(35 days)
Not Found
No
The summary describes a standard Holter recorder with data storage and download capabilities, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a recorder for diagnostic monitoring, not for delivering therapy.
Yes
The ‘Intended Use / Indications for Use’ section specifies that the device is used for "Evaluation of symptoms suggesting arrhythmia or myocardial ischemia", "Evaluation of ECG documenting therapeutic interventions", "Evaluation of patient's ST segment alterations", and "Pace maker evaluation", all of which are diagnostic activities.
No
The device description explicitly states it is a "personal three channels Ambulatory ECG recorder" with features like "USB port for fast download of recorded data," indicating it is a hardware device that records ECG data. The performance studies also mention testing according to hardware standards (IEC 601-1, EN60601-1, IEC 601-2 47, EN 601-2-47, AAMI EC 38 1994, EN60601-1-2).
Based on the provided information, the Click Holter recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Click Holter Function: The Click Holter recorder is an ambulatory ECG recorder. It records electrical activity of the heart from the body (in vivo) through electrodes placed on the skin. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes monitoring the heart's electrical activity in patients, which is an in vivo process.
- Device Description: The description focuses on recording ECG data, not analyzing biological samples.
Therefore, the Click Holter recorder falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for patients requiring ECG Ambulatory (Holter) monitoring up to 48 hours.
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
Product codes (comma separated list FDA assigned to the subject device)
MWJ
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
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
No adverse working conditions have been claimed and filed up to date.
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.
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
§ 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).
0
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. | DXP1000 | |
| Holter recorder | K993618 |
Table 5.7.1 reports a technical comparison between Click Holter device and DXP1000 Predicate device.
1
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.
2
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.
3
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
4
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
5
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: /