(178 days)
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No
The description focuses on standard signal processing and rule-based analysis (QRS detection, classification, rhythm interpretation based on predefined criteria) and does not mention AI or ML techniques. The testing follows a standard for cardiac rhythm analysis algorithms, not necessarily AI/ML specific validation.
No
The device is described as "ECG Analysis Software" intended for the assessment of arrhythmias and provides analysis of ECG data. It does not provide any treatment or therapy.
Yes
The device "provides ECG signal processing and analysis on a beat by beat basis, QRS and Ectopic Beat detection, heart rate measurement, and rhythm analysis," and supports "reading and analysis of ECG data recorded in compatible formats" for "assessment of arrhythmias." These functions are consistent with diagnostic purposes.
Yes
The device is explicitly described as "SaMD (Software as a Medical Device)" and a "software library consisting of callable functions accessible through an API." The description focuses solely on the software's functionality and its interaction with other software components (Windows application, MATLAB Runtime). There is no mention of accompanying hardware or hardware components being part of the device itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The ZOLL ECG Analysis Software analyzes electrical signals from the heart (ECG data) that are recorded externally from the body. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use clearly states it's for the "assessment of arrhythmias" based on "ECG data recorded in compatible formats." This is a non-invasive analysis of a physiological signal.
Therefore, based on the provided information, the ZOLL ECG Analysis Software falls under the category of a medical device that analyzes physiological data, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ZOLL ECG Analysis Software is intended for use by qualified medical professionals for the assessment of arrhythmias. The ECG Analysis Software supports reading and analysis of ECG data recorded in compatible formats. The ECG Analysis Software is intended for use with ECG management software through an electronic interface. The ECG Analysis Software provides ECG signal processing and analysis on a beat by beat basis, QRS and Ectopic Beat detection, heart rate measurement, and rhythm analysis. The ECG Analysis Software is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.
Product codes
DPS
Device Description
The ZOLL ECG Analysis Software is a SaMD (Software as a Medical Device) which is of Moderate Level of Concern. It is a software library consists of callable functions that are accessible through an Application Programming Interface (API).
The ZOLL ECG Analysis Software provides ECG signal processing, QRS detection, classification of normal/VEB/SVEB, heart rate measurement, and the following rhythm interpretation for up to 3 leads (any combination of the standard 12 leads) of captured ECG data:
- Bradycardia
- . Tachycardia
- Atrial Fibrillation
- . Pause
- Ventricular Runs
- Ventricular Bigeminy / Ventricular Trigeminy
- . Ventricular Tachycardia
- Supraventricular Tachycardia
- 2nd Degree Atrioventricular (AV) Block ●
- . 3rd Degree Atrioventricular (AV) Block
The ZOLL ECG Analysis Software is made up of:
- An ECG analysis engine that is responsible for ECG analysis and interpretation ●
- An API to access the ECG analysis engine
The functions of the ZOLL ECG Analysis Software are intended to be called by a Windows application program written in C++, C# or MATLAB using the Microsoft .NET architecture.
Furthermore, the ZOLL ECG Analysis Software requires the installation of MATLAB Runtime R2015B for execution. The ZOLL ECG Analysis Software has only been tested and validated to be used with MATLAB R2015B."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
qualified medical professionals
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Test (Validation Activity)
- Study Type: System level testing demonstrating the detection capability of the software.
- Sample Size: Not explicitly stated, but implies the use of standard ECG databases required by AAMI/ANSI EC 57:2012.
- Data Source: ECG databases required by the AAMI/ANSI EC 57:2012 standard.
- Key Results: "Results from the EC 57 testing demonstrates that the performance of the ZOLL ECG Analysis Software meets the clinical requirements for arrhythmia detection and heart rate estimation."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Monebo Automated ECG Analysis and Interpretation Software Library (K062282)
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.
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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
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 28, 2019
ZOLL Manufacturing Corporation Zachary Nelson Sr. Regulatory Affairs Manager 2000 Ringwood Avenue San Jose, California 95131
Re: K182093
Trade/Device Name: ZOLL ECG Analysis Software Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 20, 2018 Received: December 26, 2018
Dear Zachary Nelson:
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Arielle Drummond -S
for
Bram D. Zuckerman, M.D.
