STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G

{0}------------------------------------------------ MAY 28 1900 0 Tel 610.756.3003 Fax 610.756.3004 Post Office Box 84 Kempton, PA 19529, Toll Free 888.756.3003 www.sterilogic.com 99116.12 STERILOGIC WASTE SYSTEMS INC ## 510(k) SUMMARY 807.92(1) COMPANY NAME: COMPANY ADDRESS: TELEPHONE: FAX: (610) 756-3003 (610) 756-3004 CONTACT PERSON: CALVIN A. ODHNER, V.P. SUMMARY PREPARATION DATE: May 6, 1999 807.92(2) STERISHARP™ 2.5-GALLON RSDC TRADE OR PROPRIETARY NAME: REUSABLE SHARPS DISPOSAL CONTAINER COMMON NAME: CLASSIFICATION: 807.92(3) EQUIVALENT DEVICE (A): GRAPHICS CONTROLS - POINT-OF-USE II SHARPS-A-GATOR MAIL-DROP TORTUROUS PATH TUMBLER LID (510[k] #K964387) CLASS II -- ACCESSORY DEVICE STERILOGIC WASTE SYSTEMS, INC. KEMPTON, PA 19529-0084 9948 KISTLER VALLEY ROAD, SUITE 102 EQUIVALENT DEVICE (B): ROTONICS MANUFACTURING, INC. (RMI) ROTATIONALLY MOLDED PLASTIC REUSABLE SHARPS CONTAINER (510[k] #K964026) {1}------------------------------------------------ ### 807.92(4) DESCRIPTION: REUSABLE PLASTIC SHARPS DISPOSAL CONTAINER; two components of the device include (a) a plastic mail-drop, torturous path tumbler lid (where needles and sharps waste is inserted) and (b) a rotationally molded plastic bottom (the container), leak-proof on four sides and bottom, where needles are dropped and stored until container unit is emptied and cleaned. # 807.92(5) INTENDED USE: Reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608. #### 807.92(6) LID: The Graphics Controls' lid will be used on the top of the container. This lid is approved in 510(k) #K964387. The bottom portion of the unit has the same technological characteristics and a CONTAINER: similar design to the Rotonics Manufacturing Sharps Plus 5-Gallon Reusable Sharps Container, being made of the same process, material, densities and thickness. The only comparable changes are (1) the size of the container (reduced from 5 gallons to 2.5 gallons) and (2) the lid receiving channel, which was increased from 5/16" to 9/16" to accommodate the slightly larger rim that is present on the Graphic Controls lid. > The container is made from linear low-density polyethylene with a thickness of 0.125", rotationally molded (by building up layers of plastic). The SteriSharp™ 2.5 Gallon RSDC meets and exceeds the primary design 807.92(6)(b) characteristics needed to comply with the OSHA Bloodborne Pathogens Standard. Data for the following tests have been provided and are as follows: | Puncture | Health Devices 22 | Needle penetration force | Pass | |----------------|----------------------|--------------------------|------| | Vibration | 49 CFR 178.608 | 1 hour repetitive bounce | Pass | | Free Fall Drop | 49 CFR 178.603 | -18° C 5 drops 1.2 meter | Pass | | Stacking | 49 CFR 178.606 | 24 hrs. under 30 kg | Pass | | Penetration | 49 CFR 178.609(h)(1) | 7 kg steel rod - 1 meter | Pass | "The package, as submitted and tested, visually appears to satisfy the test criteria and be capable of preventing the loss or dispersal of the contents for conditions normal to transport." (Container Testing Laboratory, Inc.) {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 28 1999 Mr. Calvin A. Odhner Vice President Sterilogic Waste Systems, Incorporated 9948 Kistler Valley Road, Suite 102 PO Box 84 Kempton, Pennsylvania 19529 Re : K991612 Trade Name: SteriSharp™ 2.5 Gallon RSDC, Model #RSDC2.5G Regulatory Class: II Product Code: MMK Dated: May 6, 1999 Received: May 10, 1999 Dear Mr. Odhner: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Mr. Odhner this response to your premarket notification Please note: r submission does not affect any obligation you might have under Submitblor. acob ough 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 deborizone in formalence of your device to a legally rinding of bubbeandad on results in a classification for your markets produce, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (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 (800) 638-2041 or (301) 443-6597 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 {4}------------------------------------------------ ﺰ ﺗ Page 510(k) Number (if known): K 991612 Device Name: STECLSHARP™ 2.5 GALLEN Indications For Use: The SteriSharp™ 2.5 Gallon RSDC reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.1(19) OR Over-The-Counter Use X (Optional Format 1-2-96) Qun S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital ኝ 1 በሀk) Number