(64 days)
The Venusa, Ltd. Extension Set with Filter is used for IV fluid administration where The Velusa, Do. Dxtention Dot, Mai 22 mirron is desired. Use of the device helps assure the delivery of a bacteria-free product. The device is used in conjunction with an IV administration set and in-dwelling IV catheter.
The device consists of female Luer lock, TOTM (non-DEHP) plasticised PVC tubing, a Millipore 0.22 micron air eliminating filter, an on\off clamp, and a male Luer lock adapter.
This looks like a 510(k) premarket notification for a medical device. The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than detailing de novo acceptance criteria and a study specifically designed to meet them.
Here's an analysis based on the provided text, highlighting what's available and what's missing:
Acceptance Criteria and Device Performance (as stated by the manufacturer for the filter component):
| Acceptance Criteria (Functional Requirements) | Reported Device Performance (Millipore Filter) |
|---|---|
| Reverse Pressure Filter Integrity | "meets or exceeds all functional requirements" |
| Unit Venting | "meets or exceeds all functional requirements" |
| Gravity Flow | "meets or exceeds all functional requirements" |
| Inlet Axial Stress | "meets or exceeds all functional requirements" |
| Forward Pressure Filter Integrity | "meets or exceeds all functional requirements" |
| Downstream Particle Count | "meets or exceeds all functional requirements" |
| Accelerated Endurance | "meets or exceeds all functional requirements" |
| Bioburden Evaluation | "meets or exceeds all functional requirements" |
| Inline Filter Wettability | "meets or exceeds all functional requirements" |
| Burst Strength | "meets or exceeds all functional requirements" |
| MVI Resistance | "meets or exceeds all functional requirements" |
1. A table of acceptance criteria and the reported device performance:
As shown above. The document states that the filter "meets or exceeds all functional requirements" but does not provide specific numerical values for these requirements or the achieved performance. This is typical for a 510(k) where the focus is on equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for any of the tests. The document only mentions "Millipore generated data."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only states the data was generated by Millipore, the filter manufacturer.
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):
This information is not applicable to this type of device and study. The testing described is for the physical and functional performance of a filter, not for diagnostic accuracy or human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there is no human interpretation or ground truth to be adjudicated in the context of these physical performance tests.
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:
This information is not applicable. This device is an extension set with a filter, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" here would be defined physical and performance standards for medical filters (e.g., particle count limits, burst pressure thresholds, flow rates). These are established by engineering and regulatory standards rather than medical consensus or pathology. The document implies these standards exist and were met ("meets or exceeds all functional requirements"), but doesn't detail them.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
This information is not applicable. No training set exists.
Summary of the Study:
The "study" described in the 510(k) document is not a clinical study in the traditional sense, nor is it a study explicitly designed to meet de novo acceptance criteria. Instead, it relies on tests performed by the filter manufacturer (Millipore) to demonstrate that the filter component (which Venusa is incorporating without modification) meets established functional requirements.
The core of the K994429 submission is to claim substantial equivalence to existing predicate devices (Abbott K960466 and Baxter K964850). Venusa's argument for safety and effectiveness is based on:
- Same intended use.
- Similar/identical components (specifically purchasing the 0.22 micron filter from Millipore without changes).
- Similar device configuration (minus a y-injection site).
- Similar/identical raw materials.
- Similar/identical manufacturing processes.
- The fact that the Millipore filter, as a component, has undergone its own functional performance testing and "meets or exceeds all functional requirements."
Therefore, this document does not contain the detailed information typically found in a study designed to establish new acceptance criteria for a novel device, but rather a justification for substantial equivalence based on existing data for its components and similarity to predicate devices.
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MAR - 3 2000
Image /page/0/Picture/2 description: The image shows the logo for VENUS A LTD MEDICAL INDUSTRIES. The text is in bold, black letters. There are two pill-shaped objects behind the text.
December 27, 1999
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., Extension Set with Filter Common Name - Extension Set with .2 micron Air Eliminating Filter Classification Name - Intravascular Administration Set
The Venusa, Ltd. Extension Set with filter is intended to be used with an indwelling catheter for the purpose of delivering drugs and solutions. The filter assures that particulate matter greater than .2 micron is removed from the solution and insures that air is not infused. The device consists of female Luer lock, TOTM (non-DEHP) plasticised PVC tubing, a Millipore 0.22 micron air eliminating filter, an on\off clamp, and a male Luer lock adapter. The components and the processes used to manufacture these solution sets with filter are substantially equivalent to like products currently legally marketed by Abbott Laboratories, under K960466 and Baxter Healthcare under K964850. The Venusa, Ltd. Extension Set with Filter will be packaged in tyvek\mylar pouches and sterilized per AAMI guidelines.
The Venusa, Ltd. Extension Set with Filter is similar to the above named predicate devices in following ways:
-
It has the same intended use.
-
It uses the same components..
-
The device configuration is the same, with the exception the Venusa, Ltd. device will not
utilize a y-injection site.
-
The composition of the raw materials is similar if not identical.
-
The processes used to manufacture the devices are similar if not identical.
Venusa will purchase the 0.22 micron filter from Millipore and will incorporate it into an extension set. Venusa is making no
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changes to the design, components or materials of the Millipore filter. Millipore generated data regarding the functional performance of the 0.22 micron filter. Testing included Reverse Pressure Filter Integrity, Unit Venting, Gravity Flow, Inlet Axial Stress, Forward Pressure Filter Integrity, Downstream Particle Count, Accelerated Endurance, Bioburden Evaluation, Inline Filter Wettability, Burst Strength, and MVI Resistance. The data indicates that the filter meets of exceeds all functional requirements for the devices intended use.
Based on the fact that the Venusa, Ltd. Extension Set with Filter utilizes similar and equivalent designs, components, manufacturing processes as currently legally marketed products, the Venusa, Ltd. Extension Set with Filter is safe and effective when used as intended.
Sincerely,
[signature]
31C BUTTERFIELD TRAIL, EL PASO, TX 79906 (915) 771 9112 FAX: (915) 771 9107
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 image of an eagle or bird-like figure with three curved lines representing its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2000
Mr. Ross Magladry Venusa, Ltd. 31C Butterfield Trail El Paso, Texas 79906
Re : K994429 Venusa, Ltd. Extension Set with Filter Trade Name: Regulatory Class: II Product Code: FPA December 27, 1999 Dated: Received: December 30, 2000
Dear Mr. Magladry:
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 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 The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Magladry
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 described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely Yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) number: K994429 Device name: Extension Set with Filter
Indications for Use:
The Venusa, Ltd. Extension Set with Filter is used for IV fluid administration where The Velusa, Do. Dxtention Dot, Mai 22 mirron is desired. Use of the device helps assure the delivery of a bacteria-free product. The device is used in conjunction with an IV administration set and in-dwelling IV catheter.
Patricia Cuscenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number
§ 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.