NEEDLE INCAPACITATOR (NEEDLE GUARD)

K042907 · Pdmp, Inc. · FMI · Dec 22, 2004 · General Hospital

Device Facts

• Record ID: K042907
• Device Name: NEEDLE INCAPACITATOR (NEEDLE GUARD)
• Applicant: Pdmp, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luce-look syringe. The Needle Guard Will accept any standard disposable syringe and needle luer-lock up to and including a length of one and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point-of-use to promote safe disposal of needles and syringes, into a large sharps container and/or red biohazard bag. Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard. The device is for use by health care professionals in hospitals and private practices, research laboratories, specialized medical applications, clinics, nursing homes, home care, needle exchange programs, dental offices, veterinarians, mortuaries. Caution: U.S.A. law restricts this device to sale by or on the order of a physician.

Device Story

Needle Guard is a mechanical sharps management system designed for one-handed encapsulation of contaminated needles and luer-lock syringes. Used immediately post-injection at point-of-use; device accepts standard disposable syringes/needles up to 1.5 inches. Healthcare professionals insert the used syringe into the guard to fully encapsulate the needle, reducing accidental needlestick risk before final disposal into a sharps container or biohazard bag. Prepackaged in disposable plastic trays; simple mechanical operation; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical sharps encapsulation device; constructed of plastic; designed for one-handed operation; compatible with standard luer-lock syringes up to 1.5 inches; non-powered; disposable.

Indications for Use

Indicated for healthcare professionals in hospitals, clinics, labs, nursing homes, home care, dental offices, veterinary, and mortuary settings for the safe, one-handed encapsulation of contaminated standard disposable luer-lock syringes and needles up to 1.5 inches in length to facilitate disposal.

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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Public Health Service

DEC 22 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PDMP, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548

Re: K042907

Trade/Device Name: Needle Guard Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 10, 2004 Received: December 13, 2004

Dear Mr. Devine:

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. Devine

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 vour 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/dsma/dsmamain.html

Sincerely vours.

Susan Runser

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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K442447

## Indications for Use

510(k) Number (if known): K042907

Device Name: Needle Guard

Indications for Use:

NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and NEEDLE GUARD is an morvidual set occapsulates the needle of a luce-look syringe.
syringe sharps management system that fully encapsulates the needle luce look syringe sharps management system that tally encaple syringe body or needle lucr-lock. The Needle Guard Will accept any standard disposations any syringe without a mechanical safety Standard syrings and needle mer-lock are details and necdles up to and including device and one-half inches (1 ½"). It is a one-handed procedure that is used a length of one and one-half ments (1 77 ). Tr a Cities of procedure. The NEEDLE GUARD can be immediately atter the use of the syrings at polices promote of promotion and syringes, into a large sharps container and/or red biohazard bag.

Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inscrted into Needle Guard.

The device is for use by health care professionals in hospitals and private practices research a laboratories, specialized medicines applications, clinics, nursing homes, home care and a laboratories, specialized medically applications, childes, thereases and exchange programs, dental offices, veterinarians, mortuaries.

Caution: U.S.A. law restricts this device to sale by or on the order of a physician.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

in Ome

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(Civision Sian-Off) Civision of Anesthesiology, General Hospital, Infection Control Denta, Devices

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