MedSource Sharps Dart

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 8, 2015 MedSource International, LLC c/o Mr. Howard Cooper Principal Consultant EQACT INC. 11715 Fox Road Indianapolis, IN 46236 Re: K150333 Trade/Device Name: MedSource Sharps Dart Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: MMK Dated: March 10, 2015 Received: March 12, 2015 Dear Mr. Cooper: 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. {1}------------------------------------------------ Page 2 - Mr. Cooper 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/MedicalDevices/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 Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150333 Device Name MedSource Sharps Dart Indications for Use (Describe) The MedSource Sharps Datt is a non-sterile single-use disposable sharps container with a permanent closure system for a contaminated 1 ml or smaller syringe. Its intended use is by health care professionals in a setting where standard sharps containers are not accessible such as EMS, home healthcare, and laboratories. Its permanent closure system protects the user prior to disposal by incineration or decontamination by autoclave. MedSource Sharps Dart Model No. MS-64250 Color-Clear/translucent with red closure Length-17cm (6.7 in.) Diameter-3cm (1.2 in.) Empty Weight- 255 gm ( 0.9 oz) | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Toll Free: 800-876-8264 Phone: 952-472-0131 Fax: 952-472-0136 www.gomedsource.com Medical Supplies for the Healthcare Professional 4201 Norex Drive Chaska, MN 55318 USA Image /page/3/Picture/4 description: The image shows the text '510 (k) Summary'. The text is written in a simple, sans-serif font and is gray. The text is likely a title or heading for a document or section of a document. SECTION 5 Date Prepared: May 8, 2015 ### 1. General Information | Submission Sponsor | | Submission Correspondent | | |------------------------------------------------------------------------------------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------| | MedSource International<br>4201 Norex Drive<br>Chaska, MN 55318 | | Howard T. Cooper<br>EQACT, INC.<br>11715 Fox Rd.<br>Suite 400<br>Indianapolis, IN 46236<br>317-826-4398 office | | | | | | | | Device Identification | | Predicate identification | | | Characteristic | Submission Device | Predicate A | Predicate B | | Trade name | MedSource Sharps Dart | Covidien Sharps Shuttle<br>/Sharps Shuttle with<br>Locking Mechanism* | B Travel Savvy Sharps<br>Container | | 510(K) | K150333 | K972279 | K140285 | | Regulatory Name | Hypodermic Single-<br>Lumen Needle | Hypodermic Single-<br>Lumen Needle | Hypodermic Single-<br>Lumen Needle | | Common name | Sharps Container | Sharps Container | Sharps Container | | Product Code | MMK | FMI | MMK | | Classification | Class II | Class II | Class II | | CFR reference | 880.5570 | 880.5570 | 880.8570 | | Classification Panel | General Hospital | General Hospital | General Hospital | | Catalog No. | MS-64250 | Model 8801 | BTS-702 | | *Covidien Sharps Shuttle, formerly Kendall P2 Shuttle Sharps Container manufactured by Sage Products | | | | ### 2. Device Description The MedSource Sharps Dart (MSD) sharps container consists of two injected molded parts-a tubular tapered cone and a polypropylene closure. Its small size of 0.6 L qualifies it as a pocket sharps container as defined by ISO 23907 First Edition 2012-09-01, Sharps injury protection-Requirements and test {4}------------------------------------------------ methods-Sharps containers. It is designed for the storage, such sharps as small syringes, blood needles, lancets, and angio-caths prior to disposal consideration. It's intended to be used in remote settings for sharps containers are not convenient and accessible such as EMS, home healthcare, etc. It is a single use device. The MSD sharps container was designed using the above standard, ISO 23907, and its design includes the required features specified in the standard. It meets the performance requirements for the standard. In addition, it has also been tested by an independent laboratory to meet the requirements for puncture resistance specified in ASTM F2132-01 (Re-approved in 2008). Both standards are FDA recognized. The predicate device, Covidien Sharps Shuttle, was selected because of its tubular-conical configuration with a polypropylene hinge-closure , which is very similar to the construction of the MedSource Sharps Dart. They are also similar in their weight and dimensions. When comparing such factors as Indications for Use, Performance, Technology, and method of manufacture, the data shows substantial equivalence between both the Covidein Sharps Shuttle and the MedSource Sharps Dart. Although both devices are considered to be substantially equivalent, they have been or are being cleared at different periods of regulation. At the time that the predicate device was approved, there was not an FDA recognized standard for sharps container. However, Medsource Sharps Dart was designed following FDA recognized standards for the products with respect to puncture resistance testing and leak testing. ### 3. Standards | Standard | Summary of Compliance to<br>Standard | |-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 23907 First edition 2012-09-01—Sharps injury<br>protection— Requirements and test methods—<br>Sharps containers | Medsource Sharps Dart compliance<br>to the definition of the pocket<br>sharps container.