AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE

K071567 · Autosafe-Refelx, Inc. · FMI · Sep 14, 2007 · General Hospital

Device Facts

• Record ID: K071567
• Device Name: AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
• Applicant: Autosafe-Refelx, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Sep 14, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

AutoSafe Safety Needles are indicated to be used to inject fluids into or withdraw fluid from the body. They are compatible for use with standard luer slip and luer lock syringes. Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle before use, between steps and after use.

Device Story

AutoSafe-Reflex and AutoSafe Advantage Safety Needles are hypodermic single lumen needles featuring a passive safety shield mechanism. Designed for use with standard luer slip and luer lock syringes; device facilitates fluid injection or withdrawal. Passive shield covers needle before, during, and after use to mitigate risk of accidental needlestick injuries to clinicians. Device is manual; operated by healthcare professionals in clinical settings. No electronic components, software, or algorithms involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hypodermic single lumen needle with passive safety shield. Compatible with standard luer slip and luer lock syringes. Class II device, product code FMI. No electronic or software components.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body using standard luer slip or luer lock syringes. Intended for use by healthcare professionals to reduce risk of needlestick injuries via passive safety shielding.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

SEP 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Autosafe-Reflex, Incorporated C/O Mr. J A. Van Vugt Responsible Third Party Official Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K071567

Trade/Device Name: AutoSafe-Reflex® Safety Needle, AutoSafe Advantage Safety Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 30, 2007 Received: August 31, 2007

Dear Mr. Van Vugt:

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. Van Vugt

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-Yue, 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

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Indications for Use

510(k) Number (if known):

Unknown

Device Name:

AutoSafe-Reflex® Safety Needle

Indications for Use:

AutoSafe Safety Needles are indicated to be used to inject fluids into or withdraw fluid from the body. They are compatible for use with standard luer slip and luer lock syringes. Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle before use, between steps and after use.

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)

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610(k) Number:_______________________________________________________________________________________________________________________________________________________________