The Millennium Huber Plus Safety Infusion Set is a safety IV administration set with a noncoring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Plus system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.

Device Description

The Millennium Huber Plus Safety Infusion Set is a standard non-coring right angle Huber needle and administration set with a needlestick prevention feature. The Huber Plus Safety Infusion Set is designed for use with a vascular access infusion system. The Millennium Huber Plus Safety Infusion Set is fabricated from biocompatible, medical grade materials. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. Removal of the needle is done as with any standard Huber needle, using a one-handed (dominant hand) technique to pull out the needle, and stabilizing the port with the nondominant hand. As the needle is removed, the passive needlestick prevention feature actuates automatically when the users hands are positioned correctly and can be easily seen, felt, and heard by the user to ensure that the needle cover is secure. The Millennium Huber Plus Safety Infusion Set is supplied sterile and nonpyrogenic, for single use only.

AI/ML Overview

The provided K993848 510(k) summary for the Millennium Huber Plus Safety Infusion Set does not detail specific quantitative acceptance criteria or a comprehensive study report with quantified performance metrics typically expected in a modern medical device submission. Instead, it relies on a qualitative demonstration of equivalency and a simulated use study.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance Table:

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Equivalency	Device manufactured from similar biocompatible, medical-grade materials as predicate devices.	"The Millennum Huber Plus Safety Infusion Set is manufactured from the same materials as the ALL-MED Administration Set and the Angel Wing Blood Collection Set, with the exception of the hinge tube material."
Functional Equivalence	Device performs in an equivalent manner to predicate devices in areas tested.	"Equivalency performance testing has been performed on the Millenium Huber Plus Safety Infusion Set components and its two predicate devices. This testing showed that in all areas tested the devices perform in an equivalent manner."
Needlestick Prevention	No incidences of sharps injuries during simulated use.	"A Simulated Use Study was performed showing that there were no incidences of sharps injuries..."
Safety Feature Activation	The safety feature consistently activates during simulated use.	"...or incidences where the safety feature failed to be activated during the course of the study."
Biocompatibility	Fabricated from biocompatible, medical grade materials.	"The Millennium Huber Plus Safety Infusion Set is fabricated from biocompatible, medical grade materials." (Stated in device description, an implicit criterion)
Sterility	Supplied sterile and nonpyrogenic.	"The Millennium Huber Plus Safety Infusion Set is supplied sterile and nonpyrogenic, for single use only." (Stated in device description, an implicit criterion)

Detailed Study Information:

The provided document describes two main types of studies: "Equivalency performance testing" and a "Simulated Use Study." However, the details for both are minimal by modern standards.

Sample Size and Data Provenance:
- Equivalency Performance Testing: The text does not provide a sample size. It states "components and its two predicate devices," implying a comparison with the ALL-MED Non-Coring Needle Winged Administration Set and the Angel Wing Safety Blood Collection and Infusion Set. The provenance of this data (e.g., country of origin, retrospective/prospective) is not mentioned.
- Simulated Use Study: The text does not provide a sample size for this study. The provenance is not mentioned.
Number of Experts and Qualifications:
- Equivalency Performance Testing: Not specified.
- Simulated Use Study: Not specified. The study likely involved users, but whether these were "experts" in the sense of clinical specialists establishing ground truth is not indicated.
Adjudication Method:
- Equivalency Performance Testing: Not specified.
- Simulated Use Study: Not specified. Given the reported outcome ("no incidences of sharps injuries or incidences where the safety feature failed to be activated"), it implies direct observation and binary outcome recording rather than a complex adjudication process.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. The device is a physical medical device (infusion set), not an AI or imaging diagnostic tool that would typically involve human readers. Therefore, the concept of improving human reader performance with AI assistance is not applicable.
Standalone (Algorithm Only) Performance:
- Not applicable. This device is a physical medical device with a mechanical safety feature, not an algorithm.
Type of Ground Truth Used:
- Equivalency Performance Testing: Likely based on direct measurements of mechanical properties, fluid flow, or other functional aspects related to the performance of the device components compared to predicates.
- Simulated Use Study: The ground truth for "sharps injuries" and "safety feature activation failure" would be direct observation by study personnel. This is a form of observational ground truth.
Sample Size for Training Set:
- Not applicable. This device is a physical medical device, not an AI model that requires a training set.
How Ground Truth for Training Set was Established:
- Not applicable. (See point 7)

