CER-S

K213861 · Cardiocalm Srl · DQK · Apr 25, 2022 · Cardiovascular

Device Facts

• Record ID: K213861
• Device Name: CER-S
• Applicant: Cardiocalm Srl
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings. CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device. The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart thythm disorders in adult and pediatric patients. Note: This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool. CER-S analysis provides indications for evaluation of: - Patients with rhythm disturbances (cardiac arrhythmias), - Patients with transient myocardial ischemia, - Patients with pacemaker (only if pacing detection is available from the input recording), - Patients needing HRV evaluation, - Newborn patients limited to ORS detection.

Device Story

CER-S is a stand-alone PC-based software (SaMD) for analyzing, editing, and reporting continuous ECG recordings. It accepts digital ECG data from various sources (Holter, event recorders, 12-lead ambulatory devices) using conductive paste/gel electrodes or specific patch configurations. The software provides modules for beat detection, arrhythmia classification, rhythm analysis, and HRV evaluation. It features an interactive viewer for editing beats, rhythm annotations, and noise; it generates Holter-like reports and FDA HL7 XML files. Used in clinical/hospital settings by trained medical personnel. The output serves as a diagnostic aid for clinicians to interpret heart rhythm disorders. Benefits include improved beat detection in noisy/low-amplitude signals and enhanced performance for high heart rate recordings, facilitating faster clinical review and decision-making.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including ECG performance testing per ANSI/AAMI EC57:1998/(R)2003 and IEC 60601-2-47:2012, software development life cycle per IEC 62304:2006+A1:2015, usability engineering per IEC 62366-1:2015+AMD1:2020, and risk management per ISO 14971:2019.

Technological Characteristics

PC-based SaMD running on Windows OS. Features modules for ECG beat detection, classification, rhythm analysis, and HRV measurement. Supports standard electrode inputs (conductive paste/gel) and specific patch configurations. Connectivity includes ISHNE format export and FDA HL7 XML (v.2) generation. Software development follows IEC 62304; usability follows IEC 62366-1.

Indications for Use

Indicated for adult and pediatric patients requiring analysis of digital continuous ECG recordings for rhythm disturbances, transient myocardial ischemia, pacemaker function (if available), and HRV evaluation. Newborn patients are limited to QRS detection. Not for automated interpretation; intended as an aid to clinical diagnosis.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• CER-S (K193177)

Submission Summary (Full Text)

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April 25, 2022

CardioCalm Srl Fabio Badilini President Via Martiri della Liberta, nr. 40 Montichiari, Brescia 25018 Italy

Re: K213861

Trade/Device Name: CER-S Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: March 24, 2022 Received: March 29, 2022

Dear Fabio Badilini:

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

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jennifer Shih Kozen Assistant 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) K213861

Device Name CER-S

Indications for Use (Describe)

CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings.

CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device.

The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart thythm disorders in adult and pediatric patients.

Note: This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool.

CER-S analysis provides indications for evaluation of:

- · Patients with rhythm disturbances (cardiac arrhythmias),
- · Patients with transient myocardial ischemia,
- · Patients with pacemaker (only if pacing detection is available from the input recording),
- · Patients needing HRV evaluation,
- · Newborn patients limited to ORS detection.

| 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> |

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| 510(k) Summary |
|---------------------------|
| required by 21 CFR 807.92 |

| | (as required by 21 CFR 807.92) |
|--|--------------------------------|
|--|--------------------------------|

| Submitter | CardioCalm Srl<br>Corso Martiri della Libertà, nr. 40<br>25018 Montichiari (BS) | | |
|--------------------------|---------------------------------------------------------------------------------|----------|--------------|
| Telephone | + 39 030 9650782 | | |
| Fax | + 39 030 9650572 | | |
| Contact Person | Fabio Badilini<br>President & Legal Representative | | |
| Address | Corso Martiri della Libertà, nr. 40 | | |
| Telephone | + 39 030 9650782 | | |
| Fax | + 39 030 9650572 | | |
| Email | [e-mail] | | |
| Date Prepared | 17/11/2021 | | |
| Trade Name | CER-S | | |
| Common Name | Continuous ECG Recording - Suite | | |
| Panel Code | Cardiovascular/74 | | |
| Classification Name | Computer diagnostic, programmable | | |
| Class | Class II | | |
| Regulation Number | 21 CFR 870.1425 | | |
| Regulation Description | Programmable diagnostic computer | | |
| Product Code | DQK | | |
| Name of Predicate Device | | 510(k) # | Manufacturer |

| Name of Predicate Device | 510(k) # | Manufacturer |
|--------------------------|----------|----------------|
| CER-S | K193177 | CardioCalm Srl |

