(174 days)
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.
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.
The Immucise Intradermal Injection System, intended for intradermal injections of FDA approved drugs in the deltoid region for adults, did not undergo a comparative effectiveness study with human readers assisted by AI, nor a standalone AI algorithm performance study, as it is a medical device (needle and syringe system) rather than an AI-powered diagnostic or therapeutic tool. Therefore, sections pertaining to MRMC effect size, standalone AI performance, sample sizes for test/training sets, data provenance, number and qualifications of experts, and adjudication methods for AI performance are not applicable.
The device's performance was evaluated through a series of non-clinical tests (bench, animal, human factors, biocompatibility, sterilization, and packaging) to demonstrate substantial equivalence to predicate devices and ensure it met predetermined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Test Name | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bench Testing | Cleanliness | ISO 7864:2016 Section 4.3 | Met predetermined acceptance criteria. |
| Limits for acidity or alkalinity | ISO 7864:2016 Section 4.4 | Met predetermined acceptance criteria. | |
| Limits for extractable metals | ISO 7864:2016 Section 4.5 | Met predetermined acceptance criteria. | |
| Positive pressure liquid leakage | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.1 | Met predetermined acceptance criteria. | |
| Sub-atmospheric pressure air leakage | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.2 | Met predetermined acceptance criteria. | |
| Stress cracking | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.3 | Met predetermined acceptance criteria. | |
| Resistance to separation from axial load | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.4 | Met predetermined acceptance criteria. | |
| Resistance to separation from unscrewing | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.5 | Met predetermined acceptance criteria. | |
| Resistance to overriding | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.6 | Met predetermined acceptance criteria. | |
| Surface finish and visual appearance (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.2 | Met predetermined acceptance criteria. | |
| Cleanliness (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.3 | Met predetermined acceptance criteria. | |
| Limits for acidity and alkalinity (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.4 | Met predetermined acceptance criteria. | |
| Dimensions (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.6 | Met predetermined acceptance criteria. | |
| Stiffness (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.8 | Met predetermined acceptance criteria. | |
| Resistance to breakage (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.9 | Met predetermined acceptance criteria. | |
| Resistance to corrosion (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.10 | Met predetermined acceptance criteria. | |
| Freedom from defects | ISO 7864:2016 Section 4.10.3 | Met predetermined acceptance criteria. | |
| Lubricant | ISO 7864:2016 Section 4.10.4 | Met predetermined acceptance criteria. | |
| Needle point | ISO 7864:2016 Section 4.11 | Met predetermined acceptance criteria. | |
| Bond between hub and needle tube | ISO 7864:2016 Section 4.12 | Met predetermined acceptance criteria. | |
| Patency of lumen | ISO 7864:2016 Section 4.13 | Met predetermined acceptance criteria. | |
| Needle length | In-house Standard | Met predetermined acceptance criteria. | |
| Bevel length | In-house Standard | Met predetermined acceptance criteria. | |
| Needle hub strength | In-house Standard | Met predetermined acceptance criteria. | |
| Dead volume | In-house Standard | Met predetermined acceptance criteria. | |
| General (Syringe) | ISO 7886-1:2017 Section 6.1 | Met predetermined acceptance criteria. | |
| Limits for acidity or alkalinity (Syringe) | ISO 7886-1:2017 Section 6.2 | Met predetermined acceptance criteria. | |
| Limits for extractable metals (Syringe) | ISO 7886-1:2017 Section 6.3 | Met predetermined acceptance criteria. | |
| Lubricant (visual inspection - Syringe) | ISO 7886-1:2017 Section 7 | Met predetermined acceptance criteria. | |
| Lubricant (quantity - Syringe) | ISO 7886-1:2017 Section 7 | Met predetermined acceptance criteria. | |
| Tolerance on graduated capacity | ISO 7886-1:2017 Section 8 | Met predetermined acceptance criteria. | |
| Barrel (rotation of flange) | ISO 7886-1:2017 Section 10 | Met predetermined acceptance criteria. | |
| Barrel (visual inspection of flange) | ISO 7886-1:2017 Section 10 | Met predetermined acceptance criteria. | |
| Plunger stopper /plunger assembly (Detachment of plunger stopper from plunger) | ISO 7886-1:2017 Section 11 | Met predetermined acceptance criteria. | |
| Piston /plunger assembly (Distance between plunger and flange) | ISO 7886-1:2017 Section 11 | Met predetermined acceptance criteria. | |
| Nozzle | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 5 | Met predetermined acceptance criteria. | |
| Positive pressure liquid leakage (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.1 | Met predetermined acceptance criteria. | |
