ON THE GO SHARPS

K070577 · Medport, Inc. · MMK · Jul 13, 2007 · General Hospital

Device Facts

• Record ID: K070577
• Device Name: ON THE GO SHARPS
• Applicant: Medport, Inc.
• Product Code: MMK · General Hospital
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.

Device Story

Single-use, portable sharps container designed for personal, over-the-counter use. Device accepts one contaminated insulin syringe; features Safe-Lock lid mechanism that permanently locks upon closure to prevent reopening and accidental needle sticks. Constructed of puncture-resistant plastic. Used by patients in non-clinical settings for safe transport of used needles to disposal sites. Provides physical containment of biohazardous sharps; minimizes contamination risk. No electronic components or software.

Clinical Evidence

Bench testing only. Simulated use studies conducted with participants of varying educational backgrounds confirmed successful operation of the container and locking mechanism in accordance with instructions.

Technological Characteristics

Single-use, puncture-resistant plastic container. Features a proprietary Safe-Lock lid mechanism. Mechanical design only; no energy source, connectivity, or software. Dimensions and material specifications not detailed beyond puncture-resistant plastic.

Indications for Use

Indicated for personal, over-the-counter use by individuals requiring a single-use container for the transport and disposal of one contaminated insulin syringe needle.

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

• Sharps Away™ Locking Disposal Cup (K041153)

Submission Summary (Full Text)

{0}------------------------------------------------

K070577

# 510 (K) SUMMARY

## Date of Summary

July 12, 2007

## Product Name:

On the Go Sharps Transport and Disposal with Safe-Lock™

## Sponsor & Manufacturer:

MedPort, LLC 23 Acorn Street Providence, RI 02903

## Correspondent:

Fran WhitE MDC Associates, LLC 163 Cabot Street Beverly, MA 01915

## Substantially Equivalent Device: K041153 Sharps Away™ Locking Disposal Cup

## Product Description:

On the Go Sharps Container is designed as a single use device that holds a single contaminated sharp. The contaminated sharp is placed into the container and immediately locked using the Safe-Lock Lid. Once closed the device can not be opened thereby minimizing the risk of contamination.

{1}------------------------------------------------

### Intended Use:

The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.

### Performance Characteristics:

Simulated use studies confirmed that people with different educational background can successfully use the On The Go Sharps Container in accordance with instructions provided.

Once locked the device can not be opened. The contaminated sharp does not penetrate the plastic, thereby providing a safe method for transporting contaminated sharps to a site for disposal.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

#### Public Health Service

JUL 1 3 2007

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDport, Incorporated C/O Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, Massachusetts 01915

Re: K070577

Trade/Device Name: On the Go Sharps Transport & Disposal with Safe-LockTM Lid Single Use Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 28, 2007 Received: July 2, 2007

Dear Ms. White:

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.

{3}------------------------------------------------

Page 2 - Ms. White

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 (240) 276- 0115. 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 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

{4}------------------------------------------------

# Indications for Use

510(k) Number: K070577

Device Name: On the Go Sharps Transport & Disposal with Safe-Lock™ lid Single use sharps container

## Indications For Use:

The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shuli A. Murphy, MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K021522