Immucise Intradermal Injection System

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November 13, 2018 Terumo Corporation Phebe Varghese Sr. Regulatory Affairs Specialist 265 Davidson Ave., Suite 320 Somerset, New Jersey 08873 Re: K181369 Trade/Device Name: Immucise Intradermal Injection System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FMF Dated: October 10, 2018 Received: October 11, 2018 Dear Phebe Varghese: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Geeta K. Pamidimukkala -S for 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) K181369 #### Device Name Immucise Intradermal Injection System Indications for Use (Describe) The Immucise Intradermal Injection System is injections of FDA approved drugs. The system is to be used in the deltoid region for adults. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ #### SECTION 5 - 510(K) SUMMARY A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92. ## A. SUBMITTER INFORMATION (807.92(a)(1)) | Prepared by: | Phebe Varghese<br>Senior Regulatory Affairs Specialist<br>Terumo Medical Corporation<br>Tel. (732) 412-4194<br>Fax (410) 398-6079 | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Prepared for: | Owner/Operator<br>Terumo Corporation<br>44-1, 2-Chome, Hatagaya<br>Shibuya-Ku, Tokyo, Japan 151-0072<br>Registration Number: 8010026 | | | | | | Manufacturer (510(k) Applicant)<br>Kofu Factory of Terumo Corporation<br>1727-1, Tsuijiarai, Showa-Cho<br>Nakakoma-Gun, Yamanashi, Japan 409-3853<br>Registration Number: 9681835 | | | | | Contact Person: | Phebe Varghese<br>Senior Regulatory Affairs Specialist<br>Terumo Medical Corporation<br>265 Davidson Avenue, Suite 320<br>Somerset, NJ 08873<br>Tel. (732) 412-4194<br>Fax (410) 398-6079<br>E-mail: phebe.varghese@terumomedical.com | Date prepared: November 9, 2018 {4}------------------------------------------------ #### B. DEVICE NAME (807.92(a)(2)) | Proprietary Name: | Immucise Intradermal Injection System | |-----------------------|-------------------------------------------------------| | Common Name: | Intradermal Needle and Syringe | | Classification Name: | Hypodermic Single Lumen Needle and Piston Syringe | | Classification Panel: | General Hospital and Personal Use Therapeutic Devices | | Regulation: | 21 CFR 880.5570 | | Product Code: | FMI (Needle) and FMF (Syringe) | | Classification: | Class II | #### C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed devices to which substantial equivalences are claimed are: - K052034 Terumo Syringe with/without Needle, manufactured by Terumo (Philippines) Corporation - Primary Predicate - K123588 Intradermal Adapter manufactured by West Pharmaceutical Services, Inc. Note: Terumo Corporation has established the K052034 Terumo Syringe/Needle as the primary predicate. ## D. REASON FOR 510(k) SUBMISSION This premarket notification (510(k)) is being submitted for the Immucise Intradermal Injection System, manufactured by Kofu Factory of Terumo Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device. # E. DEVICE DESCRIPTION (807.92(a)(4)) #### Principle of Operation Technology The Immucise Intradermal Injection System is operated by manual process. #### Design/Construction The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. The system consists of a needle and syringe that are packed separately and assembled prior to use. The Immucise Intradermal Injection Needle consists of a needle tube and needle base, and the Immucise Syringe consists of a barrel, gasket and plunger. {5}------------------------------------------------ ## Materials The materials for the Immucise Intradermal Injection System are provided in the tables below. | | Part Name | Material | |-----------------------|----------------------|--------------------------------------------------------------| | Needle<br>Tube | Cannula* | Stainless Steel | | | Needle Lubricant* | Silicone Oil | | Needle<br>Base | Needle Hub* | Polypropylene | | | Luer Lock Connector* | Polypropylene | | | Elastic Spacer* | Styrene-based Thermoplastic Elastomers containing<br>Pigment | | | Needle Hub Adhesive | Polyacrylate | | Individual<br>Package | Protector | Polypropylene | | | Seal Film | Paper | Table 5.1: List of Materials of the Immucise Intradermal Injection Needle *Materials that contact patient's body directly or indirectly via injection formulation. | | Part Name | Material | |-------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Barrel | Barrel* | Polypropylene | | | Barrel Lubricant* | Silicone Oil | | | Barrel Printing | Black Ink | | Piston | Gasket<br>(Plunger stopper) * | Styrene-based Thermoplastic Elastomers Containing<br>Pigment | | | Gasket