SHARPS AWAY DISPOSABLE CONTAINER

{0}------------------------------------------------ K072667 ## Executive Summary 307 1 0 2007 Company Name: Company Address Solutions Inc. 3600 Chamberlain Lane, Ste. 104 Louisville, KY 40241 Telephone: Fax: (502) 228-2901 (502) 228-2931 Victor Anderson Contact Person: Summary Preparation Date: July 27, 2007 Trade Name: Sharps Away Disposable Containers Common Name: Sharps Container Classification Name: Container, Sharps Predicate Device Identification: CFR21 880.5570 Sharps Container Product Code: MMK Device Class: II #### Legally Marketed Equivalent Device: | <b>Company</b> | <b>Product</b> | <b>510(k) #</b> | |------------------|-----------------------------------------|-----------------| | Becton Dickinson | B-D Guardian Nestable Sharps Collectors | K943575 | ### Description: Sharps Away Disposable Containers are injection molded polypropylene plastic. The containers are closable, puncture resistant, leak proof on the sides and bottom and stable. The label, containing an overfill warning and an easily visible fill line, is adhered to the container at the factory. The containers are translucent and are red and yellows. The label is white with the biohazard warning fluorescent orange, Sharps Away Disposable Containers are available in a variety of sizes. Each product has two parts, which assemble together to form a unit. Assembly is easily visualized. They can be nested together to reduce storage space. Handles are present on the 2-quart, 5-quart, 2.5-gallon and the 6-gallon containers. They are strong, easy to grasp and permits control of the container with one hand. Wall brackets are available for the 2-quart, 5 quart and the 2.5-gallon size. A counter top holder is available for the 1-quart size. {1}------------------------------------------------ The Sharps Away Disposable Containers meet or exceeds OSHA recommendations for sharps containers. ### Intended Use: Sharps Away Disposable Containers are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps. | Manufacturer | Solutions Inc | Becton Dickinson | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Sharps Away Disposable Container | B-D Guardian Nestable Sharps | | K Number | | K943575 | | Indication for<br>Use | Sharps Away Disposable Containers are<br>intended to be used for the safe disposal<br>of hazardous sharps | B-D sharps containers are intended to<br>be used for the safe disposal of<br>hazardous sharps | | Target<br>population | Healthcare professional | Healthcare professional | | Where used | Healthcare facilities | Healthcare facilities | | Material | polypropylene | polypropylene | | Sharps access | Sharps inserted through the top in a<br>vertical position with sharp side down<br>through the hole formed with flaps<br>through which the sharp is inserted | Sharps inserted through the top in a<br>vertical position with sharp side down<br>through the hole formed with flaps<br>through which the sharp is inserted | | Sharps closure | Flaps are closed and locked in place for<br>removal | Flaps are closed and locked in place<br>for removal | | Impact<br>Resistance | Yes | Yes | | Puncture<br>Resistance | Yes | Yes | | Leak resistance: | Yes | Yes | | Single Use: | Yes | Yes | | Non-sterile: | Yes | Yes | ### Predicate Product Comparison Table: Substantial Equivalence Discussion of Similarities and Differences: The Sharps Away Disposable Containers are similar to the B-D Guardian Nestable Sharps containers in: - . Intended Use - . Target Population - . Materials - Design - . Performance testing Sharps Away Disposable Sharps Container introduces no new questions concerning the safety or effectiveness of the Sharps Away disposable container and is thus substantially equivalent to the predicate device. {2}------------------------------------------------ K072667 ### Performance Testing Puncture Resistance - 49 CFR; Section 178.609(h)(2); ASTM 07P1152/ ASTM F2132-01 - Passed Leak Resistance Test -Passed Impact Test-Passed Handle Test - Passed {3}------------------------------------------------ Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with a snake winding around it, symbolizing medicine and health. The seal is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### OCT 1 0 2007 Solutions, Incorporated Mr. Jeff D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709 Re: K072667 Trade/Device Name: Sharps Away Disposable Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: October 4, 2007 Received: October 9, 2007 Dear Mr. Rongero: 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. {4}------------------------------------------------ Page 2 - Mr. Rongero 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 (301) 594-4618. 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/dsma/dsmamain.html Sincerely vours. Chiu-Ling, 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 {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _K O7 2 ம்மு 2 முடி 2 ப Device Name: Sharps Away Disposable Container Indications for Use: Sharps Away Disposable Containers and accessories are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps. There are fourteen (14) containers and four (4) holders included in this submission. The model number, size, color and syringe size specification of each container and holder are as follows: (See attached sheet.) Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shule A. Murphy MD (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page of 510(k) Number: - K072667 {6}------------------------------------------------ # K072667 ## Indications for Use ## Product specifications | Item # | Size | Color | Syringe Size | |--------|---------------------------|--------|--------------| | 1901 | 1 Quart | Red | .5ml - 20ml | | 1902 | 1 Quart | Yellow | .5ml - 20ml | | 1903 | 2 Quart | Red | .5ml - 60ml | | 1904 | 2 Quart | Yellow | .5ml - 60ml | | 1905 | 5 Quart | Red | .5ml - 60ml | | 1906 | 5 Quart | Yellow | .5ml - 60ml | | 1907 | 2.5 Gal w/Horizontal Lid | Red | .5ml - 60ml | | 1908 | 2.5 Gal w/Horizontal Lid | Yellow | .5ml - 60ml | | 1909 | 2.5 Gal w/Vertical Lid | Red | .5ml - 60ml | | 1910 | 2.5 Gal w/Vertical Lid | Yellow | .5ml - 60ml | | 1911 | 6 Gal | Red | .5ml - 60ml | | 1912 | 6 Gal | Yellow | .5ml - 60ml | | 1915 | .5 Quart | Red | Needles only | | 1916 | .5 Quart | Yellow | Needles only | | 1951 | 2 Quart Wall Bracket | Beige | N/A | | 1952 | 5 Quart Wall Bracket | Beige | N/A | | 1953 | 2.5 Gal Wall Bracket | Beige | N/A | | 1954 | 1 Quart Countertop Holder | Blue | N/A |