(254 days)
No
The description focuses on software for scheduling, receiving, and annotating pacemaker testing data, with no mention of AI or ML capabilities.
No
This device is software designed to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips. It does not directly provide therapy or interact with the patient's body in a therapeutic manner.
No
The device is described as software that supports scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips. While it deals with ECG strips, its primary function is management and annotation of existing data, rather than generating new diagnostic information or interpreting signals for medical conclusions. The comparison to "released devices" for ECG quality implies it handles pre-existing ECGs, not generates them for diagnostic purposes.
No
The device description explicitly states it supports receiving and annotating transtelephonic pacemaker magnet testing and ECG strips using a "pacemaker telephonic transmitter provided to the patient by his/her physician." This indicates the device relies on external hardware (the transmitter) to function, making it not solely software.
Based on the provided information, the E-FAX Pacemaker Services software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The E-FAX Pacemaker Services software is described as supporting the scheduling, receiving, and annotating of transtelephonic pacemaker magnet testing and ECG strips. This involves receiving and processing physiological signals (ECG) transmitted from a patient's pacemaker, not analyzing specimens derived from the body.
- Intended Use: The intended use is to support the process of monitoring pacemaker function through telephonic transmission of data, not to perform diagnostic tests on biological samples.
The device is clearly focused on managing and processing data related to a medical device (pacemaker) and physiological signals (ECG), which falls outside the scope of IVD regulation.
N/A
Intended Use / 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.
Product codes
DXH
Device Description
The E-FAX Pacemaker Services software is an add on to the present E-FAX System software (K932859), that provides additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing using a pacemaker transmitter provided to the patient by his/her physician.
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
Non-Clinical tests provided included system acceptance testing and software validation.
E-FAX recordings were taken from 53 volunteers using the E-FAX System with Pacemaker Services software and transmitting the electrocardiograms over telephone lines in parallel with released devices. The quality of the electrocardiograms in very case is equivalent.
Key Metrics
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
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,
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
this device. This device has been designated as
a Class II device.
The Panel is Cardiovascular 74DXH. |
| PERFORMANCE STANDARDS | None established under Section 514 of the Act. |
| PREDICATED DEVICE | Paceart System CardioVoice System K880283,
K931296 and K952065, |
| INDICATIONS | 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. The E-FAX System is released to
market via section 510 (k) of the Act document #
K932859. |
| DEVICE DESCRIPTION | The E-FAX Pacemaker Services software is an
add on to the present E-FAX System software
(K932859), that provides additional program
directory in the E-FAX System to support
scheduling, receiving, and annotating |
1
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
a pacemaker transmitter provided to the patient
by his/her physician. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE TESTING | |
| Non-Clinical tests | Non-clinical tests provided included system
acceptance testing and software validation. |
| Clinical (parallel reviews) | E-FAX recordings were taken from 53 volunteers
using the E-FAX System with Pacemaker
Services software and transmitting the
electrocardiograms over telephone lines in
parallel with released devices. The quality of the
electrocardiograms in very case is equivalent. |
| CONCLUSIONS | The E-FAX Pacemaker Services software is
equivalent in safety and efficacy to its predicated
device. |
Comparison to predicated device.
| Parameter | E-FAX system with
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
and type. | Yes | Yes |
| Record of Magnet tests | Yes | Yes |
| Uses "POT" phone line | Yes | Yes |
| System records contain
complete patient data. | No, pacemaker
follow-up only. | Yes |
| Can schedule follow-up
appointments. | Yes | Yes |
| Can be setup to dial pager. | Yes | Yes |
| Can use any analog FM patient
transmitter. | Yes | Some |
| Transtelephonic ECG Sampling
Rate | 200 Hz | 150 Hz |
| Dedicated IBM compatible PC
receiver | Yes OS2 O/S | Yes Win95 or NT
O/S |
| Patient data base limited only
by computer system | Yes | Yes |
| System records data only
without modification or
interpretation | Yes | Yes |
2
510(k) Submission, Modification of KK932859, E-FAX System with Pacemaker Follow-Up Services
| modifies displayed results | ||
|---|---|---|
| Electronic calipers for | ||
| measurement of rate and | ||
| interval | Yes | Yes |
| K # | K932859 E-FAX | |
| System | ||
| K883152 Electronic | ||
| calipers | Parts of K880283, | |
| K931296 and | ||
| K952065 |
3
3
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
4
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 (301) 594-4648. 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, 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 (800) 638-2041 or (301) 443-6597 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
5
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.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
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)