CARDIOBEEPER CB-12L

{0} PY K965101 510(k) Summary CardioBeeper® CB-12L MAR 17 1997 1. Sponsor Meridian Medical Technology 10240 Old Columbia Road Columbia, MD 21046 TEL: (410) 309-6830 FAX: (410) 309-1475 Contact Persons: Herb Reinhold, Senior Vice President Bruce Ward, Vice President of Research and Development Date Prepared: March 10, 1997 2. Device Name Classification Name: Telephone Electrocardiograph Transmitter Proprietary Name: CardioBeeper® CB-12L 3. Intended Use The CardioBeeper® CB-12L is intended to condition an electrocardiograph signal so that it can be transmitted via a telephone line to a remote location. The CB-12L is designed to be used by a patient to transmit a rhythm strip or a 12 lead ECG signal in real time to a physician's office, hospital or other medical receiving center. Note that due to the discrete options for selecting the precordial electrode positions, the CB-12L transmission may only approximate a standard 12 lead ECG for some patients. 4. Device Description The CardioBeeper® CB-12L is a compact, hand-held, battery-powered, single channel transtelephonic ECG transmitter that is capable of transmitting a 24 second CardioBeeper® CB-12L 510(k) 3/10/97 Page G-1 {1} mar 10,1997 05:00 COPY rhythm strip or a 45 second 12 lead ECG. The CB-12L consists of a transmitter/electronics module (TEM), two limb electrodes (RA and LL) attached to the TEM via separate cables, and a chest belt containing the third limb electrode (LA) and thirteen silver silver-chloride electrodes. Prior to a patient using the CB-12L, the patient's physician must select the six most appropriate chest belt electrodes to function as the precordial V1-V6 electrodes according to the patient's chest size. Technical specifications for the CB-12L are as follows: | Low End Frequency Response | 0.05 Hz | | --- | --- | | High End Frequency Response | 150 Hz min. | | Common Mode Rejection Ratio | 80 dB min. | | System Noise | <40 μV r.t.i. | | Input Dynamic Range | ±2.3 mV | | Frequency Modulation | FM | | Carrier Frequency | 1700 ±20 Hz | | Deviation Sensitivity | 127.5 Hz/mV ±5% | | Battery | 9V alkaline | ## 5. Basis For Substantial Equivalence The CardioBeeper® CB-12L 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 physician's office, hospital, or other medical receiving center. Specifically, the rhythm strip operation of the CB-12L is substantially equivalent to the single-lead operation of the CardioBeeper® CB300 Memory Monitor (K813101), and the 12 lead operation of the CB-12L is substantially equivalent to the multiple-lead operation of the Card Guard 9000 (K924486) and the Aerotel Heartview (K950004). A clinical study was conducted with a study population of 97 patients in order to: (1) compare the diagnostic quality of 12 lead ECGs recorded using the CB-12L to those recorded using a standard 12 lead ECG system; and (2) compare the diagnostic quality of ECGs transmitted using the CB-12L with and without physician supervision. The results of the study showed that the ECGs transmitted using the CB-12L were comparable in diagnostic content to those recorded using a standard 12 lead machine. In addition, the results confirmed that the patients were capable of applying the electrodes and transmitting a quality 12 lead ECG tracing without direct medical supervision following appropriate training in the use of the CB-12L. CardioBeeper® CB-12L 510(k) 3/10/97 Page G-2