(280 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is intended as an "aid to diagnosis," which classifies it as a diagnostic device, not a therapeutic one. It analyzes signals but does not treat or alleviate a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used as an aid to diagnosis."
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, it is highly likely that the CardioStation-100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states "analysis of cardiac electrical signals". This refers to signals generated within the body (in vivo), not from samples taken from the body (in vitro). IVDs analyze samples like blood, urine, tissue, etc.
- Lack of Mention of Samples: There is no mention of analyzing any type of biological sample.
- Focus on Electrical Signals: The core function described is the analysis of electrical signals, which is characteristic of devices like electrocardiographs (ECGs) or similar cardiac monitoring equipment.
In summary, the description points towards a device that analyzes physiological signals directly from the patient, which is the domain of in vivo diagnostics, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
DQK
Device Description
Not Found
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
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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