lacks a thermal printer and ECG interpretation software, and has different interfaces (sound couple, USB, Bluetooth) and a display compared to the AR 600 predicate. These differences are described as not raising new questions of safety or effectiveness, as the intended use (acquisition and transmission of ECG signals) remains equivalent for non-interpretive applications.

2. Sample size used for the test set and the data provenance

The document describes no clinical test set in the traditional sense for evaluation of diagnostic accuracy or clinical performance. This is a 510(k) submission based on substantial equivalence to an existing device (CARDIOLINE AR 600, AR 1200, AR 2100). The "tests" mentioned are non-clinical: full safety tests and Electromagnetic Compatibility (EMC) tests according to various EN and IEC standards (EN60601-1, IEC 601-2-25, IEC 601-2-51, EN60601-1-2, ETSI EN 301 489-17, ETSI EN 300 328). The sample size for these engineering tests is not specified, but it would typically involve a small number of manufactured units of the device.

There is no mention of patient data (retrospective or prospective) from any country of origin in the context of performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert ground truth establishment is described in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No clinical test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrocardiograph that acquires and transmits ECG signals, and explicitly does not include ECG interpretation tools or analysis programs. Therefore, no AI assistance or MRMC study involving human readers is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device does not include an algorithm for interpretation or analysis. Its function is to acquire and transmit raw ECG signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical performance testing against a ground truth is described. The relevant "ground truth" for this submission are the engineering standards (EN60601-1, IEC 601-2-25, IEC 601-2-51, EN60601-1-2, ETSI EN 301 489-17, ETSI EN 300 328) for safety and EMC, to which the device demonstrated compliance.

8. The sample size for the training set

Not applicable. The device does not employ any machine learning or AI algorithms that would require a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set is described.

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:

ManufacturerName	Applicant Name	Predicate Device	510(k) Number
et medical devices SpA	et medical devices SpA	CARDIOLINEAR 600, AR 1200and 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}------------------------------------------------

彩票

:、

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

...

ParameterRECORDER	MICROTEL	AR 600	AR 1200	AR 2100
ECG Signals
Input dynamicrange	+/-300mV @ DC+/- 5.0 mV within thebandpass	+/-300mV @ DC+/- 5.0 mV within thebandpass	+/-300mV @ DC+/- 10.0 mV withinthe bandpass	+/-300mV @ DC+/- 10.0 mV withinthe bandpass
Frequencyresponse	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 / 12Cabrera	12 Standard / 12Cabrera	12 Standard / 12Cabrera	12 Standard / 12Cabrera
Sensitivity (LSB)	5 µvolts (microvolt)	5 µvolts (microvolt)	5 µvolts (microvolt)	5 µvolts (microvolt)
Writing system
Writing system	Not present	Thermal head 48mm 8 dots/mm	Thermal head 108mm 8 dots/mm	Thermal head 210mm 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% 2550mm/s +/-5%	5 mm/s +/-10% 2550mm/s +/-5%
Thermal paper	Not applicable	DOTCARD 65 mm	DOTCARD 120 mm	DOTCARD 210 mm
Mode ofoperation	Not applicable	Manual andAutomatic recording	Manual andAutomatic recording	Manual andAutomatic recording
Interfaces
Input/output	> Sound coupletransmission> USB (optional)> Blue Tooth (only formicrotel bt version).	Infrared digitalinterface	Infrared digitalinterface	Infrared digitalinterface
DISPLAY
Size	Backlit single-colourLCD 128x64 pixels	None/120 x 32 pixels	120 x 32 pixels / 240x 320 pixels	120 x 32 pixels / 240x 320 pixels
Nº of displayedchannels	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 rubber20 functional keys	Membrane21 functional keys	Membrane46 functional keys	Membrane49 functional keys
SW options
ECGInterpretation	No	InterpretationProgram HES EKGdeveloped by theMedizinischeHochschuleHannover (Germany)	InterpretationProgram HES EKGdeveloped by theMedizinischeHochschuleHannover (Germany)	InterpretationProgram HES EKGdeveloped by theMedizinischeHochschuleHannover (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:

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

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

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

Page 1 of 1

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).