Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
Patients with dizziness or lightheadedness
Patients with palpitations
Patients with syncope of unknown etiology
Patients who require monitoring for non life-threatening arrhythmias, such as atrial fibrillation, other supra-ventricular arrhythmias, evaluation of various bradvarrhythmias and intermittent bundle branch block. This includes post operative monitoring for these rhythms
Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias
7 . Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease
Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias
Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation
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 changes.

Device Description

The CardioNet Arrhythmia Detector which is also referred to as the subject device, is a modification to the CardioNet Ambulatory ECG monitor cleared by FDA under 510(k) number K003707, in May 2001. The subject device includes the addition of an ECG analysis capability that allows detection of cardiac arrhythmia. As described in the previous 510(k) the subject device is comprised of three components: 1) a patient-worn Sensor, 2) a Monitor and 3) a charging Base. The Sensor acquires the ECG signal from the patient's body. It is connected to electrodes attached to the patient's skin. It is suspended in place by a neck strap. The ECG signal is conditioned, filtered, digitized and transmitted to the Monitor via Radio Frequency bi-directional communications. The Sensor utilizes a disposable AAA battery. The Monitor receives, analyzes, stores and transmits the ECG data. The Monitor has an LCD display and handles the user interaction for the system. The Monitor has an integrated cellular modem to allow communications with and without physical connection to a phone line. The Monitor has a re-chargeable battery. When an ECG threshold is exceeded or if the patient initiates a call, the ECG data is transmitted to the CardioNet Monitoring Center where trained clinical personnel review the data. The Monitor Center can also request data from the Monitor, the Monitor will transmit ECG data are requested. All ECG data for the past 24 hours is resident on the Monitor and can be transmitted to the Monitoring Center as requested by Monitoring Center Personnel. The subject device utilizes the proven Mortara ECG analysis algorithm that is currently used in the Quinton Q-tel telemetry system, 510(k) number K003576, 807.1025, Procode DSI, Class III; and the Datex-Ohmeda CS/3 telemetry system, 510(k) number K000882, 807.1025, Procode DSI, Class III. The Quinton Q-tel telemetry system and the Datex-Ohmeda telemetry system are both Class III Preamendments devices for which FDA has not yet requested PMAs. The Base provides power, RS232, and telephone communication connectivity to allow telephone transmission of ECG data when in the Monitor is charging. The Base does not include any software; it is a passive component that provides input to the Monitor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CardioNet ECG Monitor with Arrhythmia Detection, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not present a table of specific acceptance criteria (e.g., specific sensitivity/specificity thresholds for arrhythmia detection) alongside reported device performance. Instead, it indicates that the device's ECG analysis algorithm and viewing station "meets the requirements of ANSI/AAMI EC57:1998 'Testing and reporting performance results of cardiac rhythm and ST segment algorithms'".

Therefore, the acceptance criteria are implicitly defined by the standards referenced:

ANSI/AAMI EC38:1998 'Ambulatory electrocardiographs': General requirements for ambulatory ECG monitors.
ANSI/AAMI EC57:1998 "Testing and reporting performance results of cardiac rhythm and ST segment algorithms": Specifically for the performance of arrhythmia detection algorithms.

The summary does not include a table with reported device performance metrics (e.g., sensitivity, specificity, accuracy for various arrhythmias) against specific numerical acceptance criteria. It states that the device "meets or exceeds" these standards, implying compliance without providing raw performance numbers in this document.

The summary highlights that the device "utilizes the proven Mortara ECG analysis algorithm that is currently used in the Quinton Q-tel telemetry system... and the Datex-Ohmeda CS/3 telemetry system," both of which are Class III Preamendment devices. This suggests leveraging performance validated in previously cleared devices.

