(254 days)
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 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.
The provided text describes the E-FAX System with Pacemaker Follow-Up Services and its substantial equivalence to predicate devices, focusing on its ability to transmit ECGs and pacemaker data over telephone lines. It does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) in a quantitative sense, nor does it detail a study designed to prove the device precisely meets such criteria. Instead, the "performance testing" section describes a clinical study that assesses the equivalence of ECG quality to released devices.
Based on the provided information, here's an attempt to answer your request, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
Since explicit quantitative acceptance criteria (e.g., "The device shall achieve a sensitivity of X%") are not stated, the acceptance criterion for the clinical test was based on the qualitative assessment of ECG quality.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Quality of electrocardiograms | "The quality of the electrocardiograms in every case is equivalent." (to released devices) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: 53 volunteers
- Data provenance: Not explicitly stated, but the context of "volunteers" and "transmitting over telephone lines in parallel with released devices" suggests a prospective collection within Baytown, TX, where the company is located, or surrounding areas in the US. No specific country of origin for the data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the given text. It states that "The quality of the electrocardiograms in every case is equivalent," but it does not specify who made this assessment or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the given text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No, a multi-reader multi-case comparative effectiveness study as typically understood for AI evaluation was not performed. The study described compares the ECG quality of the E-FAX system to released predicate devices.
- Effect size of human reader improvement: Not applicable, as this was not an AI-assisted diagnostic device study in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device, the E-FAX System with Pacemaker Follow-Up Services, is described as an "add on to the present E-FAX System software" that supports "scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips." It’s designed to transmit and receive ECG data, rather than inherently perform diagnostic interpretation autonomously. The performance test focused on the quality of transmitted ECGs, implying it's a data capture and transmission system, not an "algorithm-only" diagnostic tool. Therefore, a standalone diagnostic performance evaluation of an algorithm would not be relevant in the conventional sense for this device based on the provided description.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was established by comparing the "quality of the electrocardiograms" from the E-FAX system "in parallel with released devices." This implies that the accepted standard for ECG quality from the predicate/released devices served as the implicit ground truth benchmark. The method of assessing this quality is not detailed (e.g., expert review, automated metrics).
8. The sample size for the training set
The provided text describes a clinical study (n=53 volunteers) to assess the quality of ECG recordings. It does not mention a "training set" in the context of an algorithm or machine learning model. This appears to be a traditional medical device, not an AI/ML-driven device.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML model is described.
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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,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 forthis device. This device has been designated asa 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 isdesigned to provide an additional programdirectory in the E-FAX System to supportscheduling, receiving, and annotatingtranstelephonic pacemaker magnet testing andECG strips using a pacemaker telephonictransmitter provided to the patient by his/herphysician. The E-FAX System is released tomarket via section 510 (k) of the Act document #K932859. |
| DEVICE DESCRIPTION | The E-FAX Pacemaker Services software is anadd on to the present E-FAX System software(K932859), that provides additional programdirectory in the E-FAX System to supportscheduling, 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 usinga pacemaker transmitter provided to the patientby his/her physician. | |
|---|---|
| PERFORMANCE TESTING | |
| Non-Clinical tests | Non-clinical tests provided included systemacceptance testing and software validation. |
| Clinical (parallel reviews) | E-FAX recordings were taken from 53 volunteersusing the E-FAX System with PacemakerServices software and transmitting theelectrocardiograms over telephone lines inparallel with released devices. The quality of theelectrocardiograms in very case is equivalent. |
| CONCLUSIONS | The E-FAX Pacemaker Services software isequivalent in safety and efficacy to its predicateddevice. |
Comparison to predicated device.
| Parameter | E-FAX system withPacemaker 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 modeland type. | Yes | Yes |
| Record of Magnet tests | Yes | Yes |
| Uses "POT" phone line | Yes | Yes |
| System records containcomplete patient data. | No, pacemakerfollow-up only. | Yes |
| Can schedule follow-upappointments. | Yes | Yes |
| Can be setup to dial pager. | Yes | Yes |
| Can use any analog FM patienttransmitter. | Yes | Some |
| Transtelephonic ECG SamplingRate | 200 Hz | 150 Hz |
| Dedicated IBM compatible PCreceiver | Yes OS2 O/S | Yes Win95 or NTO/S |
| Patient data base limited onlyby computer system | Yes | Yes |
| System records data onlywithout modification orinterpretation | 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 formeasurement of rate andinterval | Yes | Yes |
| K # | K932859 E-FAXSystemK883152 Electroniccalipers | Parts of K880283,K931296 andK952065 |
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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 (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
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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.
(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)
§ 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).