ZOLL Arrhythmia Management Sysyem

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 19, 2019 ZOLL Manufacturing Corporation % Michael Nilo President and Principal Consultant Nilo Medical Consulting Group 5737 Kentucky Avenue #3 Pittsburgh, Pennsylvania 15232 Re: K190939 Trade/Device Name: ZOLL Arrhythmia Management System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX. DSI Dated: November 22, 2019 Received: November 25, 2019 Dear Michael Nilo: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. 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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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. 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Sincerely, for Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190939 Device Name ZOLL Arrhythmia Management System #### Indications for Use (Describe) The ZOLL Arrhythmia Management System (AMS) is intended to continuously record, store, and transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends. AMS is intended for use in clinic and home settings. AMS is indicated for patients who are 21 years of age or older who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial flutter, ventricular ectopy, and bradyarrhythmias. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------|--------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image features the word "ZOLL" in a bold, sans-serif typeface. The letters are a vibrant blue color, which contrasts against the white background. To the bottom right of the word, there is a small registered trademark symbol. # 510(k) Summary | 510(k) Owner: | ZOLL Manufacturing Corporation<br>121 Gamma Drive<br>Pittsburgh, PA 51238<br>U. S. A. | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Zachary Nelson<br>Sr. Regulatory Affairs Engineer - Premarket<br>Phone: 412-968-3333 x14814<br>Fax: 412-567-9574<br>Email: znelson@zoll.com | | Date Summary Prepared: | December 17, 2019 | | Trade Name: | ZOLL Arrhythmia Management System | | Common Name: | Management and Monitoring System | | Device Classification<br>Name: | Monitor, Physiological, Patient<br>(with arrhythmia detection or alarms)<br>Arrhythmia Detector and Alarm | | Product Code: | MHX, DSI | | Classification Regulation: | 870.1025 | | Device Classification: | II | | Classification Panel: | Circulatory System Devices Panel (74) | | Predicate Device: | K172510 - μCor Heart Failure and Arrhythmia Management System,<br>ZOLL Manufacturing Corporation | | Reference Device: | K133701 - NUVANT MCT System, Corventis, Inc. | | Comparator Devices: | K102507 - Aera CT, TZ Medical, Inc (used for validation)<br>K972795 - Cardio-Card Management System II, Nasiff<br>Associates, Inc. (used for validation) | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "ZOLL" in large, bold, blue letters. The letters are sans-serif and appear to be a custom font. A registered trademark symbol is located to the right of the second "L" in the word. # Device Description The ZOLL Arrhythmia Management System (AMS) noninvasively monitors patients' clinical parameters (ECG, Heart Rate, Respiration Rate, Activity, and Posture). These raw data are transmitted wirelessly to a remote Server for processing into the clinical parameters. The ZOLL Arrhythmia Management System is for prescription use only. It is intended for use in outpatient clinic and home settings. The ZOLL Arrhythmia Management System consists of the following components: - Sensor - a patient worn device for signal acquisition. - . Patch – a single use, disposable adhesive piece adhered to the patient's body and allow for Sensor attachment. - . Charger – the Charger recharges the Sensor and the Gateway. The Sensor typically requires recharging after 5 days. The Gateway typically requires recharging every day. - Gateway – An off-the-shelf item, the Gateway is essentially a cellphone that relays data and passes commands between the Sensor and the Server. - Server – Server refers to the hardware and the processing software, and resides in a cyber-secure location. The software analyzes the raw data received from the Sensor and processes the data into clinical values for eventual presentation to the physicians via an independent monitoring center (IDTF) that is regulated under 42 CFR 410.33. Raw data from the Sensor to the Gateway is transmitted via Bluetooth; the Gateway then transmits this data to the Server via TCP/IP over WiFi or cellular network for data processing and analysis. The ZOLL Arrhythmia Management System Patch and Sensor will be placed on the upper left chest ("front" location). #### Indications for Use Statement The ZOLL Arrhythmia Management System (AMS) is intended to continuously record, store, and transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends. AMS is intended for use in clinic and home settings. The AMS is indicated for patients who are 21 years of age or older who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias. #### Technological Characteristics and Substantial Equivalence Discussion The AMS technological characteristics are substantially equivalent to K172510 - μCor Heart Failure and Arrhythmia Management System. The devices are non-invasive, prescription use, and indicated for home setting. Both devices have similar intended uses and are identical in form and function. The ZOLL Arrhythmia Management System represents an {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "ZOLL" in a bold, sans-serif font. The color of the text is a bright, medium blue. The letters are large and take up most of the image space. The background is plain white. iterative change from the predicate ZOLL device. The new device also uses a body-worn sensor to acquire the physiological data of interest, with the Gateway to relay the physiological data, and a remote server to process the data. The proposed device prescribes placement on the upper left chest to monitor heart activity only; whereas the predicate device uses a side location to monitor heart activity and thoracic fluid index (TFI). The removal of TFI monitoring and the difference in device placement between the ZOLL Arrhythmia Management System and the uCor Heart Failure and Arrhythmia Management System does not raise new types of safety and effectiveness questions. These differences have been assessed in bench and clinical testing. Results established that the AMS performs as intended and is substantially equivalent to its predicate device. Table 1 provides a comparison chart between the subject and predicate devices. # Table 1: Comparison Chart between Arrhythmia Management System with (AMS) and µCor Heart Failure and Arrhythmia Management System (HFMAS) | | AMS<br>(Proposed Device) | HFAMS<br>K172510<br>(Predicate Device) | Comparison<br>Comments | |---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Ambulatory recording<br>and monitoring of<br>physiological<br>parameters | Ambulatory recording and<br>monitoring of physiological<br>parameters | Same | | Indications for<br>Use (IFU) | The ZOLL Arrhythmia<br>Management System<br>(AMS) is intended to<br>continuously record,<br>store, and transmit<br>ECG, Heart Rate,<br>Respiration Rate,<br>Activity and Posture.<br>The data provided will<br>aid medical<br>professionals as they<br>diagnose and identify<br>various clinical<br>conditions, events,<br>and/or trends.<br>The ZOLL Arrhythmia<br>Management System<br>is indicated for<br>patients who are 21<br>years of age or older | The $μ$ Cor Heart Failure and<br>Arrhythmia Management<br>System is intended to<br>periodically record, store,<br>and transmit Thoracic Fluid<br>Index. The $μ$ Cor Heart<br>Failure and Arrhythmia<br>Management System is also<br>intended to continuously<br>record and store, and<br>periodically transmit ECG,<br>Heart Rate, Respiration Rate,<br>Activity and Posture. The<br>data provided will aid<br>medical professionals as<br>they diagnose and identify<br>various clinical conditions,<br>events, and/or trends.