HUBERPRO SAFETY HUBER INFUSION SET

K033515 · Command Medical Products · FPA · Jan 22, 2004 · General Hospital

Device Facts

• Record ID: K033515
• Device Name: HUBERPRO SAFETY HUBER INFUSION SET
• Applicant: Command Medical Products
• Product Code: FPA · General Hospital
• Decision Date: Jan 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HuberPRO ™ Safety Huber Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulates the needle when manually activated during withdrawal.

Device Story

HuberPRO Safety Huber Infusion Set facilitates delivery of solutions/medications into vascular implant ports. Device comprises protector cap, female Luer lock, PVC tubing (4 or 8 inch), pinch clamp, optional needle-free y-site, butterfly wing, safety needle guard, and AISI 304 stainless steel needle (19ga, 20ga, 22ga). During withdrawal, user manually activates safety guard to encapsulate needle, minimizing accidental needle stick risk. Used in clinical settings by healthcare providers. Benefits include secure vascular access and enhanced clinician safety via integrated needle protection.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: AISI 304 stainless steel needle, PVC tubing. Dimensions: 19ga, 20ga, 22ga needles; 4 or 8 inch tubing. Sterilization: AAMI/ISO guidelines. Design includes manual safety guard mechanism for needle encapsulation.

Indications for Use

Indicated for administration of solutions and medications into vascular implant ports in patients requiring such access.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LifeGuard ™ Safety Infusion Set (K013871)
• Core Resistant Huber Infusion Set (K950597)

Submission Summary (Full Text)

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K0335/5

JAN 2 2 2004

November 3, 2003.

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 - HuberPRO тм Safety Huber Infusion Set Common Name - Huber Infusion Set Classification Name - Intravascular Administration Set

The HuberPRO тм Safety Huber Infusion Sets are intended to be used to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal. The device consists of a Protector cap, female Luer lock, PVC tubing, two each 4 inch, or one 8 inch tubing length and ( .3 mm) ID, a pinch clamp, with and without a needle free y- site, a butterfly wing, a safety needle guard, an AISI 304 (19ga., 20ga., 22ga.) stainless steel needle, and a needle sheath. The components and the Processes used to manufacture these solution administration sets are substantially equivalent to like Products currently legally marketed by Horizon Medical Products, İnc. K013871 LifeGuard тм Safety Infusion Set, and Micro Med, Inc. K950597 Core Resistant Huber Infusion Set, The HuberPRO TM Safety Huber Infusion Sets sets will be packaged in a Tyvek/polyethylene pouch and sterilized per AAMI / ISO guidelines.

Based on the fact that the HuberPRO тм Safety Huber Infusion Sets utilizes similar and equivalent designs, components, manufacturing Processes as currently legally marketed Products, the Safety Huber Infusion Set is safe and effective when used as intended.

Best regards, Command Medical Products

Joyce Vytlacil

Joyce Vytlacil Operations Manager

Image /page/0/Picture/11 description: The image shows the word "CONFIDENTIAL" in all caps. The letters are bold and black. The word is centered in the image.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2004

Ms. Joyce Vytlacil Operations Manager Command Medical Products, Incorporated 15 Signal Avenue Ormond Beach, Florida 32174

Re: K033515

Trade/Device Name: HuberPRO ™ Saftey Huber Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 24, 2003 Received: January 12, 2004

Dear Ms. Vytlacil:

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 enclosurc) 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 application (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 such 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.

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Page 2 - Ms. Vytlacil

Please be adviscd 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 begin 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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K033515

## Indications for Use

510(k) Number (if known): K033515

Device Name: HuberPRO TM Safety Huber Infusion Set

Indications For Use:

The HuberPRO ™ Safety Huber Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulates the needle when manually activated during withdrawal.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Viole Hibbard, Interim Branch Chief

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Dev

510(k) Number: K033515

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