The Terumo Injection Filter Needle is intended to inject fluids. The Terumo Injection Filter Needle is indication - for treatment - injection of fluids into parts of the body below the surface of the skin and into the vitreous.

Device Description

The Terumo Injection Filter Needle is a sterile injection needle for single use consisting of a stainless steel cannula with nominal outside diameter of 0.3 mm and length of 12 mm that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polymethyl methacrylate designed to be connected with a male luer connector (nozzle) of a syringe. The integrated 5u filter in the hub is intended to prevent particles from being injected. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide. Its operation is manual. The Terumo Injection Filter Needle protector and is individually packed in a soft blister made of paper and film and sterilized by ethylene oxide.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Terumo Injection Filter Needle (K230951).

Disclaimer: This device is a physical medical instrument (needle) and not an AI/software device. Therefore, many of the requested categories related to AI performance, ground truth, experts, and MRMC studies are not applicable. I will address only the relevant sections from the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Standard Applied	Reported Device Performance	Comments (compared to predicate)
Intended Use	Inject fluids into parts of the body below the surface of the skin.	Inject fluids into parts of the body below the surface of the skin.	Substantially Equivalent (SE). The subject device is only intended for injection, not fluid withdrawal, due to the filter.
Indications for Use (General)	For general application - for treatment - injection of fluids.	For general application - for treatment - injection of fluids.	Substantially Equivalent (SE). Adds "into the vitreous" to the predicate.
Indications for Use (Ophthalmic)	Injection of fluids into the vitreous.	The subject device is additionally indicated for injection of fluids into the vitreous.	This additional indication is supported by dedicated performance and biocompatibility data.
Prescription/OTC	Prescription Use	Prescription Use	Same
Materials (Cannula)	Stainless Steel	Stainless Steel	Same
Materials (Hub)	PMMA/Masterbatch	Polypropylene/Masterbatch (Predicate)	Substantially Equivalent (SE). New materials comply with internal specifications, legislation, and passed all necessary tests. Biocompatibility testing supports adequacy.
Materials (Adhesive)	Acrylic Glue	Epoxy Glue (Predicate)	Substantially Equivalent (SE). New materials comply with internal specifications, legislation, and passed all necessary tests. Biocompatibility testing supports adequacy.
Materials (Lubricant)	Silicone (Polydimethylsiloxane)	Silicone (Polydimethylsiloxane)	Same
Materials (Filter)	5µm mesh woven polyamide filter (integrated in hub)	N/A (Predicate does not have a filter)	Substantially Equivalent (SE). Function is supported by filter efficiency testing.
Design/Construction	Cannula attached to hub with an integrated 5µm filter.	Cannula attached to hub with an integrated 5µm filter.	Substantially Equivalent (SE). The added filter with 5µm pore size is supported by filter efficiency testing.
Needle Specifications	30G x 1/2", Extra Thin Wall, Regular Bevel, Filter Pore Size 5 µm	Meets 30G x 1/2", Extra Thin Wall, Regular Bevel. Filter Pore Size 5 µm.	Same needle specifications as predicate (for similar needle). The filter is an added feature supported by testing.
Principle of Operation	Manual	Manual	Same. Manual use in accordance with ISO 7864. Connection with syringes in accordance with ISO 80369-7.
Unit Packaging	Blister pack (printed paper and film)	Hard pack (cap and case) (Predicate)	Substantially Equivalent (SE). Packaging evaluation in accordance with ISO 11607-1.
Sterilization	EO to SAL 10^-6	EO to SAL 10^-6	Same. Validation process in accordance with ISO 11135. Bacterial endotoxin and EO residual limits considered per special devices (ocular) and ISO 10993-7.
Shelf Life	5 years	5 years	Same. Supported by accelerated aging per ASTM F1980.
Performance (General)	ISO 7864, ISO 9626, ISO 80369-7, ISO 6009	Performance verified against these standards.	Substantially Equivalent (SE). Same standards as predicate.
Particulate Testing	USP <788> and USP <789>	Performance verified against these standards.	Substantially Equivalent (SE).
Filter Efficiency	Test methods described in USP <788> and USP <789>	Performance verified against these methods.	Substantially Equivalent (SE).
Packaging Validation	ISO 11607-1	Performance verified against this standard.	Substantially Equivalent (SE).
Biocompatibility	ISO 10993-1 (cytotoxicity, sensitization, irritation including intracutaneous reactivity and ocular and intraocular irritation, acute systemic toxicity, material-mediated pyrogenicity, haemocompatibility), ISO 10993-18, ISO 10993-17.	All biological endpoints addressed; toxicological assessment concluded no toxicological risk; raw materials verified suitable.	Substantially Equivalent (SE).
Sterilization Validation	ISO 11135 (SAL of 10^-6), EN 556-1.	Validated sterilization method, physical and biological validation performed, labeled sterile.	Same.
Endotoxin Limits	FDA Guidance "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices", LAL testing.	Release criteria aligned with FDA guidance.	Substantially Equivalent (SE).
EO Residuals	ISO 10993-7	Considered special situations described in the standard.	Substantially Equivalent (SE).

