HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY

K072482 · Smiths Medical Asd, Inc. · MEG · Nov 29, 2007 · General Hospital

Device Facts

• Record ID: K072482
• Device Name: HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
• Applicant: Smiths Medical Asd, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Nov 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is intended for aspiration and injection of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

Device Story

Hypodermic Needle-Pro® Safety Allergy Tray consists of 25 graduated syringes with permanently affixed needles and integral hinged safety sheaths. Device used for aspiration and injection of fluids. After procedure, user manually rotates sheath to desired position and presses needle into sheath using one-handed technique to contain needle. Device discarded into sharps container. Used in clinical settings by healthcare providers. Benefits include reduction of accidental needle stick injuries via integrated safety mechanism.

Clinical Evidence

Simulated clinical use studies confirmed the device could be used effectively with the needle shielded inside the protection device after use. Bench testing performed to verify performance specifications against applicable standards and FDA guidance for sharps injury prevention features.

Technological Characteristics

Piston syringe with single lumen needle; permanently affixed needle; hinged-style protective sheath; manually activated; sterilized via irradiation; graduated syringe body.

Indications for Use

Indicated for aspiration and injection of fluids in patients requiring hypodermic delivery; intended for use by healthcare professionals to prevent accidental needle sticks.

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

• Portex® Hypodermic Needle-Pro® Fixed Needle TB Syringe (K063755)
• Terumo SurGuard™ Insulin, Allergy and General Use Safety Syringe (K024249)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the text "KO 72482 Page 1 of 2" at the top. Below that, the word "smiths" is written in a bold, sans-serif font. The text appears to be handwritten and then printed or scanned, as it has a slightly rough or imperfect quality.

#### Smiths Medical ASD, Inc.

Anesthesia and Safety Devices Division

NOV 2 9 2007

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

st 31, 2007

## Product Name:

## Trade Name: Hypodermic Needle-Pro® Safety Allergy Tray

Common Name: Fixed Needle Hypodermic Syringe with attached needle protection

Classification Name: 880.5860 Piston Syringe with Single Lumen Needle with antistick

## Predicate Device(s):

K063755 (Smiths Medical ASD, Inc) Portex® Hypodermic Needle-Pro® Fixed Needle TB Syringe

K024249 (Terumo Medical Corporation) Terumo SurGuard™ Insulin, Allergy and General Use Safety Syringe and alternate brand name Portex® Hypodermic Needle-Pro® Fixed Needle Syringe (referred to as the "Terumo SurGuard™ Safety Syringe" throughout the remainder of this submission).

## Device Description:

The Hypodermic Needle-Pro® Safety Allergy Tray contains 25 graduated hypodermic syringes with permanently affixed needles and integral needle safety sheaths. The safety sheath rotates so it can be adjusted to the desired position relative to the needle bevel and syringe graduations. Each syringe within the tray has a shield over the needle and an end cap covering the end of the plunger. The trav is sterilized using irradiation and the syringe fluid path remains sterile until the shield or end cap is removed. The syringe is used to inject fluids into the body. After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. The needle enters the protective sheath and is contained within the sheath. The device is then discarded into a sharps container.

10

. "..".

# 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: August 31, 2007

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

K072482 page 2 of 2

## Indications for Use:

This device is intended for aspiration and injection of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

## Technological Characteristics:

. . . . . . . . . . . . . .

The proposed and predicate devices have a permanently affixed needle and a hinged style protective sheath that is manually activated after use.

## Non-Clinical Data:

Bench testing confirms that the proposed device and the predicate device have similar performance specifications based on the applicable standards for this device and FDA guidance for devices with sharps injury prevention features.

## Clinical Data:

Simulated clinical use studies were conducted with these syringes which confirmed that the device could be used effectively with the needle shielded inside the protection device after use.

## Conclusion:

The bench testing and simulated clinical use studies conducted demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

BA

Brian D. Farias Regulatory Affairs Manager

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2007

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

Re: K072482

Trade/Device Name: Hypodermic Needle-Pro® Safety Allergy Tray Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 31, 2007 Received: September 4, 2007

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 Eederal 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 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,

Chih-Lin, Ph.D.

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}------------------------------------------------

K072482

SECTION 4, Indications for Use Statement

## Indications for Use

510(k) Number (if known): Device Name: Hypodermic Needle-Pro® Safety Allergy Tray

Indications for Use:

This device is intended for aspiration and injection of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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

Anthe la.

(Division Sign-Off) Division of Anesthesion ------------------------------------------------------------------------------------------------------------------------------------------------------Infection Control, Dentai المستوى المسلم .

510(k) Number: _ K 972482