SHARPS CONTAINER

K970398 · Custom Medical Plastics, Inc. · FMI · Jul 3, 1997 · General Hospital

Device Facts

• Record ID: K970398
• Device Name: SHARPS CONTAINER
• Applicant: Custom Medical Plastics, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.

Device Story

Vertical Entry Sharps Container; injection-molded polypropylene receptacle with chimney-type lid; designed for vertical deposition of used, contaminated sharps; protects user fingers during disposal; provides containment during transport to disposal site; final disposal via incineration; used in clinical or healthcare settings; operated by healthcare personnel or patients; reduces risk of accidental needle sticks; puncture-resistant but not puncture-proof.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Injection-molded polypropylene container and lid; chimney-type vertical entry opening; puncture-resistant material; non-powered; manual operation.

Indications for Use

Indicated for use as a receptacle for used, contaminated medical sharps and for enclosure during transport to ultimate disposal. Intended for over-the-counter use.

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

• Vertical Entry Sharps Containers (Sage Products Inc.)
• Vertical Entry Sharps Containers (Sherwood Medical)

Submission Summary (Full Text)

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K970398
ATTACHMENT 5, Rev. 1
JUL - 3 1997

510(k) SUMMARY

THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990.

510(k) Summary of Safety & Efficacy Vertical Entry Sharps Container

Submitted By: Custom Medical Plastics, Inc. 11811 Calhoun Road Omaha, NE 68122 [phone]

Contact: Daniel R. Brown, President

Date Prepared: December 24, 1996 (Amended April 4, 1997)

Our Vertical Entry Sharps Container consists of an injection-molded polypropylene container fitted with a tabs down, leak-resistant, polypropylene lid. The lid has a chimney-type opening into which the sharps are dropped vertically.

Sharps Containers are classified as a Class II accessory to a hypodermic needle (21 CFR Section 880.5570); Panel 80 FMI.

Our Vertical Entry Sharps Container is substantially equivalent to Vertical Entry Sharps Containers manufactured by Sage Products Inc. and Sherwood Medical. These containers are all made of polypropylene by the injection molding process. They feature a chimney-type opening which better protects user's fingers when depositing sharps.

Our Vertical Entry Sharps Container provides a receptacle for used, contaminated sharps and for enclosure during transport to ultimate disposal. The product labeling includes a cautionary statement that the "container is puncture-resistant, but not entirely puncture-proof. To avoid the possibility of accidental sticks, do not overfill, inspect unit before handling and handle with care." Final disposal is typically accomplished by incineration. When incinerated in compliant medical waste incinerators, these Sharps Containers do not present any environmental hazards resulting from plastics combustion.

Our Vertical Entry Sharps Container will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Daniel R. Brown
President
Custom Medical Plastics, Incorporated
14315 C Circle
Omaha, Nebraska 68144

JUL - 3 1997

Re: K970398
Trade Name: Sharps Container
Regulatory Class: II
Product Code: FMI
Dated: May 14, 1997
Received: May 16, 1997

Dear Dr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Smith

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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K970398
ATTACHMENT 7, Rev. 1
Page 1 of 1

510(k) Number (if known): Unknown

Device Name: Sharps Container

Indications For Use:

Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.

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

~~Consultant of CDRH, Office of Device Evaluation (ODE)~~
(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital, Dardens
(OK) Number K970398
Prescription Use ☐ OR
(Per 21 CFR 801.109)

Over-the-Counter Use ☑
(Optional Format 1-2-96)