EZ HUBER SAFETY INFUSION SET

K040533 · Pfm Medical, Inc. · FPA · Sep 17, 2004 · General Hospital

Device Facts

• Record ID: K040533
• Device Name: EZ HUBER SAFETY INFUSION SET
• Applicant: Pfm Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EZ Huber Safety Infusion Set is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks.

Device Story

Single-use, sterile, non-pyrogenic intravascular administration set; used to deliver fluids/drugs to implanted vascular ports. Features active safety mechanism to prevent accidental needle sticks. Operation: healthcare provider stabilizes port with small wings; withdraws cannula using large wings; Huber needle housing slides over cannula and locks over tip upon withdrawal. Plastic shroud covers cannula shaft between wings to prevent exposure to biohazardous materials. Used in clinical settings by healthcare providers. Benefits: facilitates fluid delivery while reducing risk of sharps injury to staff.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Components include Huber needle housing, wings, tubing, clamps, Y-site injection ports, and stopcock. Features active safety locking mechanism and protective shroud. Materials are biocompatible and consistent with legally marketed devices. Sterile, non-pyrogenic, single-use.

Indications for Use

Indicated for patients requiring administration of fluids from a container to the vascular system via an implanted port. No specific age or gender restrictions noted.

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

• Jetcan Huber Needle Set (K002471)

Submission Summary (Full Text)

{0}------------------------------------------------

K040533

/g/

## 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

| Name: | pfm Medical, Inc |
|-----------------|-----------------------------|
| Address: | 2620 Temple Heights Drive |
| | Oceanside, CA 92056 |
| CONTACT PERSON: | SALVADORE F. PALOMARES, RAC |

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | |
|--------------------------------|----------------------------------|
| Trade Name: | EZ Huber Safety Infusion Set |
| Common Name: | Intravascular Administration Set |
| Classification Name: | Same |

| Equivalent Devices: | |
|---------------------|-------------------------|
| Manufacturer: | pfm Medical, Inc |
| Name: | Jetcan Huber Needle Set |
| 510(k) #: | K002471 |

Device Description:

The EZ Huber Safety Infusion Set is a single use, sterile and non-pyrogenic device intended for use as an accessory to deliver solutions and drugs into a patient's vascular implant port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks. When removing the EZ Huber Safety Infusion Set, the healthcare provider stabilizes the port by placing two fingers on the small wings of the EZ Huber Safety Infusion Set. The cannula is withdrawn by pulling on the large wings. As the cannula is withdrawn, the Huber needle housing (with small wings) slide over the cannula and lock over the cannula tip, rendering the cannula from being reused and preventing accidental needle sticks. A plastic shroud surrounds the cannula shaft between the large wings and the small wings/cannula tip. The shroud prevents exposure to any biohazardous materials on the cannula shaft.

Components will be assembled into standard configurations or configurations specified by the customer and packaged.

Types of components that may be contained in a set include:

- � Huber Needle Housing
- Huber Needle Wing
- . Tubing
- Clamps
- Y-Site Injection Ports
- Stopcock

## Intended Use:

The EZ Huber Safety Infusion Set is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks.

## Biocompatibility:

The materials used to manufacture the EZ Huber Safety Infusion Set are used in legally marketed devices under comparable conditions of use.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

## Public Health Service

SEP 17 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Salvadore F. Palomares Regulatory Affairs Consultant PFM Medical, Incorporated 2620 Temple Heights Drive Oceanside, California 92056

Re: K040533

Trade/Device Name: EZ Huber Safety Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 2, 2004 Received: September 3, 2004

Dear Mr. Palomares:

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 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) 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 (1 vir 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.

{2}------------------------------------------------

Page 2 -Mr. Palomares

Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advisod that 1Da determination that your device complies with other requirements modi that I Drimas made statutes and regulations administered by other Federal agencies. of the Act of all ] Pouchal the Act's requirements, including, but not limited to: registration r ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 et rettin in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadistion 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) I mis letter will anon your finding of substantial equivalence of your device to a premarket notineted 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), If you desire speome 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 may overall 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

{3}------------------------------------------------

K040533

191

EZ Huber Safety Infusion Set

Indications for Use

Pfm Medical, Inc

K040533 510(k) Number:

Device Name:

Indications for Use:

The EZ Huber Safety Infusion Set is a device used i to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks.

Prescription Use (Per 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)

EZ Huber Safety Infusion Set

Concurrence of CDRH, Office of Device Evaluation (ODE)

William M. Burdick Jr
Anthony D. Watson 9/16/04

Division of Anesthesiology, General Hospital. Infection Control, Dental De

510(k) Number: K040533

Page 1 of 1