(447 days)
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.
The CARDIOVIT AT-102 G2 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms.
The provided text is a 510(k) clearance letter from the FDA for a device called "Cardiovit AT-102 G2." This document primarily covers the FDA's determination of substantial equivalence to a predicate device for marketing purposes.
It does NOT contain information about acceptance criteria, device performance results, sample sizes for testing, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory approval letter, not a study report or technical documentation.
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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.
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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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§ 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).