Study Information

Due to the nature of the 510(k) submission, specific detailed study information (like sample sizes, ground truth establishment for a new clinical study) related to the algorithmic performance is not explicitly provided in the summary. The summary refers to existing standards and leveraging a "proven" algorithm.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for a new, dedicated test. The summary indicates compliance with ANSI/AAMI EC57:1998, which would dictate testing methodologies and minimum data requirements for reporting performance. However, these details are not extracted here.
- Data Provenance: Not explicitly stated. The algorithm is noted as "proven" from other existing devices (Quinton Q-tel telemetry system, Datex-Ohmeda CS/3 telemetry system), suggesting its performance was likely established on retrospective datasets during its original development and validation, or potentially during its application in those predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not explicitly stated. For compliance with ANSI/AAMI EC57:1998, expert review (typically by cardiologists or electrophysiologists) would be standard practice for establishing ground truth on ECG databases. However, the details for this specific submission are not provided.
Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. If multiple experts were used, standard adjudication methods (e.g., 2+1, 3+1, majority vote, or expert consensus with discussion) would typically be employed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. The device focuses on standalone arrhythmia detection and subsequent review by "trained clinical personnel" at a monitoring center. It acts as an aid to detection and data transmission for human review, rather than a system directly augmenting a human reader's initial diagnostic accuracy on a given case.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, the core of the submission focuses on the standalone performance of the "ECG analysis algorithm" in detecting cardiac arrhythmias. The summary states that "The ECG analysis algorithm... meets the requirements of ANSI/AAMI EC57:1998 'Testing and reporting performance results of cardiac rhythm and ST segment algorithms'." This standard specifically addresses the performance of algorithms. The device then transmits this data for review by clinical personnel, implying a human-in-the-loop for final interpretation, but the algorithm's detection capabilities are evaluated standalone.
The type of ground truth used:
- Ground Truth Type: Not explicitly stated, but for arrhythmia detection algorithms reviewed under standards like ANSI/AAMI EC57, the ground truth is typically established by expert consensus (e.g., cardiologists, electrophysiologists) reviewing the ECG waveforms and annotations, often against well-curated public or private ECG databases. Pathology or outcomes data are generally not the direct ground truth for arrhythmia detection on an ECG.
The sample size for the training set:
- Training Set Sample Size: Not specified. The algorithm is described as "proven" and used in other existing devices. Details about its original training are not part of this 510(k) summary.
How the ground truth for the training set was established:
- Training Set Ground Truth: Not specified. For a "proven" algorithm, its ground truth for training would have been established during its initial development and validation, likely through expert consensus annotation of large ECG datasets.

Summary

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K012241

FEB 01 2

510(k) Summary

Date: 10/30/2001

Submitter Information

CardioNet, Inc. Attn: Mr. Donald V. Canal Vice President RAQA 510 Market Street San Diego, Ca 92101

1. Name of Device

Trade/Proprietary Name:

Model 1001 - CardioNet ECG Monitor with Arrhythmia Detection.

Ambulatory ECG Monitor and Arrhythmia Common/Usual Name: detector and alarm.

CFR §870.2920 'Telephone Electrocardiograph Classification Name: Transmitter and Receiver', CFR §870.2800 'Medical Magnetic Tape Recorder'. CFR §870.1025 Procode DSI 'Arrhythmia Detector and Alarm'.

Class III Preamendments Device for which FDA Class: has not yet called for PMAs.

2. Predicate Devices

The predicate devices selected are as follows:

1. CardioNet Ambulatory ECG Monitor, cleared by FDA under 510(k) number K003707; 870.2800 "Medical Magnetic Tape Recorder". Procode: MWJ "Electrocardiograph, Ambulatory (Without analysis)":
1. Cardiac Telecom Cardiac TeleCom HeartLink II ECG Arrhythmia detector and Alarm System- Manufactured by Cardiac Telecom, Inc., cleared by FDA under 510(k) number K982803; 870.1025 Procode DSI 'ECG Arrhythmia detector and alarm".

3. Device Description ·

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As described in the previous 510(k) the subject device is comprised of three components: 1) a patient-worn Sensor, 2) a Monitor and 3) a charging Base.

The Sensor acquires the ECG signal from the patient's body. It is connected to electrodes attached to the patient's skin. It is suspended in place by a neck strap. The ECG signal is conditioned, filtered, digitized and transmitted to the Monitor via Radio Frequency bi-directional communications. The Sensor utilizes a disposable AAA battery.