| Sub-atmospheric pressure air leakage (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.2 | Met predetermined acceptance criteria. | |
| Stress cracking (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.3 | Met predetermined acceptance criteria. | |
| Resistance to separation from axial load (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.4 | Met predetermined acceptance criteria. | |
| Resistance to separation from unscrewing (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.5 | Met predetermined acceptance criteria. | |
| Resistance to overriding (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.6 | Met predetermined acceptance criteria. | |
| Dead Space | ISO 7886-1:2017 Section 13.1 | Met predetermined acceptance criteria. | |
| Freedom from air leakage past piston | ISO 7886-1:2017 Section 13.2 | Met predetermined acceptance criteria. | |
| Freedom from liquid leakage past piston | ISO 7886-1:2017 Section 13.2 | Met predetermined acceptance criteria. | |
| Force to operate the piston | ISO 7886-1:2017 Section 13.3 | Met predetermined acceptance criteria. | |
| Fit of plunger stopper/plunger in barrel | ISO 7886-1:2017 Section 13.4 | Met predetermined acceptance criteria. | |
| Sliding resistance | In-house Standard (verified requirements of ISO 7886-1:2017 Section 11) | Met predetermined acceptance criteria. | |
| Stopper force | In-house Standard (verified requirements of ISO 7886-1:2017 Section 11) | Met predetermined acceptance criteria. | |
| Drug flowability | In-house Standard | Met predetermined acceptance criteria. | |
| Pressure resistance | In-house Standard | Met predetermined acceptance criteria. | |
| Particulate matter | USP 788 | Met USP acceptance criteria. | |
| Animal Study | Intradermal injection functionality | Successful wheal formation and histopathological evaluation validating injection depth for intended use, showing substantial equivalency to predicate device. | Met predetermined acceptance criteria; demonstrated substantial equivalency and validated injection depth. |
| Human Factors and Usability Engineering Study | User interface evaluation | No use-errors determined to cause serious harm, in accordance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices," issued on February 3, 2016. | No use errors causing serious harm were found. |
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemolysis (Indirect Contact), Physicochemical Profile (Non-aged, Sterile, Finished Device) | ISO 10993-1 and FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1 | Demonstrated an acceptable biocompatibility profile. |
| Cytotoxicity, Hemolysis (Indirect Contact), Physicochemical Profile (Accelerated Aged, Sterile, Finished Device) | ISO 10993-1 and FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1 | Demonstrated an acceptable biocompatibility profile throughout shelf life. | |
| Sterilization | Sterility Assurance Level (SAL) | ISO 11137-1/ISO 11137-2 to provide SAL of 10-6 | Achieved SAL of 10-6. |
| Packaging | Package integrity | ISTA 3A (after environmental conditioning and simulated transportation) | All packaging was deemed acceptable for product protection and sterility maintenance. |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the samples of the device used for the various non-clinical performance evaluations. The provenance of these samples would be the manufacturer's production line in Japan (Kofu Factory of Terumo Corporation). All testing was conducted prospectively as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to the evaluation of the medical device's physical and functional properties against established engineering and biological standards, not diagnostic or interpretive tasks requiring expert ground truth in the context of AI studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for establishing ground truth, typically in image interpretation or diagnostic performance studies. The performance of this device was assessed against objective, measurable criteria defined by international standards (ISO, USP) and in-house standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The Immucise Intradermal Injection System is a medical device (needle and syringe system), not an AI-powered diagnostic or therapeutic tool for which such studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Immucise Intradermal Injection System is a medical device, not an AI algorithm. Its performance is inherent to its physical design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance was established by:
* Bench Testing: Adherence to international standards (ISO, USP) and in-house established specifications.
* Animal Study: Direct observation of wheal formation and histopathological evaluation of injection depth.
* Human Factors and Usability Engineering Study: Observation of user interaction to identify potential use-errors that could cause serious harm, as per FDA guidance.
* Biocompatibility: Results of standardized biological tests (e.g., cytotoxicity, sensitization) evaluated against ISO 10993-1 criteria.
* Sterilization: Demonstrated Sterility Assurance Level (SAL) of 10-6 per ISO 11137 standards.
* Packaging: Verification of package integrity against ISTA 3A standards.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable. As the device is not an AI algorithm, there is no training set or associated ground truth.
