(31 days)
THE CARDIOBEEPER CB250 IS INDICATED FOR USE BY THE PATIENT IN TRANSMITTING ECG INFORMATION FROM A REMOTE LOCATION To A RECEIVING CENTER.
The CardioBeeper ® CB250 is a single-lead, compact, hand-held, battery powered, personal transtelephonic ECG transmitter enclosed in a billfold wallet. The device has been designed to enable the user to transmit a rhythm strip to a central receiving station using acoustic coupling. The ECG information is transmitted as a frequency modulation of the basic 1700Hz tone. The device is sealed (not hermetically) for life. There are no user-servicable parts inside. The batteries are not replaceable and the unit should be discarded after depletion.
The provided text describes a 510(k) summary for the Meridian Medical Technologies Ltd CardioBeeper® CB250. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for AI/software devices. Therefore, much of the requested information cannot be directly extracted from this type of regulatory submission.
However, based on the information available, here's a breakdown of what can be inferred or stated as not provided:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a formal table of acceptance criteria and reported device performance in the way a clinical study report would. Instead, it focuses on demonstrating substantial equivalence based on design comparisons and technical specifications to legally marketed predicate devices.
The "performance" is implicitly deemed acceptable if the device's technical specifications are comparable to or improved over the predicate devices. The table provided (on page 1) is a comparison of technical specifications between the CardioBeeper® CB250 and two predicate devices (CardioBeeper® CB12L and CardioBeeper® CBII).
| Feature | CardioBeeper® CB250 | CardioBeeper® CB12L | CardioBeeper® CBII |
|---|---|---|---|
| Batteries: | Two 3V LiMno2 cells | 9V disposable alkaline | 9V disposable alkaline |
| Current Drain: | 7mA max | 18mA max | 18mA max |
| Expected life: | >3 years in normal operation | Approx 1 year until batteries need replaced | Approx 1 year until batteries need replaced |
| Operating Range: | 5 to 50 degrees C, <80%RH | +10 to +40° C, 30% to 70% RH | +10 to +40° C, 30% to 70% RH |
| Amplifier - CMRR: | 80dB min | 80dB min | 80dB min |
| Frequency Response: | 0.05 to 150 Hz | 0.05Hz to 150Hz | 0.05Hz - 35Hz |
| System noise: | <40μV r.t.i. | <40μV r.t.i. | <40μV r.t.i. |
| FM Output - Center Frequency: | 1700±20Hz | 1700±20Hz | 1700Hz±20Hz |
| Sensitivity: | 127.5 Hz/mV ±5% | 127.5 Hz/mV ±5% | 127.5 Hz/mV ±7.5% |
| Transmissions: | Modified Lead 1 (real time) | Modified Lead 1 (real time) | Modified Lead 1 (real time); Rolling loop |
Acceptance Criteria (Inferred): The implicit acceptance criteria are that the CardioBeeper® CB250's technical specifications are either equivalent to or demonstrate improvements over the predicate devices, maintaining safety and effectiveness. For instance, the improved battery life and reduced current drain would likely be considered favorable, while maintaining critical electrical characteristics like CMRR, frequency response, system noise, and sensitivity indicates functional equivalence.
The "study" in this context is the detailed comparison and analysis of the device's design, materials, and technical specifications against the predicate devices, as presented in the 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. This 510(k) summary does not describe a clinical performance study using a test set of patient data. The substantiation for equivalence is based on device design and technical specifications, not an evaluation of diagnostic accuracy on a dataset.
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)
Not applicable / Not provided. No test set requiring expert-established ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. No test set requiring adjudication is mentioned.
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
Not applicable / Not provided. This device is a transtelephonic ECG transmitter, not an AI or imaging diagnostic aid. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable / Not provided. This is a hardware device for transmitting ECG signals, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable / Not provided. As this is not a diagnostic device relying on interpretation, there is no "ground truth" in the traditional sense of medical diagnostic studies. The "ground truth" for this regulatory submission is the established performance and safety of the predicate devices.
8. The sample size for the training set
Not applicable / Not provided. This device does not involve machine learning or AI, and therefore no "training set" is relevant.
9. How the ground truth for the training set was established
Not applicable / Not provided. As no training set is relevant, no ground truth for a training set was established.
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510(k) Summary for Meridian Medical Technologies Ltd CardioBeeper ® CB250
| Submitter | |
|---|---|
| Name and Address | Meridian Medical Technologies LtdEnkalon Industrial Park,25 Randalstown Road,Antrim,BT41 4LJNorthern Ireland |
| Tel: | + 44 1849 465314 |
| Fax: | + 44 1849 428192 |
| Contact Name | Gerard LynnRegulatory Affairs Manager |
Date of Application
October 7th 1998
Device Name
Trade Name: Classification Name:
CardioBeeper ® CB250 Telephone electrocardiograph transmitter and receiver per 21 CFR 880.2920
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Image /page/1/Picture/0 description: The image shows the logo for Meridian Medical Technologies. The logo consists of the word "MERIDIAN" in large, bold, sans-serif font above the words "MEDICAL TECHNOLOGIES" in a smaller, sans-serif font. Above the word "MERIDIAN" is a stylized graphic that resembles a circle with a vertical line through the center.
Image /page/1/Picture/1 description: The image contains two circular logos and some text. The logo on the left contains a triangle inside a circle, with a smaller circle inside the triangle. The logo on the right contains a heart shape inside a circle, with the words "REGISTERED FIRM" around the heart. Below the logos, the text "Certificate Number EM30383" is visible.