The Monitor receives, analyzes, stores and transmits the ECG data. The Monitor has an LCD display and handles the user interaction for the system. The Monitor has an integrated cellular modem to allow communications with and without physical connection to a phone line. The Monitor has a re-chargeable battery. When an ECG threshold is exceeded or if the patient initiates a call, the ECG data is transmitted to the CardioNet Monitoring Center where trained clinical personnel review the data. The Monitor Center can also request data from the Monitor, the Monitor will transmit ECG data are requested. All ECG data for the past 24 hours is resident on the Monitor and can be transmitted to the Monitoring Center as requested by Monitoring Center Personnel. The subject device utilizes the proven Mortara ECG analysis algorithm that is currently used in the Quinton Q-tel telemetry system, 510(k) number K003576, 807.1025, Procode DSI, Class III; and the Datex-Ohmeda CS/3 telemetry system, 510(k) number K000882, 807.1025, Procode DSI, Class III. The Quinton Q-tel telemetry system and the Datex-Ohmeda telemetry system are both Class III Preamendments devices for which FDA has not yet requested PMAs.

The Base provides power, RS232, and telephone communication connectivity to allow telephone transmission of ECG data when in the Monitor is charging. The Base does not include any software; it is a passive component that provides input to the Monitor.

4. Indications For Use

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

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
1. Patients with dizziness or lightheadedness
1. Patients with palpitations
1. Patients with syncope of unknown etiology
1. Patients who require monitoring for non life-threatening arrhythmias, such as atrial fibrillation, other supra-ventricular arrhythmias, evaluation of various bradvarrhythmias and intermittent bundle branch block. This includes post operative monitoring for these rhythms
1. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias
7 . Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease
1. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias

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1. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation
1. 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 changes.

	CardioNet ArrhythmiaDetector(Subject device)	CardioNet AmbulatoryECG Monitor	Cardiac TelecomHeartLink II
Manufacturer	CardioNet, Inc.	CardioNet, Inc.	Cardiac Telecom, Inc.
510k number	Subject DeviceClass III DSI870.1025	K003707Class II MWJ	K982803Class IIIPreamendmentsdevice, DSI870.1025
Maximum storagecapacity.	24 hours	24 hours	Last 30 minutes ofdata
Includestranstelephoniccapability	Yes	Yes	Yes
Event Recordingtime.	Marker inserted into full disclosure data. All data is available for 24 hours at the request of Monitoring Center.	+/- 5 minutes from Patient Marker in event mode. Patient Marker inserted into full disclosure data in Holter mode.	Marker inserted into full disclosure data. All data is available for 30 minutes at the request of the Monitoring Center.
Pacer PulseDetection andreporting	Yes	Yes	Yes
Leads off detection	Yes	Yes	Yes
Power input/Battery Type	Sensor - 1 AAA,Monitor - Li lon,rechargeableBase - 6 volts	Sensor - 1 AAA,Monitor - Li Ion,rechargeableBase - 6 volts	Sensor - NiCadTower PC - 120 V AC
Enclosure	Sensor - Molded TPE,Monitor - Molded Plastic	Sensor - Molded TPE,Monitor - MoldedPlastic	Molded plastic
A to D samplingrate (samples/sec)	250	250	Not Specified inavailable literature
Resolution (A/Dconversion bits)	12 bit	12 bit	Not Specified inavailable literature
Number ofchannels	3	3	1
Number ofElectrodes	3	3	3
Storage Type(digital or Tape)	Digital flash non-removable	Digital flash non-removable	Hard disk
	CardioNet ArrhythmiaDetector(Subject device)	CardioNet AmbulatoryECG Monitor	Cardiac TelecomHeartLink II
Input impedance	>1 Mohm	>1 Mohm	2.5 Mohm @10 Hz
FrequencyResponse	0.5 Hz up to 40 Hz	0.5 Hz up to 40 Hz	Not Specified inavailable literature
CommunicationMeans	Cellular Phone,PSTN phone,RS232, audio Coupled	Cellular Phone,PSTN phone,RS232, audio Coupled	PSTN telephoneconnection
Operatingtemperature range	Sensor: 20°C to 45°CMonitor: 0°C to 45°C	Sensor: 20°C to 45°CMonitor: 0°C to 45°C	25+/- 10 degrees C
Storagetemperature range	-20°C to 65°C	-20°C to 65°C	Not Specified inavailable literature
Relative Humidity	5% to 95%	5% to 95%	50%+/-30%
Dimensions	Sensor -2" x 12" x 0.5"Monitor - 4.5" x 3.5" x 1.5"	Sensor -2" x 12" x 0.5"Monitor - 4.5" x 3.5" x1.5"	Sensor - 3. 5" x 1.25"x 4.5 "Tower PC - 17" x 5" x12"
Weight	Sensor 1.8 ouncesMonitor 10 ounces	Sensor 1.8 ouncesMonitor 10 ounces	Sensor 10.5 ouncesMonitor 10 lbs.
RF Modulation	902 - 928 MHz withfrequency hopping(30 foot range)	902 - 928 MHz withfrequency hopping (30foot range)	902-928 MHzNo frequency hopping(300 foot range)
LCD display	Yes with touch screen	Yes	Yes on the Tower PC

