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 infants aged two months (excluding low birth weight and/or preterm birth) to adults.

Device Description

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. This system consists of an Intradermal Injection Needle and an Immucise Syringe. The system is made of common materials used in needles and syringes. The Immucise Intradermal Injection Needle is comprised of a needle base. The Immucise Syringe is comprised of a barrel, a gasket and a plunger. The sterile Immucise Intradermal Injection Needle and Immucise Syringe are packed separately and assembled prior to use. The Immucise Intradermal Injection System is operated by a manual process.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Immucise Intradermal Injection System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K181369) for an expanded indication (including infants). Therefore, the "acceptance criteria" are largely implied by meeting the same performance standards as the predicate, or by achieving successful outcomes in functionality tests.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Bench Test Performance	Device meets predetermined acceptance criteria for non-aged and aged samples as established for the primary predicate (K181369). (Specific criteria not detailed in this document but implied as met by K181369).	Bench testing for Immucise Intradermal Injection System was performed in K181369 using non-aged and aged samples and met the predetermined acceptance criteria. No additional bench tests were deemed necessary for the expanded indication as the subject device is identical to K181369.
Animal Study (Functionality)	Successful wheal formation post-injection for the Immucise Intradermal Injection System, comparable to the reference device (West Intradermal Adapter), for the expanded patient population (infants to adults). (Specific success rate not quantified but implied as met).	The study "evaluated the efficacy of Immucise Intradermal Injection System for the indication for use. The test compared the post-injection wheal formation success rate between the Immucise Intradermal Injection System and the reference device of West Intradermal Adapter." The conclusion states, "Terumo concludes that the Immucise Intradermal Injection System has been found to be substantially equivalent for the intended use and for the target patient population without raising different questions of safety and effectiveness." This implies successful wheal formation in the target population.
Animal Study (Histopathological)	Validation of the required injection depth for intradermal injections in the expanded patient population (infants to adults). (Specific depth criteria not detailed but implied as met).	The study was "conducted to validate the injection depth required for the indications for use." The conclusion states, "Terumo concludes that the Immucise Intradermal Injection System has been found to be substantially equivalent for the intended use and for the target patient population without raising different questions of safety and effectiveness." This implies successful validation of injection depth for the target population.
Material Biocompatibility	Patient contacting parts assessed in accordance with ISO-10993-1.	The finished device's patient contacting parts were assessed in accordance with tests recommended in the FDA Guidance - Use of International Standard ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." It is stated as "Biocompatible."
Sterilization Method (Electron Beam)	Device able to be sterilized effectively by Electron Beam radiation.	Electron Beam radiation.
Shelf Life	Needle: 36 months, Syringe: 12 months.	Needle: 36 months, Syringe: 12 months.

2. Sample Size and Data Provenance for Test Set:

Bench Test: No specific sample sizes for "non-aged and aged samples" are provided in this document, but it refers to the prior submission K181369. Data provenance is not explicitly stated beyond "performed in K181369."
Animal Test: No specific sample sizes for the animal study are provided in this document. The data provenance is Terumo (Japan). The study was conducted specifically to support the expanded indication, suggesting it was prospective for this submission, though the methodology was based on a previous study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Neither the bench tests nor the animal studies described in this document involved human experts establishing ground truth in the way a clinical study with image interpretation might.
For the animal study, the "ground truth" (e.g., successful wheal formation, validated injection depth) would have been assessed by trained personnel through observation and potentially histological analysis. No specific number or qualifications of experts are mentioned.

4. Adjudication Method for Test Set:

This type of information (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation, such as radiology reads.
For bench and animal studies (focused on objective measurements and physiological responses), such adjudication methods are not applicable. The assessment would be based on predefined protocols and measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
This device is a physical medical device (intradermal injection system), not an AI-powered diagnostic tool that human readers would use in conjunction with. The comparative effectiveness focused on technical performance against a reference device, not human reader improvement with AI.

6. Standalone (Algorithm Only) Performance:

No, standalone performance was not done.
Again, this is a physical medical device. The concept of "algorithm only" performance is not applicable here as there is no AI algorithm involved in its direct function. The device's performance is its physical function.

