(63 days)
Not Found
Not Found
No
The summary describes a mechanical I.V. catheter system with a needlestick protection feature, and there is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The device is used to access a vein or artery for infusion, which is a method of administering a therapeutic agent, but the catheter itself is an access device, not the therapeutic agent.
No
Explanation: The device is an I.V. catheter system designed for accessing a vein or artery for fluid infusion, not for diagnosing medical conditions.
No
The device description clearly identifies the device as an "I.V. Catheter," which is a physical hardware component used for accessing veins or arteries. The summary describes features related to the physical catheter and its safety mechanisms, not software functionality.
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 to access a vein or artery for infusion purposes. This is a direct interaction with the patient's circulatory system, not the examination of specimens in vitro (outside the body).
- Device Description: The description of an "I.V. Catheter" further confirms its purpose as a device for accessing blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are typically used to examine specimens like blood, urine, or tissue to diagnose diseases or conditions. This device is a therapeutic and access device used directly on the patient.
N/A
Intended Use / Indications for Use
A properly placed I.V. catheter provides access to a vein or artery. The I.V. catheter system is designed for single use and has a needlestick protection feature. The needle guard that automatically locks over the needle as the catheter is threaded into the vessel reduces the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. 16 to 24 gauge catheters may be used with power injectors up to 300 psi.
Product codes
FOZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
vein or artery
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing feathers.
Public Health Service
JUL 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara Law Regulatory Affairs Manager Medex, Incorporated 6250 Shier-Rings Road Dublin, Ohio 43016
Re: K041345
Trade/Device Name: Protectiv® Jelco® Safety I.V. Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 17, 2004 Received: May 20, 2004
Dear Ms. Law:
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.
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Page 2 - Ms. Law
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 (301) 594-4618. 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,
Oul
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
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K0413415
Indications for Use Statement
510(k) Number (if known):
Protectiv® Jelco® Safety I.V. Catheter Device Name:
Indications for Use:
A properly placed I.V. catheter provides access to a vein or artery. TThe I.V. catheter system is designed for single use and has a needlestick protection feature. The needle guard that automatically locks over the needle as the catheter is threaded into the vessel reduces the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. 16 to 24 gauge catheters may be used with power injectors up to 300 psi.
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)
Cathy Ko. m
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental E
510(k) Number:
Image /page/2/Picture/15 description: The image shows a black and white abstract pattern. The pattern appears to be a collection of small dots or specks, densely packed together. The overall shape is somewhat rectangular, with a slightly irregular outline. There are some horizontal lines or bands visible within the pattern, adding to the complexity of the design.
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