Summary of Limitations:

The 510(k) summary K993848 provides a high-level overview consistent with submissions from the year 2000. It lacks the quantitative detail, specific metrics, statistical analysis, and transparent reporting of study methodologies that are common in more recent device submissions, especially for AI/ML-enabled devices. The "acceptance criteria" are largely implicit and based on demonstrating equivalence to predicate devices and a qualitative assessment of the safety feature's function in a simulated environment.

Summary

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K993848

JAN 2 7 2000

510(k) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SODA and 21CFR § 807.92

Submitted by:	Millennium Medical Distribution696 Unionville Road, Suite 6Kennett Square, PA 19348
	Contact Person:Robert Rosato, President(610) 455-0258(610) 455-0768 fax
Date Prepared:	November 4, 1999
Device Name:
Proprietary Name:	Millennium Huber Plus Safety Infusion Set
Common Name:	Huber Needle and Administration Set
Classification:	Class II: Product Code FPARegulation Number 21 CFR 880.5440

Identification of Predicate Devices

ALL-MED Non-Coring Needle Winged Administration Set, Multi-Med Corporation, West Swanzey, NH; K890127, K890340, K891072, K891919.
Angel Wing Safety Blood Collection and Infusion Set, MBO Laboratories, Inc., Lowell, MA . (now owned by Kendall TYCO/Sherwood Davis and Geck), K912563

Device Description:

The Millennium Huber Plus Safety Infusion Set is fabricated from biocompatible, medical grade materials. The needle is inserted into the vascular access port in a standard manner for fluid infusion or for blood sampling. Removal of the needle is done as with any standard Huber needle, using a one-handed (dominant hand) technique to pull out the needle, and stabilizing the port with the nondominant hand. As the needle is removed, the passive needlestick prevention feature actuates automatically when the users hands are positioned correctly and can be easily seen, felt,

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and heard by the user to ensure that the needle cover is secure.

The Millennium Huber Plus Safety Infusion Set is supplied sterile and nonpyrogenic, for single use only.

Indication for Use:

Technological Characteristics

The Millennum Huber Plus Safety Infusion Set is manufactured from the same materials as the ALL-MED Administration Set and the Angel Wing Blood Collection Set, with the exception of the hinge tube material. The needle, components and safety mechanism are all fabricated out of medical grade material. The Millennium Huber Plus Safety Infusion Set operates as a standard Huber needle with the addition of a safety feature to help prevent needlestick injuries.

Performance Data

Equivalency performance testing has been performed on the Millenium Huber Plus Safety Infusion Set components and its two predicate devices. This testing showed that in all areas tested the devices perform in an equivalent manner. A Simulated Use Study was performed showing that there were no incidences of sharps injuries or incidences where the safety feature failed to be activated during the course of the study.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.

Public Health Service

JAN 2 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christine Emanuel RA Consultant, Millennium Medical Distribution, Incorporated P.O. Box 936 19317 Chadds Ford, PA

K993848 Re : Millennium Huber Plus Safety Infusion Set Trade Name: Regulatory Class: II Product Code: FPA January 11, 2000 Dated: Received: January 13, 2000

Dear Ms. Emmanuel:

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, Druq, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Emmanuel

obligation you might have under sections 531 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 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 regulation (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 regulation entitled, "Misbranding by reference to ene regaracion chercisco. "Alberanding by avther 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 R. Whatmore

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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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement.

*For a new submission, do NOT fill in the 510(k) number blank.

INDICATIONS FOR USE

Applicant: Millennium Medical Distribution

510(k) Number (if known): N/A*

Device Name: Millennium Huber Plus Safety Infusion Set

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription UsePer 21 CFR 801.109	OR	Over-the-Counter
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Latura Cucenti
(Division Sign-Off)
Division of Dental, Infection Control,
000016and General Hospital De

510(k) Number _

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.