As this is a physical medical device, not an AI/software device, the following points are not applicable to the provided 510(k) summary:

Sample size used for the test set and the data provenance: Not explicitly stated for each test, but standard compliance implies specific sample sizes. Data provenance is implied to be laboratory testing of the manufactured device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through direct physical and chemical testing against recognized standards.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is for AI-assisted human reading.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is for AI algorithm performance.
The type of ground truth used: For this physical device, the "ground truth" is defined by the requirements of the recognized consensus standards (e.g., ISO, USP, ASTM) and the inherent physical properties and chemical composition of the materials. Performance is measured against these established quantitative and qualitative criteria.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Terumo Injection Filter Needle (NF-3013RBKE05M) demonstrates substantial equivalence to its predicate device (K-Pack II Needle, K192057) through a comprehensive set of non-clinical performance, biocompatibility, and sterilization tests. The key difference in the subject device is the inclusion of an integrated 5µm filter and an additional indication for use in the vitreous.

This substantial equivalence is supported by:

Performance Verification: Adherence to established international and national standards including:
- ISO 7864:2016 (Sterile hypodermic needle for Single use)
- ISO 9626:2016 (Stainless steel needle tubing for the manufacturing of medical devices)
- ISO 80369-7:2017 (Small bore connectors for liquids & gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications)
- ISO 6009:2016 (Color coding)
- USP <788> (Particulate matter in injections) and USP <789> (Particulate matter in ophthalmic solutions) to evaluate particulate control and filter efficiency.
- ISO 11607-1:2019 (Packaging for terminally sterilized medical devices) for packaging integrity.
Biocompatibility Studies: Evaluation performed in accordance with EN ISO 10993-1:2020, targeting endpoints such as cytotoxicity, sensitization, irritation (including ocular and intraocular), acute systemic toxicity, pyrogenicity, and haemocompatibility. Chemical extraction (ISO 10993-18:2020) and toxicological assessment (ISO 10993-17:2009) were conducted to ensure material safety, particularly for ophthalmic use.
Sterilization and Shelf Life Validation:
- Sterilization validated using ISO 11135:2014 (Ethylene oxide sterilization), ensuring a Sterility Assurance Level (SAL) of 10^-6.
- Bacterial endotoxin limits determined by LAL testing and aligned with FDA Guidance for ophthalmic devices.
- Ethylene oxide residual limits addressed per ISO 10993-7:2008/Amd.1:2019, considering special situations for ocular devices.
- Shelf life of 5 years supported by accelerated aging studies (ASTM F1980).

The company asserts that the differences in intended use (no fluid withdrawal, added vitreous injection) and technological characteristics (integrated filter) are adequately supported by these performance validations and do not raise new or different questions of safety or effectiveness compared to the predicate device. No clinical tests were included in this 510(k) submission.

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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

October 18, 2023

Terumo Europe N.V. Liesbeth Decoster Regulatory Affairs Manager Interleuvenlaan 40 Leuven, 3012 Belgium

Re: K230951

Trade/Device Name: Terumo Injection Filter Needle (NF-3013RBKE05M) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: QYM Dated: September 15, 2023 Received: September 15, 2023

Dear Liesbeth Decoster:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

Juliane C. Lessard -S Sincerely,

Juliane C. Lessard, Ph.D. 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230951

Device Name

Terumo Injection Filter Needle (NF-3013RBKE05M)

Indications for Use (Describe)

The Terumo Injection Filter Needle is intended to inject fluids.

The Terumo Injection Filter Needle is indication - for treatment - injection of fluids into parts of the body below the surface of the skin and into the vitreous.

Type of Use (Select one or both, as applicable)
☒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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Terumo company logo. The logo consists of a red arc above the company name, which is written in green, block letters. The arc is positioned above and to the left of the word "TERUMO."

Terumo Europe NV

Researchpark Haasrode 1520 Interleuvenlaan 40 3001 Leuven, Belgium Tel.: +32 16 38 12 11 Fax: +32 16 40 02 49

www.terumo-europe.com

K230951 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

Prepared for:

TERUMO EUROPE N.V. Interleuvenlaan 40, 3001 Leuven, BELGIUM

Prepared by/Contact Person: Mrs. L. Decoster - Regulatory Affairs Manager Tel. (+32) 16 38 13 02 Fax (+32) 16 40 02 49

Date prepared:

October 2023

Note: Class III Summary & Certification is not applicable for the submission of a Class II device

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Terumo company logo. The logo features a red swoosh above the company name, which is written in green, block letters. The font is sans-serif and appears to be bolded.

