Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three faces in profile, one behind the other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 11, 2015 Cardiac Insight, Inc. % Deborah Sheffield Regulatory Consultant Deborah L. Sheffield Consulting 5672 Flagler Road Norland, Washington 98358 Re: K142468 Trade/Device Name: StealthTM Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MLO, DXH, DPS, DSH Dated: August 31, 2014 Received: September 3, 2014 Dear Deborah Sheffield, 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. 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 {1}------------------------------------------------ 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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. A. Mitchell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 510(k) PREMARKET NOTIFICATION INDICATION FOR USE 510(k) Number: _ k142468 ________ #### Device Name: Stealth™ Monitor #### Indications For Use: The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable. | Prescription Use | X | |-----------------------------|--------| | (Part 21 CFR 801 Subpart D) | | | | AND/OR | | Over-The-Counter Use | | | (21CFR 801 Subpart C) | | #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ ## 510(k) Premarket Notification Summary ### 1. Submitter's Information | Company Name: | Cardiac Insight, Inc. | |----------------------|----------------------------------------------------------------------------| | Company Address: | 2815 Eastlake Avenue, Suite 300<br>Seattle, WA 98102 | | Company Phone: | 206-596-2060 | | Contact: | Brad Harlow / bharlow@cardiacinsightinc.com | | Trade Name: | Stealth System | | Common Name: | ECG Recorder | | Classification Name: | Electrocardiograph, Ambulatory, With Analysis Algorithm<br>21 CFR 870.2800 | ## 2. Predicate Device Identification | Device Name | Clearance Number | Product Code | |------------------------|------------------|--------------| | SEER MC | K042782 | MLO | | AliveCor Heart Monitor | K142743 | DXH, DPS | | Stealth™ System (M100) | K130288 | DSH | All predicates are Class II devices. ## 3. Indications for Use and Device Description #### Indications for Use The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable. The Indications for Use are consistent with those of the predicate devices. {4}------------------------------------------------ #### Device Description The Stealth™ Monitor is a small, lightweight, patch-style, single-use cardiac monitor designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 168 hours (7 days) and ECG signal characterization. It is worn on the patient's chest similar to an adhesive bandage. The housing is constructed of a foam material making the device very lightweight (less than 9 grams). Image /page/4/Picture/4 description: The image shows a white, three-compartment tray against a dark background. Each compartment is square-shaped with rounded corners and slightly raised edges. The compartments are connected to each other, forming a single unit. The tray appears to be made of a molded material, possibly plastic or foam. A software application is installed at a physician's office to receive the data from the monitor using a direct connection. Data retrieved from the monitor may be printed or saved and stored for later viewing. The DSD software has the ability to generate reports as well as the ability to save a full disclosure ECG file for viewing. ## 4. Technological Characteristics of the Device as Compared to Predicate Devices | Device<br>Characteristics | Stealth™ System S200<br>(K142468) | SEER MC (K042782) | AliveCor Heart Monitor<br>(K142743) | Stealth™ System S100<br>(K130288) | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Stealth™ Monitor is a<br>prescription only single<br>use, continuous recording<br>ECG monitor<br>that can be worn up to<br>168 hours<br>(7 days) during activities<br>of daily living.<br>It is indicated for use on<br>adult patients who may be<br>asymptomatic or<br>who may suffer from<br>transient symptoms such<br>as palpitations, dizziness,<br>anxiety, fatigue, syncope,<br>pre-syncope, light-<br>headedness, shortness of<br>breath and where a<br>software-assisted analysis<br>of the potential causes of<br>these symptoms<br>is desirable. | The SEER MC Ambulatory<br>Digital Analysis Recorder<br>is intended to provide<br>ambulatory ECG signal<br>and automated analysis of<br>the recorded ECG data.