SHARPS CONTAINER, MODEL 039-413
Device Facts
| Record ID | K063666 |
|---|---|
| Device Name | SHARPS CONTAINER, MODEL 039-413 |
| Applicant | Biodex Medical Systems, Inc. |
| Product Code | MMK · General Hospital |
| Decision Date | Jan 25, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
Indications for Use
Our Vertical Entry Sharps Container provides a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
Device Story
Injection-molded polypropylene container with snap-on cover and lid; features vertical entry oval opening for sharps disposal. Designed for use in Nuclear Medicine Departments and clinics; fits into locking lead-lined shields. Single-use device; includes fill-line indicator and untextured section for visual monitoring. Provides puncture-resistant enclosure for contaminated sharps during transport to disposal. Benefits patient and staff by providing secure containment of hazardous medical waste.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Material: Injection-molded polypropylene. Form factor: Cylindrical container with snap-on cover and lid. Entry: Vertical oval opening. Compatibility: Fits into locking lead-lined shields. Single-use.
Indications for Use
Indicated for use as a receptacle for used, contaminated medical sharps and for enclosure during transport to ultimate disposal in clinical or medical settings.
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
- B-D Sharps Collector, Model #305469
Submission Summary (Full Text)
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K063666
## EXHIBIT #7
## 510K SUMMARY OF SAFETY AND EFFECTIVENESS BIODEX SHARPS CONTAINER, MODEL #039-413
JAN 2 5 2007
The Biodex Sharps Container consists of an injection molded polypropylene container fitted with an injection-molded snap on cover with a connected lid to the cover. The lid snaps onto the cover when the container is filled. The cover and lid are shipped not installed on the container bottom so the containers can be nested to save space. The cover is snapped onto the cover before use. The cover has an oval opening into which the Sharps are dropped vertically into the container.
The Sharps Container is classified as a Class II accessory to a hypodermic needle (Section 880.5570): Classification Name: Container, Sharps 80 MMK.
The Biodex Sharps Container is substantially equivalent to the B-D Sharps Collector, Model #305469. Both containers have a cylindrical shape. Both are injection-molded polypropylene with snap on covers and lids. Both have a vertical entry for the sharps.
The Biodex Sharps Container fits into the locking lead-lined shield used in Nuclear Medicine Departments and clinics for contaminated sharps.
The Biodex Sharps Container labeling has the cautionary statement that, "This container is puncture resistant, but not puncture proof. To avoid injury, examine the collector carefully before you fill, carry or dispose of it".
This container is labeled for single use only and has a label and marking for, "Do not fill above this line".
The container also has an untextured section above the full line to help the user see that container is full.
The intended use of the vertical entry Sharps Container is to provide a receptacle for used, contaminated medical sharps and for enclosure during transport to ultimate disposal.
The container will be manufactured to the product specifications.
## CERTIFICATION:
I hereby certify that this summary of Safety and Effectiveness applies for the above indicated device.
**Date:** 1/12/07
Name:
Clyde Schlein, Director of Regulatory Affairs & Compliance Biodex Medical Systems 20 Ramsay Road Shirley, New York 11967-4704 Phone: (631) 924-9000 ext. 2343
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Clyde Schlein Director of Regulatory Affairs Compliance Biodex Medical Systems, Incorporated 20 Ramsay Road Shirley, New York 11967-4704
JAN 2 5 2007
Re: K063666 Trade/Device Name: Sharps Container Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: December 8, 2006 Received: December 11, 2006
Dear Mr. Schlein:
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. Schlein
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 (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours.
Chiu Lin, 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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## Indications for Use
1
(21 CFR 801 Subpart C)
| 510(k) Number (if known): | K063666 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sharps Container |
| Indications for Use: | Our Vertical Entry Sharps Container provides a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND / OR |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | X |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Shula P. Murphy, MD
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