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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
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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
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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)
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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 VargheseSenior Regulatory Affairs SpecialistTerumo Medical CorporationTel. (732) 412-4194Fax (410) 398-6079 |
|---|---|
| Prepared for: | Owner/OperatorTerumo Corporation44-1, 2-Chome, HatagayaShibuya-Ku, Tokyo, Japan 151-0072Registration Number: 8010026 |
| Manufacturer (510(k) Applicant)Kofu Factory of Terumo Corporation1727-1, Tsuijiarai, Showa-ChoNakakoma-Gun, Yamanashi, Japan 409-3853Registration Number: 9681835 | |
| Contact Person: | Phebe VargheseSenior Regulatory Affairs SpecialistTerumo Medical Corporation265 Davidson Avenue, Suite 320Somerset, NJ 08873Tel. (732) 412-4194Fax (410) 398-6079E-mail: phebe.varghese@terumomedical.com |
Date prepared: November 9, 2018
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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.
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Materials
The materials for the Immucise Intradermal Injection System are provided in the tables below.
| Part Name | Material | |
|---|---|---|
| NeedleTube | Cannula* | Stainless Steel |
| Needle Lubricant* | Silicone Oil | |
| NeedleBase | Needle Hub* | Polypropylene |
| Luer Lock Connector* | Polypropylene | |
| Elastic Spacer* | Styrene-based Thermoplastic Elastomers containingPigment | |
| Needle Hub Adhesive | Polyacrylate | |
| IndividualPackage | 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(Plunger stopper) * | Styrene-based Thermoplastic Elastomers ContainingPigment |
| Gasket Lubricant* | Silicone Oil | |
| Plunger | Polystyrene | |
| IndividualPackage | Top Film | |
| Bottom Film | LDPE+AB - Ionomer - L-LDPE - LDPE+AB (LowDensity Polyethylene + Acrylonitrile Butadiene - LinearLow-Density Polyethylene - Low Density Polyethylene +Acrylonitrile Butadiene) |
Table 5.2: List of Materials of the Immucise Syringe
*Materials that contact patients' body directly or indirectly via injection formulation.
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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.
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A comparison of the technological characteristics is summarized in the table, below.
| Device Characteristics | Subject Device:Immucise IntradermalInjection System | Primary PredicateDevice:K052034TERUMO Syringewith/without Needle | Predicate Device #2:K123588Intradermal Adapter |
|---|---|---|---|
| Manufacturer | Kofu Factory ofTerumo Corporation(Japan) | Terumo (Philippines)Corporation | West PharmaceuticalServices, Inc. |
| Product Code | FMI, FMF | FMI, FMF | FMF |
| Intended Use/Indications for Use | The ImmuciseIntradermal InjectionSystem is indicated forintradermal injectionsof FDA approveddrugs. The system is tobe used in the deltoidregion for adults. | The Terumo Syringewith/without needle isintended to be used formedical purposes toinject fluids into orwithdraw fluids fromthe body. | The IntradermalAdapter is an accessoryto a 1 ml, ½ inch fixed-needle allergy syringeindicated for use as aguide for performingintradermal injections. |
| Operation Principle | Manual | Manual | Manual |
| Needle and SyringeCollectively, the"system" is designed tofacilitate intradermalinjections of fluids andformulations that havebeen deemedacceptable for injection. | Needle and SyringeCollectively, the needleand syringe aredesigned to facilitateinjection of fluids to thebody and can be used towithdraw fluid from thebody. | AdapterDesigned to be attachedto a 1cc syringe withneedle to control thedepth and angle ofneedle insertion intodermis. | |
| Design andConstruction | NeedleConsists of needle tubeand needle base - andfeatures a designcontrolling depth andangle of needleinsertion into thedermis.SyringeConsists of barrel,gasket and plunger. | Syringe with NeedleConsists of needle tube,needle hub, barrel,gasket and plunger. | AdapterA single componentthat is designed forattachment to a syringefor subsequent deliveryof fluid into the dermis. |
| Device Characteristics | Subject Device:Immucise IntradermalInjection System | Primary PredicateDevice:K052034TERUMO Syringewith/without Needle | Predicate Device #2:K123588Intradermal Adapter |
