(95 days)
Not Found
No
The description focuses on signal processing and transmission, with no mention of AI or ML techniques for analysis or interpretation.
No.
The device is described as a cardiac monitoring system that detects and transmits ECG signals for review by medical personnel, not for treating any condition.
Yes
The device processes and transmits ECG signals, and detects "abnormal ECGs and arrhythmias" for review by "medical personnel," indicating its use in identifying medical conditions.
No
The device description explicitly mentions hardware components like the "Tele-Link monitoring unit" and a "Central Station" that receive, process, and transmit signals. It is not solely software.
Based on the provided information, the HEARTLink II System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HEARTLink II Function: The HEARTLink II System monitors and transmits ECG signals, which are electrical signals from the heart. This is a measurement of physiological activity within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes cardiac monitoring from a patient's home. This involves external sensing of the heart's electrical activity.
Therefore, the HEARTLink II System falls under the category of a medical device that performs physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
-
- 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
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.
Product codes (comma separated list FDA assigned to the subject device)
QYX, DSI
74 DSI
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.
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
Remote Central Station in a healthcare institution or patient monitoring facility; patient's home.
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
To test the Usability Issue, clincal trials were done at Saint Francis Medical Center (Pittsburgh, PA) and at Washington Center Hospital (Washington, DC).
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
The HEARTLink I System (in K934913) complied with all safety, emissions, and effectiveness standards under the FDA's MDS 201-0004, the 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:
Two studies were designed to address usability and transmissibility issues in the home environment.
Usability Study: Clinical trials at Saint Francis Medical Center (Pittsburgh, PA) and Washington Center Hospital (Washington, DC) determined that the HEARTLink II System is "as usable" as the predicate Event Recorder System.
Transmissibility Study: Healthy volunteers wore both the HEARTLink II System and the predicate for four days. Data transmitted to Central Monitoring facilities showed that the HEARTLink II System is capable of transmitting data with equal fidelity as its predicate Event Recorder System.
Conclusions: The HEARTLink II System is substantially equivalent to the HEARTLink I, King of Hearts, and the Aegis ECG monitoring systems. Performance data from bench-testing and clinical/healthy volunteer trials showed no new safety and effectiveness questions raised by modifications to the HEARTLink I System.
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.
HEARTLink I (K934913), King of Hearts (K880626), Aegis (K843503)
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.
0
Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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
1
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.
2
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
3
Page 1 of of 1 a
510(k) Number (If known): K982803
HEARTLink II _________________________________________________________________________________________________________________________________________________________________ Device Name:
Indications For Use:
-
- Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
-
- 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)
4
NOV 1 3 1998
Premarket Notification 510(k) Summary [807.92]
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]
5
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)
6
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:
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.
10.5. Intended Use:
The HEARTLink II System is intended to provide cardiac monitoring from a low-risk patient's home
7
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
8
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
9
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.