The HEARTLink II System is intended to provide cardiac monitoring from a low-risk patient's home a central monitoring facility pursuant to to physician prescription.

Device Description

The HEARTLink II System receives and processes radiofrequency encoded transmitted ECG signals on the Tele-Link monitoring unit. Abnormal ECGs and arrhythmias detected by the Tele-Link can be displayed on an optional video display monitor, while being simultaneously transmitted through standard telephone lines to a remote Central Station. The Central Station, located within health care institution or patient monitoring facility, is where an alarm is sounded and the ECG is again displayed for the review of medical personnel. The Central Station system has four dedicated phone lines and can provide remote monitoring of ECG data received from 30 individual Tele-Links. A total of 30 patients can be monitored at one time by a single one Central Station.

AI/ML Overview

The provided documents describe the HEARTLink II (Arrhythmia Detector and Alarm System), a device intended for cardiac monitoring of low-risk patients in their home environment. The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials to prove safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in the context of demonstrating substantial equivalence.

Here's an analysis of the available information according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) submission primarily focused on substantial equivalence to existing devices (HEARTLink I, King of Hearts, Aegis), the "acceptance criteria" are generally derived from the performance of these predicate devices and relevant standards. The document doesn't explicitly state quantitative acceptance criteria for arrhythmias detected but rather focuses on usability and transmissibility in the new home-use environment.

Criteria Category	Specific Criteria (Implied / Explicit)	Reported Device Performance and Study Findings
Safety and Effectiveness	Compliance with relevant standards for arrhythmia detectors, emissions, safety.	Bench Testing: HEARTLink I (and by extension HEARTLink II due to technical equivalence with minimal changes) complied with: - FDA's MDS 201-0004 - FCC's Parts 15 and 68 Rules - Draft AAMI EC-13-R-4/91 standards (now adopted as standard). HEARTLink II was re-tested for safety and emissions and complies with the current EMC Directive.
Usability	Ability of a patient to effectively use the device in a home environment.	Clinical Trials: Conducted at Saint Francis Medical Center (Pittsburgh, PA) and Washington Center Hospital (Washington, DC). Finding: HEARTLink II is "as usable" as the predicate Event Recorder System.
Transmissibility	Ability to accurately transmit ECG data to a Central Monitoring facility.	Healthy Volunteer Trials: Healthy volunteers wore both HEARTLink II and a predicate device for 4 days. Finding: HEARTLink II is capable of transmitting data with "equal fidelity" as its predicate Event Recorder System.

2. Sample Size Used for the Test Set and Data Provenance

Usability Study (Clinical Trials):
- Sample Size: Not explicitly stated. The document mentions "clinical trials were done," but does not provide the number of patients or participants.
- Data Provenance: Prospective (clinical trials). Conducted in two U.S. states: Pittsburgh, PA (Saint Francis Medical Center) and Washington, DC (Washington Center Hospital).
Transmissibility Study (Healthy Volunteer Trials):
- Sample Size: Not explicitly stated. The document mentions "healthy volunteers were to wear both the HEARTLink II System."
- Data Provenance: Prospective (healthy volunteer trials). Location not specified beyond "healthy volunteers," but likely U.S.-based given the U.S. clinical trial sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not detail the establishment of "ground truth" in the traditional sense of expert adjudication for arrhythmia detection performance in these specific studies because:

The usability study assessed user interaction, not diagnostic accuracy of arrhythmia detection.
The transmissibility study assessed data fidelity, not diagnostic accuracy.

The accuracy of arrhythmia detection itself was largely addressed by substantial equivalence to the predicate devices which would have already established their own accuracy. Personnel involved in reviewing transmitted ECGs for the transmissibility study would likely be medical personnel at the Central Monitoring facilities, but their qualifications and numbers are not specified.

4. Adjudication Method for the Test Set

No explicit adjudication method is described for the "test set" in the context of diagnostic accuracy, as the studies focused on usability and transmissibility.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is an "Arrhythmia Detector and Alarm System," implying an automated or semi-automated detection component, but the studies described focus on usability and data transmission, not on comparing human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document heavily relies on the technical equivalence of HEARTLink II to HEARTLink I. HEARTLink I was previously cleared by the FDA (K934913) as an arrhythmia detector and alarm system. The HEARTLink II is described as "identical to the HEARTLink I System" with the exception of a name change and a minimal change to non-physiological information in the database management software.

The bench testing and compliance with standards (MDS 201-0004, AAMI EC-13-R-4/91) would cover the standalone performance aspects of the arrhythmia detection algorithm, as these standards are designed to ensure its functional performance. However, a separate, specific study explicitly labeled as a "standalone algorithm performance study" is not detailed for HEARTLink II. Its standalone performance is primarily extrapolated from HEARTLink I's prior clearance and compliance with recognized standards.

