MONOJECT SAFETY NEEDLE

K012736 · Tyco Healthcare · FMI · Oct 25, 2001 · General Hospital

Device Facts

• Record ID: K012736
• Device Name: MONOJECT SAFETY NEEDLE
• Applicant: Tyco Healthcare
• Product Code: FMI · General Hospital
• Decision Date: Oct 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The primary function of the device is to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The needle stick prevention feature of the device helps prevent accidental needle sticks by shielding the needle after use.

Device Story

Sterile, single-lumen hypodermic needle with integrated safety shield. Designed for fluid injection or withdrawal. Safety shield manually activated via fingertip or hard surface pressure; locks permanently to cover needle post-use. Used in clinical settings to prevent sharps injuries to healthcare personnel.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993, Part 1, and FDA memorandum G95-1.

Technological Characteristics

Single-lumen hypodermic needle with integrated segmented safety shield. Biocompatibility per ISO 10993-1. Manual activation mechanism. Sterile.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body. Intended for use by healthcare professionals to reduce the risk of accidental needle stick injuries.

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

• Becton Dickinson's SafetyGlide™ Needle (K951254)
• Concord/Portex (Sims) Needle-Pro® (K911037)

Submission Summary (Full Text)

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EXHIBIT # 11

K012736

OCT 2 5 2001

510(k) Summary

In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:

The Kendall Company 15 Hampshire Street Mansfield, MA 02048 Date Prepared: August 10, 2001

- Contact Person 1.
David A. Olson Director, Regulatory Affairs [phone]

#### 2. Name of Medical Device

Classification Name: Needle, Hypodermic, Single Lumen

Common or Usual Name: Hypodermic Needle with Sharps Injury Prevention Feature.

## Identification of Legally Marketed Device 3.

The proposed Kendall Monoject® Safety Needle is substantially equivalent in intended use, design and function to Becton Dickinson's SafetyGlide™ Needle, 510(k) No. K951254 and the Concord/Portex (Sims) Needle-Pro®, 510(k) No. K911037.

## 4. Device Description

The proposed device consists of a sterile, single-lumen hypodermic needle with an attached safety shield. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a finger-tip operation or by pressing the shield against a hard surface. Once activated, the safety shield is securely and permanently locked.

## 5. Device Intended Use

The proposed device is primarily intended to inject fluid into, or withdraw fluid from the body. The safety shield is designed to protect against sharps injuries when activated.

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## 6. Product Comparison

The proposed device has the same technological characteristics as the predicate rne proposed it with the consists of a hypodermic needle with a manually operated safety feature.

# Nonclinical Testing 7.

Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2001

Mr. David A. Olson Director, Regulatory Affairs Tyco Healthcare 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K012736

Trade/Device Name: Monoject Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, Hypodermic, Single Lumen Regulatory Class: Class II Product Code: FMI Dated: August 15, 2001 Received: August 16, 2001

Dear Mr. Olson:

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.

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

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Page 2 - Mr. Olson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Since

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K012736 510(k) Number (if known):___

Kendall Monoject Safety Needle

Device Name:_

Indications For Use:

The primary function of the device is to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The needle stick prevention feature of the device helps prevent accidental needle sticks by shielding the needle after use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Crescentz

on of Dental, Infection Control. and General Hospital Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

. . . . . . . .

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Over-The-Counter Use_ ...

(Optional Formal 1-2-96)