(170 days)
Not Found
Unknown
The document mentions an "automated arrhythmia analysis algorithm" but does not provide enough detail to determine if this algorithm utilizes AI or ML techniques. It could be based on traditional signal processing methods.
No
The device is used for monitoring, detection, and analysis of cardiac arrhythmias and ECG data, but it does not provide any therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section clearly states that the device is used for monitoring patients for various cardiac conditions, evaluating symptoms, and assessing treatment effects, all of which fall under the scope of diagnosis. The "Device Description" also mentions its capability to "detect cardiac arrhythmias" and that data is "analyzed by an automated arrhythmia analysis algorithm," supporting its role in identifying medical conditions.
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 biological samples in vitro (outside the body). The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection acquires an ECG signal directly from the patient's body in vivo (within the body).
- The device's function is to monitor and detect cardiac arrhythmias based on electrical signals from the heart. This is a physiological measurement, not an analysis of a biological sample like blood, urine, or tissue.
- The intended use and device description clearly indicate a focus on monitoring the electrical activity of the heart in a living patient.
Therefore, this device falls under the category of a medical device that performs physiological monitoring, not an In Vitro Diagnostic.
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 fung 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: c) dyspnea (shortness of breath).
-
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
-
- Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) 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.
-
- Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter
-
- Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation).
-
- Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes.
Product codes
QYX, DSI
Device Description
The CardioNet ECG Monitor with Arrhythmia Detection CN1006 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 charging 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 residing in the Monitor. When events are detected by the analysis algorithm or when indicated by the patient pressing the event key on the Monitor, the Monitor will transmit the data 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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The subject device meets the requirements of the following performance standards in accordance with Class II Special Controls Guidance document: Arrhythmia Detector and Alarm
- . AAMI/ANSI EC 57 1998/(R) 2003 - Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
- AAMI EC 53/(R) 2001 ECG Cables and leadwires.
- International Electrotechnical Commission (IEC) 60601-1:1988 +A1:1991 +A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001)
- AAMI / ANSI EC38:2007, Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. (Cardiovascular)
- AAMI / ANSI / ISO 10993-1:2003, Biological evaluation of medical devices --. Part 1: Evaluation and testing. (Biocompatibility)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2023
Cardionet, Inc Kent Sayler Director, Qa/ra 1010 2nd Ave., Suite 700 San Diego, California 92101
Re: K093288
Trade/Device Name: Cardionet Ambulatory Ecg Monitor With Arrhythmia Detection 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 Kent Sayler:
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 April 8, 2010. 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 8 2010
CardioNet. Inc. c/o Mr. Kent Sayler Director RA/QA 1010 2nd Avenue, Suite 700 San Diego, CA 92101
Re: K093288
Device Name: Ambulatory ECG Monitor with Arrhythmia Detection Model # CN1006 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (Two) Product Code: DSI Dated: April 1, 2010 Received: April 6, 2010
Dear Mr. Sayler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
2
Page 2 - Mr. Kent Sayler
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours
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
510(k) Number (if known): K093288
CardioNet Ambulatory ECG_Monitor with_Arrhythmia Detection Device Name:
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 fung 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: c) dyspnea (shortness of breath).
-
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
-
- Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) 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.
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)
Page 1 of 2
3
4
- 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 ischemia, possibly secondary to atrial fibrillation or atrial flutter.
- Patients requiring measurement, analysis and reporting of QT interval, excluding 8. patients with a documented history of sustained atrial fibrillation or atrial flutter
- Patients who require monitoring for potential arrhythmias based on risk factors (e.g. 9. atrial fibrillation).
- Patients requiring measurement of ST segment changes. The device is not intended 10. to sound any alarms for ST segment changes.
Contraindications:
- Patients with potentially life-threatening arrhythmias who require inpatient 1. Monitoring,
- Patients who the attending physician recommends should be hospitalized for ECG 2. monitoring.
- This device should not be used for monitoring of QT interval during the initiation of 3. antiarrhythmic therapy, where in-hospital monitoring is required by the labeling of that drug.
- The device does not replace the QT interval measurement by a trained observer 4. using diagnostic 12 lead ECG in a clinical environment. This device is not intended to sound any alarms for QT interval changes.