| The subject device isconstructed of materialscommonly used inmedical devices.Needle:• Needle Tube• Stainless steelcannula*• Silicone oillubricant*• Needle base• Polypropylene hub*• Polypropylene luerlock connector*• Styrene-based TPEw/ pigment elasticspacer*• Polyacrylate needlehub_adhesive | The predicate Terumodevice is constructed ofmaterials commonlyused in medicaldevices.Needle:• Needle Tube• Stainless steelcannula*• Silicone oillubricant*• Needle hub• Polypropylene hub*• Epoxy adhesive | The WestPharmaceutical deviceis constructed ofmaterials commonlyused in medicaldevices.Adapter• Polycarbonate | |
| Components Materials | Syringe:• Barrel• Polypropylenebarrel*• Silicone oillubricant*• Black ink barrelprinting• Gasket• Styrene-based TPEw/ pigment*• Silicone oillubricant*• Plunger• Polystyrene*Patient bodycontacting material | Syringe:• Barrel• Polypropylenebarrel*• Silicone oillubricant*• Black ink barrelprinting• Gasket• Styrene-based TPEw/ pigment*• Silicone oillubricant*• Plunger• Polystyrene*Patient bodycontacting material | |
| Device Characteristics | Subject Device:Immucise IntradermalInjection System | Primary PredicateDevice:K052034TERUMO Syringewith/without Needle | Predicate Device #2:K123588Intradermal Adapter |
| Specifications | Needle Gauge:33 G (0.2 mm) | Needle Gauge:23 - 27 G (0.4 - 0.65 mm) | Adapter:Specified/designed toadapt to a disposable1cc piston syringe withneedle (1 ml ofcapacity, 1/2" needlelength, 27 - 29 Gneedle gauge). |
| Needle Length:1.15 mm | Needle Length:3/8"-1/2" (10 - 12 mm) | ||
| Syringe NominalCapacity:0.4 mL | Syringe NominalCapacity:1mL | ||
| Package (Primary) | Needle:Individual packageSyringe:Blister package | Syringe w/wo Needle:Blister Package | Adapter:Blister Package |
| Sterilization | Electron Beamradiation | Electron Beamradiation | Ethylene Oxide |
| Shelf life | Needle: 36 monthsSyringe: 12 months | 60 months | Information notavailable |
Table 5.4: Summary of Comparative Information
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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.
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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 4.8.1ISO 80369-7:2016 Section 6.1 |
| Sub-atmospheric pressure air leakage | ISO 7864:2016 Section 4.8.1ISO 80369-7:2016 Section 6.2 |
| Stress cracking | ISO 7864:2016 Section 4.8.1ISO 80369-7:2016 Section 6.3 |
| Resistance to separation from axial load | ISO 7864:2016 Section 4.8.1ISO 80369-7:2016 Section 6.4 |
| Resistance to separation from unscrewing | ISO 7864:2016 Section 4.8.1ISO 80369-7:2016 Section 6.5 |
| Resistance to overriding | ISO 7864:2016 Section 4.8.1ISO 80369-7:2016 Section 6.6 |
| Surface finish and visual appearance (Needletube) | ISO 7864:2016 Section 4.10.1ISO 9626:2016 Section 5.2 |
| Cleanliness (Needle tube) | ISO 7864:2016 Section 4.10.1ISO 9626:2016 Section 5.3 |
| Limits for acidity and alkalinity(Needle tube) | ISO 7864:2016 Section 4.10.1ISO 9626:2016 Section 5.4 |
| Dimensions (Needle tube) | ISO 7864:2016 Section 4.10.1ISO 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
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| Test | Standard |
|---|---|
| Stiffness (Needle tube) | ISO 7864:2016 Section 4.10.1ISO 9626:2016 Section 5.8 |
| Resistance to breakage (Needle tube) | ISO 7864:2016 Section 4.10.1ISO 9626:2016 Section 5.9 |
| Resistance to corrosion (Needle tube) | ISO 7864:2016 Section 4.10.1ISO 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(Detachment of plunger stopper from plunger) | ISO 7886-1:2017 Section 11 |
| Piston /plunger assembly(Distance between plunger and flange) | ISO 7886-1:2017 Section 11 |
| Nozzle | ISO 7886-1:2017 Section 12.1ISO 80369-7:2016 Section 5 |
Table 5.6: Summary of Bench Test (Immucise Syringe)
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| Test | Standard |
|---|---|
| Positive pressure liquid leakage | ISO 7886-1:2017 Section 12.1ISO 80369-7:2016 Section 6.1 |
| Sub-atmospheric pressure air leakage | ISO 7886-1:2017 Section 12.1ISO 80369-7:2016 Section 6.2 |
| Stress cracking | ISO 7886-1:2017 Section 12.1ISO 80369-7:2016 Section 6.3 |
| Resistance to separation from axial load | ISO 7886-1:2017 Section 12.1ISO 80369-7:2016 Section 6.4 |
| Resistance to separation from unscrewing | ISO 7886-1:2017 Section 12.1ISO 80369-7:2016 Section 6.5 |
| Resistance to overriding | ISO 7886-1:2017 Section 12.1ISO 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 (verifiedrequirements of ISO 7886-1:2017 Section 11) |
| Stopper force | In-house Standard (verifiedrequirements of ISO 7886-1:2017 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.
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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
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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.
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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.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).