<br>The $μ$ Cor Heart Failure and<br>Arrhythmia Management | Indications for<br>use have been<br>updated to<br>remove<br>monitoring of<br>Thoracic Fluid<br>Index. Cleared<br>reference<br>devices also do<br>not monitor<br>Thoracic Fluid<br>Index. | | | | | | | | who require<br>monitoring for the<br>detection of non-<br>lethal cardiac<br>arrhythmias, such as,<br>but not limited to,<br>atrial fibrillation, atrial<br>flutter, ventricular<br>ectopy, and<br>bradyarrhythmias. | System is intended for use in<br>clinic and home settings and<br>is indicated for patients who<br>are 21 years of age or older<br>(i) who require monitoring<br>for the detection of non-<br>lethal cardiac arrhythmias,<br>such as, but not limited to,<br>atrial fibrillation, atrial<br>flutter, ventricular ectopy,<br>and bradyarrhythmias or, (ii)<br>require fluid management. | | | Intended Use<br>Environment | Home, clinic | Home, clinic | Same. | | Parameters<br>Monitored | ECG | ECG | Same. | | | Heart Rate | Heart Rate | | | | Respiration Rate | Respiration Rate | | | | Activity | Activity | | | | Posture | Posture | | | | n/a | Thoracic Fluid | The proposed<br>device has the<br>capability to<br>monitor Thoracic<br>Fluid; however,<br>the API has been<br>updated to<br>disable access to<br>this data. | | System Configuration & Components Characteristics | | | | | Components | - Sensor<br>- Patch<br>- Charger<br>- Gateway<br>- Server | - Sensor<br>- Patch<br>- Charger<br>- Gateway<br>- Server | Same. | | Product<br>Configuration | The Sensor acquires<br>the physiological data<br>of interest. Data is<br>transmitted to the<br>Gateway embedded<br>within the Charger,<br>which is then | The Sensor acquires the<br>physiological data of<br>interest. Data is transmitted<br>to the Gateway embedded<br>within the Charger, which is<br>then forwarded to the<br>Server for derivation. | Same. | | | | | | | | forwarded to the<br>Server for derivation. | | | | Body Worn<br>Component<br>Form Factor<br>and Wear<br>Location | The Sensor is attached<br>to the (adhesive)<br>Patch, which enables<br>the patient worn<br>effect.<br>Image: ZOLL patch<br><br>The device is placed<br>on the upper left<br>chest, just below the<br>collarbone.<br>Image: Chest placement | The Sensor is attached to the<br>(adhesive) Patch, which<br>enables the patient worn<br>effect.<br>Image: ZOLL patch<br><br>The device is placed on the<br>"side" location: below the<br>left armpit with the nipple<br>aligned anywhere between<br>the top and middle of the<br>Sensor.<br>Image: Side placement | Similar. The<br>body worn<br>component is<br>identical. ZOLL is<br>proposing<br>placement in the<br>upper chest<br>location.<br>Corventis<br>reference device<br>is also worn in<br>the upper chest<br>with the same<br>configuration. | | Disposable<br>Patch or<br>Electrodes<br>Wear Duration | 5 days for each Patch. | 5 days for each Patch. | Same. | | Data<br>Transmission<br>Technology | -<br>- Sensor to<br>Gateway:<br>Bluetooth<br>- Gateway to<br>Server: WiFi or<br>Cellular | -<br>- Sensor to Gateway:<br>Bluetooth<br>- Gateway to Server: WiFi<br>or Cellular | Same. | | Clinical Parameters | | | | | Clinical<br>Parameters<br>Monitored | -<br>- ECG (script)<br>- Heart Rate (beats<br>per minute)<br>- Respiration Rate<br>(breaths per<br>minute) | -<br>Thoracic Fluid Index<br>- ECG (script)<br>- Heart Rate (beats per<br>minute)<br>- Respiration Rate<br>(breaths per minute) | Similar. Thoracic<br>Fluid Index is no<br>longer included. | | | - Activity ('active'<br>vs. 'rest')<br>- Posture ('supine',<br>'recline', or<br>'upright') | - Activity ('active' vs.<br>'rest')<br>- Posture ('supine',<br>'recline', or 'upright') | | | Arrhythmia<br>detection | Detect non-lethal<br>cardiac arrhythmias1,<br>such as, but not<br>limited to, atrial<br>fibrillation, atrial<br>flutter, ventricular<br>ectopy and<br>bradyarrhythmias | Detect non-lethal cardiac<br>arrhythmias, such as, but not<br>limited to, atrial fibrillation,<br>atrial flutter, ventricular<br>ectopy and<br>bradyarrhythmias. | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "ZOLL" in blue font. The letters are bold and sans-serif. There is a registered trademark symbol to the right of the second "L". {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "ZOLL" in large, blue, sans-serif font. The letters are bold and evenly spaced. A registered trademark symbol is located to the lower right of the second "L". {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the word "ZOLL" in a bold, sans-serif font. The color of the text is a bright, medium blue. A small registered trademark symbol is located to the right of the second "L". # Performance Data The ZOLL Arrhythmia Management System was evaluated through non-clinical and clinical testing, as well as leveraged applicable