(76 days)
Not Found
No
The device description and intended use describe a purely mechanical infusion set with no mention of software, data processing, or AI/ML terms.
No
The device is an infusion set designed to deliver drugs and solutions, but it does not directly treat a disease or condition itself. It is an accessory used in the administration of therapeutic substances.
No
The device is described as an infusion set for delivering drugs and solutions, which is a therapeutic function, not a diagnostic one. No part of its stated intended use or description mentions diagnosing any condition.
No
The device description clearly lists physical components such as a needle, tubing, and a Luer lock adapter, indicating it is a hardware device.
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 accessing an implanted port to deliver drugs and solutions into vascular implant ports. This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details components like needles, tubing, and a Luer lock adapter, all consistent with a device used for infusion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is used to administer substances into the body.
N/A
Intended Use / Indications for Use
The Venusa, Ltd. Huber Needle Infusion Set is intended to be used access an implanted port for the purpose of delivering drugs and solutions.
The Venusa, Ltd. Huber Needle Infusion Set is intended to be used to deliver solutions and drugs into vascular implant ports.
Product codes
FPA
Device Description
The device consists of female Luer lock adapter, Non-DEHP PVC tubing, an onloff clamp, 314 stainless steel Huber point non-coring needle bent to 90 degrees. The device includes a winged hub that surrounds the needle to aid in the insertion, securement, and removal of the device.
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)
Reference Device(s)
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
K 98/683
January 18, 1998
To whom it may concern:
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Trade Name - Venusa, Ltd. Huber Needle Infusion Set Common Name -Huber Needle Set, Vascular Access Device Classification Name - Intravascular Administration Set
The Venusa, Ltd. Huber Needle Infusion Set is intended to be used access an implanted port for the purpose of delivering drugs and solutions. The device consists of female Luer lock adapter, Non-DEHP PVC tubing, an onloff clamp, 314 stainless steel Huber point non-coring needle bent to 90 degrees. The device includes a winged hub that surrounds the needle to aid in the insertion, securement, and removal of the device. The components and the processes used to manufacture these Huber needle infusion sets are substantially equivalent to like products currently legally marketed by Pfizer Strato (K921674), Douglas Medical Products (K932638), and Marquette Medical (K884212). Venusa, Ltd. Huber Needle Infusion Sets will be packaged in tyvek\mylar pouches or tyvek and polyethylene form\fillseal container and sterilized per AAMI quidelines.
Based on the fact that the Venusa, Ltd. Huber Needle Infusion Sets utilize similar and equivalent designs, components, manufacturing processes, and have the same intended use as the currently legally marketed products, the Venusa, Ltd. Huber Needle Infusion Sets are safe and effective when used as intended.
Sincerely.
Neil Kulkarni
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 1998
Mr. Neil Kulkarni ·Product Development Engineer Venusa Ltd. 31 Butterfield Trail, Suite C El Paso, Texas 79906
K981683 Re : Huber Needle Infusion Set Model Number Trade Name: 20601, Huber Needle Infusion Set w/y-site Model Number 20601y Requlatory Class: II Product Code: FPA Dated: May 8, 1998 Received: May 13, 1998
Dear Mr. Kulkarni:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Kulkarni
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
S. Aitken for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
510(k) Number (if known):_
Device Name: Huber Nieedle Infosion Se t
Indications For Use:
The Venusa, Ltd. Huber Needle Infusion Set is intended to be used to deliver solutions and drugs into vascular implant ports.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)