Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical injection system and does not mention any AI or ML components or capabilities.

Therapeutic

No.
The device is described as an injection system for delivering FDA-approved drugs, not as a device that provides therapy itself.

Diagnostic

No

The device is an injection system designed for administering drugs intradermally, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a single-use, electron beam radiation sterilized device consisting of a needle and syringe, which are physical hardware components. The performance studies also focus on the physical properties and performance of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "intradermal injections of FDA approved drugs." This describes a device used to administer a substance into the body, not to perform tests on samples taken from the body.
Device Description: The device is described as a "needle and syringe." These are tools for injection, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of the device being used to test blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with IVD devices.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to deliver a substance into the body, which is a therapeutic or preventative action, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FMI, FMF

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. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

deltoid region

Indicated Patient Age Range

adults

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Testing: Performance testing 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. Bench testing met the predetermined acceptance criteria, and results support a determination of substantial equivalence.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K052034, K123588

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

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
Senior Regulatory Affairs Specialist
Terumo Medical Corporation
Tel. (732) 412-4194
Fax (410) 398-6079 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared for: | Owner/Operator
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku, Tokyo, Japan 151-0072
Registration Number: 8010026 |
| | |
| | Manufacturer (510(k) Applicant)
Kofu Factory of Terumo Corporation
1727-1, Tsuijiarai, Showa-Cho
Nakakoma-Gun, Yamanashi, Japan 409-3853
Registration Number: 9681835 |
| | |
| Contact Person: | Phebe Varghese
Senior Regulatory Affairs Specialist
Terumo Medical Corporation
265 Davidson Avenue, Suite 320
Somerset, NJ 08873
Tel. (732) 412-4194
Fax (410) 398-6079
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
Tube	Cannula*	Stainless Steel
	Needle Lubricant*	Silicone Oil
Needle
Base	Needle Hub*	Polypropylene
	Luer Lock Connector*	Polypropylene
	Elastic Spacer*	Styrene-based Thermoplastic Elastomers containing
Pigment
	Needle Hub Adhesive	Polyacrylate
Individual
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
(Plunger stopper) *	Styrene-based Thermoplastic Elastomers Containing
Pigment
	Gasket Lubricant*	Silicone Oil
	Plunger	Polystyrene
	Individual
Package	Top Film
Bottom Film		LDPE+AB - Ionomer - L-LDPE - LDPE+AB (Low
Density Polyethylene + Acrylonitrile Butadiene - Linear
Low-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.

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:
Immucise Intradermal
Injection System | Primary Predicate
Device:
K052034
TERUMO Syringe
with/without Needle | Predicate Device #2:
K123588
Intradermal Adapter |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kofu Factory of
Terumo Corporation
(Japan) | Terumo (Philippines)
Corporation | West Pharmaceutical
Services, Inc. |
| Product Code | FMI, FMF | FMI, FMF | FMF |
| Intended Use/
Indications for Use | 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 Terumo Syringe
with/without needle is
intended to be used for
medical purposes to
inject fluids into or
withdraw fluids from
the body. | The Intradermal
Adapter is an accessory
to a 1 ml, ½ inch fixed-
needle allergy syringe
indicated for use as a
guide for performing
intradermal injections. |
| Operation Principle | Manual | Manual | Manual |
| | Needle and Syringe
Collectively, the
"system" is designed to
facilitate intradermal
injections of fluids and
formulations that have
been deemed
acceptable for injection. | Needle and Syringe
Collectively, the needle
and syringe are
designed to facilitate
injection of fluids to the
body and can be used to
withdraw fluid from the
body. | Adapter
Designed to be attached
to a 1cc syringe with
needle to control the
depth and angle of
needle insertion into
dermis. |
| Design and
Construction | Needle
Consists of needle tube
and needle base - and
features a design
controlling depth and
angle of needle
insertion into the
dermis.

