The Click Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below:
a) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
b) Evaluation of ECG documenting therapeutic interventions in individual patients or group of patients.
c) Evaluation of patient's ST segment alterations.
d) Patient follow up after M.I. or cardiac surgery.
e) Clinical and epidemiological studies
f) Pace maker evaluation
g) Time or Frequency domain heart rate variability analysis
h) Qt interval analysis

Device Description

Click Holter is a personal three channels Ambulatory ECG recorder characterized by the following features:

Up to 48 hours continuous ECG recording on three independent leads
USB port for fast download of recorded data
Possibility to store patient data in the recorder via USB port

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Click Holter," an ambulatory ECG recorder. It does not contain specific acceptance criteria, study data proving the device met those criteria, or details regarding sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (DXP1000 Holter recorder) through a comparison of technical characteristics and compliance with recognized safety and performance standards.

Here's a breakdown of the information that is available related to your request, and where the document is lacking:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds. The "acceptance" is implied through the successful completion of standard compliance tests and demonstrating substantial equivalence to the predicate device.
Reported Device Performance: The document lists the specifications and features of the Click Holter and compares them against the predicate device DXP1000. This comparison serves as the basis for claiming similar performance.

Parameter	Click Holter (Reported Performance - Implicit Acceptance)
Storage capacity	Up to 48 hours
Memory type	Flash (non-volatile)
Memory portability	Non removable
On-board ECG analysis	No
Liquid Crystal Display (LCD)	No
Led indicators	Yes
Data Transfer method	USB port
Pacemaker detection & reporting	Yes
Battery	Two AA
Size	11 x 8 x 1.5 cm
Weight	149 gr
Continuous ECG recording	Up to 48 hours on three independent leads
Fast data download	Via USB port
Patient data storage	Via USB port

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

Not specified. The document states that "Full safety tests according to IEC 601-1 / EN60601-1 Standard and performances tests according to IEC 601-2 47 / EN 601-2-47 and AAMI EC 38 1994 Standard have been performed on Click Holter." These are standard compliance tests, not clinical performance studies with specific patient test sets.

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

Not applicable. This device is an ambulatory ECG recorder without analysis. There's no AI algorithm performing diagnosis or measurement that would require expert-established ground truth for a test set in the context of this 510(k). The regulatory submission focuses on the safety and technical performance of the recording device itself, not an interpretive algorithm.

4. Adjudication method for the test set:

Not applicable for the same reasons as point 3.

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:

No. This device does not include AI for analysis, so an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

No. This device is a data acquisition device, not an algorithm.

7. The type of ground truth used:

Not applicable. The tests performed are engineering and electrical safety/performance tests (e.g., electrical safety, electromagnetic compatibility, accuracy of recording parameters as per standards like AAMI EC 38). The "ground truth" for these types of tests would be established by reference to calibrated test equipment and standard methodologies, not medical expert consensus or pathology.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

In summary: The provided document is a regulatory submission for a Class II medical device (ambulatory ECG recorder without analysis). The "acceptance criteria" and "study" described are in the context of demonstrating substantial equivalence to a predicate device and compliance with recognized industry standards for device safety and technical performance, rather than clinical performance or algorithmic accuracy as would be seen for devices with diagnostic algorithms. Therefore, many of the requested details related to "acceptance criteria" and "study" in your prompt (which often apply to AI/ML or diagnostic devices) are not present in this type of submission.

Summary

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AUG 2 7 2003

REMCO ITALIA

FDA DOCUMENT NUMBER:

lof 3

Summary of Safety and Effectiveness 5.

5.1 Date of application: 07/07/2003
Applicant's name and address: Remco Italia spa 5.2 Via Rivoltana Nuova 53 20060 San Pedrino di Vignate (Milan) ITALY
Mr. Luigi Bucchi 5.3 Contact person: +39029505181 Tel: +39029566013 Fax: E-mail: L.bucchi@cardioline.it
5.4 Device Trade Name Click Holter
5.5 Device Common Name Electrocardiograph, Ambulatory (without analysis)
5.6 Device Classification Name CFR 870.2800 Medical magnetic tape recorder Class II MWJ

5.7 Predicate Device

The legally marketed device to which equivalence is being claimed is:

Manufacturer Name	Applicant Name	Predicate Device	510(k) Number
Braemar Inc.	Braemar Inc.	DXP1000Holter recorder	K993618

Table 5.7.1 reports a technical comparison between Click Holter device and DXP1000 Predicate device.

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Summary of Safety and Effectiveness (con't)

Table 5.7.1

Parameter	Click Holter	DXP1000
Storage capacity	Up to 48 hours	Up to 48 hours
Memory type	Flash (non-volatile)	Flash (non-volatile)
Memory portability	Non removable	Non removable
On-board ECG analysis	No	No
Liquid Cristal Display (LCD)	No	Yes
Led indicators	Yes	No
Data Transfer method	USB port	USB port
Pace maker detection &reporting	Yes	Yes
Battery	Two AA	Two AA
Size	11 x 8 x 1.5 cm	11 x 7 x 2 cm
Weight	149 gr	141 gr

5.8 Device description

Click Holter is a personal three channels Ambulatory ECG recorder characterized by the following features:

· Up to 48 hours continuous ECG recording on three independent leads
· USB port for fast download of recorded data
· Possibility to store patient data in the recorder via USB port

5.9 Intended use

The device is intended for patients requiring ECG Ambulatory (Holter) monitoring up to 48 hours.

5.10 Comparison of technological characteristics

Click Holter ECG Ambulatory recorder is based on technological characteristics similar to the predicate device DXP 1000.

5.11 Non clinical tests used for Substantial Equivalence Determination

Full safety tests according to IEC 601-1 / EN60601-1 Standard and performances tests according to IEC 601-2 47 / EN 601-2-47 and AAMI EC 38 1994 Standard have been performed on Click Holter.

The equipment have been subject to Electromagnetic Compatibility testing procedures according to EN60601-1-2 standard.

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REMCO ITALIA

Summary of Safety and Effectiveness (con't)

No adverse working conditions have been claimed and filed up to date.

An identical version of the device is CE marked according to 93/42/CEE Medical Device Directive.

5.12 Conclusions

Based on the above, Remco Italia believes that Click Holter Ambulatory ECG recorder is substantially equivalent to Predicate device DXP 1000.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes extending from its head.

AUG 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

REMCO ITALIA S.p.A. c/o Mr. Ligui Bucchi Strada Rivoltana Nuova, 53 20060 San Pedrino di Vignate Milan, Italy 20060

Re: K032276

Trade Name: Click Holter Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: July 7, 2003 Received: July 23, 2003

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 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 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.

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

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Page 2 – Mr. Ligui Bucchi

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 (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K032276

Device Name: CLICK Holter Three-Channel Ambulatory ECG Recorder

Indications For Use:

The Click Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below:

a) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
b) Evaluation of ECG documenting therapeutic interventions in individual patients or group of patients.
c) Evaluation of patient's ST segment alterations.
d) Patient follow up after M.I. or cardiac surgery.
e) Clinical and epidemiological studies
Pace maker evaluation f)
g) Time or Frequency domain heart rate variability analysis
h) Qt interval analysis

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division
Divisio
510(k) numbe: /<032276 (Optional Format 3-10-98)

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).