(491 days)
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No
The provided text describes a standard IV cannula and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device, Cathy IV Cannula, is used to administer fluids intravenously, which is a delivery mechanism, not a therapeutic action itself.
No
Explanation: The intended use of the Cathy IV Cannula is to administer fluids intravenously, not to diagnose a condition.
No
The device is described as an "IV Cannula," which is a physical medical device used for intravenous administration. The summary does not mention 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 clearly states that the device is used to "administer fluids intravenously" and for "writtence of propoduce intravenously". This describes a device used in vivo (within the living body) for direct patient treatment.
- Definition of IVD: In vitro diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening. The intended use of this device does not involve the examination of specimens outside the body.
Therefore, the Cathy IV Cannula, as described, is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
As described in 21 CFR section 880.5200, Cathy IV Cannula is used to administer fluids intravenously. Cathy IV Cannula may be used for intermittent or continuous infusions.
Product codes
FOZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
JAN 1 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sanjiv Kumar President Myco Medical Supplies, Incorporated 113 Centre West Court Cary, North Carolina 27513
Re: K042504
Trade/Device Name: Cathy IV Cannula Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 15, 2005 Received: September 19, 2005
Dear Mr. Kumar:
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.
1
Page 2 - Mr. Kumar
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisour mar 1 DT to learnination that your device complies with other requirements moun that 1 DT may made statutes and regulations administered by other Federal agencies. or the Act of ally 1 ederal base use - use - uirements, including, but not limited to: registration r ou inust comply while and 807; labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ion 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) Fins reter will and in J . The FDA finding of substantial equivalence of your device to a premarket notifieddion. - The evice 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), rryou desire spleine acritics of Compliance at (240) 276-0115 . 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 maj obtain 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,
Snytte y. Michieu Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
and the artistic and the first of the first of the former of
Indications for Use
510(k) Number (if known): __K042504
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
As described in 21 CFR section 880.5200, Cathy IV Cannula is used to administer fluids As described in 21 CFR section 600.5200, Oakly IV ecanalian with consideration
intravenously. Cathy IV Cannula may be used for writtence of propoduce intravenously. Cathy IV Califiala may be accurity of the may of procedure.
| 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 In Vitro Diagnostic Devices (OIVD)
Cita Ding
a of Actact raniclegy, Cieneral Hospits i Control, Control, Dental Devices
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