TELESENTRY, MODEL TS01

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for ScottCare. The logo consists of a stylized letter "S" to the left of the word "ScottCare". The letter "S" is enclosed in a square and has a decorative, swirling design. The word "ScottCare" is written in a simple, sans-serif font. ScottCare Corporation 4791 West 150th Street Cleveland, Ohio 44135 P 800.243.9412 F 216.267 6129 www.scottcare.com 113 #### 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92 ## FEB 2 6 2010 The assigned 510(k) number is K092947. Date: January 25, 2010 Submitted by: ScottCare Corporation Registration No: 1527715 4791 West 150th Street Cleveland, OH 44135 Contact Person: Mr. Timothy J. Leyva 216-362-0550 # 113 216-264-6129 Fax tleyva@scottcare.com ScottCare Corporation Manufacturing Site: Registration No: 1527715 4791 West 150th Street Cleveland, OH 44135 TeleSentry Wireless Ambulatory ECG Arrhythmia Monitor Trade Name: Common Name: Cardiac Event Monitor Mobile Cardiac Telemetry Classification: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) (21 CFR 870.1025) Class: Class II. Special Controls Product Code: DSI Subsequent Product Code: DRG Legally Marketed Predicate Device(s): Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring System (K081444), July 31, 2008 A Scott Fetzer, Berkshire Hathaway Company {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for ScottCare. The logo consists of a stylized letter "S" on the left, followed by the text "ScottCare" in a bold, sans-serif font. The letter "S" is designed to resemble a medical symbol, possibly a caduceus or a similar emblem associated with healthcare. ScottCare Corporatio 4791 West 150th Street Cleveland, Ohio 44135 P 800 243.9412 F 216.267 6129 www.scolicare.com #### 1. Device Description: TeleSentry is a battery powered ambulatory ECG monitor which analyzes an electrocardiographic signal. The TeleSentry device classifies all detected heart beats and recognizes specific rhythm abnormalities. All detected results, including annotations for every detected heart beat and the ECG signals are securely transmitted via a cellular telephony network to a remote server. The server is accessible by a monitoring center for review and evaluation by trained qualified medical staff. The data transmission is automatically triggered when abnormalities are detected. The triggering criteria are based on physician's recommended predetermined settings and adjustable thresholds programmed for brady, tachy, pause and afib events. The data will also be transmitted when manually triggered by the patient; or periodically if programmed for regular transmission. The TeleSentry device is equipped with sufficient memory and processing capacity to record the signal received from the sensor, even while in parallel, allowing interrogation of the device data or adjustment of triggering thresholds. The TeleSentry device records and stores the entire ECG full disclosure for up to 30 days on its internal storage card. When cellular service is not available, the monitoring center is immediately notified and data can be transmitted via land-line telephone using a USB connection or a Bluetooth connection, or via broadband internet connection. ### 2. Indications for Use: The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia. The device continuously monitors and records the data, automatically records alarm events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. #### Contraindications: - Patients with potentially life-threatening arrhythmias who require inpatient monitoring. a. - Patients who the attending physician thinks should be hospitalized. b. #### 3. Substantial Equivalence: The TeleSentry device is technologically equivalent and identical to the predicate device except as specifically highlighted below: | | Predicate Device<br>Braemar Fusion | ScottCare TeleSentry | |----------------------------|------------------------------------|-----------------------| | RF transmission range | 10 meters open space | 100 meters open space | | Acoustic Transmission | Yes | No | | Bandwidth | 0.5hz to 40Hz | 0.5Hz - 100 Hz | | Display | LCD | LED | | Input Impedance | 20 Mohm | >20 Mohm | | 12 Lead | No | Yes | | Differential Input@ AC15HZ | is + 5mV p-p | +/- 1mV p-p | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for ScottCare. The logo consists of a stylized letter "S" on the left, followed by the word "ScottCare" in a serif font. The letter "S" is designed with a heart shape incorporated into its form. The text is in all caps. K092947 4791 West 150th Street Cleveland, Ohio 44135 F 216.267.6129 | Differential Input Range | DC ± 165mV | DC ± 100mV | |--------------------------|----------------------|-----------------------------------| | Common Mode Ratio (CMR) | 60dB | 92 dB | | Battery Type | 3.6V AA Disposable | 3.7V lithium polymer rechargeable | | Battery Life | 7 days then disposed | 24-36 hours before re-charge | | Relative Humidity | 30% to 85% | 25% to 95% RH, nc | | SPS | 256 | 100,200,1000 | | Alarm-no connection | No | Yes | In each of these instances, the technology of the TeleSentry device meets or exceeds the operating specifications of the predicate device and they do not have any adverse impact on the safety and efficacy of the device as validated through our performance testing. #### Referenced Standards and Performance Testing 4 The TeleSentry device was tested and meets the requirements of following performance standards in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm. - IEC 60601-1:1999 "Medical Electrical Equipment Part 1: General . Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995" - . IEC 60601-1-2:2001/AI:2004 "Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests" Class B - . AAM1/ANSI EC38:2007 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems - . AAMI / ANSI EC57:1998/(R)2003 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms ### 5. Conclusion: ScottCare's TeleSentry ECG device (K092947) is safe, effective and substantially equivalent to the predicate Braemar Fusion device (K081444) as supported by the descriptive information and the performance testing. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, depicted in a minimalist, abstract design. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 FEB 2 6 2010 Scottcare Corporation c/o Mr. Timothy Leyva Director, Operations & Regulatory Affairs 4791 West 1500 St. Cleveland, OH 44135 Re: K092947 Trade/Device Name: TeleSentry Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (Special Controls) Product Code: DSI, DRG Dated: January 25, 2010 Received: January 26, 2010 Dear Mr. Leyva: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading. {4}------------------------------------------------ #### Page 2 – Mr. Timothy Leyva If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use # 510(k) Number (if known): K092947 # Device Name: TeleSentry # Indications for Use: The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia. The device continuously monitors and records the data, automatically records alarm events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. #### Contraindications: - Patients with potentially life-threatening arrhythmias who require inpatient monitoring. a. - Patients who the attending physician thinks should be hospitalized. b. _ V Prescription Use (Part 21 CFR 801 Subpart D) . "" เ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) W.M. West (Division Sian-Off) Division of Cardiovascular Devices 510(k) Number Page 1 of 1