(280 days)
The CardioStation-100 is intended to be used as an aid to diagnosis by means of analysis of cardiac electrical signals in the frequency domain, the power spectral estimate.
Not Found
The provided document is an FDA 510(k) clearance letter for the CardioStation-100 device. While it indicates that the device has been cleared based on substantial equivalence to a predicate device, it does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter primarily focuses on:
- Acknowledging the 510(k) premarket notification.
- Stating that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory classification (Class II).
- Reminding the manufacturer of general controls provisions and other applicable regulations.
- Stating the intended use of the device.
Therefore, I cannot provide the requested table and details from this document. The information typically needed to answer these questions would be found in the 510(k) submission itself or a separate clinical study report, which is not part of this clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 abstract image of an eagle.
JAN 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
US Clover Co. c/o Ms Cecilia L. Yu Law Offices of Cecilia L. Yu & Associates 17800 Castleton St. Suite 415 City of Industry, CA 91748
Re: K041031
Trade Name: CardioStation-100 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: November 22, 2004 Received: November 24, 2004
Dear Ms. Yu:
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 for are connection 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Cecilia Yu
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r fouro oe arribed 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 or any I cathar states and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product fraultitel. I will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 5944646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (2001) 974 1057 and 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimmer 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): Not assigned yet
Device Name:CardioStation-100, Trade Name: CS-100
Indications For Use: The CardioStation-100 is intended to be used as an aid to diagnosis by means of analysis of cardiac electrical signals in the frequency domain, the power spectral estimate.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1/11/2/1/1/2/16/2000
Division Sign-Off) Division of Cardicvascular Devices 510(k) Number_K 24/Q
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).