(63 days)
Not Found
No
The document explicitly states that the data is analyzed by an "automated arrhythmia analysis algorithm" and reviewed by "trained technicians," with no mention of AI or ML.
No
The device is used for monitoring and detection of cardiac arrhythmias, not for treating any condition.
Yes
Explanation: The device is used to monitor and detect cardiac arrhythmias, evaluate symptoms that may be due to cardiac arrhythmias, and monitor the effect of drugs, all of which are diagnostic functions.
No
The device description explicitly states it is comprised of three main hardware components: a patient-worn Sensor, a Monitor, and a charging Base.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., in vitro (outside the body).
- This device analyzes signals from the body. The CardioNet Ambulatory ECG Monitor acquires and analyzes the electrical signals of the heart (ECG) directly from the patient's body via a sensor. This is an in vivo (within the body) measurement.
The device is clearly described as an ambulatory ECG monitor that detects cardiac arrhythmias by analyzing the electrical activity of the heart as measured on the patient's skin. This falls under the category of medical devices that monitor physiological signals in vivo, not IVDs.
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 1. 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 2. 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 3. rhythm with symptoms.
- 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 6. (obstructive, central) to evaluate possible nocturnal arrhythmias
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral 7. ischemia, possibly secondary to atrial fibrillation or atrial flutter
- Data from the device may be used by another device to analyze, measure or report 8. QT interval. The device is not intended to sound any alarms for QT interval changes
Product codes (comma separated list FDA assigned to the subject device)
QYX, DSI
Device Description
The CardioNet ECG Monitor with Arrhythmia Detection 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 and 3) a charqing Base.
A Sensor acquires the ECG signal from the patient's body and transmits the signal to PDA sized monitor where the data is stored and analyzed by an automated arrhythmia analysis algorithm. When an arrhythmic event is defected the monitor can transmit the ECG data to the monitoring center utilizing a cellular modem or telephone data line. The patient can also initiate the recording and transmission of ECG data if symptoms are felt. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was performed in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm. The CardioNet Ambulatory ECG Monitor meets or intends to conform to the applicable standards suggested in the guidance document including:
- 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 (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
§ 870.1025 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.
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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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
November 15, 2023
Cardionet, Inc Jack Gaikwad Director, RA/qa 1010 2nd Ave., Suite 700 San Diego, California 92101
Re: K052240
Trade/Device Name: Cardionet Ambulatory Ecg Monitor With Arrhythmia Detection, Model 1002 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 dated October 19, 2005. 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
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2005
Cardionet, Inc. c/o Mr. Jack Gaikwad Director, Quality and Regulatory 1010 2nd Avenue, Suite 700 San Diego, CA 92101
Re: K052240
Trade Name: Cardionet Ambulatory ECG Monitor with Arrhythmia Detection Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: DSI Dated: August 11, 2005 Received: August 17, 2005
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Bhimmerfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known):__K052240
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 1. 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 2. 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 3. rhythm with symptoms.
Prescription Use (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)
Blamema
scular Devices
Page 1 of 2
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 6. (obstructive, central) to evaluate possible nocturnal arrhythmias
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral 7. ischemia, possibly secondary to atrial fibrillation or atrial flutter
- Data from the device may be used by another device to analyze, measure or report 8. 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 1. monitoring.
- Patients who the attending physician thinks should be hospitalized. 2.
elwise
Jivision Sign-Off vision of Cardiovascular Devices
510(k) Number
Page 2 of 2
5
510(k) Summary
510(k) Summary
Date: 08/11/2005
2007 1 8 200
Submitter Name and Address CardioNet, Inc. 1010 2nd Avenue, Suite 700
Contact Person: Jack Gaikwad 619-243-7527
San Diego, CA 92101
| Name of Device
Trade/Proprietary Name: | Model 1002 - CardioNet ECG Monitor with
Arrhythmia Detection |
|-------------------------------------------|-----------------------------------------------------------------|
| Common/Usual Name: | Arrhythmia detector and alarm |
| Classification Name: | CFR §870.1025 Procode DSI 'Arrhythmia Detector
and Alarm' |
| Class: | Class II, Special Controls |
Predicate Device
CardioNet Ambulatory ECG Monitor, (K012241)
Substantial Equivalence
The features and functions of the CardioNet ECG Monitor with Arrhythmia Detection, Model 1002 are substantially equivalent to the previously cleared CardioNet Ambulatory ECG Monitor with Arrhythmia Detection, (K012241).
Intended Use
The CardioNet ECG Monitor with Arrhythmia Detection, Model 1002 is intended to be used for ambulatory diagnostic monitoring for cardiac arrhythmias. The specific indication statements differ slightly from those of the predicate device. These changes are intended to update terminology and provide examples of clinical usage scenarios. These changes do not affect the intended use or affect the safety and effectiveness of the device.
Device Description
The CardioNet ECG Monitor with Arrhythmia Detection 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 and 3) a charqing Base.
CardioNet, Inc 1010 2nd Avenue, Suite 700 San Diego, CA 92101 (619) 243-7500
6
2 " . 1 - 4 -
A Sensor acquires the ECG signal from the patient's body and transmits the signal to PDA sized monitor where the data is stored and analyzed by an automated arrhythmia analysis algorithm. When an arrhythmic event is defected the monitor can transmit the ECG data to the monitoring center utilizing a cellular modem or telephone data line. The patient can also initiate the recording and transmission of ECG data if symptoms are felt. The data is received and reviewed by trained technicians using the Monitoring Services Application.
Technological comparison to predicate device
The CardioNet ECG Monitor with Arrhythmia Detection differs from the predicate device only with respect to the arrhythmia analysis algorithm. The predicate device included an arrhythmia analysis algorithm licensed from Mortara Instrument. The new algorithm was developed by CardioNet and includes the same functions supplied by the previous algorithm.
Summary of Performance Testing
Performance testing was performed in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm. The CardioNet Ambulatory ECG Monitor meets or intends to conform to the applicable standards suggested in the guidance document including:
- 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
Conclusions
As stated above, CardioNet's conclusion is that the CardioNet ECG Monitor with Arrhythmia Detection, Model 1002 is safe, effective, is substantially equivalent to the predicate device and will comply with appropriate medical device standards and FDA special controls guidance prior to market release.