Lubricant* | Silicone Oil | | | Plunger | Polystyrene | | | Individual<br>Package | Top Film | | Bottom Film | | LDPE+AB - Ionomer - L-LDPE - LDPE+AB (Low<br>Density Polyethylene + Acrylonitrile Butadiene - Linear<br>Low-Density Polyethylene - Low Density Polyethylene +<br>Acrylonitrile Butadiene) | Table 5.2: List of Materials of the Immucise Syringe *Materials that contact patients' body directly or indirectly via injection formulation. {6}------------------------------------------------ #### Specifications The specifications for the Immucise Intradermal Injection System are provided in the table, below. | Part | Specification | |--------------------------|----------------| | Needle Gauge | 33 G (0.2 mm) | | Needle Length | 1.15 ± 0.10 mm | | Syringe Nominal Capacity | 0.4 mL | Table 5.3: Immucise Intradermal Injection System Specifications #### F. INDICATIONS FOR USE (807.92(a)(5)) The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for adults. Note: The proposed indications for use for the subject device has been modified to include a specific user population and injection site. This differences in the indications for use between the subject device and the predicate devices (K052034 and K123588) does not create a new intended use. Since the intended use between the subject and predicate devices remain unchanged, the differences in indications for use does not raise different questions of safety and effectiveness. ## G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) The Immucise Intradermal Injection System, the subject of this 510(k), is substantially equivalent in its intended use, technology/principles of operation, materials, and performance to: - K052034 Terumo Syringe with/without Needle, manufactured by Terumo (Philippines) Corporation - Primary Predicate. - K123588 Intradermal Adapter manufactured by West Pharmaceutical Services, Inc. {7}------------------------------------------------ A comparison of the technological characteristics is summarized in the table, below. | Device Characteristics | Subject Device:<br>Immucise Intradermal<br>Injection System | Primary Predicate<br>Device:<br>K052034<br>TERUMO Syringe<br>with/without Needle | Predicate Device #2:<br>K123588<br>Intradermal Adapter | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Kofu Factory of<br>Terumo Corporation<br>(Japan) | Terumo (Philippines)<br>Corporation | West Pharmaceutical<br>Services, Inc. | | Product Code | FMI, FMF | FMI, FMF | FMF | | Intended Use/<br>Indications for Use | The Immucise<br>Intradermal Injection<br>System is indicated for<br>intradermal injections<br>of FDA approved<br>drugs. The system is to<br>be used in the deltoid<br>region for adults. | The Terumo Syringe<br>with/without needle is<br>intended to be used for<br>medical purposes to<br>inject fluids into or<br>withdraw fluids from<br>the body. | The Intradermal<br>Adapter is an accessory<br>to a 1 ml, ½ inch fixed-<br>needle allergy syringe<br>indicated for use as a<br>guide for performing<br>intradermal injections. | | Operation Principle | Manual | Manual | Manual | | | Needle and Syringe<br>Collectively, the<br>"system" is designed to<br>facilitate intradermal<br>injections of fluids and<br>formulations that have<br>been deemed<br>acceptable for injection. | Needle and Syringe<br>Collectively, the needle<br>and syringe are<br>designed to facilitate<br>injection of fluids to the<br>body and can be used to<br>withdraw fluid from the<br>body. | Adapter<br>Designed to be attached<br>to a 1cc syringe with<br>needle to control the<br>depth and angle of<br>needle insertion into<br>dermis. | | Design and<br>Construction | Needle<br>Consists of needle tube<br>and needle base - and<br>features a design<br>controlling depth and<br>angle of needle<br>insertion into the<br>dermis.<br><br>Syringe<br>Consists of barrel,<br>gasket and plunger. | Syringe with Needle<br>Consists of needle tube,<br>needle hub, barrel,<br>gasket and plunger. | Adapter<br>A single component<br>that is designed for<br>attachment to a syringe<br>for subsequent delivery<br>of fluid into the dermis. | | Device Characteristics | Subject Device:<br>Immucise Intradermal<br>Injection System | Primary Predicate<br>Device:<br>K052034<br>TERUMO Syringe<br>with/without Needle | Predicate Device #2:<br>K123588<br>Intradermal Adapter | | | The subject device is<br>constructed of materials<br>commonly used in<br>medical devices.<br><br>Needle:<br>• Needle Tube<br>• Stainless steel<br>cannula*<br>• Silicone oil<br>lubricant*<br><br>• Needle base<br>• Polypropylene hub*<br>• Polypropylene luer<br>lock connector*<br>• Styrene-based TPE<br>w/ pigment elastic<br>spacer*<br>• Polyacrylate needle<br>hub_adhesive | The predicate Terumo<br>device is constructed of<br>materials commonly<br>used in medical<br>devices.