- The device does not annotate QT interval for QRS durations >160 ms or for T wave 5. amplitudes ≤5% of the peak QRS amplitude.
X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| Page 2 of 2 |
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| ------------- |
510(k) Number
5
510(k) Summary
Date: 3/31/2010
Submitter Name and Address CardioNet, Inc. 1010 2nd Avenue, Suite 700 San Diego, CA 92101
APR - 8 2010
- Contact Person: Kent Sayler 619-243-7560
- Name of Device Trade/Proprietary Name: Model CN1006 - 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
2. Predicate Devices
The predicate devices selected are as follows:
-
- CardioNet Ambulatory ECG Monitor with Arrhythmia Detection manufactured by CardioNet, Inc. cleared by FDA under 510(k) number K053263 on April 25, 2006.
-
- CardioNet Ambulatory ECG Monitor with Arrhythmia Detection manufactured by CardioNet, Inc. cleared by FDA under 510(k) number K063222 on November 14, 2006.
- CG6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector . 3. manufactured by Card Guard Scientific Survival Ltd., cleared by FDA under 510(k) number K081257 on May 29, 2008.
3. Device Description
The CardioNet ECG Monitor with Arrhythmia Detection CN1006 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 charging 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 residing in the Monitor. When events are detected by the analysis algorithm or when indicated by the patient pressing
CardioNet, Inc 1010 2nd Avenue, Suite 700 San Diego, CA 92101 (619) 243-7500
Page 1 of 4
6
the event key on the Monitor, the Monitor will transmit the data 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.
4. 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; c) dyspnea (shortness of breath).
-
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
-
- Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) 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
- റ. 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.
-
- Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter
- ത് Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation).
-
- Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes.
CardioNet. Inc 1010 2nd Avenue, Suite 700 San Diego, CA 92101 (619) 243-7500
7
Contraindications:
-
- Patients with potentially life-threatening arrhythmias who require inpatient Monitoring.
-
- Patients who the attending physician recommends should be hospitalized for ECG monitoring.
-
- This device should not be used for monitoring of QT interval during the initiation of antiarrhythmic therapy, where in-hospital monitoring is required by the labeling of that drug.
-
- The device does not replace the QT interval measurement by a trained observer using diagnostic 12 lead ECG in a clinical environment. This device is not intended to sound any alarms for QT interval changes.
- ട. The device does not annotate QT interval for QRS durations >160 ms or for T wave amplitudes ≤5% of the peak QRS amplitude.
5. Comparison to predicate devices
The table below compares the features between the subject device and predicate devices.
| Feature being compared | Subject Device | Predicate Device |
|---|---|---|
| ECG algorithm | Model CN1006 (K093288) | CardioNet Model CN1003 |
| (K053263) | ||
| QT Interval Measurement | Model CN1006 (K093288) | CardioNet Model CN1004 |
| (K063222) | ||
| ST Segment Measurement | Model CN1006 (K093288) | Card Guard CG6108-ACT3L |
| (K081257) |
Predicate Device Feature Comparison Table
6. Performance Test Summary
The subject device meets the requirements of the following performance standards in accordance with Class II Special Controls Guidance document: Arrhythmia Detector and Alarm
- . AAMI/ANSI EC 57 1998/(R) 2003 - Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
- AAMI EC 53/(R) 2001 ECG Cables and leadwires .
- International Electrotechnical Commission (IEC) 60601-1:1988 +A1:1991 . +A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001)
- AAMI / ANSI EC38:2007, Medical electrical equipment Part 2-47: .
CardioNet. Inc 1010 2nd Avenue, Suite 700 -San Diego, CA 92101 (619) 243-7500
8
..
Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. (Cardiovascular)
- AAMI / ANSI / ISO 10993-1:2003, Biological evaluation of medical devices --. Part 1: Evaluation and testing. (Biocompatibility)
7. Substantial Equivalence Conclusion
CardioNet ECG Monitor with Arrhythmia Detection, Model CN1006 is safe, effective, and substantially equivalent to the predicate devices as supported by the descriptive information and the performance testing.
CardioNet, Inc 1010 2nd Avenue, Suite 700 San Diego, CA 92101 (619) 243-7500