STAT MEDICAL PEN NEEDLE

K042917 · Emergogroup, Inc. · FMI · Apr 22, 2005 · General Hospital

Device Facts

• Record ID: K042917
• Device Name: STAT MEDICAL PEN NEEDLE
• Applicant: Emergogroup, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Apr 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin.

Device Story

Stat Medical Pen Needle is a single-use, sterile, hypodermic needle designed for attachment to pen injector devices. It facilitates subcutaneous insulin delivery. Used by patients or healthcare providers in clinical or home settings. Device functions as a fluid pathway for insulin administration. Benefits include simplified, precise insulin dosing via pen injectors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single lumen hypodermic needle; single-use; sterile; designed for compatibility with standard pen injector devices; Class II device (21 CFR 880.5570).

Indications for Use

Indicated for subcutaneous insulin injection using a pen injector device.

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

• K972911

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.

APR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Emergo Group, Incorporated C/O Mr. Paul Brooks Responsible Third Party Official BSI, Incorporated 12110 Sunset Hills Road, Suite 200 Reston, Virginia 20190

Re: K042917

Trade/Device Name: Stat Medical Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 7, 2005 Received: April 8, 2005

Dear Mr. Brooks:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalent be oces) the device is substantially equivalent (for the referenced above and nave determined to legally marketed predicate devices marketed in indications for use stated in the encreases in the enactment date of the Medical Device interstate comments, or to thay 20, 1978, as secured in accordance with the provisions of Amendinents, of to devrees mat news Act (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmetic Pool , Love, Lore, subject to the general approval application (1 Mr.). I The general controls provisions of the Act include controls provisions of the rec. "The genting of devices, good manufacturing practice, requirements for and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into crontrols. Existing major regulations affecting (PMA), it may oe subject to suer additions, Title 21, Parts 800 to 898. In the Colors your device can be found in the South no announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Brooks

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I DA b issuance on that your device complies with other requirements mean that ITDA nas made a decommanent and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regarments, including, but not limited to: registration You must comply with an all also hot s rog 21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 607), laceling (QS) regulation (21 CFR Pat 820); and if requirents as set forth in the quality by start of Steans (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) This letter will anow you to began manisting of substantial equivalence of your device to a premiarket notification. This Printers 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), If you desire specific at 150 for your we 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 illay obtain other general micromational and Consumer Assistance at its toll-free Dribber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jenite y. M. Mchane O md.

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stat Medical Pen Needle

Indications for Use:

The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin.

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X Prescription Use only

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Chir Vm

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510(k) Number:

K972911