(231 days)
Not Found
Not Found
No
The provided text describes a simple, disposable, one-directional fluid flow device for medication infusion, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is described as an accessory for infusion of medication, rather than a device that directly provides therapy itself.
No
The device is described as an accessory for infusion of medication, indicating a therapeutic or drug delivery function, not a diagnostic one.
No
The intended use describes a physical device (accessory for luer connector, sterile, disposable, one-directional fluid flow device) which is clearly hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is used for the "infusion of medication to a patient." This is a direct interaction with the patient's body for therapeutic purposes.
- IVD Definition: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily specimens.
- Device Description (or lack thereof): While the description is "Not Found," the intended use is the primary indicator. The description of it being a "ONE-DIRECTIONAL FLUID FLOW DEVICE" further supports its role in fluid delivery, not diagnostic testing.
Therefore, this device falls under the category of a medical device used for patient treatment, not an IVD.
N/A
Intended Use / Indications for Use
THIS DEVICE IS USED AS AN ACCESSORY FOR WHICH CAN BE CONNECTED TO A FEMALE LUER CONNECTOR, ie; WINGED INFUSION SET OR AN I.V. SET, FOR INFUSION OF MEDICATION TO A PATIENT. IT IS STERILE , DISPOSABLE & "ONE-DIRECTIONAL FLUID FLOW DEVICE".
Product codes
FPA
Device Description
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 resembling a human figure with outstretched arms, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2005
Ms. Tammie Ewing Executive Assistant Exelint International Company International Headquarters Medical Products Division P.O. Box 3194 Culver City, California 90231-3194
Re: K992290
Trade/Device Name: Exel Injection Plug W/Cap Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 24, 2000 Received: February 1, 2000
Dear Ms. Ewing:
This letter corrects our substantially equivalent letter of February 23, 2000.
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 (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 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 - Ms. Ewing
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Synette Y. Michael Davis.
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
Page 1 of 1
510(k) Number (if known): K992290
Device Name: EXEL INJECTION PLUG W/CAP
Indications For Use:
THIS DEVICE IS USED AS AN ACCESSORY FOR WHICH CAN BE CONNECTED TO A FEMALE LUER CONNECTOR, ie; WINGED INFUSION SET OR AN I.V. SET, FOR INFUSION OF MEDICATION TO A PATIENT. IT IS STERILE , DISPOSABLE & "ONE-DIRECTIONAL FLUID FLOW DEVICE".
:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
escription Use
(Per 21 CFR 801.109)
OR
$\gamma$
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sian-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number. 5