<br><br>Needle:<br>• Needle Tube<br>• Stainless steel<br>cannula*<br>• Silicone oil<br>lubricant*<br><br>• Needle hub<br>• Polypropylene hub*<br>• Epoxy adhesive | The West<br>Pharmaceutical device<br>is constructed of<br>materials commonly<br>used in medical<br>devices.<br><br>Adapter<br>• Polycarbonate | | Components Materials | Syringe:<br>• Barrel<br>• Polypropylene<br>barrel*<br>• Silicone oil<br>lubricant*<br>• Black ink barrel<br>printing<br><br>• Gasket<br>• Styrene-based TPE<br>w/ pigment*<br>• Silicone oil<br>lubricant*<br><br>• Plunger<br>• Polystyrene<br><br>*Patient body<br>contacting material | Syringe:<br>• Barrel<br>• Polypropylene<br>barrel*<br>• Silicone oil<br>lubricant*<br>• Black ink barrel<br>printing<br><br>• Gasket<br>• Styrene-based TPE<br>w/ pigment*<br>• Silicone oil<br>lubricant*<br><br>• Plunger<br>• Polystyrene<br><br>*Patient body<br>contacting material | | | Device Characteristics | Subject Device:<br>Immucise Intradermal<br>Injection System | Primary Predicate<br>Device:<br>K052034<br>TERUMO Syringe<br>with/without Needle | Predicate Device #2:<br>K123588<br>Intradermal Adapter | | Specifications | Needle Gauge:<br>33 G (0.2 mm) | Needle Gauge:<br>23 - 27 G (0.4 - 0.65 mm) | Adapter:<br>Specified/designed to<br>adapt to a disposable<br>1cc piston syringe with<br>needle (1 ml of<br>capacity, 1/2" needle<br>length, 27 - 29 G<br>needle gauge). | | | Needle Length:<br>1.15 mm | Needle Length:<br>3/8"-1/2" (10 - 12 mm) | | | | Syringe Nominal<br>Capacity:<br>0.4 mL | Syringe Nominal<br>Capacity:<br>1mL | | | Package (Primary) | Needle:<br>Individual package<br><br>Syringe:<br>Blister package | Syringe w/wo Needle:<br>Blister Package | Adapter:<br>Blister Package | | Sterilization | Electron Beam<br>radiation | Electron Beam<br>radiation | Ethylene Oxide | | Shelf life | Needle: 36 months<br>Syringe: 12 months | 60 months | Information not<br>available | Table 5.4: Summary of Comparative Information {8}------------------------------------------------ {9}------------------------------------------------ #### Substantial Equivalence Discussion The Immucise Intradermal Injection System (subject device) and Terumo Syringe with/without Needle (predicate device - K052034) have the same intended use, operating principle, basic design, construction, materials, and sterilization method. The proposed device has a modified design specification to the needle gauge, needle length, and syringe nominal capacity. The differences between the subject device and K052034 have been evaluated through bench and human factors and usability engineering studies, and test results concluded that the differences between the subject and predicate devices do not raise different questions of safety and effectiveness. The Immucise Intradermal Injection System (subject device) and Intradermal Adapter (predicate device - K123588) have the same intended use and operating principle and a similar design and construction. The proposed device has differences in design specification, materials, and sterilization method. The differences between the subject device and K123588 have been evaluated through bench and animal testing, and test results concluded that the differences between the subject and predicate devices do not raise different questions of safety and effectiveness. {10}------------------------------------------------ #### H. NON CLINICAL TESTS (807.92(b)(1)) # Performance Testing #### Bench Testing Performance testing (Bench) was conducted to ensure that the Immucise Intradermal Injection System met the applicable design and performance requirements throughout its shelf life, verify conformity to the applicable external and internal standards and FDA guidance , and demonstrate substantial equivalence to the predicate devices. The following bench tests were performed on the Immucise Intradermal Injection System. | Test | Standard | |-------------------------------------------------------|-------------------------------------------------------------| | Cleanliness | ISO 7864:2016 Section 4.3 | | Limits for acidity or alkalinity | ISO 7864:2016 Section 4.4 | | Limits for extractable metals | ISO 7864:2016 Section 4.5 | | Positive pressure liquid leakage | ISO 7864:2016 Section 4.8.1<br>ISO 80369-7:2016 Section 6.1 | | Sub-atmospheric pressure air leakage | ISO 7864:2016 Section 4.8.1<br>ISO 80369-7:2016 Section 6.2 | | Stress cracking | ISO 7864:2016 Section 4.8.1<br>ISO 80369-7:2016 Section 6.3 | | Resistance to separation from axial load | ISO 7864:2016 Section 4.8.1<br>ISO 