5. Comparison to Predicate Devices

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6. Non-Clinical Performance Test Summary

There are no applicable device-specific quidance documents for the subject device. The CardioNet Ambulatory ECG Monitor meets or exceeds the applicable requirements in ANSI/AAMI/ISO EC38 'Ambulatory electrocardiographs', 1998. The ECG analysis algorithm and the ECG viewing station meets the requirements of ANSI/AAMI EC57:1998 "Testing and reporting performance results of cardiac rhythm and ST segment algorithms". Note: the CardioNet Arrhythmia detector does not generate alarms for ST segment changes.

Several other ECG related standards have also been considered as design inputs for the CardioNet Ambulatory ECG Monitor: ANSI/AAMI EC13:'Cardiac Monitors, Heart rate meters and alarms', 1992; ANSI/AAMI EC11 "Diagnostic Electrocardiographic devices", 1991; and ANSI/AAMI EC53-1995 "ECG Cable and Lead wires".

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The Sensor skin contact materials will be tested to meet the requirements for surface devices, skin contact > 30 days as required in ISO10993 'FDA modified Biocompatibility' table.

The Sensor, Monitor and Base comply with the applicable requirements in UL2601, and ANSI/AAMI EC1-1993, "Safe Current Limits for electromechanical Apparatus: December", 1993.

The applicable communications for the Monitor will meet the applicable requirements in FCC part 15, subpart C, and part 68.

7. Substantial Equivalence Conclusion

The CardioNet Arrhythmia detector is equivalent to the predicate devices as supported by the descriptive information and the performance testing demonstrates that it meets the applicable requirements of ANSI/AAMI EC38:1998 'Ambulatory electrocardiographs', the ECG analysis algorithm and the ECG viewing station meet the requirements of ANSI/AAMI EC57:1998 "Testing and reporting performance results of cardiac rhythm and ST segment algorithms".

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create a sense of movement and dynamism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 1 2002

Mr. Jerry Kalieta Director Quality Assurance CardioNet, Inc. 510 Market Street San Diego, CA 92101

Re: K012241

Trade Name: CardioNet Ambulatory ECG Monitor with Arrhythmia Detection Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: October 31, 2001 Received: November 5, 2001

Dear Mr. Kalieta:

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. Jerry Kalieta

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: CardioNet Ambulatory Monitor with Arrhythmia Detection

Indications for Use:

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
1. Patients with dizziness or lightheadedness
1. Patients with palpitations
1. Patients with syncope of unknown etiology
1. Patients who require monitoring for non life-threatening arrhythmias. such as atrial fibrillation, other supra-ventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block. This includes post operative monitoring for these rhythms
1. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias
1. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease
1. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias
1. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation
1. 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.

Image /page/7/Figure/14 description: The image is a black and white photograph of an object. The object is long and narrow, and it appears to be made of a solid material. The object is dark in color, and it has a rough surface. The object is positioned horizontally in the image.

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 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.