CARDIOBEEPER CB250

{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<br>Enkalon Industrial Park,<br>25 Randalstown Road,<br>Antrim,<br>BT41 4LJ<br>Northern Ireland | | Tel: | + 44 1849 465314 | | Fax: | + 44 1849 428192 | | Contact Name | Gerard Lynn<br>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<br>operation | Approx 1 year until<br>batteries need replaced | Approx 1 year until<br>batteries need replaced | | Operating<br>Range: | 5 to 50 degrees C,<br><80%RH | +10 to +40° C<br>30% to 70% RH | +10 to +40° C<br>30% to 70% RH | | Amplifier: | | | | | CMRR: | 80dB min | 80dB min | 80dB, min | | Frequency<br>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<br>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<br>time) | Modified Lead 1 (real<br>time) | Modified Lead 1 (real<br>time); 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 {2}------------------------------------------------ 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. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows a partial seal of the Department of Health & Human Services in the USA. The seal features an eagle-like symbol with stylized lines representing the bird's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN..." is visible, partially obscured by the image cropping. The seal is black and white. **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. {4}------------------------------------------------ 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 {5}------------------------------------------------ 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