7. Type of Ground Truth Used:

Bench Test: Physical and functional measurements against predefined specifications (e.g., durability, material properties, dimensional accuracy).
Animal Test: Direct physiological observations (wheal formation) and histological evaluation for injection depth, based on in-house standards designed to confirm intended physiological effects of intradermal injection.

8. Sample Size for Training Set:

This concept is not applicable for this device. This is a physical medical device, not a machine learning model that requires a training set. The "training" in the context of device development would refer to design iterations and engineering testing, not data used to train an algorithm.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set in the context of machine learning. The "ground truth" for the device's design and engineering would be established through established engineering principles, material science, and regulatory standards.

Summary

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July 18, 2019

Terumo Corporation % Rudima Jackson Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Ave Suite 320 Somerset, New Jersey 08873

Re: K190427

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: June 19, 2019 Received: June 20, 2019

Dear Rudima Jackson:

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

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190427

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 infants aged two months (excluding low birth weight and/or preterm birth) to adults.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary: K190427

Manufacturer:	Kofu Factory of Terumo Corporation (510(k) applicant)Registration Number: 9681835
Address:	1727-1 Tsuijiarai, Showa-ChoNakakoma-Gun, Yamanashi, Japan 409-3853
Corresponding official:	Rudima L JacksonRegulatory Affairs SpecialistTerumo Medical Corporation
Telephone Number:Email:	(732)302-4900rudima.jackson@terumomedical.com
Summary Date:	July 8, 2019
Trade Name:	Immucise Intradermal Injection System
Common or Usual Name:	Intradermal Needle and Syringe
Regulation Number:	21 CFR 880.5570
Regulation Name:	Hypodermic Single Lumen Needle
Product Code:	FMI (Needle) and FMF (Syringe)
Class:	II
Panel:	General Hospital
Primary Predicate Device:	Immucise Intradermal Injection System, Manufactured byKofu Factory of Terumo Corporation (Japan)(K181369)
Reference Device:	Intradermal Adapter, Manufactured by WestPharmaceutical Services, Inc.(K123588)

Device Description:

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Indications for Use:

Technological Characteristics:

The Immucise Intradermal Injection System with the pediatric indication is the same as its primary predicate device, K181369. The only change is the expanded indication to include infants aged two months (excluding low birth weight and/or preterm birth) to adults. Therefore, all technological characteristics are the exact same.

Summary of Comparative Information

This traditional 510(k) is being submitted for the Immucise Intradermal Injection System with the intent of expanding the indication to include infants aged two months (excluding low birth weight and/or preterm birth) to adults. The subject device is the same device as the primary predicate cleared under K181369 except for the Indications for Use. It has the same intended use, operating principle, design, construction, materials, and sterilization method. The proposed device also has the same design specification to the needle gauge, needle length, and syringe nominal capacity.