| Reason for<br>Submission | Intention to introduce into commercial distribution a device, CER-S, that has undergone significant<br>changes that could affect the substantial equivalence with the predicate device. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | CER-S is a tool, designed to offer a framework for the interaction of different software-modules,<br>providing advanced solutions for Continuous ECG Recording (CER).<br>Different modules provide:<br>ECG Beat detection and classification Analysis of ECG rhythm, arrhythmia detection interactive Viewer and set of tools to perform editing of ECG beats, Rhythm annotations<br>and noise Windows interactive Continuous ECG Viewer interactive display/management of ECG Templates Holter-like report for analyzed Continuous ECG records, record exportation, in ISHNE<br>format generation of aECG FDA HL7 XML (v. 2), for the submission of continuous ECG<br>recording to the FDA ECG Warehouse. Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel<br>(dry and dry/metal electrodes are not intended to be used) placed on standard location in<br>compatible formats from any device used for the arrhythmia diagnostics such as Holter, event<br>recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary.<br>Moreover, CER-S allows the automatic analysis for the following patch location: two-electrode patches positioned in the left upper chest area at a roughly inclined angle three-electrode triangular shape patches positioned on the patient's left upper chest area<br>below the 1st rib, at an inclined angle three-electrode T-shaped patches positioned in the center-thoracic position between the<br>upper part of the chest (manubrium) and the sternum In all cases, patch placement must strictly follow the indication provided by the manufacturer of the<br>certified-patch device. |
| Indications for<br>use | CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital<br>continuous ECG recordings.<br>CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or<br>adequately trained professional personnel working under the supervision and responsibility of a |

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## Traditional 510(k) Premarket Notification CER-S

| | clinician. Users must undergo a thorough software training before using the medical device.<br>The device provides the clinician an additional tool to aid in the interpretation of ECG data for<br>diagnosis of heart rhythm disorders in adult and pediatric patients.<br>Note: This device does not provide an automated interpretation and is not intended for use as the<br>only diagnostic tool.<br>CER-S analysis provides indications for evaluation of:<br>Patients with rhythm disturbances (cardiac arrhythmias), Patients with transient myocardial ischemia, Patients with pacemaker (only if pacing detection is available from the input recording), Patients needing HRV evaluation, Newborn patients limited to QRS detection. |
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| Technological<br>Characteristics<br>and Substantial<br>Equivalence | The fundamental scientific principles and technological characteristic, including the indications for<br>use and general design are equivalent to the predicate device, as summarized hereafter:<br>Software type, Holter Analyzer, working in Windows Operative System, as the predicate; Patient population, adults and pediatrics; User groups: qualified medical personnel or adequately trained professional personnel<br>working under the supervision and responsibility of a clinician., equivalent to predicate<br>device; Indications for use, equivalent to the predicate; Environmental use, equivalent to the predicate. The technological characteristics of the subject device and the predicate device are substantially<br>equivalent to the predicate.<br>As for the predicate device described below, the Subject device is a PC based SaMD, working in<br>Windows Operative System.<br>The following significant differences exist between the subject and predicate devices:<br>The subject device improves the performance in beat detection in recordings with low<br>amplitude and with noise; The subject device improves the performance of the beat measures in recording with<br>higher heart rate; The subject device allows HRV measurements in the frequency domain and Sinus<br>Tachycardia detection; Further minor changes in subject device are developed to enhance the usability of the software<br>and the graphic interface of some its components, which provides a smooth and faster editing of<br>automatically detected arrhythmic events. |
| Performance<br>Data | Non-clinical tests have been conducted on the Subject Device:<br>ECG performance testing, according to:<br>ANSI/AAMI EC57:1998/(R)2003 and IEC 60601-2-47:2012 (Recognition<br>Number 3-155) IEC 60601-2-25:2011 (Recognition Number 3-105) Software development life cycle, according to:<br>IEC 62304:2006+A1:2015 (Recognition Number 13-79) Usability engineering process, according to:<br>IEC 62366-1:2015+AMD1:2020 (Recognition Number 5-129) Any potential hazards have been evaluated and controlled through Risk Management<br>activities, according to:<br>ISO 14971:2019 (Recognition Number 5-125) The testing demonstrated that CER-S is substantially equivalent to the predicate for the proposed<br>intended use.<br>No clinical tests were performed to demonstrate the substantial equivalence of CER-S. |
| Conclusion | Based on the indications for use, technological characteristics, and comparison to predicate devices, the Subject device CER-S has been shown to be substantially equivalent to the legally marketed predicate devices. |