Director Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182093
Device Name ZOLL ECG Analysis Software
Indications for Use (Describe)
The ZOLL ECG Analysis Software is intended for use by qualified medical professionals for the assessment of arrhythmias. The ECG Analysis Software supports reading and analysis of ECG data recorded in compatible formats. The ECG Analysis Software is intended for use with ECG management software through an electronic interface. The ECG Analysis Software provides ECG signal processing and analysis on a beat by beat basis, QRS and Ectopic Beat detection, heart rate measurement, and rhythm analysis. The ECG Analysis Software is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| [x] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the word "ZOLL" in a bold, sans-serif font. The letters are a bright blue color. A small registered trademark symbol is located to the right of the second "L".
7. 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
Phone: 412-968-3333 x14814
Fax: 412-592-0953
Email: znelson@zoll.com |
| Date Summary Prepared: | January 24, 2019 |
| Trade Name: | ZOLL ECG Analysis Software |
| Common Name: | ECG Analysis Software |
| Device Classification Name: | Electrocardiograph |
| Product Code: | DPS |
| Classification Regulation: | 870.2340 |
| Device Classification: | II |
| Classification Panel: | Cardiovascular (74) |
| Predicate Device: | Monebo Automated ECG Analysis and Interpretation Software Library
(K062282)
The predicate device has not been subjected to recall. |
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Image /page/4/Picture/1 description: The image shows the word "ZOLL" in large, bold, blue letters. The letters are stylized and connected, with a registered trademark symbol next to the second "L". Above the word "ZOLL" is the text "K182093" in a smaller, black font. The background is plain white.
Device Description
The ZOLL ECG Analysis Software is a SaMD (Software as a Medical Device) which is of Moderate Level of Concern. It is a software library consists of callable functions that are accessible through an Application Programming Interface (API).
The ZOLL ECG Analysis Software provides ECG signal processing, QRS detection, classification of normal/VEB/SVEB, heart rate measurement, and the following rhythm interpretation for up to 3 leads (any combination of the standard 12 leads) of captured ECG data:
- Bradycardia
- . Tachycardia
- Atrial Fibrillation
- . Pause
- Ventricular Runs
- Ventricular Bigeminy / Ventricular Trigeminy
- . Ventricular Tachycardia
- Supraventricular Tachycardia
- 2nd Degree Atrioventricular (AV) Block ●
- . 3rd Degree Atrioventricular (AV) Block
The ZOLL ECG Analysis Software is made up of:
- An ECG analysis engine that is responsible for ECG analysis and interpretation ●
- An API to access the ECG analysis engine
The functions of the ZOLL ECG Analysis Software are intended to be called by a Windows application program written in C++, C# or MATLAB using the Microsoft .NET architecture.
Furthermore, the ZOLL ECG Analysis Software requires the installation of MATLAB Runtime R2015B for execution. The ZOLL ECG Analysis Software has only been tested and validated to be used with MATLAB R2015B."
Indications for Use Statement
The ZOLL ECG Analysis Software is intended for use by qualified medical professionals for the assessment of arrhythmias. The ECG Analysis Software supports reading and analysis of ECG data recorded in compatible formats. The ECG Analysis Software is intended for use with ECG management software through an electronic interface. The ECG Analysis Software provides ECG signal processing and analysis on a beat by beat basis, QRS and Ectopic Beat detection, heart rate measurement, and rhythm analysis. The ECG Analysis Software is not intended for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.
Level of Concern Statement
The ZOLL ECG Analysis Software is a Moderate Level of Concern Software Device.
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Image /page/5/Picture/0 description: The image contains the text "K182093" in the upper left corner. To the right of this text is the word "ZOLL" in large, bold, blue letters. The letters are stylized and connected, with a registered trademark symbol to the right of the second "L".
The library is intended for use only with devices authorized for commercialization by FDA for acquiring an ECG signal.
The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.
A latent design flaw, failure or malfunction of the software, which were not revealed during the validation, verification and testing process, is possible over the life of the product. The results could result in a delayed response of appropriate medical care that would lead to injury or further diagnostic evaluations. The intended end users of the ECG analysis information are trained medical professional who are responsible for reviewing the device output and rendering the final diagnostic treatment decision.
