SHARPS TRANSPORT TUBE, MODEL 50035

K073577 · Sharps Compliance, Inc. · MMK · Jun 23, 2008 · General Hospital

Device Facts

• Record ID: K073577
• Device Name: SHARPS TRANSPORT TUBE, MODEL 50035
• Applicant: Sharps Compliance, Inc.
• Product Code: MMK · General Hospital
• Decision Date: Jun 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Sharps Transport Tube with screw top lid is a single use or single patient use, non-sterile, disposable, sharps transportation container used in setting where traditional sharps containers cannot be conveniently accessible, such as home use, traveling, EMS, home health, etc.

Device Story

Sharps Transport Tube Model 50035 is a single-use, non-sterile, disposable container designed for temporary storage and transport of used sharps. It features a screw-top lid. Intended for use in environments where standard sharps containers are inconvenient or inaccessible, such as home settings, during travel, or by EMS personnel. The device provides a portable containment solution for sharps disposal, enhancing safety by preventing accidental needle sticks during transport. It is a mechanical device with no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical sharps container with screw-top lid. Single-use, non-sterile, disposable. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by patients or healthcare providers in settings where traditional sharps containers are inaccessible, including home, travel, EMS, and home health environments, for the temporary storage and transport of used sharps.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2008

Sharps Compliance, Incorporated C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K073577

Trade/Device Name: Sharps Compliance Sharps Transport Tube Model 50035 Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 6, 2008 Received: June 9, 2008

Dear Mr. Kogoma:

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. Kogoma

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 (OS) 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,

Sylvie H. Mckain Omd.

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: Not yet assigned

Device Name: Sharps Compliance Sharps Transport Tube Model 50035

Indications for Use:

The Sharps Transport Tube with screw top lid is a single use or single patient use, non-sterile, disposable, sharps transportation container used in setting where traditional sharps containers cannot be conveniently accessible, such as home use, traveling, EMS, home health, etc.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shala A.M. Murphy, KP
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073577

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