SHARPSCAN

{0}------------------------------------------------ MEDS MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC. ## SECTION 5 - 1 F JUL 2 3 2013 . K123807 sharpsCAN™ Traditional 510(k) Submission ・・ #### 5 510(k) Summary खन्न Terri ## 5.1 Submitted by: | Owner: | Medical Engineering Development Solutions, Inc.<br>11060 Irma Drive<br>Northglenn, Colorado 80233 | |------------------------------|---------------------------------------------------------------------------------------------------| | Contact Person: | Tim Coressel<br>V.P. Engineering<br>Office Phone: (303) 452-0484<br>Cell Phone: (303) 563-9263 | | Date of Summary Preparation: | June 12, 2013 | ## 5.2 Device Identification: | Trade Name of Device: | sharpsCAN™ | |-----------------------|-----------------------------------------------------| | Common Name: | Sharps Container | | Classification Name: | MMK<br>Accessory to hypodermic single lumen needles | | CFR Reference: | 21CFR 880.5570- Class II | | Classification Panel: | General Hospital | ## 5.3 Predicate Device Identification Substantial equivalence is being claimed to the following legally marketed device: | Trade Name: | Demolizer #47 1 Gallon Point of Generation Sharps Container (K982781) | |-----------------------|-----------------------------------------------------------------------| | Common Name: | Sharps Container | | Classification Name: | MMK | | CFR Reference: | Accessory to hypodermic single lumen needles 21CFR 880.5570- Class II | | Classification Panel: | General Hospital | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for MEDS, which stands for Medical Engineering Development Solutions, Inc. The logo is in black and white and features the acronym "MEDS" in large, bold letters. Above and below the acronym are thin, stylized lines that add a visual element to the logo. Below the acronym, the full name of the company is written in smaller letters. ### K123807 # 5.4 Description of Device The SharpsCAN™ is a disposable sharps container that is intended for the safe disposal of used medical sharps. This sharpsCAN™ is marketed as one model. - * sharpsCAN™ Model 1 pint, The sharpsCAN™ container is stable, closable, puncture resistant, impact resistant, and leak-proof on both the sides and bottom. The sharpsCAN™ uses a vertical opening for the disposal of sharps and is intended to be used in an upright position during use with the required wall mount unit accessory. Performance testing consisted of confirming the key safety and reliability aspects of the sharpsCAN™ container. Four types of performance tests were performed: - Puncture Resistance Testing- According to ASTM F2132-01 . - . Leak-Proof Testing- According to 29 CFR 1910.1030 - . Toppling Resistance - According to CSA Z316.6-07 - Impact Resistance and Spillage Testing . The performance test results have proved the sharpsCAN™ not only met but exceeded in one case performance testing according to its design specifications and is substantially equivalent to the predicate device. {2}------------------------------------------------ ### SECTION 5 - 3 Image /page/2/Picture/1 description: The image shows the logo for MEDS, which stands for Medical Engineering Development Solutions, Inc. The logo is in black and white, with the letters "MEDS" in large, bold font. Below the logo, the full name of the company is written in a smaller font. The logo is simple and professional, and it conveys the company's focus on medical engineering and development. K123807 sharpsCAN™ Traditional 510(k) Submission ## 5.5 Indications For Use The sharpsCAN™ Model 1 Pint required to be used with a wall mount unit accessory is intended for single use and for the disposal of contaminated medical sharps in health care facilities. This device is not intended for areas with unsupervised patient access. ﺎﺭ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ ## 5.6 Predicate Device The sharpsCAN™ containers are similar in design and intended use to the Demolizer #47 1 Gallon Point of Generation Sharps Container (K982781). Substantial equivalence to the predicate device was evaluated according to the criteria identified in the FDA guidance document "Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers," issued in October , 1993. Tables 5-1 shows the device comparisons of the SharpsCAN™ and the predicate device respectively. | | sharpsCAN™ | Demolizer #47 | |---------------------------|----------------------|----------------------| | 510(k) Number | TBD | K982781 | | Construction | 3 Piece Construction | 3 Piece Construction | | Material | Tin plated steel | Tin plated steel | | Sharps Closure | Metal Cover | Metal Cover | | Sharps Access | Vertical Inlet | Vertical Inlet | | Geometry | Cylindrical | Cylindrical | | Leak Proof | Yes | Yes | | Puncture Resistance | Yes | Yes | | Non-sterile | Yes | Yes | | Single Use | Yes | Yes | | Stability Testing | Yes | No | | Impact & Spillage Testing | Yes | No | {3}------------------------------------------------ ### SECTION 5 - 4 Image /page/3/Picture/1 description: The image shows the alphanumeric string "K123807" in a bold, sans-serif font. The string appears to be a code or identifier. The characters are uniformly sized and spaced, with the "K" standing out as the only letter. **K123807** sharpsCAN™ Traditional 510(k) Submission | Aperture Dimension | 2.5" | 2-3/8" | |--------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Temporary/Permanent<br>Closure | Both | Both | | Mechanism to Prevent<br>Hand/Finger Access | No | No | | Mechanism to Prevent<br>Spillage | No | No | | Mechanism to Prevent<br>Overfilling | Yes | Yes | | Description of Accessories | Yes | No | | Intended Use | Intended for the disposal of<br>contaminated medical<br>sharps in health care<br>facilities. | Intended for clinical, non-<br>clinical healthcare settings<br>such as laboratories,<br>dentists' office, doctor's<br>office, corporate clinics<br>and nursing homes. | • Table 5-1. # 5.7 Design and Materials The design and construction of the sharpsCAN™ and the predicate device are similar. They both are of a three piece constructed design using seam welded tin plated steel with a tin plated steel metal cover lid. They both use a vertical opening for the disposal of sharps waste. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for MEDS, which stands for Medical Engineering Development Solutions, Inc. The logo is in black and white, with the letters "MEDS" in large, bold font. Below the letters is the full name of the company in a smaller font. There are some decorative lines above and below the letters. ## K123807 sharpsCAN™ Traditional 510(k) Submission ## 5.8 Description of Accessory wall mount unit is a required accessory intended to be used with the The sharpsCAN™. The accessory is a fixture secured to a stable vertical surface providing a restrictive aperture and a secured lockable containment for the sharpsCAN™ . The sharpsCAN™ is required to be used with the wall mount unit accessory. ## 5.9 Conclusion The sharpsCAN™ is substantially equivalent to the predicate device based on the descriptive data, compliance with standards and indications for use. {5}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a person with outstretched arms, with three wavy lines representing the body and arms. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol. July 23, 2013 Medical Engineering Development Solutions. Incorporated Mr. Tim Coressel Vice President Engineering 11060 Irma Drive NORTHGLENN CO 80233 Re: K123807 Trade/Device Name: SharpsCANTM Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 12, 2013 Received: June 14, 2013 Dear Mr. Coressel: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 {6}------------------------------------------------ ### Page 2 - Mr. Coressel 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purohi Clinical Deputy DAGRID Teiashri Purohit-Sheth, M.D. Clinical Deputy Director FOR Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### SECTION 4- 1 K123807 sharpsCAN™ Traditional 510(k) Submission #### Indications for Use Statement 4 気になる。 ## Indications for Use 510(k) Number: K123807 Device Name: sharpsCAN™ Indications for Use: The sharpsCAN™ Model I Pint required to be used with a wall mount unit accessory is intended for single use and for the disposal of contaminated medical sharps in health care facilities. This device is not intended for areas with unsupervised patient access. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use 117. (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) Sreekanth Gutala -5 2013.07.18 15:12:36 -04'00' Division Sign-Off) Page | of | | : iection Control, Dental Devices Pivision of Anesthesiology, General Hospital 510(k) Number: K123601