(85 days)
Not Found
No
The document mentions an "automated arrhythmia analysis algorithm" but provides no details suggesting it uses AI/ML. The performance standards cited are general for arrhythmia detection and do not specifically indicate AI/ML use.
No.
The device is described as a monitor that detects and transmits ECG data for analysis and review by trained technicians. It is not intended to treat or prevent a disease or condition; rather, it provides diagnostic information.
Yes
The device detects cardiac arrhythmias, evaluates bradyarrhythmias, monitors the effect of drugs to control heart rate, and aids in the evaluation of the etiology of stroke or transient cerebral ischemia, which are all diagnostic purposes. It identifies and analyzes physiological conditions to determine the presence or nature of a disease or condition.
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 human body. The CardioNet Ambulatory ECG Monitor directly acquires an electrical signal (ECG) from the patient's body. It does not analyze a biological sample like blood, urine, or tissue.
- The intended use is for monitoring cardiac electrical activity. The device is used to detect and analyze the electrical signals of the heart, not to perform tests on biological specimens.
- The device description focuses on ECG acquisition and transmission. The components and function described are related to capturing and transmitting electrical signals, not processing biological samples.
Therefore, the CardioNet Ambulatory ECG Monitor with Arrhythmia Detection falls under the category of a medical device that directly interacts with the patient's body to acquire physiological data, rather than an IVD which analyzes samples taken from the body.
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 (comma separated list FDA assigned to the subject device)
QYX, DSI, MLO
Device Description
The CardioNet ECG Monitor with Arrhythmia Detection Model CN1005 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
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)
The CardioNet ECG Monitor with Arrhythmia Detection Model CN1005 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 (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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 15, 2023
Cardionet, Inc Jack Gaikwad Consultant 1010 2nd Ave., Suite 700 San Diego, California 92101
Re: K072558
Trade/Device Name: Cardionet Ambulatory Ecg Monitor With Arrhythmia Detection, Model Cn1005 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, MLO
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 December 5, 2007. 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 Ouality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
DEC 0 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
J 11 11 11 11 .
1
CardioNet, Inc. c/o Mr. Jack Gaitwad 1010 2nd Avenue, Suite 700 San Diego, CA 92101
Re: K072558
Trade/Device Name: CardioNet Ambulatory ECG Monitor with Arrhythmia Detection CN1005 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: DSI, MLO Dated: August 31, 2007 Received: September 11, 2007
Dear Mr. Gaitwad:
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 Gaitwad
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
B. Zimmerman M.D.
2
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): Ko72558
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 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 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 U (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)
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072558
- Patients who require monitoring of effect of drugs to control ventricular rate in 4. various atrial arrhythmias (e.g. atrial fibrillation).
- ട്. 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
Contraindications:
- Patients with potentially life-threatening arrhythmias who require inpatient 1. monitoring.
- Patients who the attending physician thinks should be hospitalized. 2.
印刷 1-
4
5
CardioNet Arrhythmia Detector
510(k) Summary
510(k) Summary
Date: 09/07/2007
| 1. Submitter Name and Address | CardioNet, Inc.
1010 2nd Avenue, Suite 700
San Diego, CA 92101 |
|----------------------------------------------|----------------------------------------------------------------------|
| 2. Contact Person | Jack Gaikwad
Tel # 714-713-9011
DEC 05 2007 |
| 3. Name of Device
Trade/Proprietary Name: | Model CN1005 - 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 |
4. Predicate Device/s
The predicate devices selected are as follows:
-
- CardioNet Ambulatory ECG Monitor, cleared by FDA under 510(k) number K063222; 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"
5. Device Description
The CardioNet ECG Monitor with Arrhythmia Detection Model CN1005 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.
CardioNet, Inc 1010 2nd Avenue, Suite 700 San Diego, CA 92101 (619) 243-7500
6
CardioNet Arrhythmia Detector
The data is received and reviewed by trained technicians using the Monitoring Services Application.
6. 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 1. 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 2. 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 3. correlation of rhythm with symptoms.
- Patients who require monitoring of effect of drugs to control ventricular rate in র . various atrial arrhythmias (e.g. atrial fibrillation).
- Patients recovering from cardiac surgery who are indicated for outpatient 5. arrhythmia 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 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 1. monitoring.
- Patients who the attending physician thinks should be hospitalized. 2.
7
7. Technological comparison to predicate devices
The primary technological difference between the subject device and the predicate device (K063222) is that the subject device uses an arrhythmia analysis algorithm licensed from Mortara Instrument while the predicate device uses a proprietary arrhythmia analysis algorithm developed by CardioNet.
The primary difference between the subject device and predicate device (K012241) is slight differences in Indications for use statements. The subject device and predicate device have identical technological characteristics.
8. Summary of Performance Testing
The CardioNet ECG Monitor with Arrhythmia Detection Model CN1005 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
9. Substantial Equivalence Conclusion
CardioNet ECG Monitor with Arrhythmia Detection, Model CN1005 is safe, effective, and substantially equivalent to the predicate devices as supported by the descriptive information and the performance testing.