(177 days)
The CARDIOVIT F - 1 is a 12-channel ECG unit used for the recording, viewing, storage and transmission of ECG waveforms.
The CARDIOVIT FT-1 is designed for indoor use and can be used for all patient populations.
The CARDIOVIT FT-1 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients.
The CARDIOVIT FT-1 is intended for use in hospitals, cardiology units, out-patient clinical units and general physician's offices.
The CARDIOVIT FT-1 is a 12-lead ECG (Electrocardiograph) device used in the recording, analysis, viewing, storage and transmission of ECG waveforms.
The CARDIOVIT FT-1 does not provide a patient monitoring capability with alarm annunciation.
The CARDIOVIT FT-1 has a color display. It accepts user input via a touch panel or barcode scanner. It can generate a variety of reports that can be viewed on the display or printed on a strip chart recorder that is built into the device.
The CARDIOVIT FT-1 is mains- or battery- powered and uses sensors that come in contact with the patient.
The CARDIOVIT FT-1 is intended to function in the patient vicinity alongside other medical devices. It can operate as a stand-alone device or can be connected to the SCHILLER SEMA3 Data Management System via Ethernet (land-line or WiFi) in order to store reports and retrieve work orders for a given patient.
The provided FDA 510(k) summary for the CARDIOVIT FT-1 states that the device is substantially equivalent to predicate devices, but it does not include a study or specific acceptance criteria for the device's diagnostic performance (e.g., accuracy in diagnosing cardiac abnormalities or detecting myocardial ischemia/infarctions).
Instead, the performance data provided focuses on:
- Electrical safety, essential performance, and electromagnetic compatibility (EMC) testing: This confirms compliance with various IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-25, IEC 62366).
- Software Verification and Validation Testing: This confirms the software's compliance with FDA guidance for "moderate" level of concern software.
Therefore, many of the requested details about acceptance criteria for diagnostic accuracy, sample sizes for test sets, ground truth establishment, expert qualifications, and MRMC studies are not present in this document.
Here's a breakdown of the information that can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Compliance |
|---|---|---|
| Diagnostic Performance (e.g., Sensitivity/Specificity for Cardiac Abnormalities) | MISSING - NOT SPECIFIED IN THIS DOCUMENT | MISSING - NO DIAGNOSTIC PERFORMANCE STUDY RESULTS INCLUDED |
| Electrical Safety | Compliance with IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 | Successfully tested to IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 | Successfully tested to IEC 60601-1-2:2014 |
| Usability | Compliance with IEC 60601-1-6:2010 (Third Edition) + A1:2013 | Successfully tested to IEC 60601-1-6:2010 (Third Edition) + A1:2013 |
| Electrocardiographs | Compliance with IEC 60601-2-25:2011 | Successfully tested to IEC 60601-2-25:2011 |
| Application of Usability Engineering | Compliance with IEC 62366:2007 (First Edition) + A1:2014 | Successfully tested to IEC 62366:2007 (First Edition) + A1:2014 |
| Medical Device Software Life Cycle Processes | Compliance with IEC 62304:2006 | Successfully tested to IEC 62304:2006 |
| Software Verification & Validation (Level of Concern) | Compliance with FDA Guidance for "moderate" level of concern software | Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software is considered a "moderate" level of concern. |
2. Sample size used for the test set and the data provenance
Not applicable for diagnostic performance. The document only references compliance with general engineering and software standards, not a specific clinical test set for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for diagnostic performance. This information is not provided as there is no diagnostic performance study detailed.
4. Adjudication method for the test set
Not applicable for diagnostic performance. This information is not provided as there is no diagnostic performance study detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document describes a traditional ECG device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The device is an electrocardiograph, which directly records and analyzes ECG waveforms. The "analysis" component is likely based on established algorithms for ECG interpretation, but there is no mention of a separate standalone algorithmic performance study in the context of AI or machine learning for diagnostic accuracy. The performance is tied to its measurement and interpretation capabilities as part of a medical device, which is primarily assessed through its adherence to standards for electrocardiographs (e.g., IEC 60601-2-25) and its equivalence to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for diagnostic performance. This information is not provided as there is no diagnostic performance study detailed. The device records ECG waveforms, and its "diagnosis" capabilities would generally rely on internal algorithms that interpret these waveforms based on established cardiology principles. The substantial equivalence argument relies on comparing this interpretation to that of predicate devices, which implicitly assumes the predicate devices have an acceptable "ground truth" performance.