Syringe
Consists of barrel,
gasket and plunger. | Syringe with Needle
Consists of needle tube,
needle hub, barrel,
gasket and plunger. | Adapter
A single component
that is designed for
attachment to a syringe
for subsequent delivery
of fluid into the dermis. |
| Device Characteristics | Subject Device:
Immucise Intradermal
Injection System | Primary Predicate
Device:
K052034
TERUMO Syringe
with/without Needle | Predicate Device #2:
K123588
Intradermal Adapter |
| | The subject device is
constructed of materials
commonly used in
medical devices.

Needle:
• Needle Tube
• Stainless steel
cannula*
• Silicone oil
lubricant*

• Needle base
• Polypropylene hub*
• Polypropylene luer
lock connector*
• Styrene-based TPE
w/ pigment elastic
spacer*
• Polyacrylate needle
hub_adhesive | The predicate Terumo
device is constructed of
materials commonly
used in medical
devices.

Needle:
• Needle Tube
• Stainless steel
cannula*
• Silicone oil
lubricant*

• Needle hub
• Polypropylene hub*
• Epoxy adhesive | The West
Pharmaceutical device
is constructed of
materials commonly
used in medical
devices.

Adapter
• Polycarbonate |
| Components Materials | Syringe:
• Barrel
• Polypropylene
barrel*
• Silicone oil
lubricant*
• Black ink barrel
printing

• Gasket
• Styrene-based TPE
w/ pigment*
• Silicone oil
lubricant*

• Plunger
• Polystyrene

Patient body
contacting material | Syringe:
• Barrel
• Polypropylene
barrel
• Silicone oil
lubricant*
• Black ink barrel
printing

• Gasket
• Styrene-based TPE
w/ pigment*
• Silicone oil
lubricant*

• Plunger
• Polystyrene

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
ISO 80369-7:2016 Section 6.1
Sub-atmospheric pressure air leakage	ISO 7864:2016 Section 4.8.1
ISO 80369-7:2016 Section 6.2
Stress cracking	ISO 7864:2016 Section 4.8.1
ISO 80369-7:2016 Section 6.3
Resistance to separation from axial load	ISO 7864:2016 Section 4.8.1
ISO 80369-7:2016 Section 6.4
Resistance to separation from unscrewing	ISO 7864:2016 Section 4.8.1
ISO 80369-7:2016 Section 6.5
Resistance to overriding	ISO 7864:2016 Section 4.8.1
ISO 80369-7:2016 Section 6.6
Surface finish and visual appearance (Needle
tube)	ISO 7864:2016 Section 4.10.1
ISO 9626:2016 Section 5.2
Cleanliness (Needle tube)	ISO 7864:2016 Section 4.10.1
ISO 9626:2016 Section 5.3
Limits for acidity and alkalinity
(Needle tube)	ISO 7864:2016 Section 4.10.1
ISO 9626:2016 Section 5.4
Dimensions (Needle tube)	ISO 7864:2016 Section 4.10.1
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
ISO 9626:2016 Section 5.8
Resistance to breakage (Needle tube)	ISO 7864:2016 Section 4.10.1
ISO 9626:2016 Section 5.9
Resistance to corrosion (Needle tube)	ISO 7864:2016 Section 4.10.1
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
(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 12.1
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
ISO 80369-7:2016 Section 6.1
Sub-atmospheric pressure air leakage	ISO 7886-1:2017 Section 12.1
ISO 80369-7:2016 Section 6.2
Stress cracking	ISO 7886-1:2017 Section 12.1
ISO 80369-7:2016 Section 6.3
Resistance to separation from axial load	ISO 7886-1:2017 Section 12.1
ISO 80369-7:2016 Section 6.4
Resistance to separation from unscrewing	ISO 7886-1:2017 Section 12.1
ISO 80369-7:2016 Section 6.5
Resistance to overriding	ISO 7886-1:2017 Section 12.1
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
requirements of ISO 7886-
1:2017 Section 11)
Stopper force	In-house Standard (verified
requirements 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.

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 ( 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.