Technological Characteristics and Substantial Equivalence Discussion
The ZOLL ECG Analysis Software and the predicate device Monebo have the same intended use. Both of them are intended for ECG signal analysis and interpretation, intended for use with ECG management software, and not intended for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.
The ZOLL ECG Analysis Software and Monebo have the same technological characteristics. Both of them are software libraries consist of callable functions that are accessible through an API. Both are provided to the users in compiled file (Dynamic Link Library) and for installation in the user's hardware. Both provide ECG signal processing, QRS detection, beat classification, heart rate measurement, and rhythm interpretation.
Table 7-1 provides further comparison between the ZOLL ECG Analysis Software and Monebo.
| | ZOLL ECG Analysis
Software
(Subject Device) | Monebo
(Predicate Device) | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DPS | DPS | Same |
| Device
Classification | Electrocardiograph | Electrocardiograph | Same |
| Regulation
Number | 870.2340 | 870.2340 | Same |
| Device Class | II | II | Same |
| Intended Use | ECG signal analysis and
interpretation | ECG signal analysis
and interpretation | Same |
| Patient Population | Adult | Adult | Same |
| Level of Concern | Moderate | Moderate | Same |
| | ZOLL ECG Analysis | Monebo | |
| | Software | (Predicate Device) | Comparison |
| | (Subject Device) | | |
| Beat Classification | Classifies and label all
beats as "N" (Normal),
("V") Ventricular Ectopic
Beat, or ("A")
Supraventricular Ectopic
Beat. | Classifies and labels all
beats as Normal (N) or
Ventricular (V).
V is a Ventricular
Ectopic Beat. | Similar.
Both the ZOLL ECG Analysis
Software and Monebo classify and
label Normal, VEB and SVEB.
Monebo uses the term APC (Atrial
Premature Contraction under their
rhythm interpretation section),
which is equivalent to SVEB. ZOLL
ECG Analysis Software adopts the
term SVEB following AAMI/ANSI EC
57:2012. |
| Measurement | Heart Rate | - Heart Rate
- PR interval
- QRS duration
- QT interval | Similar.
Both the ZOLL ECG Analysis
Software and Monebo measure
Heart Rate. Monebo additionally
provides PR interval, QRS duration
and QT interval, lacking of which
does not affect the safety and
effectiveness of the ZOLL ECG
Analysis Software. Both the ZOLL
ECG Analysis Software and Monebo
are subjected to EC57 testing to
verify the accuracy of Heart Rate
measurement. Test results
demonstrate that the ZOLL ECG
Analysis Software is at least as safe
and effective as Monebo. |
| Arrhythmia
Detection | - Bradycardia - Tachycardia
- Atrial Fibrillation
- Pause
- Ventricular Runs
- Ventricular Bigeminy /
- Ventricular Trigeminy
- Ventricular
- Tachycardia
- Supraventricular
- Tachycardia
- 2nd degree
- Atrioventricular (AV)
- Block
- 3rd degree
- Atrioventricular (AV)
- Block | - Normal Sinus Rhythm
(NSR) - Bradycardia
- Tachycardia
- Nodal Rhythm
- Pause
- Premature
- Ventricular
Complexes (PVC) - Atrial Premature
Contraction (APC) - Atrial Fibrillation or
Flutter - Ventricular
- Tachycardia
- Supraventricular
- Tachycardia
- Ventricular Flutter
- AV Blocks | Similar.
Arrhythmia detected by the ZOLL
ECG Analysis Software is a subset of
Monebo. Those arrhythmia
detected by Monebo but not by the
ZOLL ECG Analysis Software are
underlined, lacking of which does
not affect the safety and
effectiveness of the ZOLL ECG
Analysis Software.
Note that the ZOLL ECG Analysis
Software does not explicitly label
NSR, and that VEB and SVEB are
equivalent to PVC and APC. ZOLL
ECG Analysis Software adopts the
term VEB and SVEB following
AAMI/ANSI EC 57:2012. |
| ZOLL ECG Analysis
Software
(Subject Device) | Monebo
(Predicate Device) | Comparison | |
| | - Bundle Branch Block - Ventricular Trigeminy
- Ventricular Bigeminy
- Accelerated
Idioventricular
Rhythm | Both the ZOLL ECG Analysis
Software and Monebo are
subjected to EC57 testing to
validate their arrhythmia detection
capability. Test results
demonstrate that the ZOLL ECG
Analysis Software is at least as safe
and effective as Monebo. | |
Table 7-1: Comparison Chart between the ZOLL ECG Analysis Software and Monebo
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Image /page/6/Picture/1 description: The image shows the word "ZOLL" in large, bold, blue letters. The letters are stylized and appear to be part of a logo. Above the word "ZOLL" is the text "K182093" in a smaller, black font. The registered trademark symbol is to the right of the second L.
