(274 days)
Not Found
Not Found
No
The provided 510(k) summary describes a central venous catheter and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the treatment of diseases or conditions requiring central venous access, making it a therapeutic device.
No
Explanation: The intended use of this device is to provide short-term central venous access for treatment, including administration of fluids, medications, nutrition, blood sampling, and contrast media injection. While it mentions "Central venous pressure monitoring," this is a measurement aspect of a treatment device, not its primary diagnostic purpose. There is no indication that the device itself performs diagnosis or analysis of medical conditions.
No
The provided text describes the intended use of a central venous catheter, which is a physical medical device, not software. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for accessing the central venous system for various therapeutic and monitoring purposes (infusions, blood sampling, pressure monitoring, etc.). This is a direct medical intervention on the patient's body.
- IVD Definition: In vitro diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
This device is a central venous catheter, which is a medical device used for direct patient care, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Indicated to permit short-term (
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 1 2011
Ameco Medical Industries C/O Mr. Ray Kelly RA/QA Specialist Rav Kelly 79 Brookline Road Mason, New Hampshire 03048
Re: K110794
Trade/Device Name: Amecath CVC and Amecath Pressure CVC short term single and multi-lumen catheterization kits Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: December 15, 2011 Received: December 19, 2011
Dear Mr. 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. 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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Page 2 - Mr. Kelly
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ameco Medical Industries Industrial area B4 # 119 east, 10th of Ramadan city -Egypt Phone +20.15.383.066/7 | Fax +20.15.383.068 | www.amecath.com
Section 3
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
"Amecath CVC" and "Amecath Pressure CVC" short term single and multi-lumen catheterization kits
Indications For Use:
Indicated to permit short-term (