Feature of thedevice	Subject DeviceImmuciseIntradermalInjection System	Primary Predicate(K181369)ImmuciseIntradermalInjection System	Reference Device(K123588)IntradermalAdapter	Discussion /Comment toPrimaryPredicate
Product Code	FMI, FMF	FMI, FMF	FMF	Same asK181369
Classification	II	II	II	Same asK181369
Number ofuses	Single use Rx only	Single use Rx only	Single use Rx only	Same asK181369
Materials	The subject device isconstructed ofmaterials commonlyused in medicaldevices.Needle• Needle Tube• Stainless steelcannula• Silicone oil lubricant• Needle base• Polypropylene hub*	The subject device isconstructed ofmaterials commonlyused in medicaldevices.Needle• Needle Tube• Stainless steelcannula• Silicone oil lubricant• Needle base• Polypropylene hub*	The WestPharmaceuticaldevice isconstructed ofmaterialscommonly used inmedical devices.Adapter• Polycarbonate	Same asK181369
	• Polypropylene luerlock connector• Styrene-based TPE w/pigment elastic spacer• Polyacrylate needlehub adhesiveSyringe• Barrel• Polypropylene barrel• Silicone oil lubricant• Black ink barrelprinting• Gasket• Styrene-based TPE w/pigment• Silicone oil lubricant• Plunger• Polystyrene*Patient bodycontacting material	• Polypropylene luerlock connector• Styrene-based TPE w/pigment elastic spacer• Polyacrylate needlehub adhesiveSyringe• Barrel• Polypropylene barrel• Silicone oil lubricant• Black ink barrelprinting• Gasket• Styrene-based TPE w/pigment• Silicone oil lubricant• Plunger• Polystyrene*Patient bodycontacting material
Sterilizationmethod	Electron Beamradiation	Electron Beamradiation	Ethylene Oxide	Same asK181369
Biocompatibility	BiocompatibleThe finished device'spatient contactingparts were assessed inaccordance with testsrecommended in theFDA Guidance - Useof InternationalStandard ISO-10993-1, "Biologicalevaluation of medicaldevices - Part 1:Evaluation and testingwithin a riskmanagementprocess."	BiocompatibleThe finished device'spatient contactingparts were assessed inaccordance with testsrecommended in theFDA Guidance - Useof InternationalStandard ISO-10993-1, "Biologicalevaluation of medicaldevices - Part 1:Evaluation and testingwithin a riskmanagementprocess."	Information notavailable	Same asK181369
Indications forUse	The ImmuciseIntradermal InjectionSystem is indicatedfor use in intradermalinjections of FDAapproved drugs.The system is to beused in the deltoidregion for infantsaged two months(excluding low birthweight and/orpreterm birth) toadults	The ImmuciseIntradermal InjectionSystem is indicatedfor use in intradermalinjections of FDAapproved drugs.The system is to beused in the deltoidregion for adults.	The IntradermalAdapter is anaccessory to a 1ml, ½ inch fixed-needle allergysyringe indicatedfor use as a guidefor performingintradermalinjections.	The proposedindications foruse for thesubject devicehave beenmodified toinclude aspecific userpopulation(pediatric) tothe primarypredicate. Thedifferences inthe indications

Operatingprinciples	Manual	Manual	Manual	a new intendeduse. As theintended use inthe subject andpredicatedevices has notchanged, themodification tothe indicationsfor use does notraise differentquestions ofsafety andeffectiveness.
				Same asK181369
Designspecifications	Needle Gauge33G (0.2 mm)Needle Length1.15 mmSyringe NominalCapacity0.4 mL	Needle Gauge33G (0.2 mm)Needle Length1.15 mmSyringe NominalCapacity0.4 mL	AdapterDesigned to adaptto a disposable 1ccpiston syringe withneedle (1 ml ofcapacity, 1/2"needle length, 27 –29G needle gauge).	Same asK181369
Package(Primary)	NeedleIndividual packageSyringeBlister package	NeedleIndividual packageSyringeBlister package	AdapterBlister package	Same asK181369
Shelf life	Needle: 36 monthsSyringe: 12 months	Needle: 36 monthsSyringe: 12 months	Information notavailable	Same asK181369

Summary of comparative information

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Performance Data:

Bench Test

Bench testing for Immucise Intradermal Injection System was performed in K181369 using non-aged and aged samples and met the predetermined acceptance criteria. No additional bench tests were deemed necessary to support the expanded indication, since the subject device is identical to the primary predicate K181369.

Animal Test

Terumo conducted an animal study to demonstrate the intended use of intradermal injection for adults in K181369. In order to expand the indications for use from adults only to infants (aged two months) to adults, Terumo conducted an additional animal study. The test method and acceptance criteria are same as the study performed previously except for the skin thickness.

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Test Name	Test Description / Standard
Animal study(Functionality test)	In-house standard: This study was conducted to evaluatethe efficacy of Immucise Intradermal Injection System forthe indication for use. The test compared the post-injectionwheal formation success rate between the ImmuciseIntradermal Injection System and the reference device ofWest Intradermal Adapter.
Animal study(Histopathologicalevaluation)	In-house standard: This study was conducted to validatethe injection depth required for the indications for use.

Based on these animal studies, Terumo concludes that the Immucise Intradermal Injection System has been found to be substantially equivalent for the intended use and for the target patient population without raising different questions of safety and effectiveness. The test results support a determination of substantial equivalence.

Conclusion:

In summary, the intended use, technology/principle of operation, materials, and performance showed that the subject device did not raise different questions of safety and effectiveness when compared to the predicate devices. Therefore, Immucise Intradermal Injection System is substantially equivalent to the legally marketed Predicate Device.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).