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Image /page/7/Picture/1 description: The image shows the word "ZOLL" in large, bold, blue letters. Above the word "ZOLL" is the text "K182093" in a smaller, black font. The letters of the word "ZOLL" are connected to each other. There is a registered trademark symbol to the right of the second "L" in "ZOLL".
Verification and Validation Activities Data
Since the ZOLL ECG Analysis Software is a SaMD, safety and effectiveness for the software is demonstrated through verification and validation activities (V&V) at the unit, integration and system level. Validation includes performance testing following AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms. Table 7-2 below provides a summary of the V&V activities for the ZOLL ECG Analysis Software.
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Image /page/8/Picture/1 description: The image shows the word "ZOLL" in blue, with the registration mark on the bottom right. The letters are large and bold. Above the word "ZOLL" is the text "K182093" in black.
| Table 7-2:
Verification and
Validation
| ActivitiesTitle | Description |
|---|---|
| Unit Tests | In this verification activity, the smallest testable parts of the ZOLL |
| ECG Analysis Software are individually and independently | |
| scrutinized for proper operation. The test cases simulate various | |
| operation conditions and error conditions of the ZOLL ECG | |
| Analysis Software. Each test case has an input test vector and an | |
| expected output. The actual output of each test case is | |
| compared to the expected output. All unit tests pass. | |
| Functional Tests | Also a part of the verification activities, functional tests are |
| conducted at the integration level. This testing verifies that each | |
| function of the ZOLL ECG Analysis Software operates in | |
| conformance with the requirement specification when program | |
| units are combined. Similar to the unit tests, each functional test | |
| case simulates the operation conditions and boundary conditions | |
| of the ZOLL ECG Analysis Software. Each test case has an input | |
| test vector and an expected output. The actual output of each | |
| test case is compared to the expected output. All functional tests | |
| pass. | |
| API Test | As the sole function of the API is to correctly transfer the input |
| and output parameters into and out of the ZOLL ECG Analysis | |
| Software, the API Test therefore is a simple atomic test to verify | |
| that the API transfers the input and output parameters correctly. | |
| Test result demonstrates that the API correctly transfer the input | |
| and output parameters. | |
| Performance Test | Performance test is the validation activity conducted for the ZOLL |
| ECG Analysis Software. It is a system level testing that | |
| demonstrates the detection capability of the software. Following | |
| AAMI/ANSI EC 57:2012 Testing and Reporting Performance | |
| Results of Cardiac Rhythm and ST Segment Measurement | |
| Algorithms, the ZOLL ECG Analysis Software is applied to the ECG | |
| databases required by the standard. The ZOLL ECG Analysis | |
| Software is required to generate an attribute file with the analysis | |
| results. The test results from the ZOLL ECG Analysis Software are | |
| compared to the reference results (which are available as part of | |
| the databases) using the comparison applications. Results from | |
| the EC 57 testing demonstrates that the performance of the ZOLL | |
| ECG Analysis Software meets the clinical requirements for | |
| arrhythmia detection and heart rate estimation. |
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Image /page/9/Picture/1 description: The image shows the Zoll Medical Corporation logo in blue. The logo is a stylized version of the company name, with the letters "ZOLL" in a bold, sans-serif font. The registration mark is on the bottom right of the logo. The number K182093 is on the top left of the logo.
Conclusion
As demonstrated in this 510(k), the ZOLL ECG Analysis Software has the same intended use and technological characteristics as the predicate device Monebo. Both devices have the same questions of safety and effectiveness. Verification and validation activities demonstrate that the ZOLL ECG Analysis Software is at least as safe and effective as Monebo. Therefore, the ZOLL ECG Analysis Software is substantially equivalent to Monebo.