510(k) SUMMARY

Submitter Information (807.92(a)(1)) 1.
1. Device Name (807.92(a)(2))
1. Predicate Devices (807.92(a)(3))
1. Reason for Submission
1. Device Description (807.92(a)(4))
1. Indications for Use (807.92(a)(5))
1. Comparison of the intended use and the technological characteristics between the proposed and predicate device
1. Substantial Equivalence Comparison (807.92(a)(6))
1. Non Clinical Test (807.92(b)(1))
Clinical Test (807.92(b)(2)) 10.
1. Conclusion (807.92(b)(3))

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the Terumo company logo. The logo features a red swoosh above the company name, which is written in green, block letters. The font is sans-serif and the letters are bold.

1. Submitter Information (807.92(a)(1))

Prepared for:	TERUMO EUROPE N.V.Interleuvenlaan 40,3001 Leuven,BELGIUM
Prepared by/Contact person:	Mrs. L. Decoster – Regulatory Affairs ManagerTel. (+32) 16 38 13 02Fax (+32) 16 40 02 49
Date prepared:	March 2023
2. Device Name (807.92(a)(2))
Proprietary Name:	Terumo Injection Filter Needle

Proprietary Name:	Terumo Injection Filter Needle
Common Name:	Injection Filter Needle
Classification Name:	Hypodermic Single Lumen Needle
Classification Panel:	General Hospital
Regulation:	21CFR, Section §880.5570
Product Code:	QYM (Ophthalmic Needle)
Classification:	Class II

3. Predicate Devices (807.92(a)(3))

The legally marketed device(s) to which substantial equivalence is claimed:

K-Pack II Needle 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall (K192057) manufactured by Terumo Europe N.V.

4. Reason for 510(k) Submission

This premarket notification [510(k)] is being submitted for the Terumo Injection Filter Needle to provide supporting information that the proposed device is safe and effective and substantially equivalent to the following devices:

K-Pack II Needle 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall (K192057) manufactured by Terumo Europe N.V.

5. Device Description (807.92(a)(4))

Principle of Operation Technology

The Terumo Injection Filter Needle is operated manually or by manual process.

Design/Construction

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Terumo, a medical device company. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is curved and tapers to a point on the left side of the logo. The logo is simple and modern, and the colors are bright and eye-catching.

made of polymethyl methacrylate designed to be connected with a male luer connector (nozzle) of a syringe. The integrated 5u filter in the hub is intended to prevent particles from being injected. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide. Its operation is manual. The Terumo Injection Filter Needle protector and is individually packed in a soft blister made of paper and film and sterilized by ethylene oxide.

Specifications

The following table shows the product codes, needle gauge and needle length.

Table 1 - Product Specifications

PRODUCT CODE	NEEDLEGAUGE	NEEDLELENGTH	NEEDLEBEVEL	CANNULAWALL
NF-3013RBKE05M	30 G (0.3 mm)	1/2" (12 mm)	Regular bevel	Extra-thin

6. Indications for Use (807.92(a)(5))

The Terumo Injection Filter Needle is inject fluids. The Terumo Injection Filter Needle is indicated for general application - for treatment - injection of fluids into parts of the body below the surface of the skin and into the vitreous.

Note: The Terumo Injection Filter Needle has equivalent intended use as the following predicate devices, being the subject device additionally indicated for injection of fluids into the vitreous:

K-Pack II Needle 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x -1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall (K192057) manufactured by Terumo Europe N.V.

7. Substantial Equivalence Comparison (807.92(a)(6))

The Terumo Injection Filter Needle, the subject of this 510(k), is substantially equivalent to the following predicate devices:

K-Pack II Needle 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x -1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall (K192057) manufactured by Terumo Europe N.V.
The similarities and differences are summarized below.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Terumo. The logo features the word "TERUMO" in a bold, green sans-serif font. Above the word, there is a red curved line that resembles a swoosh or a stylized checkmark, adding a dynamic element to the design.

