(31 days)
No
The description focuses on basic signal transmission and acoustic coupling, with no mention of AI/ML terms or capabilities.
No.
The device transmits ECG information and does not directly treat or remedy a medical condition.
Yes
The device transmits ECG information, which is a diagnostic modality used to assess the heart's electrical activity and diagnose cardiac conditions. While the device itself doesn't interpret the data, it is a tool for acquiring diagnostic information.
No
The device description explicitly states it is a "hand-held, battery powered, personal transtelephonic ECG transmitter enclosed in a billfold wallet," indicating it is a physical hardware device.
Based on the provided information, the CardioBeeper CB250 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CardioBeeper CB250 Function: The description clearly states that the CardioBeeper CB250 is a device used to transmit ECG information. ECG (Electrocardiogram) is a measurement of the electrical activity of the heart, which is a physiological signal, not a sample taken from the body for analysis.
- Intended Use: The intended use is to transmit ECG information from a remote location to a receiving center, which is a form of remote monitoring of a physiological parameter.
Therefore, the CardioBeeper CB250 falls under the category of a medical device used for physiological monitoring and transmission, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
74 DXH
Device Description
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.
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
...to be used by a patient to transmit a rhythm strip in realtime to a physician's office, hospital or other medical receiving center.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CardioBeeper ® CBII (K883843), CardioBeeper ® CB12-L (K965101)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Meridian Medical Technologies. The logo is black and white and features the company name in bold, sans-serif font. Above the company name, the text "NOV 13 1998" is visible.
Image /page/0/Picture/1 description: The image contains text that reads "TECHNOLOGY SOLUTIONS" in a bold, sans-serif font. Below this, the text "FOR MEDICINE" is displayed, also in a bold, sans-serif font. The text is stacked vertically, with "TECHNOLOGY SOLUTIONS" appearing above "FOR MEDICINE".
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be "K983582". The characters are written in a cursive style, and the image is in black and white. The characters are somewhat distorted, but still legible.
Image /page/0/Picture/3 description: The image shows two circular logos and the text "Certificate Number EM30383". 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 downward-pointing triangle inside a circle, with the words "REGISTERED FIRM" around the circle. The certificate number is located below the two logos.
510(k) Summary for Meridian Medical Technologies Ltd CardioBeeper ® CB250
| Submitter | |
|---|---|
| Name and Address | Meridian Medical Technologies Ltd |
| Enkalon Industrial Park, | |
| 25 Randalstown Road, | |
| Antrim, | |
| BT41 4LJ | |
| Northern Ireland | |
| Tel: | + 44 1849 465314 |
| Fax: | + 44 1849 428192 |
| Contact Name | Gerard Lynn |
| Regulatory 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
1
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 normal | ||
| operation | Approx 1 year until | ||
| batteries need replaced | Approx 1 year until | ||
| batteries need replaced | |||
| Operating | |||
| Range: | 5 to 50 degrees C, |