TECHNOLOGY SOLUTIONS FOR MEDICINE
Substantially Equivalent Devices
The CardioBeeper ® CB250 is substantially equivalent to other telephone electrocardiograph transmitters that have received 510(k) clearance for use by the patient in transmitting ECG information from a remote location to a receiving center.
Specifically, the CardioBeeper ® CB250 is used in a similar manner to the CardioBeeper ® CBII (K883843), and it shares some, but not all, of the functions of the CardioBeeper ® CB II (K883843) and the CardioBeeper ® CB12-L (K965101).
The CardioBeeper ® CB250 is substantially equivalent to a CardioBeeper® CBII (K883843) in Mode 1 (modified single channel). Both units have fixed electrodes and both transmit a realtime rhythm strip. The CardioBeeper® CB250 uses a reduced set of the electronic circuitry of the CardioBeeper® CB II (K883843) and the CardioBeeper® CB12-L (K965101). The main differences are:
- the lead selection logic has been removed from the CardioBeeper®CB12L .
| CardioBeeper® CB250 | CardioBeeper® CB12L | CardioBeeper® CBII | |
|---|---|---|---|
| Batteries: | Two 3V LiMno2 cells | 9Vdisposable alkaline | 9Vdisposable alkaline |
| Current Drain: | 7mA max | 18mA max | 18mA max |
| Expected life: | >3 years in normaloperation | Approx 1 year untilbatteries need replaced | Approx 1 year untilbatteries need replaced |
| OperatingRange: | 5 to 50 degrees C,<80%RH | +10 to +40° C30% to 70% RH | +10 to +40° C30% to 70% RH |
| Amplifier: | |||
| CMRR: | 80dB min | 80dB min | 80dB, min |
| FrequencyResponse: | 0.05 to 150 Hz | 0.05Hz to 150Hz | 0.05Hz - 35Hz |
| System noise: | <40μV r.t.i. | <40μV r.t.i. | <40μV r.t.i. |
| FM Output: | |||
| CenterFrequency: | 1700±20Hz | 1700±20Hz | 1700Hz±20Hz |
| Sensitivity | 127.5 Hz/mV ±5% | 127.5 Hz/mV ±5% | 127.5 Hz/mV ±7.5% |
| Transmissions: | Modified Lead 1 (realtime) | Modified Lead 1 (realtime) | Modified Lead 1 (realtime); Rolling loop |
- . surface mount and low-profile components have been used in the CardioBeeper® CB250 to allow the entire device to fit inside a bill-fold wallet.
Comparison of CardioBeeper® CB250 and substantially equivalent devices
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Image /page/2/Picture/0 description: The image shows the logo for Meridian Medical Technologies. The logo consists of the word "MERIDIAN" in bold, sans-serif font, stacked above the words "MEDICAL TECHNOLOGIES" in a smaller, sans-serif font. A stylized graphic resembling a meridian line bisects the logo vertically, with curved lines extending from the top and bottom of the word "MERIDIAN" towards a vertical line.
Image /page/2/Picture/1 description: The image contains two circular logos and some text. The logo on the left has a triangle inside a circle, with a "G" shape surrounding the circle. The logo on the right has a heart shape inside a circle, with the text "REGISTERED FIRM" surrounding the circle. Below the logos, the text "Certificate Number EM30383" is visible.
TECHNOLOGY SOLUTIONS FOR MEDICINE
Description of the Device
The CardioBeeper ® CB250 is a single-lead, compact, hand-held, battery powered, personal transtelephonic ECG transmitter enclosed in a billfold wallet. The device has been designed to enable the user to transmit a rhythm strip to a central receiving station using acoustic coupling. The ECG information is transmitted as a frequency modulation of the basic 1700Hz tone. The device is sealed (not hermetically) for life. There are no user-servicable parts inside. The batteries are not replaceable and the unit should be discarded after depletion.
Intended Use of the Device
The CardioBeeper ® CB250 is intended to condition an electrocardiographic signal so that it can be transmitted via telephone to a remote location. The CardioBeeper ® CB250 is designed to be incorporated in a custom wallet to be used by a patient to transmit a rhythm strip in realtime to a physician's office, hospital or other medical receiving center. The device has permanently attached re-useable dry silver electrodes.
CardioBeeper ® is a registered trademark of Meridian Medical Technologies Inc.
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NOV 13 1988
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gerard Lynn Manager, Regulatory Affairs Meridan Medical Technologies Ltd. Enkalon Industrial Estate 25 Randalstown Road Antrim, Co. Antrim BT41 4LJ
K983582 Re: CardioBeeper® CB250 Requlatory Class: II (two) Product Code: 74 DXH Dated: October 7, 1998 Received: October 13, 1998
Dear Mr. Lynn:
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 A substantially equivalent determination assumes compliance to 895. 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 concerning your device in the Federal Reqister. 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.
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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 diaqnostic 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.gov/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 Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN): K983582
CARDIOBEEPER CB250 DEVICE NAME :
INDICATIONS FOR USE:
THE CARDIOBEEPER CB250 IS INDICATED FOR ()ડદ BY THE PATIENT IN TRANSMITTING ECG INFORMATION FROM A REMOTE LOCATION To A RECEIVING CENTER.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign Off)
Division Respiratory.
and
510(k) Number K983582
§ 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).