DEPOTONE

K061032 · Imprint Pharmaceuticals Limited · FMI · Jun 21, 2006 · General Hospital

Device Facts

• Record ID: K061032
• Device Name: DEPOTONE
• Applicant: Imprint Pharmaceuticals Limited
• Product Code: FMI · General Hospital
• Decision Date: Jun 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.

Device Story

DepotOne is a sterile hypodermic single lumen needle; designed to interface with male luer connectors of syringes or intravascular administration sets. Used by healthcare professionals for injection or aspiration of fluids from below the skin surface. Single-use device.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile hypodermic single lumen needle; features male luer connector interface; single-use; Class II device.

Indications for Use

Indicated for the injection and removal of fluids from below the surface of the skin in humans. For single use only.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.

JUN 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mervyn Little Device Development Director Imprint Pharmaceuticals, Limited 53 Langton Road East Molesey, Surrey KT8 2HX United Kingdom

Re: K061032

Trade/Device Name: DepotOne™ Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 31, 2006 Received: June 1, 2006

Dear Mr. Little:

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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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.

Syndie Y. Mickens DMD
Shirlie Y. Mickens, 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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LOCLOS2

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## Indication for Use

510(k) Number

Device Name:

DepotOne™

Intended Use

DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.

Prescription Use X (Per 21 CFR 801.Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.C. Chapman for Aon 6/20/2006

of Anaesthesiology, General Hospital.
ion Control, Dental Devices

Number: K061032