NovaGuard SA Pro Safety System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing right, with flowing lines beneath them, resembling water or fabric. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 2, 2017 West Pharmaceutical Services, Inc. Ms. Ana Ladino Director of Regulatory Affairs 530 Herman O. West Drive Exton, Pennsylvania 19341-1147 Re: K163511 Trade/Device Name: NovaGuard SA Pro Safety System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 14, 2016 Received: December 15, 2016 Dear Ms. Ladino: 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 (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, Tina Kiang-S Tina Kiang, Ph.D. Acting 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) K163511 Device Name NovaGuard SA Pro Safety System #### Indications for Use (Describe) Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist seff-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY : K163511 #### NovaGuard SA Pro Safety System Device: ### Company Name: West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341-1147 Phone: (610) 594-3105 ## Contact Person: Ana Ladino Director of Regulatory Affairs West Pharmaceutical Services, Inc. Phone: 610-594-3165 Fax: 610-717-0668 E-mail: ana.ladino@westpharma.com ## US Agent: Kevin Lentz Senior Director of Regulatory Affairs West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341-1147 Phone: 610-594-4353 Fax: 610-717-0668 E-mail: kevin.lentz@westpharma.com Preparation date: January 31, 2017 ## Classification: Classification Name: Piston Syringe Trade Name: NovaGuard SA Safety System Common/Usual Name: Anti Stick Syringe Product Code: MEG Regulation No.: 21 CFR 880.5860 Class: II Panel Identification: General Hospital Panel {4}------------------------------------------------ # Predicate Device: NovaGuard SA Safety System 510(k) K141464. # Device Description: The proposed device, NovaGuard SA Pro Safety System, is a non-sterile, single use anti needlestick accessory for pre-filled ISO standard glass syringes that are 1ml long with a max needle length of 5/8". The NovaGuard SA Pro Safety System consist of three components, syringe holder, sleeve and spring. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the injection, the needle is then covered by the sleeve protecting the user from potential sharps needle stick injury. There is a visual, tactile and audible recognition that the device safety feature has activated. # Indications for use: Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. ## Substantial equivalence: Based on the indications for use, technology, materials of construction and principle of operation the proposed device, NovaGuard SA Pro Safety System, is substantially equivalent to the predicate device, NovaGuard SA Safety System 510(k) K141464. The following modifications have been made to the predicate device, NovaGuard SA Safety System 510(k) K14146: - . Syringe holder modifications to implement integrated clip features instead of a separate clip component. - . Syringe holder modifications to aid in the molding and assembly process and to smooth the syringe holder fingers profile. The predicate device. NovaGuard SA Safety System (K141464) includes a separate clip component. The proposed device, NovaGuard SA Pro Safety System includes an integrated clip feature on the syringe holder instead of a separate clip component. This change was implemented to facilitate the pharmaceutical manufacturer assembly process of the proposed device, NovaGuard SA Pro Safety System, with their prefilled syringe. This device modification eliminates the need to assemble a clip component as a separate operation. {5}------------------------------------------------ | Areas for<br>Comparison | Predicate Device:<br>NovaGuard SA Safety<br>System (K141464) | Proposed Device:<br>NovaGuard SA Pro<br>Safety System | Comparison | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Indications for<br>Use | Single use device that is<br>indicated for use as an<br>accessory with pre-<br>filled ISO Standard<br>glass syringes to aid in<br>the protection of<br>healthcare<br>professionals, patients<br>who self-inject doctor<br>prescribed medications<br>and individuals that<br>assist self-injecting<br>patients from accidental<br>needle sticks. The<br>intended patient<br>population is<br>unrestricted and may<br>include children and<br>adults and parenteral<br>methods of<br>administration. | Single use device that is<br>indicated for use as an<br>accessory with pre-<br>filled ISO Standard<br>glass syringes to aid in<br>the protection of<br>healthcare<br>professionals, patients<br>who self-inject doctor<br>prescribed medications<br>and individuals that<br>assist self-injecting<br>patients from accidental<br>needle sticks. The<br>intended patient<br>population is<br>unrestricted and may<br>include children and<br>adults and parenteral<br>methods of<br>administration. | Identical | | Use | Single Use | Single Use | Identical | | Prescription Use | Yes | Yes | Identical | | Contraindication | None | None | Identical | | Components | Syringe holder, sleeve,<br>spring and clip | Syringe holder, sleeve<br>and spring | Modified<br>Integrated clip<br>replaces the clip<br>component | | Compatible<br>Syringes | Pre-filled ISO Standard<br>glass syringes | Pre-filled ISO Standard<br>glass syringes | Identical | | Syringe size | 1mL Long | 1mL Long | Identical | | Needle Length | Max 5/8" length | Max 5/8" length | Identical | | Needle shield<br>requirement | Rigid | Rigid | Identical | | Syringe holder<br>material of | Polycarbonate | Polycarbonate | Identical | | Areas for<br>Comparison | Predicate Device:<br>NovaGuard SA Safety<br>System (K141464) | Proposed Device:<br>NovaGuard SA Pro<br>Safety System | Comparison | | construction | | | | | Sleeve material of<br>construction | Polycarbonate | Polycarbonate | Identical | | Spring material of<br>construction | Stainless Steel | Stainless Steel | Identical | | Clip material of<br>construction | Polycarbonate | N/A | Modified<br>The NovaGuard SA<br>Pro Safety System<br>does not have a<br>separate clip<br>component | | Biocompatible | Yes<br>Per ISO 10993-1 | Yes<br>Per ISO 10993-1 | Identical | | Sterilization | Non- sterile | Non- sterile | Identical | {6}------------------------------------------------ # Performance Testing: Based on the verification and validation activities, along with the risk assessment evaluation, it was determined that the following tests needed to be performed on the proposed device, NovaGuard SA Pro Safety System. - Syringe assembly force - Pre-activation disassembly force (force applied to RNS) ● - . Pre-Activation Disassembly Force Test (force applied to cannula) - Clip impact test (Integrated clip feature test) ● - Drop Test Post-activation with PFS ● - Drop Test - Pre-activation with PFS - Activation Security - . RNS replacement All testing met the required acceptance criteria. {7}------------------------------------------------ | Performance Testing Summary | | |------------------------------------------------------------------|------------------------------------------| | Test Name | Testing Standard | | Syringe assembly force | Tested to internal performance standards | | Pre-activation disassembly force (force applied to RNS) | Tested to internal performance standards | | Pre-Activation Disassembly Force Test (force applied to cannula) | Tested to internal performance standards | | Clip impact test (Integrated clip feature test) | Tested to internal performance standards | | Drop Test - Post-activation with PFS | Tested to internal performance standards | | Drop Test - Pre-activation with PFS | Tested to internal performance standards | | Activation Security | Tested to internal performance standards | | RNS replacement | Tested to internal performance standards | The bench testing evaluation of the proposed device, NovaGuard SA Pro Safety System, does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device. ## Clinical Testing: The proposed device, NovaGuard SA Pro Safety System, modifications did not affect the device design impacting activation of the safety prevention feature therefore based upon their risk analysis a simulated use study was deemed not necessary. # Conclusion: Based on the indications for use, technology, materials of construction and principle of operation the proposed device NovaGuard SA Pro Safety System, is substantially equivalent to the predicate device, NovaGuard SA Safety System (K141464).