(245 days)
The GALIX WinTer ECG Holter Analysis system is intended for patients requiring 24hr ambulatory monitoring. It is indicated for use in:
- the replay, analysis, display, editing and report generation of ambulatory ECG data
- . the assessment of cardiac disturbance and myocardial ischemia
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "GALIX WinTer ECG Holter Analyzer." It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance, or specific study details such as sample sizes, expert qualifications, or ground truth establishment.
The document states the intended use of the device: "the replay, analysis, display, editing and report generation of ambulatory ECG data" and "the assessment of cardiac disturbance and myocardial ischemia." However, it does not specify performance metrics or the studies conducted to demonstrate these.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the information given. This type of information is typically found in the 510(k) summary or the full 510(k) submission, which is not provided here.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 description: The image shows a black and white logo of three birds flying in a circle. The birds are stylized and have curved lines for their bodies and wings. The circle is made up of small dots or dashes. The logo has a simple and clean design.
SEP 1 7 2003
ond and Drug Administra Rockville MD 20050
Galix Biomedical Instrumentation, Inc. c/o Mr. Jordan Gavrielides President 2555 Collins Avenue, Suite C-5 Miami Beach, FL 33140
Re: K030145 Trade Name: GalixWinTer Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 24, 2003 Received: August 12, 2003
Dear Mr. Gavrielides:
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.
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.
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
{1}------------------------------------------------
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); good manufacturing practice requirements as set forth 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. This letter 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) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
VeahtM
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
GALIX BIOMEDICAL INSTRUMENTATION INC. 2555 Collins Avenue, Suite C-5 - Miami Beach, FL 33140, U.S.A.
Tel .: (305) 534-5905 Fax : (305) 534-8222
510(K) GALIX WinTer ECG Holter Analyzer
Indications for Use:
The GALIX WinTer ECG Holter Analysis system is intended for patients requiring 24hr ambulatory monitoring. It is indicated for use in:
- the replay, analysis, display, editing and report generation of ambulatory ECG data ●
- . the assessment of cardiac disturbance and myocardial ischemia
...
Prescription Use Only
Kala Th
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030145
§ 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).