CLICK HOLTER

K032276 · Remco Italia S.P.A. · MWJ · Aug 27, 2003 · Cardiovascular

Device Facts

• Record ID: K032276
• Device Name: CLICK HOLTER
• Applicant: Remco Italia S.P.A.
• Product Code: MWJ · Cardiovascular
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended 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 f) Pace maker evaluation g) Time or Frequency domain heart rate variability analysis h) Qt interval analysis

Device Story

Click Holter is a 3-channel ambulatory ECG recorder; captures continuous ECG data for up to 48 hours; stores data on internal non-volatile flash memory. Device features USB port for data download and patient data storage; LED indicators for status; powered by two AA batteries. Used in clinical settings; operated by healthcare professionals. Device records raw ECG signals; no on-board analysis performed. Data transferred via USB to external system for review. Enables physician assessment of cardiac rhythm, ST segments, and pacemaker function; supports clinical decision-making regarding therapeutic interventions and patient follow-up.

Clinical Evidence

Bench testing only. Safety and performance verified per IEC 60601-1, IEC 60601-2-47, and AAMI EC 38 standards. Electromagnetic compatibility testing performed per EN 60601-1-2.

Technological Characteristics

3-channel ambulatory ECG recorder; non-volatile flash memory; USB connectivity; powered by two AA batteries; dimensions 11 x 8 x 1.5 cm; weight 149g. No on-board ECG analysis. Complies with IEC 60601-1, IEC 60601-2-47, AAMI EC 38, and EN 60601-1-2 standards.

Indications for Use

Indicated for patients requiring ambulatory (Holter) ECG monitoring for 1 to 48 hours for evaluation of arrhythmia, myocardial ischemia, ST segment alterations, post-MI or cardiac surgery follow-up, pacemaker evaluation, heart rate variability, and QT interval analysis.

Regulatory Classification

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.

Predicate Devices

• DXP1000 Holter recorder (K993618)

Submission Summary (Full Text)

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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: [phone] Tel: [phone] Fax: E-mail: [e-mail]
- 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. | DXP1000<br>Holter 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 &<br>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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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 [phone]. 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 [phone] or [phone] 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)