8. The sample size for the training set
Not applicable. This device is an electrocardiograph, and while it performs "analysis," the document does not indicate that this analysis is based on machine learning or AI that would require a "training set" in the modern sense (e.g., for deep learning). Its algorithms are based on established signal processing and diagnostic rules for ECG interpretation.
9. How the ground truth for the training set was established
Not applicable. As above, there is no mention of a "training set" in the context of machine learning.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
Schiller AG % Jim Chickering Regulatory Affairs Manager Zoe Medical. Inc 460 Boston Street Topsfield, Massachusetts 01983
Re: K170182
Trade/Device Name: CARDIOVIT FT-1 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 8, 2017 Received: June 12, 2017
Dear Jim Chickering:
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. 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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Willehemen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170182
Device Name CARDIOVIT FT-1
Indications for Use (Describe)
The CARDIOVIT F - 1 is a 12-channel ECG unit used for the recording, viewing, storage and transmission of ECG waveforms.
The CARDIOVIT FT-1 is designed for indoor use and can be used for all patient populations.
The CARDIOVIT FT-1 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients.
The CARDIOVIT FT-1 is intended for use in hospitals, cardiology units, out-patient clinical units and general physician's offices.
| 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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SCHILLER AG Altgasse 68, Postfach CH-6341 Baar, Switzerland Tel: +41 41 766 42 42 Fax: +41 41 761 08 80
MWST Nr. 212 858 e-mail: sales@schiller.ch http://www.schiller.ch
Image /page/3/Picture/3 description: The image shows a logo for Schiller, a company that specializes in diagnostics. The logo features three colorful icons: a yellow heart on a red background, pink lungs on an orange background, and a green heart on a yellow background. To the right of the icons is the company name "SCHILLER" in red, with the tagline "The Art of Diagnostics" in black underneath.
510(k) Summary
1. General information
| Submitter | |
|---|---|
| Address: | Schiller AGAltgasse 68CH-6341 BaarSwitzerland |
| Phone : | +41 41 766 42 52 |
| Fax: | +41 41 761 08 80 |
| Contact Person: | Zhenrong Yu, MD, Ph.D.Vice President Regulatory Affairs and Quality Assurance |
| Date Prepared: | May 22, 2017 |
| Device | |
|---|---|
| Device Trade Name | CARDIOVIT FT-1 |
| Manufacturer | Schiller AG |
| Altgasse 68 | |
| CH-6341 Baar | |
| Switzerland | |
| Common Name: | Electrocardiograph |
| Product Code: | DPS - Electrocardiograph (21 CFR 870.2340) |
| Regulatory Class | II |
2. Predicate Device
The primary predicate device is the SCHILLER CARDIOVIT AT-10 Plus.
A secondary predicate device is cited for its use of the same electrocardiograph physiological parameter technology as the subject device.
No reference devices were used in this submission.
| Predicate Scope | Predicate Device | 510(k) | Classification |
|---|---|---|---|
| Primary Predicate | SCHILLER CARDIOVIT | K050686 | DPS |
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SCHILLER AG Altgasse 68, Postfach CH-6341 Baar, Switzerland Tel: +41 41 766 42 42 Fax: +41 41 761 08 80
MWST Nr. 212 858 e-mail: sales@schiller.ch http://www.schiller.ch
Image /page/4/Picture/3 description: The image shows a logo for Schiller, a company that specializes in diagnostics. The logo features three colorful squares, each containing a different organ: a yellow heart, pink lungs, and a green heart. To the right of the squares is the company name, "SCHILLER," in bold red letters, followed by the tagline "The Art of Diagnostics" in smaller black letters.
| Predicate Scope | Predicate Device | 510(k) | Classification |
|---|---|---|---|
| AT-10 Plus | |||
| Secondary Predicate(electrocardiographphysiological parametertechnology) | SCHILLER DiagnosticStation DS20 | K152043 | DPS |
3. Device Description
The CARDIOVIT FT-1 is a 12-lead ECG (Electrocardiograph) device used in the recording, analysis, viewing, storage and transmission of ECG waveforms.
The CARDIOVIT FT-1 does not provide a patient monitoring capability with alarm annunciation.