80369-7:2016 Section 6.4 | | Resistance to separation from unscrewing | ISO 7864:2016 Section 4.8.1<br>ISO 80369-7:2016 Section 6.5 | | Resistance to overriding | ISO 7864:2016 Section 4.8.1<br>ISO 80369-7:2016 Section 6.6 | | Surface finish and visual appearance (Needle<br>tube) | ISO 7864:2016 Section 4.10.1<br>ISO 9626:2016 Section 5.2 | | Cleanliness (Needle tube) | ISO 7864:2016 Section 4.10.1<br>ISO 9626:2016 Section 5.3 | | Limits for acidity and alkalinity<br>(Needle tube) | ISO 7864:2016 Section 4.10.1<br>ISO 9626:2016 Section 5.4 | | Dimensions (Needle tube) | ISO 7864:2016 Section 4.10.1<br>ISO 9626:2016 Section 5.6 | Table 5.5: Summary of Bench Test (Immucise Intradermal Injection Needle) ¹ Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles and Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes {11}------------------------------------------------ | Test | Standard | |---------------------------------------|------------------------------------------------------------| | Stiffness (Needle tube) | ISO 7864:2016 Section 4.10.1<br>ISO 9626:2016 Section 5.8 | | Resistance to breakage (Needle tube) | ISO 7864:2016 Section 4.10.1<br>ISO 9626:2016 Section 5.9 | | Resistance to corrosion (Needle tube) | ISO 7864:2016 Section 4.10.1<br>ISO 9626:2016 Section 5.10 | | Freedom from defects | ISO 7864:2016 Section 4.10.3 | | Lubricant | ISO 7864:2016 Section 4.10.4 | | Needle point | ISO 7864:2016 Section 4.11 | | Bond between hub and needle tube | ISO 7864:2016 Section 4.12 | | Patency of lumen | ISO 7864:2016 Section 4.13 | | Needle length | In-house Standard | | Bevel length | In-house Standard | | Needle hub strength | In-house Standard | | Dead volume | In-house Standard | | Table 5.6: Summary of Bench Test (Immucise Syringe) | | |-----------------------------------------------------------------------------------|------------------------------------------------------------| | Test | Standard | | General | ISO 7886-1:2017 Section 6.1 | | Limits for acidity or alkalinity | ISO 7886-1:2017 Section 6.2 | | Limits for extractable metals | ISO 7886-1:2017 Section 6.3 | | Lubricant (visual inspection) | ISO 7886-1:2017 Section 7 | | Lubricant (quantity) | ISO 7886-1:2017 Section 7 | | Tolerance on graduated capacity | ISO 7886-1:2017 Section 8 | | Barrel (rotation of flange) | ISO 7886-1:2017 Section 10 | | Barrel (visual inspection of flange) | ISO 7886-1:2017 Section 10 | | Plunger stopper /plunger assembly<br>(Detachment of plunger stopper from plunger) | ISO 7886-1:2017 Section 11 | | Piston /plunger assembly<br>(Distance between plunger and flange) | ISO 7886-1:2017 Section 11 | | Nozzle | ISO 7886-1:2017 Section 12.1<br>ISO 80369-7:2016 Section 5 | Table 5.6: Summary of Bench Test (Immucise Syringe) {12}------------------------------------------------ | Test | Standard | |------------------------------------------|--------------------------------------------------------------------------------| | Positive pressure liquid leakage | ISO 7886-1:2017 Section 12.1<br>ISO 80369-7:2016 Section 6.1 | | Sub-atmospheric pressure air leakage | ISO 7886-1:2017 Section 12.1<br>ISO 80369-7:2016 Section 6.2 | | Stress cracking | ISO 7886-1:2017 Section 12.1<br>ISO 80369-7:2016 Section 6.3 | | Resistance to separation from axial load | ISO 7886-1:2017 Section 12.1<br>ISO 80369-7:2016 Section 6.4 | | Resistance to separation from unscrewing | ISO 7886-1:2017 Section 12.1<br>ISO 80369-7:2016 Section 6.5 | | Resistance to overriding | ISO 7886-1:2017 Section 12.1<br>ISO 80369-7:2016 Section 6.6 | | Dead Space | ISO 7886-1:2017 Section 13.1 | | Freedom from air leakage past piston | ISO 7886-1:2017 Section 13.2 | | Freedom from liquid leakage past piston | ISO 7886-1:2017 Section 13.2 | | Force to operate the piston | ISO 7886-1:2017 Section 13.3 | | Fit of plunger stopper/plunger in barrel | ISO 7886-1:2017 Section 13.4 | | Sliding resistance | In-house Standard (verified<br>requirements of ISO 7886-<br>1:2017 Section 11) | | Stopper force | In-house Standard (verified<br>requirements of ISO 7886-<br>1:2017 Section 11) | Table 5.7: Summary of Bench Test (Immucise Intradermal Injection System) | Test | Standard | |---------------------|-------------------| | Drug flowability | In-house Standard | | Pressure resistance | In-house Standard | | Particulate matter | USP 788 | Bench testing met the predetermined acceptance criteria, and results support a determination of substantial equivalence. {13}------------------------------------------------ #### Animal Study Terumo conducted the animal study to evaluate the intended purpose of intradermal injection in a simulated use condition. The functionality test