(271 days)
The GALIX ECG Professional Station system is intended for 12 Channel ECG recording and monitoring (running the ECG-PS software module) and 12 channel cardiac stress testing (running the ERGO-PS software). It is indicated for use:
- with Male/Female Pediatric to Adult population
- in Hospital, Clinic and Physician´s office
- under prescription by a physician
Not Found
The provided document is an FDA 510(k) clearance letter for the "GALIX ECG Professional Station, Models ECG-PS and ERGO-PS". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or an associated study report detailing device performance against such criteria.
The 510(k) clearance letter is a regulatory approval document, not a detailed technical study report. It states the indications for use and classification but typically doesn't include the raw data, methodology, or results of performance testing that would be submitted to the FDA during the review process.
Therefore, I cannot provide the requested information based solely on the text provided. The document itself does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
- Results of a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, one would typically need to review the full 510(k) submission summary or associated clinical/performance study reports, which are not part of this clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2006
Galix Biomedical Instrumentation, Inc. c/o Mr. Jordan Gavrielides President 2555 Collins Avenue Suite C-5 Miami Beach, FL 33140
Re: K051163
Trade Name: GALIX ECG Professional Station, Models ECG-PS and ERGO-PS, Regulation Number: 21 CFR 870,2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: November 28, 2005 Received: December 2, 2005
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. Ilsting 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 - Mr. Jordan Gavrielides
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); 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 (240) 276-0210lso, 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/industry/support/index.html.
Sincerely yours,
Bfremmer for
Bram D. Zuckerman, M.D. Director Divison 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): K051163
GALIX ECG Professional Station Device Name:
Indications For Use:
The GALIX ECG Professional Station system is intended for 12 Channel ECG recording and monitoring (running the ECG-PS software module) and 12 channel cardiac stress testing (running the ERGO-PS software). It is indicated for use:
- · with Male/Female Pediatric to Adult population
- · in Hospital, Clinic and Physician´s office
- · under prescription by a physician
X Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhammuna
510(in Namber
Page 1 of
§ 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).