MODIFICATION TO EZ HUBER SAFETY INFUSION SET

K071846 · Pfm Medical, Inc. · FPA · Aug 30, 2007 · General Hospital

Device Facts

• Record ID: K071846
• Device Name: MODIFICATION TO EZ HUBER SAFETY INFUSION SET
• Applicant: Pfm Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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. The EZ Huber Safety Infusion Set is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks. The EZ Huber Safety Infusion Set is compatible with power injection procedures up to 300 psi.

Device Story

EZ Huber Safety Infusion Set; intravascular administration set for accessing implanted ports. Components: Huber housing, wing, spring, needle cannula, tubing, foam pad, pinch clamp, luer cap, Y-site. Anti-coring needle tip configuration; delivers fluids/drugs from container to patient vascular system. Active safety mechanism activated by practitioner during normal needle removal to prevent accidental needle sticks. Used in clinical settings by healthcare professionals. Compatible with power injection procedures up to 300 psi. Device discarded after single use.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Components: Huber housing, wing, spring, needle cannula, tubing, foam pad, pinch clamp, luer cap, Y-site. Anti-coring needle tip. Active safety mechanism for needle retraction. Materials are biocompatible and used in legally marketed devices. Compatible with power injection up to 300 psi.

Indications for Use

Indicated for patients requiring fluid or drug administration via implanted vascular ports. Compatible with power injection up to 300 psi. Intended for use by healthcare practitioners.

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

• EZ Huber Safety Infusion Set (K040533)
• Power Loc Safety Infusion Set (K060812)

Submission Summary (Full Text)

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

AUG 3 0 2007

K071846
(of)

# 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: | 2605 Temple Heights Drive, Ste A |
| | 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: | K071846 |
|--------------------------------|----------------------------------|
| Trade Name: | EZ Huber Safety Infusion Set |
| Common Name: | Intravascular Administration Set |
| Classification Name: | Same |

Equivalent Devices: Manufacturer: PFM Medical, Inc CR Bard, Inc Name: EZ Huber Safety Infusion Set Power Loc Safety Infusion Set 510(k) #: K040533 K060812

### Device Description:

The EZ Huber Safety Infusion Set is used to access implanted septums for the purpose of drug and IV infusion. The Needle is constructed so that after patient use and upon needle removal, the needle can be removed and the safety mechanism will be activated. The product is designed so that the practitioner activates the safety mechanism during normal needle removal following typical removal procedures used for non-safety Huber needles. Upon activation of the safety mechanism, the total function of the EZ Huber Safety Infusion Set is complete and the unit is discarded in accordance with hospital protocol

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 Housing |
|----------------|
| Huber Wing |
| Spring |
| Needle Cannula |

Needle Sheath Tubing, PE lined Foam Pad Pinch Clamp

Female Luer Dust Cap Y-site Swabable Y-site, Medegen

#### 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.

The EZ Huber Safety Infusion Set is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks.

The EZ Huber Safety Infusion Set is compatible with power injection procedures up to 300 psi.

#### 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 3 0 2007

PFM Medical, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K071846

Trade/Device Name: EZ Huber Safety Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 18, 2007 Received: August 20, 2007

Dear Mr. Job:

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 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.

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

Page 2 -- Mr. Job

Please be advised 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/industry/support/index.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}------------------------------------------------

Y671846 1 of

510(k) Number:

Device Name: EZ Huber Safety Infusion Set

Indications for 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. The EZ Huber Safety Infusion Set is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks. The EZ Huber Safety Infusion Set is compatible with power injection procedures up to 300 psi.

Prescription Use x AND/OR (Per 21 CFR 801 Subpart D)

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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071846