data from the predicate device, as summarized below. Non-Clinical Testing - The ZOLL Arrhythmia Management System detection algorithm was tested to ANSI/AAMI EC57:2012. The test results met the algorithm performance requirements and can be found in the Clinical Manual. - . Software validation testing of the API and Analysis Software. The testing successfully validated the device software. #### Non-Clinical Testing leveraged from the predicate device The testing below was leveraged directly from the predicate device, as the ZOLL Arrhythmia Management System uses identical hardware and much of the same software as the predicate device. - Mechanical bench testing of the Sensor and Patch - Respiration Rate accuracy bench testing - Safety testing to: . - o AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012, and A2:2010/(R)2012 - o IEC 60601-1-11 Ed. 2.0 2015-01 - o AAMI/ANSI/IEC 60601-2-47:2012 - Electromagnetic Compatibility testing to AAMI/ANSI/IEC 60601-1-2:2014 - . Wireless co-existence testing ¹ AMS detects arrhythmias and 2nd and 3rd degree AV nodal conduction disorders. This single lead ECG device should not be considered a substitute for a 12-lead ECG for assessing ECG intervals (ex. intraventricular conduction delays, QT intervals). {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the word "ZOLL" in a large, sans-serif font. The word is a bright, solid blue color. The letters are bold and evenly spaced, creating a clear and easily readable logo. The background is plain white. - Biocompatibility testing - Shelf-Life Testing - Shipping and Packaging Testing - Software Testing ● ## Clinical Testing - Equivalency of Electrocardiograms (ECGs) Recorded by the ZOLL Arrhythmia Management System to that of a Standard Lead II ECG System This prospective, non-significant risk, premarket study demonstrated the ability of the ZOLL Arrhythmia Management System to capture ECGs as compared to a standard lead-II device. During the study 43 volunteers (22 females, 21 males) wore the AMS and a lead-II device simultaneously in sitting, supine, and standing positions. There were no adverse effects of complications during the study. The study demonstrated that the AMS was equivalent in capturing the below aspects of the ECG waveform, as compared to the standard lead II device: - P waves O - O QRS complexes - PR duration O - QRS duration O - O RR interval The median amplitude of the AMS QRS complex was greater than or equal to the median amplitude of the standard lead-II of a 12-lead ECG comparator device. # Clinical Testing leveraged from the predicate device - . Vital Signs Validation Study of the uCor System (ViVUS) This prospective, non-significant risk, premarket study validated the capability of the device to monitor ECG, Heart Rate, Respiration Rate, Posture, and Activity. During the study, 15 healthy volunteers (9 females, 6 males) wore the device and were asked to perform the following activities: breathing, walking, and resting. Respiration Rate, ECG, Heart Rate, Activity, and Posture were collected during these activities. There were no adverse effects or complications during the study. The results demonstrated the ability of the device to collect ECG data, measure Heart Rate and Respiration Rate, and classify Posture and Activity. The results from this study apply to the ZOLL Arrhythmia Management System, as the Arrhythmia Management System utilizes the same accelerometer and ECG acquisition circuitry as the predicate device. # Conclusion The ZOLL Arrhythmia Management System is substantially equivalent to the μCor Heart Failure and Arrhythmia Management System (K172510). Both devices are both intended to {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "ZOLL" in large, blue, sans-serif font. The letters are bold and evenly spaced. A registered trademark symbol is located to the right of the second "L". continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture, as well as monitor and detect non-lethal cardiac arrhythmias. Both devices are identical in form. The ZOLL Arrhythmia Management System has removed the ability to analyze Thoracic Fluid Index in order to allow for placement of the device on the upper chest, which allows for appropriate detection of non-lethal arrhythmias.