E-FAX SYSTEM

K982034 · Blakbag, Ltd., Division of Coherent Systems · DXH · Feb 19, 1999 · Cardiovascular

Device Facts

• Record ID: K982034
• Device Name: E-FAX SYSTEM
• Applicant: Blakbag, Ltd., Division of Coherent Systems
• Product Code: DXH · Cardiovascular
• Decision Date: Feb 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The E-FAX Pacemaker Services software is designed to provide an additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips using a pacemaker telephonic transmitter provided to the patient by his/her physician. Prescription Device. Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

E-FAX System with Pacemaker Services is a software add-on for the E-FAX System (K932859) facilitating remote pacemaker follow-up. Patients use a physician-provided analog FM telephonic transmitter to send ECG strips and magnet test data over standard telephone lines. The system receives, schedules, and annotates these transmissions on an IBM-compatible PC running OS/2. It provides electronic calipers for rate and interval measurement but does not modify or interpret the underlying clinical data. Healthcare providers use the system to manage patient follow-up appointments and review transmitted data. The device benefits patients by enabling remote monitoring of pacemaker function without requiring in-person clinic visits.

Clinical Evidence

Clinical evidence consisted of a parallel review study involving 53 volunteers. ECG recordings were captured using the E-FAX System with Pacemaker Services software and transmitted over telephone lines in parallel with released predicate devices. Results demonstrated that the quality of the electrocardiograms was equivalent in every case.

Technological Characteristics

Software add-on for E-FAX System; operates on IBM-compatible PC with OS/2 operating system. Supports 200 Hz transtelephonic ECG sampling rate. Features include electronic calipers for rate/interval measurement, scheduling, and data annotation. Connectivity via analog FM telephone transmission. System records data without modification or interpretation.

Indications for Use

Indicated for patients requiring transtelephonic pacemaker magnet testing and ECG monitoring. Used by physicians to schedule, receive, and annotate pacemaker follow-up data transmitted via telephone.

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 System CardioVoice System (K880283, K931296, K952065)

Reference Devices

• E-FAX System (K932859)
• Electronic calipers (K883152)

Submission Summary (Full Text)

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KG82034

## Section 2 Summary

The following is a Summary of the E-FAX System with Pacemaker Follow-Up Services substantial equivalence and safety and efficacy.

Blakbag Technology, Ltd. 1101 Decker Drive, 2nd Floor Baytown, TX 77520 1-800-936-4003 1-800-936-2615 fax www.blakbag.com

Submission Correspondent: Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071-3404 713-723-8169 713-723-4080 www.delphiconsulting.com

| CLASSIFICATION NAME | Transmits and receives Electrocardiograph,<br>Pacemaker Follow-up, Telephone. |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMMON/USUAL NAME | ECG Transtelephonic Transmitter and Receiver |
| PROPRIETARY NAME | E-FAX System with Pacemaker Follow-up |
| CLASSIFICATION | The agency has not established classification for<br>this device. This device has been designated as<br>a Class II device.<br>The Panel is Cardiovascular 74DXH. |
| PERFORMANCE STANDARDS | None established under Section 514 of the Act. |
| PREDICATED DEVICE | Paceart System CardioVoice System K880283,<br>K931296 and K952065, |
| INDICATIONS | The E-FAX Pacemaker Services software is<br>designed to provide an additional program<br>directory in the E-FAX System to support<br>scheduling, receiving, and annotating<br>transtelephonic pacemaker magnet testing and<br>ECG strips using a pacemaker telephonic<br>transmitter provided to the patient by his/her<br>physician. The E-FAX System is released to<br>market via section 510 (k) of the Act document #<br>K932859. |
| DEVICE DESCRIPTION | The E-FAX Pacemaker Services software is an<br>add on to the present E-FAX System software<br>(K932859), that provides additional program<br>directory in the E-FAX System to support<br>scheduling, receiving, and annotating |

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510(k) Submission, Modification of KK932859, E-FAX System with Pacemaker Follow-Up Services Blakbag Technology Ltd., Baytown, Texas 77520

| | transtelephonic pacemaker magnet testing using<br>a pacemaker transmitter provided to the patient<br>by his/her physician. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE TESTING | |
| Non-Clinical tests | Non-clinical tests provided included system<br>acceptance testing and software validation. |
| Clinical (parallel reviews) | E-FAX recordings were taken from 53 volunteers<br>using the E-FAX System with Pacemaker<br>Services software and transmitting the<br>electrocardiograms over telephone lines in<br>parallel with released devices. The quality of the<br>electrocardiograms in very case is equivalent. |
| CONCLUSIONS | The E-FAX Pacemaker Services software is<br>equivalent in safety and efficacy to its predicated<br>device. |

Comparison to predicated device.

| Parameter | E-FAX system with<br>Pacemaker Services | Paceart Systems |
|-----------------------------------------------------------------------|-----------------------------------------|------------------------|
| Hardware and Software System | Yes | Yes |
| Automatic recording of ECG | Yes | Yes |
| Printer or fax print out of ECG | Yes | Yes |
| Record of Pacemaker model<br>and type. | Yes | Yes |
| Record of Magnet tests | Yes | Yes |
| Uses "POT" phone line | Yes | Yes |
| System records contain<br>complete patient data. | No, pacemaker<br>follow-up only. | Yes |
| Can schedule follow-up<br>appointments. | Yes | Yes |
| Can be setup to dial pager. | Yes | Yes |
| Can use any analog FM patient<br>transmitter. | Yes | Some |
| Transtelephonic ECG Sampling<br>Rate | 200 Hz | 150 Hz |
| Dedicated IBM compatible PC<br>receiver | Yes OS2 O/S | Yes Win95 or NT<br>O/S |
| Patient data base limited only<br>by computer system | Yes | Yes |
| System records data only<br>without modification or<br>interpretation | Yes | Yes |

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510(k) Submission, Modification of KK932859, E-FAX System with Pacemaker Follow-Up Services

| modifies displayed results | | |
|----------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------|
| Electronic calipers for<br>measurement of rate and<br>interval | Yes | Yes |
| K # | K932859 E-FAX<br>System<br>K883152 Electronic<br>calipers | Parts of K880283,<br>K931296 and<br>K952065 |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1999

Mr. J. Harvey Knauss Consultant Blakbaq Limited Division of Coherent Systems c/o Delphi Consultant Group 11874 South Evelyn Circle Houston, TX 77071-3404

Re : K982034 E-FAX System II (two) Regulatory Class: Product Code: DXH Dated: January 13, 1999 Received: January 19, 1999

Dear Mr. Knauss:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements

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Page 2 - Mr. J. Harvey Knauss

concerning your device in the Federal Register. Please note: this 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 requlations.

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 requlation (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, 2Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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510(k) Number : ¥982034

Device Name: E-FAX System with Pacemaker Services

Indications for use: The E-FAX Pacemaker Services software is designed to provide an additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips using a pacemaker telephonic transmitter provided to the patient by his/her physician.

Prescription Device. Federal Law (US) restricts this device to sale by or on the order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Ortelln

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number.

510(k) P

OR Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use
X
(Per 21 CFR 801.109)