<br>Results of the automated<br>analysis, when used in<br>conjunction with an<br>ECG review system, are<br>intended to assist the<br>physician in the<br>interpretation of the<br>recorded data. | The AliveCor Heart<br>Monitor is intended to<br>record, store and transfer<br>single-channel<br>electrocardiogram<br>(ECG) rhythms. The<br>AliveCor Heart Monitor<br>also displays ECG rhythms<br>and detects the presence of<br>atrial fibrillation and<br>normal sinus rhythm<br>(when prescribed or used<br>under the care of a<br>physician). The AliveCor<br>Heart Monitor is intended<br>for use by healthcare<br>professionals, patients<br>with known or suspected<br>heart conditions and<br>health conscious<br>individuals. | The Stealth™ Monitor is a<br>prescription only<br>single use, continuous<br>recording ECG monitor<br>that can be worn up to<br>24 hours. It is indicated<br>for use with patients<br>where it would be<br>desirable to record<br>ECG signals for this period<br>of time. | | Product Code | MLO | MLO | DXH, DPS | DSH | | Device<br>Classification | II / 870.2800 | II / 870.2800 | II / 870.2920 | II / 870.2800 | | Where used | Ambulatory outpatient<br>use | Ambulatory outpatient<br>use | Ambulatory outpatient use | Ambulatory outpatient use | | Prescription Req'd | Prescription only | Prescription only | Prescription only | Prescription only | | Adult/Pediatric | Adult | Both | Adult | Adult | {5}------------------------------------------------ | Single Use/<br>Reusable | Single use | Reusable, single-use<br>electrodes | Reusable | Single use | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------| | ECG Storage | At least 168 hours | 48 hours | "Practically unlimited" | At least 24 hours | | Recording Type | Continuous | Continuous | Continuous | Continuous | | Application/Wear | Adhesive, body worn | Holster for device,<br>adhesive electrodes | Patient applied, held in<br>place for duration of<br>recording | Adhesive, body worn | | User Interface | On/Off, Event button | On/Off, Event Button | Smartphone app | On, Event Button | | Data Transfer | USB 2.0 | Serial | Telephonic/Network | RS-232 to USB 2.0 | | Arrhythmias<br>and/or statistics | Normal, fastest heart<br>rate, slowest heart rate,<br>average heart rate,<br>pauses, bradycardia<br>(run), tachycardia (run) | Normal, fastest heart rate,<br>slowest heart rate,<br>ventricular beats,<br>supraventricular beats,<br>pauses, ST segment<br>changes, prolonged QT,<br>T-wave alternans, Heart<br>rate turbulence, Heart Rate<br>Variability | Normal Rhythm, Atrial<br>fibrillation | None | | Software Used | Yes | Yes | Yes | Yes | | Full Disclosure | | | | | | Power Supply | Battery | Battery | Battery | Battery | | Electrodes | 3 integrated electrodes | 3 individual electrodes | 2 integrated electrodes | 3 integrated electrodes | | Lead Wires | Integrated into device | External | Integrated into device. | Integrated into device | | Lead Vector | Lead I | Multiple | Lead I | Lead I | | Sterile | No | No | No | No | | Patient Contact<br>Materials | Conventional electrodes<br>/ hydrogel | Conventional electrodes<br>/ hydrogel | Hard electrodes<br>(metallic) | Conventional electrodes<br>/ hydrogel | None of the differences outlined in this table raise new issues of safety or effectiveness. The Indications for Use and technological characteristics of the device and its predicates are consistent with one another. Therefore, we believe the device to be Substantially Equivalent to the predicate devices. Note: Response-Part 5 (Substantial Equivalence Discussion) contains a detailed analysis of this table. #### 5. Biocompatibility No new issues of biocompatibility are raised with this device. All materials contained in the device are commonly employed in medical devices in the United States. # 6. Summary of Performance Testing {6}------------------------------------------------ The device was evaluated for safety and performance to accepted standards in a laboratory environment and detailed documentation has been provided. | Performance Documentation | Status | |---------------------------------------------------|----------| | Level of Concern Determination (Moderate) | Provided | | Development Plans | Provided | | Device Description | Provided | | System Requirement Specifications | Provided | | Risk Management / Safety | Provided | | Hazard Analysis Report | Provided | | Component Requirement Specifications | Provided | | Software/Hardware Design Descriptions | Provided | | Traceability Matrix | Provided | | Verification and Validation Protocols and Reports | Provided | | Unresolved Anomalies (Bugs or Defects) | Provided |