The CARDIOVIT FT-1 has a color display. It accepts user input via a touch panel or barcode scanner. It can generate a variety of reports that can be viewed on the display or printed on a strip chart recorder that is built into the device.
The CARDIOVIT FT-1 is mains- or battery- powered and uses sensors that come in contact with the patient.
The CARDIOVIT FT-1 is intended to function in the patient vicinity alongside other medical devices. It can operate as a stand-alone device or can be connected to the SCHILLER SEMA3 Data Management System via Ethernet (land-line or WiFi) in order to store reports and retrieve work orders for a given patient.
4. Indication For Use
The CARDIOVIT FT-1 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms.
The CARDIOVIT FT-1 is designed for indoor use and can be used for all patient populations.
The CARDIOVIT FT-1 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients.
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SCHILLER AG Altgasse 68, Postfach CH-6341 Baar, Switzerland Tel: +41 41 766 42 42 Fax: +41 41 761 08 80
MWST Nr. 212 858
e-mail: sales@schiller.ch
http://www.schiller.ch
Image /page/5/Picture/3 description: The image shows a logo for Schiller. The logo has three different colored squares with a different organ in each square. The first square is red and has a yellow heart, the second square is orange and has pink lungs, and the third square is yellow and has a green heart. To the right of the squares is the word "SCHILLER" in red, with the words "The Art of Diagnostics" in black below it.
The CARDIOVIT FT-1 is intended for use in hospitals, cardiology units, outpatient clinical units and general physician's offices.
5. Comparison of Technological Characteristics with Predicate
The subject device has the same device characteristics and intended use as the primary predicate device. The subject device has exactly the same electrocardiograph physiological parameter technology as the secondary predicate device.
At a high level, the subject and predicate devise are based on the following same technological elements:
- 12 lead ECG electrocardiographs -
- with data analysis
- without alarm annunciation
The following technological differences, corresponding to technological upgrades, exist between the subject and the predicate device:
- -Slimmer and lighter design
- Virtual keyboard and keys instead of an integrated keyboard -
- Higher display resolution -
- -Increased Database Storage
- Modern network technology (including WLAN) -
- Wider range of operating and storage conditions -
- -Use of a more readily available electrical components (e.q., microcontrollers, memory chips)
- -Use of an external (rather than internal) medical-grade power supply
- Use of a newer battery technology -
These differences do not raise new questions of safety and effectiveness.
6. Performance Data
6.1. Electrical safety, essential performance and electromagnetic compatibility (EMC) testing
The CARDIOVIT FT-1 was successfully tested to the following requlatory standards:
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SCHILLER AG Altgasse 68, Postfach CH-6341 Baar, Switzerland Tel: +41 41 766 42 42 Fax: +41 41 761 08 80
MWST Nr. 212 858 e-mail: sales@schiller.ch http://www.schiller.ch
Image /page/6/Picture/3 description: The image shows a logo for Schiller. The logo has a yellow heart on a red background, pink lungs on an orange background, and a green heart on a yellow background. To the right of the images is the word "SCHILLER" in red, with the words "The Art of Diagnostics" in a smaller font below.
| Standard | Standard Title |
|---|---|
| IEC 60601-1: 2005 +CORR. 1:2006 + CORR.2:2007 + AM1:2012 (orIEC 60601-1: 2012reprint) | 3rd Edition, Medical Electrical Equipment, Part 1: Generalrequirements for basic safety and essential performance |
| IEC 60601-1-2:2014 | 4th Edition. Medical Electrical Equipment, Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic Compatibility |
| IEC 60601-1-6 : 2010(Third Edition) + A1:2013 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability |
| IEC 60601-2-25:2011 | 2nd Edition. Medical Electrical Equipment, Part 2-25:Particular requirements for the basic safety and essentialperformance of electrocardiographs |
| IEC 62366:2007 (FirstEdition) + A1:2014 | Medical Devices - Application of usability engineering tomedical devices |
| IEC 62304:2006 | Medical Device Software - Software life cycle processes |
6.2. Software Verification and Validation Testing
Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient through incorrect or delayed information or through the action of a care provider.
7. Conclusions
Based upon a comparison of devices and performance testing results, the SCHILLER CARDIOVIT FT-1 is substantially equivalent to the predicate devices.
§ 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).