<br>1. Summary report prepared<br>demonstrating compliance<br>to the standard for pocket<br>sharps container<br>2. Testing was conducted for<br>puncture resistance and leak<br>resistance and product met<br>the testing criteria | | ASTM F2132- 01 (2008) Standard Specification for<br>Puncture Resistance of Materials Used in Containers<br>for Discarded Medical Needles and Other Sharps | See revised standards Summary<br>report prepared demonstrating<br>compliance to standard.<br>See Section 18. Performance Testing | The following FDA recognized standards were used in the preparation of this 510K: {5}------------------------------------------------ | FDA OSHA | 29 CFR 1910.1030 | Meets requirements by compliance<br>to applicable parts of ISO 23907 | |----------|------------------|----------------------------------------------------------------------| | | | (Impact Test) and<br>ASTM F 2132 (Puncture Resistance) | # 4. Device Comparison | Predicate ID | Submission Device | Predicate A | Predicate B | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade | MedSource Sharps Dart | Covidien Sharps<br>Shuttle With Locking | B Travel Savvy Sharps<br>Container | | Name | K150333 | K972279 | K140285 | | Indications for<br>Use | The MedSource Sharps<br>Dart is a non-sterile<br>single-use disposable<br>sharps container with a<br>permanent closure<br>system for a<br>contaminated 1ml or<br>smaller syringe. Its<br>intended use is by health<br>care professionals in a<br>setting where standard<br>sharps containers are not<br>accessible such as EMS,<br>home healthcare and<br>laboratories. Its<br>permanent closure<br>system protects the user<br>prior to disposal by<br>incineration or<br>decontamination by<br>autoclave.<br><br>MedSource Sharps Dart<br>Model No. MS-64250<br><br>Color-Clear/translucent<br>with red closure | The Sharps Shuttle<br>and Sharp Shuttle<br>with Locking<br>Mechanism are<br>single use, non-<br>sterile, disposable,<br>sharps transport<br>containers intended<br>for use in any setting<br>where standard<br>sharps containers are<br>not conveniently<br>accessible, such as<br>EMS home health<br>care, etc | The Travel Savvy<br>Sharps Container is a<br>single-use device<br>intended for disposal<br>of sharps waste by a<br>single user in a<br>private site of use.<br>When mounted with<br>the appropriate<br>bracket, the Travel<br>Savvy Sharps<br>Container can be<br>used for sharps<br>disposal in vehicles.<br>The B Travel Savvy<br>Sharps container<br>color is red. The<br>length of the device<br>is 6.5 inches, the<br>width is 2.1 inches<br>and the height is 2.3<br>inches. The aperture<br>opening is 1.5 inches<br>wide and the length<br>is 2.5 inches. | {6}------------------------------------------------ | Length-17cm (6.7 in.)<br>Diameter-3cm (1.2 in.)<br>Empty Weight- 255 gm (<br>0.9 oz) | | | | |--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | RX or OTC | OTC | OTC | OTC | | Material | Polypropylene | Polypropylene | Polypropylene | | Sharps Access | Top opening | Top Opening | Top Opening | | Sharps Closure | Hinged closure | Hinged closure | Hinged closure | | Dimensions & Weight | Length-17cm (6.7 in.)<br>Diameter-3cm (1.2 in.)<br>Empty Weight- 255 gm (<br>0.9 oz) | Approximately 6in. long & 1 in. diameter<br>Empty weight not<br>available | The length of the device is 6.5 inches,<br>the width is 2.1 inches and the height<br>is 2.3 inches. The aperture opening is<br>1.5 inches wide and the length is 2.5<br>inches. | | Single use | Yes | Yes | Yes | | Non-sterile | Yes | Yes | Yes | | Translucent | Yes | Yes | Yes | | Impact and<br>leak resistance | Yes | Yes | Yes | | Needle<br>Penetration<br>Resistance- | Yes | Yes | Yes | # 5. Comparison Results | | Category of comparison | Results | |----|----------------------------------------------------|------------| | 1. | Regulatory Requirements<br>Characteristics | Equivalent | | 2. | Indications for Use & RX/OTC | Equivalent | | 3. | Design & Construction and Method of<br>Manufacture | Equivalent | | 4. | Technology | Equivalent | | 5. | Product Features | Equivalent | {7}------------------------------------------------ ### 6. Test Methods | Test Methods | Standards | |-----------------------|--------------------------| | Puncture Resistance | ISO 23907- Section 4.2.4 | | Resistance to Leakage | ISO 23907- Section 4.2.5 | | Puncture Resistance | ASTM- F2132-01 | ### 7. Conclusion The MedSource Sharps Dart sharps container was compared to the above predicate devices in such areas as technology, indications for use, materials of construction, performance testing, product testing, and product features. Based on the review of this data, the data supports the conclusion that the subject device is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised by the introduction this device. Therefore, we conclude that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices [Covidien Sharps Shuttle/ Sharps Shuttle with Locking Mechanism (K972279) and B Travel Savvy Sharps Container (K140285)].