HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y by VENUSA LTD.

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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Venusa, Ltd. Huber Needle Infusion Set." It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, meaning it's as safe and effective.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving those criteria are met:

The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way you've described. This is typical for a 510(k) submission that relies on demonstrating substantial equivalence to predicate devices.

Instead of reporting on a new study with defined acceptance criteria for performance, the submission argues that the Venusa, Ltd. Huber Needle Infusion Set is safe and effective because it is substantially equivalent to existing, legally marketed devices.

Let's break down why your specific questions cannot be fully answered by this document and what information is provided:

1. A table of acceptance criteria and the reported device performance

Not present. The document does not define specific performance acceptance criteria (e.g., flow rate, puncture force, durability) and does not report on performance data against such criteria for the Venusa device itself.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. There is no "test set" in the context of a performance study described here. The submission uses a comparison to predicate devices, not new performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No expert ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an infusion set, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an infusion set, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Indirectly, through predicate devices. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices (Pfizer Strato K921674, Douglas Medical Products K932638, and Marquette Medical K884212). The assumption is that because those devices are safe and effective, and the Venusa device is substantially equivalent, then the Venusa device is also safe and effective. No primary ground truth determination for the Venusa device is described.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this type of submission.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" in the context of this type of submission.

What the document does state in lieu of a performance study against acceptance criteria:

The core of the submission (and the "study" in a loose sense for 510(k)) is the demonstration of substantial equivalence.

"Acceptance Criteria" (Implicit): The implicit acceptance criterion for a 510(k) is that the new device is substantially equivalent to a legally marketed predicate device(s) in terms of:
- Intended Use: The Venusa device's intended use ("access an implanted port for the purpose of delivering drugs and solutions" / "to deliver solutions and drugs into vascular implant ports") is identical to that of its predicates.
- Technological Characteristics: The submission states, "The Venusa, Ltd. Huber Needle Infusion Sets utilize similar and equivalent designs, components, manufacturing processes..." This implies that the materials (Luer lock adapter, Non-DEHP PVC tubing, on/off clamp, 314 stainless steel Huber point non-coring needle, winged hub), design (90-degree bent needle), and manufacturing processes are comparable to the predicates.
- Performance (Implied): By claiming similar designs, components, and manufacturing processes, the submission implicitly argues that the performance (e.g., integrity, sterility, biocompatibility, flow characteristics, ease of insertion) will be equivalent to the predicates, which are already deemed safe and effective.
"Study that proves the device meets the acceptance criteria": The "study" here is the substantiation of substantial equivalence through comparative analysis, not a new clinical or laboratory performance trial for the Venusa device itself.
- The document explicitly states: "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)."
- And concludes: "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."

In summary, this 510(k) submission for the Venusa, Ltd. Huber Needle Infusion Set relies on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a dedicated study against predefined acceptance criteria.

Summary

{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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.