(21 days)
Not Found
No
The document describes an "analysis algorithm" for detecting cardiac arrhythmias, but there is no mention of AI, ML, or any related technologies. The performance studies reference standards for cardiac rhythm and ST segment measurement algorithms, which are typically based on traditional signal processing techniques.
No
The device is solely for monitoring and detecting cardiac arrhythmias, not providing treatment or therapy.
Yes
The device is intended to monitor patients for arrhythmias, evaluate various cardiac conditions, detect the etiology of certain symptoms, and assess the effect of drugs, all of which involve identifying or characterizing disease states or health conditions.
No
The device description explicitly states it is comprised of three main hardware components: a patient-worn Sensor, a Monitor (communications Gateway), and a charging Base.
Based on the provided information, the CardioNet Ambulatory ECG Monitor with Arrhythmia Detection is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CardioNet Device Function: The CardioNet device directly acquires physiological data (ECG) from the patient's body through external sensors. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes monitoring cardiac rhythms and detecting arrhythmias in patients, which is a direct physiological measurement and analysis, not an in vitro test.
- Device Description: The description details a patient-worn sensor, monitor, and charging base, all components for acquiring and transmitting physiological signals.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, the CardioNet Ambulatory ECG Monitor with Arrhythmia Detection is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for:
-
- 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
-
- 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).
-
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
-
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
-
- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
-
- 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 cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter
-
- 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
Product codes
QYX, DSI
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.
The data is received and reviewed by trained technicians using the Monitoring Services Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a sans-serif font.
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, jennifer.kozen@fda.hhs.gov.
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
1
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.
2
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 (240) 276-0120. 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 (240) 276-3150 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
3
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:
-
- 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
-
- 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
4
- 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
-
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter
-
- 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:
-
- Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
-
- Patients who the attending physician thinks should be hospitalized.
Page 2 of 2
5
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 |
| Arrhythmia Detection | |
| Common/Usual Name: | Arrhythmia detector and alarm |
| Classification Name: | CFR §870.1025 Product code DSI 'Arrhythmia |
| Detector and Alarm' | |
| Class: | Class II, Special Controls |
Predicate Device
The predicate devices selected are as follows:
-
- CardioNet Ambulatory ECG Monitor, cleared by FDA under 510(k) number K052240; 870.1025 DSI "Arrhythmia Detector and Alarm"
-
- 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.
6
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:
-
- 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
-
- 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).
-
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
-
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
-
- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring,
-
- 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
-
- 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:
-
- 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
7
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.