PACEART TX3 CARDIAC EVENT RECORDER

K012407 · Paceart, Inc. · DXH · Aug 14, 2001 · Cardiovascular

Device Facts

• Record ID: K012407
• Device Name: PACEART TX3 CARDIAC EVENT RECORDER
• Applicant: Paceart, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Aug 14, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

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.

Device Story

TX3 Cardiac Event Recorder captures 3-lead ECG samples via four electrodes; operates in post-event mode (records after patient trigger) or arrhythmia/looping mode (records before and after patient trigger). Device also measures pulse duration of implanted pacemakers in post-event mode. Patient-worn device; patient initiates recording and transmits stored ECG data via telephone to central station (Paceart WINCPTS 86-12). Physician programs device settings, including recording count and duration. Output allows physician to review ECG data for diagnosis of symptoms and arrhythmias, facilitating clinical decision-making regarding cardiac health.

Clinical Evidence

No clinical data. Device equivalence supported by bench testing, including compliance with AAMI standard EC38 and extensive software validation testing.

Technological Characteristics

3-lead ECG recorder using four electrodes. Supports post-event and looping recording modes. Includes pacemaker pulse duration measurement capability. Connectivity via telephone transmission to central station. Software validation performed. Complies with AAMI EC38 standards.

Indications for Use

Indicated for patients requiring ECG recordings for diagnosis of symptoms and arrhythmias as directed by a physician.

Regulatory Classification

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.

Predicate Devices

• Paceart Heart Access Plus Event Recorder (K973141)

Reference Devices

• Paceart WINCPTS 86-12 system (K915632)

Submission Summary (Full Text)

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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 [phone] 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).

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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.

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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

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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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