7. The Type of Ground Truth Used

Usability Study: The "ground truth" would be subjective patient/user feedback and observations of their ability to use the system, compared to a predicate system.
Transmissibility Study: The "ground truth" would be the quality and accuracy of the transmitted ECG waveforms compared to the original signals or what was received from the predicate device simultaneously, indicating data fidelity.
For the core arrhythmia detection accuracy: This is not directly addressed by new "ground truth" experiments in this 510(k) submission for HEARTLink II. Instead, it relies on the substantial equivalence to the HEARTLink I which, as a previously cleared device, would have established its own accuracy (likely using expert-adjudicated ECG recordings or a validated database as ground truth, but this information is not in the provided text).

8. The Sample Size for the Training Set

The document is for a 510(k) premarket notification and does not detail the internal development or training of the arrhythmia detection algorithms. Therefore, the sample size for any training set used to develop the algorithms for HEARTLink I (and by extension HEARTLink II) is not provided.

9. How the Ground Truth for the Training Set Was Established

Similar to point 8, the document does not discuss the establishment of ground truth for any training set, as it focuses on demonstrating substantial equivalence for regulatory clearance rather than the specifics of algorithm development. Such information would typically be part of a design and development file, not necessarily summarized in the 510(k) public summary unless specifically requested for novel aspects.

Summary

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December 6, 2023

Cardiac Telecom Corp. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth Street. N.W. Washington, DC 20004-1109

Re: K982803

Trade/Device Name: Heartlink II (Arrhythmia Detector and Alarm System) 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 Jonathan S. Kahan:

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 November 13, 1998. 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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1998

Cardiac Telecom Corporation c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109

K982803 Re : HeartLink II (Arrhythmia Detector and Alarm System) Requlatory Class: III (three) Product Code: 74 DSI Dated: Auqust 10, 1998 Received: August 11, 1998

Dear Mr. Kahan:

We have reviewed your Section 510(k) notification of intent to market we nave reviews for above and we have determined the device is che device forcemed above a the indications for use stated in the enclosure) to legally marketed predicate devices marketed in enclosure) to regally marketed problems the enactment date of the Interstate Commerce proble of to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In actoriation with one may, therefore, market the device, subject to Cosmeral controls provisions of the Act. The general controls che general concreas provinements for annual registration, provisions of the not on manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device ID Srabbing approval), it may be subject to such controls) of Crabb III- (isting major regulations affecting your device ( audicional Concervior - Enzor-Federal Regulations, Title 21, Parts 800 can be really equivalent determination assumes compliance co 093. If babbaneadad
with the Current Good Manufacturing Practice requirements, as set with the Ourlone oty System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocherar rogalation on Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in aboumperone. In addition, FDA may publish further announcements regaratory acoronvice in the Federal Register. Please note: this concerning your actroom submission submission does not affect any response to your premaire sections 531 through 542 of the Act obrigation you might well and the Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jonathan S. Kahan

This letter will allow you to begin marketing your device as described
ing the begineer tification - The FDA finding of substantial This letter will allow you to begin marketing your and of substantial
in your 510(k) premarket notification. The Finding device in your 510(k) premarket notification. The best breaticate device equivalence of your device to a regarly marroos.
results in a classification for your device and thus, permits your resures I proceed to the market.

If you desire specific advice for your device on our labeling
If you desire specific advice book a bodditionally 809 10 for in vi If you desire specific advice for your actlys 09 10 for in vitro
regulation (21 CFR Part 801 and additionally 809.10 for in vitro regulation (2) CFR Part our and actressff oof Compliance at diagnostic devices), please contact on the promotion and (301) 594–4648. Additionaly, for questions on effec promocoment.
advertising of your device, please contact the office of Compliance at
advertising of your device, please co advertising of your device, prouse the regulation entitled, (301) 594-4639. Also, please note the regarication"(21 CFR 807.97).
"Misbranding by reference to premarket notification"(21 CFR 807.97) "Misbranding by reference to premation on the Act may Other general information of Small Manufacturers Assistance at its
be obtained from the Division of Small Manufacturers Assistance at its internet be obtained from the Division of Silations of Subles
toll-free number (800) 638–2041 or (301) 443–6597, or at its internet
toll-free number (800) esse-stadeb (dama/ghtml") toll-free number (800) 036-2011 01:51:00 address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Vision of Caralo Neurological Devices Office of Device Evaluation Center for Devices and Radiclogical Health

Enclosure

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Page 1 of of 1 a

510(k) Number (If known): K982803

HEARTLink II _________________________________________________________________________________________________________________________________________________________________ Device Name:

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. Specific criteria for Indications for use are as follows :
-Patients with dizziness or lightheadedness
Patients with palpitations .
Patients with syncope of unknown edglogy .
Patients who require monitoring for non life-threstening arrhythmias, such as atrial fibrillation. . other supra-vestricular armythmias, evaluation of various bradyarhythmias and intermittent bundle branch block. This indudes post operative monitoring for these rhythims
Patients recovering from coronary artery bypess graft (CABG) surgery who require monitoring . for arrivthmias
Patlents requiring monitoring for antitythmia-inducing co-morbid conditions such as . hyperthyroidism or chronic lung disasse
Patients with obstructive steep apnea to evaluate possible nocturnal arrhythmias ◀
Patients requiring arrhythmia evaluation for ediology of stroke or translent cerebral ischemia. ● possibly secondery to atrial fibrillation

