CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004

K063222 · Cardionet, Inc. · QYX · Nov 14, 2006 · Cardiovascular

Device Facts

• Record ID: K063222
• Device Name: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
• Applicant: Cardionet, Inc.
• Product Code: QYX · Cardiovascular
• Decision Date: Nov 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Indications for Use

The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath). 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring. 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter 8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes

Device Story

Ambulatory ECG monitor (Model CN1004) captures 2-channel ECG data via patient-worn sensor; sensor performs real-time arrhythmia detection using internal algorithm; detected events or patient-triggered events uploaded to communications gateway (Monitor); data transmitted to remote monitoring center via cellular RF or landline; trained technicians review data via Monitoring Services Application; output informs clinical decision-making regarding arrhythmia management; benefits include continuous outpatient monitoring for symptomatic patients.

Clinical Evidence

Bench testing only. Device met requirements of ANSI/AAMI EC 38:1998 (Ambulatory Electrocardiographs), ANSI/AAMI EC 57:1998 (Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms), and IEC 60601-1 (General Requirements for Safety).

Technological Characteristics

Ambulatory 2-channel ECG monitor; consists of patient-worn sensor, communications gateway (monitor), and charging base. Connectivity via cellular RF or landline. Algorithm resides in sensor for real-time detection. Complies with ANSI/AAMI EC 38, EC 57, and IEC 60601-1.

Indications for Use

Indicated for patients requiring cardiac monitoring for non-life-threatening arrhythmias, evaluation of symptoms (dizziness, syncope, dyspnea, palpitations), drug effect monitoring, post-cardiac surgery monitoring, sleep-disordered breathing, or stroke/TIA etiology evaluation. Contraindicated for patients with potentially life-threatening arrhythmias requiring inpatient monitoring or those requiring hospitalization.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• CardioNet Ambulatory ECG Monitor (K052240)
• CardioNet Ambulatory ECG Monitor (K012241)

Submission Summary (Full Text)

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November 15, 2023

Cardionet, Inc Jack Gaikwad Director, RA/qa 1010 2nd Ave., Suite 700 San Diego, California 92101

Re: K063222

Trade/Device Name: Cardionet Ambulatory Ecg Monitor With Arrhythmia Detection, Model Cn1004 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: QYX, DSI

Dear Jack Gaikwad:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter November 14, 2006. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, [e-mail].

Sincerely,

# Jennifer W. Shih -S

Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2006

CardioNet, Inc. c/o Mr. Jack Gaikwad Director RA/QA 1010 2nd Avenue, Suite 700 San Diego, CA 92101

Re: K063222

Trade Name: Ambulatory ECG Monitor with Arrhythmia Detector, Model CN 1004 Regulation Number: 21 CFR 870.1025

· Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm)

Regulatory Class: Class II Product Code: DSI Dated: October 19, 2006 Received: October 24, 2006

Dear Mr. Gaikwad:

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.

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Page 2 – Mr. Jack Gaikwad

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 (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/industry/support/index.html.

Sincerely yours,

Bhimineman, for

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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## Indications for Use

KOG3222 510(k) Number (if known):

Device Name: __CardioNet Ambulatory ECG Monitor with Arrhythmia Detection

#### Indications for Use:

The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for:

- 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease
- 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
- లు Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blymmiman

Division Sian-Of Division of Cardlovascular Devices 510iki N

Page 1 of 2

3

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- Patients who require monitoring of effect of drugs to control ventricular rate in 4. various atrial arrhythmias (e.g. atrial fibrillation).
- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia 5. monitoring.
- Patients with diagnosed sleep disordered breathing including sleep apnea ్. (obstructive, central) to evaluate possible nocturnal arrhythmias
- 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter
- 8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes

#### Contraindications:

- 1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
- 2. Patients who the attending physician thinks should be hospitalized.

Page 2 of 2

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063222

510(k) Summarv

### 510(k) Summary

#### Date: 10/19/2006

NOV 1 4 2006

Submitter Name and Address CardioNet, Inc. 1010 2nd Avenue, Suite 700 San Diego, CA 92101

Contact Person: Jack Gaikwad 619-243-7527

| Name of Device | |
|-------------------------|-------------------------------------------------------------------|
| Trade/Proprietary Name: | Model CN1004 - CardioNet ECG Monitor with<br>Arrhythmia Detection |
| Common/Usual Name: | Arrhythmia detector and alarm |
| Classification Name: | CFR §870.1025 Product code DSI 'Arrhythmia<br>Detector and Alarm' |
| Class: | Class II, Special Controls |

#### Predicate Device

The predicate devices selected are as follows:

- 1. CardioNet Ambulatory ECG Monitor, cleared by FDA under 510(k) number K052240; 870.1025 DSI "Arrhythmia Detector and Alarm"
- 2. CardioNet Ambulatory ECG Monitor, cleared by FDA under 510(k) number K012241; 870.1025 DSI "Arrhythmia Detector and Alarm"

#### Device Description

The CardioNet ECG Monitor with Arrhythmia Detection Model CN1004 is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a CardioNet staffed monitoring center.

The subject device is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Monitor (communications Gateway) and 3) a charning Base.

A Sensor acquires two (2) channels of ECG data from the patient's body. This ECG in the Sames Will in the Sensor. When events are detected by the analysis algorithm or when indicated by the patient pressing the event key on the Monitor, the Sensor will upload the data to the Monitor. The ECG data is then uploaded to the Monitoring Center. Data can be uploaded to the Monitoring Center in a variety of ways - Transmitted via Cellular RF modem or via RF to the Base for transmission via the patient's landline telephone.

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The data is received and reviewed by trained technicians using the Monitoring Services Application.

#### Indications for Use and Contraindications

The indications for use for the subject device are as follows:

- 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease
- 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
- 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
- 4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
- 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring,
- 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
- Patients requiring arrhythmia evaluation of etiology of stroke or transient 7. cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter
- 8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes.

#### Contraindications:

- 1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
- Patients who the attending physician thinks should be hospitalized. 2.

#### Technological comparison to predicate devices

The primary technological difference between the subject device and the predicate devices is that in the subject device the CardioNet proprios and the proprietary

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#### CardioNet Arrhythmia Detector

algorithm resides in the Sensor and detection of events is performed in the Sensor instead of the Monitor. The predicate devices have algorithms residing in the Monitor. The primary reason for moving the ECG detector algorithm is to enhance performance by improving communications between Sensor and Monitor and analyzing the ECG real time.

#### Summary of Performance Testing

The CardioNet ECG Monitor with Arrhythmia Detection Model CN1004 meets the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm.

- . ANSI/AAMI EC 38: 1998 - Ambulatory Electrocardiographs
- ANSI/AAMI EC 57: 1998 Testing and Reporting Performance Results of . Cardiac Rhythm and ST Segment Measurement Algorithms
- International Electrotechnical Commission (IEC) 60601-1 Medical Electrical ● Equipment - Part 1: General Requirements for Safety

#### Substantial Equivalence Conclusion

CardioNet ECG Monitor with Arrhythmia Detection, Model CN1004 is safe, effective, and substantially equivalent to the predicate devices as supported by the describtive information and the performance testing.