BD SafeAssist

{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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 6, 2016 Becton, Dickinson And Company Meriam Youssef Staff Regulatory Affairs Specialist 1 Becton Dr Franklin Lakes, New Jersey 07417 Re: K161553 Trade/Device Name: BD SafeAssist™ Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 3. 2016 Received: June 6, 2016 Dear Meriam Youssef: 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}------------------------------------------------ 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 of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Tina Kiang -s 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 Statement 510(k) Number (if known): K161553 BD SafeAssist™ Pen Needle Device Name: Indications for Use: The BD SafeAssist™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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) Page __ of ___ {3}------------------------------------------------ ## 510(k) Summary | Submitted By: | Meriam Youssef<br>Staff Regulatory Affairs Specialist, BD Medical<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Tel: 201 847 6557<br>Fax: 201 847 5307 | | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | June 30, 2016 | | | Device Name: | Trade Name:<br>Common Name:<br>Classification:<br>Product Code: | BD SafeAssist™<br>Insulin Pen Needle<br>Class II device; 21 CFR 880.5570,<br>(hypodermic single lumen needle)<br>FMI (hypodermic single lumen needle) | Legally marketed predicate devices to which substantial equivalence is being claimed: K060007: BD AutoShield™ Pen Needle #### Reference device: K110703: BD AutoShield™ Duo Pen Needle ### Device Description: Device Description. The BD SafeAssist" safety pen needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The BD SafeAssist™ features a 30G needle gauge size and is offered in needle lengths of 5mm and 8mm. It is a single-use disposable device that is provided sterile (gamma irradiation sterilization). BD SafeAssist™ is non-toxic and non-pyrogenic. The BD SafeAssist is designed to reduce occurrence of accidental needle sticks from the patient end of the needle by providing a shield that locks over the needle after use. Prior to injection, the user will attach the BD SafeAssist" to the pen injector. The shield of the BD SafeAssist" will hide the needle prior to use. As the user presses the BD SafeAssist against the skin at a 90° angle, the shield retracts to expose the needle and allows it to penetrate the skin. After injection is completed and the BD SafeAssist" is removed from the skin, the shield extends automatically and locks in place to cover the needle. The locked shield is designed to reduce the occurrence of accidental needle stick injuries. The device also features a red band indicator which provides the user visual confirmation the needle's safety mechanism has been activated. The BD SafeAssist ""should be removed from the pen and discarded after use. The BD SafeAssist™ device comprised of modifications to the BD AutoShield™ predicate cleared under K060007. These modifications consist of design, material and labeling changes. {4}------------------------------------------------ ### Intended Use: The BD SafeAssist™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. #### Comparison with Predicate Devices: The BD SafeAssist™ Pen Needle has the same intended use as its predicate device. The modifications made to the device design and materials do not impact the fundamental scientific technology or performance of the device. Non-clinical testing supports substantial equivalence of the subject device despite these technological differences. The table below provides a side by side comparison of the subject device compared to its predicate. | Feature | Subject Device: BD<br>SafeAssistTM | Predicate Device: BD<br>AutoShieldTM Pen<br>Needle | Reference Device: BD<br>AutoShieldTM Duo Pen<br>Needle | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Pending | K060007 | K110703 | | Intended Use | The BD SafeAssistTM Pen<br>Needle is intended for<br>use with pen injector<br>devices for the injection<br>of drugs, including<br>insulin and exenatide.<br>Additionally, the attached<br>safety shield<br>automatically locks in<br>place and reduces the<br>occurrence of accidental<br>needle sticks from the<br>patient end of the needle.<br>The shield also serves to<br>hide the needle before<br>and after injection. | The AutoShieldTM Pen<br>Needle is intended for use<br>with pen injector devices<br>for the injection of drugs,<br>including insulin and<br>exenatide.<br>Additionally, the attached<br>safety shield automatically<br>locks in place and reduces<br>the occurrence of<br>accidental needle sticks<br>from the patient end of the<br>needle. The shield also<br>serves to hide the needle<br>before and after injection. | For use with pen injector<br>devices for the injection of<br>drugs.<br>The product has two<br>safety shields, which lock<br>in place after use (patient-<br>end) and upon removal of<br>the needle from the pen<br>(pen connection-end).<br>The locked shields help<br>reduce the occurrence of<br>needle sticks from both<br>ends of the needle. | | Needle Gauge Size(s) | 30G | 29G, 30G and 31G | 30G and 31G | | Needle Length Size(s) | 5mm and 8mm | 5mm, 8mm and 12.7mm | 5mm and 8mm | | Tip Geometry<br>(Configuration) | 3 bevel | 3 bevel | 3 bevel | | Needle insertion method | Manual | Manual | Manual | | Sterility Barrier | YES (peel-away label) | YES (label on cover) | YES (peel-away label) | | Provided Sterile | YES (Gamma Irradiation) | YES (Gamma Irradiation) | YES (Gamma Irradiation) | | Visual Indicator | Red band | Metal Clips/ Tabs | Red band | | Patient end shield | Sleeve and Shield | Shield | Sleeve and Shield | | Locking Element | YES (molded) | YES (metal clips) | YES (molded) | | Component Material | | | | | Outer Cover | Polyethylene (White) | Polypropylene (White) | Polyethylene (White) | | Sleeve | Polycarbonate (Grey) | N/A | Polycarbonate (White) | | Outer Shield | Polycarbonate (Clear) | Polypropylene (White) | Polycarbonate (Clear) | | Inner Shield | Polycarbonate (Clear) | N/A | Polycarbonate (Clear) | | Non-Patient Shield | Polycarbonate (Clear) | N/A | Polycarbonate (Orange) | {5}------------------------------------------------ ## Testing: BD has performed non-clinical performance testing based on its risk assessment. This testing included functional performance per ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles, sterilization per ISO 11137-2 (Sterilization of Health Care Product - Radiation Part 2: Establishing the Sterilization Dose), and material biocompatibility per ISO 10993-1 (Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process) for the following tests: - Cytoxicity in Cell Culture ● - Hemolysis ● - Acute Systemic Toxicity ● - Intracutaneous Reactivity ● - Primary Dermal Irritation ● - Pyrogenicity - Sensitization ● - Genotoxicity (Bacterial and Mammalian) - Subchronic Toxicity ● - Leachable Colorant ● - Bacterial Endotoxin Results of testing demonstrated the BD SafeAssist™ pen needle device met requirements for its intended use and demonstrated substantial equivalence to its predicate devices. ### Conclusion: Based on the testing conducted, the BD SafeAssist" pen needle device is substantially equivalent to its predicate device.