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Vene

mar Prescription Use V (Per 21 CFR 801.109)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Over-The Counter Use

510(k) Number ________________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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NOV 1 3 1998

Premarket Notification 510(k) Summary [807.92]

K982803

for

CARDIAC TELECOM CORPORATION's

"HEARTLink II " [ECG Arrhythmia Detector and Alarm System]

Prepared on August 1, 1998 [807.92(a)(1)]

cardiactelecom
corporation

We Don't Miss a Beat! 503 Braddock Ave. Turtle Creek, PA 15145 412-824.6600 Fax 412-824.4225

[A Division of Telemed Technologies, International]

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10. 510(k) Summary:

10.1. Company Name and Contact Person:

Cardiac Telecom Corporation, Inc.

503 Braddock Avenue Turtle Creek, PA 15145

412.824.6600 (Voice) 412.824.4225 (FAX)

LEE G. DENEAULT [Director of Operations]

10.2. Name of the Device:

Proprietary Name: HEARTLink, Model II

Common or Usual Name: ECG Arrhythmia Detection and Alarm System

Classification Name:

Radio frequency physiological signal transmitter and receiver (21 C.F.R. § 870.2910)

Telephone electrocardiograph transmitter and receiver (21 C.F.R. § 870.2920)

Arrhythmia detector and alarm (21 C.F.R. & 870.1025)

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10.3. Predicate or Legally Marketed Devices:

。 HEARTLink I (K934913) Cardiac Telecom Corporation (Turtle Creek, PA)
King of Hearts (K880626) Instromedix, Inc (Hillsboro, OR)
· Aegis (K843503) Medical Concepts, Inc (Gibbsboro, NJ)

10.4. Device Description:

10.5. Intended Use:

The HEARTLink II System is intended to provide cardiac monitoring from a low-risk patient's home

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a central monitoring facility pursuant to to physician prescription.

10.6. Technological Characteristics:

The HEARTLink II System is a microprocessorbased ECG arrhythmia detection and alarm system. The HEARTLink II is substantially equivalent to marketed ECG monitoring systems with arrhythmia detection capabilities, that have the same intended use and have received 510(k) premarket notification clearance from FDA (K880626 and K843503). The HEARTLink II is also technically equivalent to the hospital-based version of the HEARTLink I System (a.k.a. The HEARTrac System) that has already received clearance by the FDA as an arrhythmia detector and alarm system. The HEARTLink II System is intended for use in a low-risk patient's home environment and with the exception of a name change and a minimal change to the nonphysiological information in the database management software is identical to the HEARTLink I System. The HEARTLink I was approved for use by the FDA on June 5, 1995 (K934913).

10.7. Summary of Performance Data:

Bench Testing:

The HEARTLink I System (in K934913) complied with all safety, emissions, and effectiveness standards under the FDA's MDS 201-0004, the

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FCC's Parts 15 and 68 Rules, and the draft version of the AAMI EC-13-R-4/91 standards. The FDA's MDS 201-0004 standard has since been updated with the current version of the EMC Directive (EN 60601-1-2) and the draft of the AMMI standard has been adopted as a standard (with minimal changes). The FCC's Parts 15 and 68 have not changed since K934913. Since the HEARTLink II is technically equivalent to the HEARTLink I System, the compliance to the draft of the AAMI and the FCC's standards still apply. The HEARTLink II System, however, was safety and emissions re-tested and now complies with the current EMC Directive.

Clinical and Healthy Volunteers Trials:

Since the HEARTLink II System's intended environment for use is in the home of low-risk patients, this new environment raised following two safety and effectiveness issues:

· Would the patient be able to effectively use the HEARTLink II System in the home environment (Usability Issue).
· Would the ECG data be able to be accurately transmitted to the Central Monitoring facility (Transmissability Issue).

To test these two safety and effectiveness issues, two studies were designed. To test the Usability Issue, clincal trials were done at Saint Francis Medical Center (Pittsburgh, PA) and at Washington

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Center Hospital (Washington, DC). The results of this study determined that the HEARTLink II System is "as usable" as the predicate Event Recorder System. To test the "Transmissability Issue", healthy volunteers were to wear both the HEARTLink II System and the predicate for a total of four days. Data collected simultaneously on these two systems were transmitted to their appropriate Central Monitoring facilities and subsequently analyzed for transmission quality. The results of this study determined that the HEARTLink II System is capable of transmitting data with equal fidelity as its predicate Event Recorder System.

10.8. Conclusions:

The HEARTLink II System is substantially equivalent to the HEARTLink I, King of Hearts, and the Aegis ECG monitoring systems. Performance data collected in laboratory bench-testing and in both clinical and healthy volunteer trails demonstrated that there are no new safety and effectiveness questions raised by the modifications made to the currently marketed HEARTLink I System.

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.