compared the post-injection wheal formation success rate between the Immucise Intradermal Injection System and West Intradermal Adapter. The test demonstrated the substantial equivalency to the predicate, and the histopathological evaluation validated the injection depth required for the intended use. Animal testing met the predetermined acceptance criteria, and results support a determination of substantial equivalence. #### Human Factors and Usability Engineering Study Terumo conducted the human factors and usability engineering study to evaluate the user interface with the Immucise Intradermal Injection System in accordance with the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices," issued on February 3, 2016, and to ensure the design of the system does not result in use-errors that may cause serious harm. The testing resulted in no use errors that may cause serious harm. Therefore, Terumo believes that based on the design validation test, the whole device specification is substantially equivalent to the predicates in human factors and usability aspect. including user interface. In summary, performance test (Bench, Animal, and Human Factors and Usability Engineering studies) results support a determination of substantial equivalence to the predicate devices. #### Biocompatibilitv In accordance with ISO 10993-1, the Immucise Intradermal Injection System is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (< 24 hours). The finished device's patient contacting parts were assessed in accordance with tests recommended in the FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Screening tests were performed on devices subjected to appropriate simulated aging {14}------------------------------------------------ to demonstrate that an acceptable biocompatibility profile is maintained throughout the shelf life of the product. The table below provides a list of biocompatibility tests conducted on the Immucise Intradermal Injection System. Table 5.8: Summary of ISO 10993 Biocompatibility Testing on Immucise Intradermal Injection System | (Needle and Syringe) | | |----------------------------------------------------|--| | Non-aged, Sterile, Finished Device | | | Cytotoxicity | | | Sensitization | | | Intracutaneous Reactivity | | | Acute Systemic Toxicity | | | Pyrogenicity | | | Hemolysis (Indirect Contact) | | | Physicochemical Profile: Physicochemical and FT-IR | | | Accelerated Aged, Sterile, Finished Device | | | Cytotoxicity | | | Hemolysis (Indirect Contact) | | | Physicochemical Profile: Physicochemical and FT-IR | | Additionally, Terumo conducted particulate matter test in accordance with USP <788> Particulate Matter in Injections, and the test met the USP acceptance criteria. Results of the testing demonstrated that the device is biocompatible throughout the product's shelf life. #### Sterilization The Immucise Intradermal Injection System is sterilized via electron beam radiation. The sterility of the device is assured using a sterilization method validated in accordance with ISO11137-1 First edition: 2006-04-15 Sterilization Of Health Care Products - Radiation - Part 1 : Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices and ISO 11137-2 Third edition: 2013-06-01 Sterilization Of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose to provide a Sterility Assurance Level (SAL) of 10° to provide a Sterility Assurance Level (SAL) of 10-6. {15}------------------------------------------------ #### Packaging Package integrity testing, after environmental conditioning and simulated transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance. #### CLINICAL TESTS (807.92(b)(2)) I. This 510(k) does not include data from clinical tests. However, data from a publication (Laurent A. et al.2) was used as evidence to support the needle length and tolerance of the Immucise Intradermal Injection System. The data from the publication showed that the differences in technological characteristics of the subject device did not raise different questions of safety, when compared to the predicate devices. #### J. CONCLUSION (807.92(b)(3)) In summary, the Immucise Intradermal Injection System, subject of this 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the following predicates: K052034 - Terumo Syringe with/without Needle, manufactured by Terumo (Philippines) Corporation - Primary Predicate K123588 - Intradermal Adapter manufactured by West Pharmaceutical Services, Inc. ² Laurent A, et al. Echographic measurement of skin thickness in adults by high frequency ultrasound to assess the appropriate microneedle length for intradermal delivery of vaccines. Vaccine 2007; 25(34):6423-6430.