(253 days)
Unknown
The summary mentions "processing software" and "analyzes the raw data received from the Sensor and processes the data into clinical values," but does not explicitly state whether AI/ML is used in this analysis. The testing section mentions "algorithm testing" but doesn't specify the nature of the algorithm.
No
The device is intended to record, store, and transmit data to aid medical professionals in diagnosis and identification of clinical conditions, not to provide therapy.
Yes
The "Intended Use" section explicitly states that "The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends." This indicates that the device's output is used to inform medical diagnoses.
No
The device description explicitly lists multiple hardware components including a Sensor, Patch, Charger, and Gateway, in addition to the software components.
Based on the provided information, the ZOLL Arrhythmia Management System (AMS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body ("in vitro").
- AMS Function: The ZOLL AMS noninvasively monitors physiological parameters (ECG, Heart Rate, Respiration Rate, Activity, and Posture) directly from the patient's body. It records, stores, and transmits this data for analysis. This is a form of in vivo monitoring (within the living body).
- Lack of Specimen Testing: The description does not mention the collection or analysis of any biological specimens.
Therefore, the ZOLL Arrhythmia Management System falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper left chest ("front" location)
Indicated Patient Age Range
21 years of age or older
Intended User / Care Setting
medical professionals / clinic and home settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
- QRS complexes
- PR duration
- QRS duration
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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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. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| 510(k) Owner: | ZOLL Manufacturing Corporation
121 Gamma Drive
Pittsburgh, PA 51238
U. S. A. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Zachary Nelson
Sr. Regulatory Affairs Engineer - Premarket
Phone: 412-968-3333 x14814
Fax: 412-567-9574
Email: znelson@zoll.com |
| Date Summary Prepared: | December 17, 2019 |
| Trade Name: | ZOLL Arrhythmia Management System |
| Common Name: | Management and Monitoring System |
| Device Classification
Name: | Monitor, Physiological, Patient
(with arrhythmia detection or alarms)
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,
ZOLL Manufacturing Corporation |
| Reference Device: | K133701 - NUVANT MCT System, Corventis, Inc. |
| Comparator Devices: | K102507 - Aera CT, TZ Medical, Inc (used for validation)
K972795 - Cardio-Card Management System II, Nasiff
Associates, Inc. (used for validation) |
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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
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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
(Proposed Device) | HFAMS
K172510
(Predicate Device) | Comparison
Comments |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Ambulatory recording
and monitoring of
physiological
parameters | Ambulatory recording and
monitoring of physiological
parameters | Same |
| Indications for
Use (IFU) | 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.
The ZOLL Arrhythmia
Management System
is indicated for
patients who are 21
years of age or older | The $μ$ Cor Heart Failure and
Arrhythmia Management
System is intended to
periodically record, store,
and transmit Thoracic Fluid
Index. The $μ$ Cor Heart
Failure and Arrhythmia
Management System is also
intended to continuously
record and store, and
periodically 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.
The $μ$ Cor Heart Failure and
Arrhythmia Management | Indications for
use have been
updated to
remove
monitoring of
Thoracic Fluid
Index. Cleared
reference
devices also do
not monitor
Thoracic Fluid
Index. |
| | | | |
| | 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. | System is intended for use in
clinic and home settings and
is indicated for patients who
are 21 years of age or older
(i) 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 or, (ii)
require fluid management. | |
| Intended Use
Environment | Home, clinic | Home, clinic | Same. |
| Parameters
Monitored | ECG | ECG | Same. |
| | Heart Rate | Heart Rate | |
| | Respiration Rate | Respiration Rate | |
| | Activity | Activity | |
| | Posture | Posture | |
| | n/a | Thoracic Fluid | The proposed
device has the
capability to
monitor Thoracic
Fluid; however,
the API has been
updated to
disable access to
this data. |
| System Configuration & Components Characteristics | | | |
| Components | - Sensor
- Patch
- Charger
- Gateway
- Server | - Sensor
- Patch
- Charger
- Gateway
- Server | Same. |
| Product
Configuration | The Sensor acquires
the physiological data
of interest. Data is
transmitted to the
Gateway embedded
within the Charger,
which is then | The Sensor acquires the
physiological data of
interest. Data is transmitted
to the Gateway embedded
within the Charger, which is
then forwarded to the
Server for derivation. | Same. |
| | | | |
| | forwarded to the
Server for derivation. | | |
| Body Worn
Component
Form Factor
and Wear
Location | The Sensor is attached
to the (adhesive)
Patch, which enables
the patient worn
effect.
Image: ZOLL patch
The device is placed
on the upper left
chest, just below the
collarbone.
Image: Chest placement | The Sensor is attached to the
(adhesive) Patch, which
enables the patient worn
effect.
Image: ZOLL patch
The device is placed on the
"side" location: below the
left armpit with the nipple
aligned anywhere between
the top and middle of the
Sensor.
Image: Side placement | Similar. The
body worn
component is
identical. ZOLL is
proposing
placement in the
upper chest
location.
Corventis
reference device
is also worn in
the upper chest
with the same
configuration. |
| Disposable
Patch or
Electrodes
Wear Duration | 5 days for each Patch. | 5 days for each Patch. | Same. |
| Data
Transmission
Technology | -
- Sensor to
Gateway:
Bluetooth - Gateway to
Server: WiFi or
Cellular | - - Sensor to Gateway:
Bluetooth - Gateway to Server: WiFi
or Cellular | Same. |
| Clinical Parameters | | | |
| Clinical
Parameters
Monitored | - - ECG (script)
- Heart Rate (beats
per minute) - Respiration Rate
(breaths per
minute) | -
Thoracic Fluid Index - ECG (script)
- Heart Rate (beats per
minute) - Respiration Rate
(breaths per minute) | Similar. Thoracic
Fluid Index is no
longer included. |
| | - Activity ('active'
vs. 'rest') - Posture ('supine',
'recline', or
'upright') | - Activity ('active' vs.
'rest') - Posture ('supine',
'recline', or 'upright') | |
| Arrhythmia
detection | Detect non-lethal
cardiac arrhythmias1,
such as, but not
limited to, atrial
fibrillation, atrial
flutter, ventricular
ectopy and
bradyarrhythmias | Detect non-lethal cardiac
arrhythmias, such as, but not
limited to, atrial fibrillation,
atrial flutter, ventricular
ectopy and
bradyarrhythmias. | |
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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).
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- 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
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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.