(282 days)
Not Found
No
The document describes standard ECG analysis techniques and software modules without mentioning AI or ML. The analysis is described as "automatic analysis" but this does not necessarily imply AI/ML, and the document explicitly states it does not provide "automated interpretation" and is not intended as the "only diagnostic tool," which would be more common for AI/ML-driven diagnostic aids.
No.
The device is intended to aid in the interpretation of ECG data for diagnosis, not to provide therapy.
Yes
The device aids in the interpretation of ECG data for the diagnosis of heart rhythm disorders. It is explicitly stated that "The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart rhythm disorders in adult and pediatric patients." While it doesn't provide automated interpretation and isn't intended as the only diagnostic tool, its purpose is to support the diagnostic process.
Yes
The device is explicitly described as a "stand-alone software medical device" and its description focuses solely on software modules and functionalities for analyzing, editing, reviewing, and reporting digital ECG recordings. There is no mention of accompanying hardware components included with the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD typically involves the examination of specimens such as blood, urine, tissue, etc., in vitro (outside the body).
- This device analyzes digital continuous ECG recordings. These recordings are electrical signals captured from the body, not biological samples taken from the body.
- The intended use is for analyzing and interpreting ECG data for diagnosis of heart rhythm disorders. This is a diagnostic tool, but it operates on electrical signals, not biological specimens.
Therefore, while CER-S is a medical device used for diagnosis, it falls under a different category than In Vitro Diagnostics. It is a software medical device that analyzes physiological signals.
N/A
Intended Use / Indications for 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 rhythm 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, but not limited to, 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 QRS detection.
Product codes
DQK
Device Description
CER-S is a tool, designed to offer a framework for the interaction of different software-modules, providing advanced solutions for Continuous ECG Recording (CER).
Different modules provide:
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 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 format generation of aECG FDA HL7 XML (v. 2), for the submission of continuous ECG recording to the FDA ECG Warehouse.
Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel (dry and dry/metal electrodes are not intended to be used) placed on standard location in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary.
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 below the 1st rib, at an inclined angle three-electrode T-shaped patches positioned in the center-thoracic position between the 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 certified-patch device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric patients, newborn patients limited to QRS detection.
Intended User / Care Setting
Qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician.
Clinical and hospital 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)
The following non-clinical tests have been conducted on the Subject Device:
ECG performance testing, according to: ANSI/AAMI EC57:1998/(R)2003 and IEC 60601-2-47:2012 (Recognition Number 3-155) IEC 60601-2-25:2011 (Recognition Number 3-105)
Software development life cycle, according to: ANSI AAMI IEC 62304:2006 (Recognition Number 13-32)
Usability engineering process, according to: IEC 62366:2007
Any potential hazards have been evaluated and controlled through Risk Management activities. The testing demonstrated that CER-S is safe and effectiveness for the propose intended use.
No clinical tests were performed to demonstrate safety and effectiveness of CER-S
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
August 26, 2020
CardioCalm Fabio Badilini President & Legal Representative Corso Martiri della Libertà, nr. 40 Montichiari, 25018, Italy
Re: K193177
Trade/Device Name: CER-S Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: July 17, 2020 Received: July 27, 2020
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 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
1
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 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
Jennifer Shih Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
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 rhythm 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, but not limited to, 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 QRS detection.
| 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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510(k) Summary (as required by 21 CFR 807.92)
| Submitter | CardioCalm
Corso Martiri della Libertà, nr. 40
25018 Montichiari (BS) | |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Telephone | +39 030 9650782 | |
| Fax | +39 030 9650572 | |
| Contact Person | Fabio Badilini
President & Legal Representative | |
| Address | Corso Martiri della Libertà, nr. 40 | |
| Telephone | +39 030 9650782 | |
| Fax | +39 030 9650572 | |
| Email | badilini@cardiocalm.com | |
| Date Prepared | 10/29/2019 | |
| 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 |
| SyneScopeTM, EasyScopeTM, SyneComTM
HolterReader | K042002 | Sorin Group
(Ela Medical, Inc) |
| Reason for Submission | Pre-market notification for CER-S, a new Device, seeking authority to market the product under
Section 510(k), as substantially equivalent to the Predicate Devices listed above, legally marketed
on US territory. | |
| Device Description | CER-S is a tool, designed to offer a framework for the interaction of different software-modules,
providing advanced solutions for Continuous ECG Recording (CER).
Different modules provide:
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 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 format generation of aECG FDA HL7 XML (v. 2), for the submission of continuous ECG recording to the FDA ECG Warehouse. Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel
(dry and dry/metal electrodes are not intended to be used) placed on standard location in
compatible formats from any device used for the arrhythmia diagnostics such as Holter, event
recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary.
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 below the 1st rib, at an inclined angle three-electrode T-shaped patches positioned in the center-thoracic position between the 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 certified-patch device. | |
| Indications for
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 rhythm 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, but not limited to, 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 QRS detection. | |
| Technological
Characteristics
and
Substantial
Equivalence | The fundamental scientific principles and technological characteristic, including the indications for use
and general design are equivalent to the predicate device, as summarized hereafter:
Software type, Holter Analyzer, working in Windows Operative
System, as the predicate; Patient population, adults and pediatrics; User groups: trained operators under the direct supervision of a
licensed healthcare practitioner, equivalent to predicate 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 equivalent to the predicate. | |
| | As for the predicate device described below, the Subject device is a PC based SaMD, working in Windows Operative System | |
| Performance
Data | The following non-clinical tests have been conducted on the Subject Device:
ECG performance testing, according to: ANSI/AAMI EC57:1998/(R)2003 and IEC 60601-2-47:2012 (Recognition
Number 3-155) IEC 60601-2-25:2011 (Recognition Number 3-105) Software development life cycle, according to: ANSI AAMI IEC 62304:2006 (Recognition Number 13-32) Usability engineering process, according to: IEC 62366:2007 | |
| | Any potential hazards have been evaluated and controlled through Risk Management activities.
The testing demonstrated that CER-S is safe and effectiveness for the propose intended use.
No clinical tests were performed to demonstrate safety and effectiveness 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 and is safe and effective for its intended use. | |
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Traditional 510(k) Premarket Notification
CER-S