(142 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The device description is also not provided, which would be a key place to look for such information.
Yes
The device is indicated for the infusion of IV fluids and pain control, which are therapeutic interventions.
No
The device is described as IV administration sets for facilitating the infusion of IV fluids and pain control. This description indicates a therapeutic or delivery function, not a diagnostic one.
No
The 510(k) summary describes IV administration sets, which are physical medical devices used for fluid infusion. There is no mention of software as the primary or sole 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 the device is for "facilitate the continuous and bolus infusion of IV fluids, pain control includes in the systems." This describes a device used for administering substances directly into the body, which is a therapeutic or delivery function, not a diagnostic one.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition. IVDs are designed to perform tests on samples to aid in diagnosis, monitoring, or screening.
Therefore, based solely on the provided text, the CODAN US IV Administration sets, In-line sets and Connect Sets are not IVDs. They are medical devices used for the delivery of fluids and medications.
N/A
Intended Use / Indications for Use
CODAN IV Administration sets, In-line sets and Connect Sets are indicated for use to facilitate the continuous and bolus infusion of IV fluids, pain control includes in the systems.
Product codes
FPA
Device Description
IV Administration sets, In-line sets and Connect Sets
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 2004
Mr. Rohit Patel Quality Assurance Manager CODAN US Corporation 3511 West Sunflower Avenue Santa Ana, California 92704-6944
Re: K033301
Trade/Device Name: IV Administration and Connect Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 8, 2004 Received: January 9, 2004
Dear Mr. Patel:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reveal yoursed yourse 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 Interstate contineree prior to thay as, been reclassified in accordance with the provisions of A. Holloments, or to act route Act (Act) that do not require approval of a premarket the Federal F 00a; Drag). You may, therefore, market the device, subject to the general af provisions of the Act. The general controls provisions of the Act include controls provins 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 (1 Nr.), it may of backed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear no rouldish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Patel
Please be advised that FIDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements Incall that I DAY mas made a detes and regulations administered by other Federal agencies. of the Act of all y I occrat barates and set sequirements, including, but not limited to: registration 1 od intelse comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by 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) I institution will anow you to organ finding of substantial equivalence of your device to a premarket notification. - The PD Presults in a classification for your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice to: Jour de 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 may 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/dsma/dsmamain.html
Sincercly yours,
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
510(k) Submission 510(K) Submission
IV Administration set, In-line set and Connect set 2/9/04
Page_1 of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CODAN US IV Administration sets, In-line sets and Connect Sets Device Natile: OODAN IV Administration sets, In-line sets and Connect Sets are callulis For See.
indicated for use to facilitate the continuous and bolus infusion of IV fluids, pain control includes in the systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _