PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558

K061194 · Smiths Medical Asd, Inc. · MEG · Aug 24, 2006 · General Hospital

Device Facts

• Record ID: K061194
• Device Name: PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
• Applicant: Smiths Medical Asd, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Aug 24, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

Device Story

Device consists of pre-attached syringe and hypodermic needle with integrated safety protection; features one-piece needle hub and protective sheath with living hinge. Used by clinicians to inject or withdraw fluids; after procedure, user manually presses needle into sheath using one-handed technique; needle engages under hook for containment; device discarded in sharps container. Safety mechanism reduces risk of accidental needle sticks.

Clinical Evidence

No clinical data; bench testing only. Conformance to ISO 594-1, ISO 594-2, ISO 7864, and ISO 7886-1 standards demonstrated safety and effectiveness.

Technological Characteristics

Manual, hinged-style protective sheath; needle hub with living hinge; 6% taper conical fittings per ISO 594-1/2; sterile, single-use. Materials identical to predicates. Standards: ISO 594-1:1986(E), ISO 594-2:1998(E), ISO 7864:1993(E), ISO 7886-1:1993.

Indications for Use

Indicated for patients requiring fluid injection or withdrawal. No specific age or gender restrictions. Contraindications not specified.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Hypodermic Needle-Pro® EDGE™ Needle Protection Device (K041399)
• Nipro Disposable Syringes (K030683)

Submission Summary (Full Text)

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

K061194

AUG 2 4 2006

# ហ

Anesthesia and Safety Devices Division

Smiths Medical ASD, Inc.

Keene NH 03431-0724 USA

10 Bowman Drive

Tel: [phone]

Fax: [phone] www.smitns-medical.com

# SECTION 5, 510(k) Summary

### Company Information:

Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 [phone], prompt 4, ext 2493 Contact: Brian D. Farias Regulatory Affairs Manager

Summary Prepared: April 27, 2006

#### Product Name:

## Trade Name: Portex® Needle-Pro® EDGE Safety Device with Syringe

Common Name: Syringe with attached needle and needle protection.

Classification Name: Syringe, Piston (21 CFR 880.5860, Product Code B

#### Predicate Device(s):

K041399 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro® EDGE™ Needle Protection Device

K030683 (Nipro Corporation) Nipro Disposable Syringes

#### Device Description:

This device consists of the two predicate devices preattached, packaged and sterilized. This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of needle hub and protective sheath with a living hinge. The needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation. i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the needle is engaged under the hook and contained within the sheath. The device is then discarded into a sharps container.

8

&G
ode F)

ORTE

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

#### Indications for Use:

This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks,

#### Technological Characteristics:

The proposed and predicate devices are made of the EXACT same materials and employ the same hinged style protective sheath that is manually activated after use.

#### Non-Clinical Data:

This abbreviated 510(k) submission declares conformance to the following standards:

ISO 594-1:1986(E), International Standard, Conical fittings with a 6% taper for syringes, needles and certain other medical equipment-Part 1: General requirements

ISO 594-2:1998(E), International Standard, Conical fittings with a 6% taper for syringes, needles and certain other medical equipment-Part 2: Lock Fittings

ISO 7864:1993(E), International Standard, Sterile hypodermic needles for single use

ISO 7886-1:1993, International Standard, Sterile hypodermic syringes for single use

#### Clinical Data:

Not required

#### Conclusion:

The standards compliance demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

R
R
Brian D. Farias

Brian D. Farias Regulatory Affairs Manager

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

Image /page/2/Picture/1 description: The image shows the logo for the United States 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 with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 4 2006

Mr. Brian D. Farias, Regulatory Affairs Manager Smiths Medical ASD, Incorporated Anesthesia and Safety Devices Division 10 Bowman Drive Keene, New Hampshire 03431-0724

Re: K061194

Trade/Device Name: Portex Needle-Pro Edge Safety Device with syringe

22 g 1 inch needle with 3 ml syringe

23 g 1inch needle with 3 ml syringe

25 g 1 inch needle with 3 ml syringe

25 g 5/8 inch needle with 3 ml syringe

Regulation Number: 880.5860

Regulation Name: Syringe, Antistick Regulatory Class: II

Product Code: MEG

Dated: August 18, 2006

Received: August 21, 2006

#### Dear Mr. Farias:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are 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 vour devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

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

#### Page 2 - Mr. Farias

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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,

signature

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

{4}------------------------------------------------

## SECTION 4, Indications for Use Statement

# Indications for Use

510(k) Number (if known): + 0601194 Device Name: Portex® Needle-Pro® EDGE" Safety Device with Syringe

Indications for Use:

This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

Prescription Use X (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)

Page_1_of_1

Anthony Vent

ാന Gigh Olgh Sthesiology, General Hospital, ്cion Control, Dental Devices

Number. Kq61194