(447 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms, and the description of the device's function (recording, analysis, viewing, storage, and transmission of ECG waveforms) does not inherently require AI/ML.
No.
The device is used for diagnosis and monitoring of cardiac abnormalities, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The CARDIOVIT AT-102 G2 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients."
No
The device description explicitly states it is a "12-channel ECG unit," which implies the presence of hardware components for recording ECG waveforms, not just software for analysis and viewing.
Based on the provided information, the CARDIOVIT AT-102 G2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The CARDIOVIT AT-102 G2 directly records electrical signals from the patient's body (ECG waveforms) rather than analyzing a biological sample like blood, urine, or tissue.
- The intended use describes direct patient monitoring and diagnosis based on physiological signals. The device is used to record, analyze, and view ECG waveforms from the patient to diagnose cardiac abnormalities.
Therefore, the CARDIOVIT AT-102 G2 falls under the category of a medical device used for physiological monitoring and diagnosis, but not an IVD.
N/A
Intended Use / Indications for Use
The CARDIOVIT AT-102 G2 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms.
The CARDIOVIT AT-102 G2 is designed for indoor use and can be used for all patient populations.
The CARDIOVIT AT-102 G2 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients.
The CARDIOVIT AT-102 G2 is intended for use in hospitals, cardiology units, outpatient clinical units and general physician's offices.
Product codes
DPS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
all patient populations
Intended User / Care Setting
hospitals, cardiology units, outpatient clinical units and general physician's offices.
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 2, 2020
Schiller AG % Ray Kelly Consultant Arazy Group Consultants Inc. 68 Southwood Terrace Southbury, Connecticut 06488
Re: K183425
Trade/Device Name: Cardiovit At-102 G2 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: February 6, 2020 Received: February 26, 2020
Dear Ray Kelly:
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.
1
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 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,
Hetal Odobasic 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name CARDIOVIT AT-102 G2
Indications for Use (Describe)
The CARDIOVIT AT-102 G2 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms.
The CARDIOVIT AT-102 G2 is designed for indoor use and can be used for all patient populations.
The CARDIOVIT AT-102 G2 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients.
The CARDIOVIT AT-102 G2 is intended for use in hospitals, cardiology units, outpatient 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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