(15 days)
No
The summary describes a standard cardiac event recorder that records and transmits ECG data. There is no mention of AI, ML, or any algorithms that would interpret or analyze the data using such technologies. The device's functionality is based on patient-triggered recording and basic pacemaker pulse detection, which are not indicative of AI/ML.
No.
The device is a diagnostic tool designed to record and transmit ECG data for the diagnosis, prognosis, and management of transient symptoms. It does not provide therapy or treatment.
Yes
The device is described as recording electrocardiograms "when such recordings are required for diagnosis, prognosis, and management of transient symptoms such as dizziness, syncope, palpitations, and arrhythmias." This explicitly states its use in diagnosis.
No
The device description explicitly states it is a "unit" that records a 3-lead ECG using four electrodes and is worn by the patient, indicating it includes hardware components for data acquisition.
Based on the provided information, the TX3 Cardiac Event Recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- TX3 Function: The TX3 Cardiac Event Recorder directly measures and records electrical activity of the heart (ECG) from the patient's body. It does not analyze specimens taken from the body.
The TX3 is a medical device used for in vivo (within the living body) measurement and recording of physiological signals.
N/A
Intended Use / Indications for Use
The TX3 Cardiac Event Recorder is intended to record samples of a patient's electrocardiograph (ECG) when indicated by the patient, store the ECGs in a temporary storage, and then to be transmitted to a central station by the patient, by telephone.
The TX3 Cardiac Event Recorder, called the TX3, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient deploys it as indicated to him by his physician. It is indicated when such recordings are required for diagnosis, e.g. in the intended patient population is suspected symptoms and arrhythmias.
Product codes
74DXH
Device Description
The TX3 Cardiac Event Recorder is intended to record samples of a patient's electrocardiograph (ECG) when indicated by the patient, store the ECGs in a temporary storage, and then to be transmitted to a central station by the patient, by telephone. The unit has two modes: Post-event and Arrhythmia, or "Looping.". In post-event mode, the unit records a period of ECG following the pressing of a button by the patient. The unit can also determine the pulse duration of implanted pacemakers in Post-Event mode. In arthythmia mode, the unit is a so-called "looping recorder." it is always active, and thus records a sample of ECG both before and after the "patient event."
The unit records a 3-lead ECG, using four electrodes. Normally, the unit records the limb leads.
The Central Station unit is the Paceart WINCPTS 86-12 system (K915632).
The physician can program the unit and set the number of recordings and the duration of the recording that can be made before they must be transmitted to the 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
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)
Non-clinical tests: The TX3 and/or its predicate device have met the requirements of AAMI standard EC38. The software has had extensive validition testing.
Clinical tests: Not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
PaceArt Division of Data Critical Corporation Special 510(k) TX3 Cardiac Event Recorder
510(k) Summary
(1) Submitter Information
Name: PaceArt Division of Data Critical Corporation
Address: 81 Two Bridges Road Fairfield. NJ 07004
Telephone Number: 973-439-9393
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703 fax 201-727-1708 Date Prepared: July 23, 2001
(2) Name of Device:
Trade Name: TX3 Cardiac Event recorder Common Name: Cardiac Event Recorder Classification Name: Transmitters and Receivers, Electrocardiograph, Telephone (74DXH)
(3) Equivalent legally-marketed device: Paceart Heart Access Plus Event Recorder K973141
(4) Description
The TX3 Cardiac Event Recorder is intended to record samples of a patient's electrocardiograph (ECG) when indicated by the patient, store the ECGs in a temporary storage, and then to be transmitted to a central station by the patient, by telephone. The unit has two modes: Post-event and Arrhythmia, or "Looping.". In post-event mode, the unit records a period of ECG following the pressing of a button by the patient. The unit can also determine the pulse duration of implanted pacemakers in Post-Event mode. In arthythmia mode, the unit is a so-called "looping recorder." it is always active, and thus records a sample of ECG both before and after the "patient event."
The unit records a 3-lead ECG, using four electrodes. Normally, the unit records the limb leads.
The Central Station unit is the Paceart WINCPTS 86-12 system (K915632).
1
The physician can program the unit and set the number of recordings and the duration of the recording that can be made before they must be transmitted to the central station.
(5) Intended Use
The TX3 Cardiac Event Recorder is intended to record samples of a patient's electrocardiograph (ECG) when indicated by the patient, store the ECGs in a temporary storage, and then to be transmitted to a central station by the patient, by telephone.
(b) Performance data
(1) Non-clinical tests
The TX3 and/or its predicate device have met the requirements of AAMI standard EC38. The software has had extensive validition testing.
(2) Clinical tests
Not required.
(3) Conclusions
The TX3 Cardiac Event Recorder is equivalent in safety and efficacy to the legally-marketed predicate device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2001
Paceart, Inc. c/o Dr. George Myers Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K012407
Trade Name: TX3 Cardiac Event Recorder Regulation Number: 21 CFR 870.2929 Regulatory Class: II (two) Product Code: 74 DXH Dated: July 27, 2001 Received: July 30, 2001
Dear Dr. Myers:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon - Fronty nevers substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the enclosure) to legally manote of the Medical Device Amendments, or to devices that prior to May 26, 1970, the chaomical date of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general controls practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) anto such additional controls. Existing major regulations (1 charkst Approval), it they of our cases of Federal Regulations, Title 21, Parts 800 to 895. allecting Jour at riov lent determination assumes compliance with the Current Good A suostantany equirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspotions, the Food and may result in regulatory action. In addition, FDA may publish comply with the GMT regararing your device in the Federal Register. Please note: this
3
Page 2 - Dr. George Myers
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your some 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,
K. D. K. Tulle
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 9
Page 1 __ of _________________________________________________________________________________________________________________________________________________________________ ﻠﺴﺮ
K012407 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Indications for Use Form
Device Name: TX3 Cardiac Event Recorder
Indications for Use:
The TX3 Cardiac Event Recorder, called the TX3, is intended to be worn by the patient and to record a short The TX3 Cardiac Event Recorder, called the 1723, is minuse systems indicated to him by his period of electrocardiogram when the patient depts are required for disensis, gop in thended patient population is
physician. It is indicated when such recordings are require physician. It is indicated which such recordings are request and arrhythmias.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
NEWS – CONTINUE – VEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109) OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number
510(k) Number
K012407
TX3