PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110

K063450 · Smiths Medical Asd, Inc. · FMI · Jan 25, 2007 · General Hospital

Device Facts

• Record ID: K063450
• Device Name: PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
• Applicant: Smiths Medical Asd, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jan 25, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

Device Story

Hypodermic needle with integrated safety protection mechanism; one-piece design featuring needle hub and protective sheath connected by living hinge. Needle cannula permanently affixed to hub. Sheath includes visual indicator for bevel orientation. Post-procedure, user performs one-handed technique to press needle into sheath; needle engages under internal hook for containment. Device discarded into sharps container. Used in clinical settings for fluid injection/aspiration; protects clinicians from accidental needle sticks.

Clinical Evidence

Simulated clinical use study conducted to evaluate device effectiveness. Results confirmed the device could be used effectively with the needle shielded inside the protection device after use.

Technological Characteristics

Hinged protective sheath manually activated post-use. Conforms to ISO 594-1 (conical fittings), ISO 594-2 (lock fittings), and ISO 7864 (sterile hypodermic needles). Single-lumen needle design.

Indications for Use

Indicated for patients requiring fluid injection or aspiration via Luer lock or Luer slip syringes; intended for use by healthcare professionals to prevent accidental needle sticks.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Hypodermic Needle-Pro® EDGE™ Needle Protection Device (K041399)
• SurGuard2™ Safety Hypodermic Needle (K031453)

Submission Summary (Full Text)

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K063450

## JAN 2 5 2007

### 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: November 14, 2006

#### Product Name:

### Trade Name: Portex® Hypodermic Needle-Pro® EDGE™ Safety Device

Common Name: Hypodermic Needle with attached needle protection

Classification Name: Hypodermic Single Lumen Needles (21 CFR 880.5570, Product Code FMI)

#### Predicate Device(s):

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

K031453 (Terumo Medical Corporation) SurGuard2™ Safety Hypodermic Needle

### Device Description:

This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. 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 onehanded 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.

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#### Smiths Medical ASD, Inc.

Anesthesia and Safety Devices Division

10 Bowman Drive Keene NH 03431 USA Tel: [phone] Fax: [phone] www.smiths-medical.com

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### Indications for Use:

This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. This device is intended for informed after use to help prevent needle sticks.

### Technological Characteristics:

The proposed and predicate devices all 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 100 001 in 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

### Clinical Data:

A simulated clinical use study was conducted which confirmed that the device could be used effectively with the needle shielded inside the protection device after use.

### Conclusion:

The standards compliance and simulated clinical use study demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

Brian D. Farias Regulatory Affairs Manager

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian Farias Manager, Regulatory Affairs Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431-0724

JAN 2 5 , GD

Re: K063450

Trade/Device Name: Portex® Hypodermic Needle-Pro® EDGE Safety Device Model 401810 18gx1" Model 401910 19gx1" Model 402010 20gx1" Model 402110 21gx1"

Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 14, 2006 Received: November 15, 2006

Dear Mr. Farias:

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.

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#### 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 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

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### SECTION 4, Indications for Use Statement

# Indications for Use

510(k) Number (if known): f) CCC 9 '>(

Device Name: Portex® Hypodermic Needle-Pro® EDGE™ Safety Device

Indications for Use:

This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. 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)

in D.m.

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Status Capital 11:22:00 11:22 2020