Table 2 - Intended Use/Indications for Use

Characteristics	Subject Device:Terumo Injection Filter Needle30G x 1/2" ETW5µm filter	Predicate device:K-Pack II Needle27G x 1/2" ETW, 27G x 1/2" UTW,30G x 1/2" ETW and 30G x 1/2" UltraThin Wall(K192057)	Comments
Intended Use	The Terumo Injection FilterNeedle is a sterile medical devicefor single use intended to injectfluids.	The K-Pack II Needles beingHypodermic Single Lumen Needles aresterile medical devices for single useintended to inject fluids into, orwithdraw fluids from, parts of the bodybelow the surface of the skin.	SE
Indications for Use	For general application - fortreatment - injection of fluids intoparts of the body below thesurface of the skin and thevitreous.	Indications for Use: No specificindications for use identified	SE
PrescriptionorOTC (over thecounter)	Prescription	Prescription	Same
Characteristics	Subject Device:Terumo Injection Filter Needle30G x 1/2" ETW5µm filter	Predicate device:K-Pack II Needle27G x 1/2" ETW, 27G x 1/2" UTW,30G x 1/2" ETW, 30G x 1/2" UTW(K192057)	Comments
Manufacturer	Terumo Europe N.V.	Terumo Europe N.V.	Same manufacturer
Materials	Cannula - Stainless SteelHub - PMMA/ MasterbatchAdhesive - Acrylic GlueLubricant - Silicone(Polydimethylsiloxane)Filter component - 5µm meshwoven polyamide filter	Cannula - Stainless SteelHub - Polypropylene/MasterbatchAdhesive – Epoxy GlueLubricant - Silicone(Polydimethylsiloxane)	SEThe materials introduced with thesubject device comply with therequired internal specifications (withreference to standards and/orguidance if applicable) andapplicable legislation and havepassed all necessary tests duringincoming inspection.Biocompatibility testing on thefinished device supports theadequacy of the selected materials.
Design/Constructions	Same as predicate but with theadded feature of a filter weldedin the hub	The device consists of a cannulaattached to a hub.	SEThe subject device additionally hasa filter welded in the hub with poresize of 5 µm which its function issupported by filter efficiency testing.
Specifications	30G x 1/2"Extra Thin WallRegular BevelFilter Pore Size 5 µm	30G x 1/2"Extra Thin WallRegular Bevel	Same needles specifications inaccordance with ISO 7864.The subject device additionally hasa filter welded in the hub with poresize of 5 µm which its function issupported by filter efficiency testing.
Principle ofOperation	Manual.	Manual	Same operation principle.Manual use in accordance with ISO7864.
Characteristics	Subject Device:Terumo Injection Filter Needle30G x 1/2" ETW5µm filter	Predicate device:K-Pack II Needle27G x 1/2" ETW, 27G x 1/2" UTW,30G x 1/2" ETW, 30G x 1/2" UTW(K192057)	Comments
			Connection with syringes inaccordance with ISO 80369-7.
Unit packaging	Blister pack consisting of printedpaper and film.	Hard pack consisting of cap and case.	SE
			Packaging evaluation inaccordance with ISO 11607-1.
			SE
Sterilization	EO to SAL 10-6	EO to SAL 10-6	Same sterilization validationprocess in accordance with ISO11135.
			Bacterial endotoxin limits and EOresidual limits (ISO 10993-7) areset taking into consideration specialdevices (ocular).
Shelf life	5 years	5 years	Same shelf life.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the word "TERUMO" in a bold, green font. Above the word is a red, curved line that appears to be part of the logo. The logo is simple and modern, with the focus on the company name.

Table 3 - Technological characteristics

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO", which is written in green. The font is sans-serif and the letters are bold.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The font is sans-serif and bolded.

8. Substantial Equivalence Comparison (807.92(a)(6))

The subject device is substantially equivalent (SE) to the predicate device when evaluating intended use and indications for use and technological characteristics given that:

. The Terumo Injection Filter Needle is SE to the predicate device with respect to intended use except that the subject device is only intended for injection of fluids not for withdrawal of fluids (from parts of the body below the surface of the skin) due to presence of the filter. The intended use of the Terumo Injection Filter Needle is additionally supported by the necessary information provided within the product labeling and IFU.
. The subject device, being also a prescription use device for the general purpose of injection of fluids into parts of the body below the surface of the skin (hypodermic use) the same as the predicate, is additionally indicated for injection of fluids into the vitreous. This additional intravitreal use is supported by different performance and biocompatibility data (see non-clinical test section) and by the necessary information provided within the product labeling and IFU.
The differences in the technological characteristics of the subject device to the ● predicate device are supported by the below performance verification:
- -Performance verification is evaluated according to the following standards: ISO 7864, ISO 9626 and ISO 80369-7. The same standards were utilized for the predicate device K-Pack II Needle (K192057) to demonstrate performance.
- Particulate testing is evaluated according to USP <788> and USP <789>. -
- -Filter efficiency is evaluated considering the test methods described in USP <788> and USP <789>.
- Packaging verification is evaluated according to ISO 11607-1. -
- Biological evaluation is performed in accordance with ISO 10993-1 to demonstrate the subject device is as safe and effective as the legally marketed predicate device, and that any minor differences in technological characteristics do not raise new or different questions of safety and effectiveness as compared to the predicate device.
- The Terumo Injection Filter Needle is sterilized following a validated sterilization process to guarantee a sterility assurance level (SAL) of 10% same as the predicate device. The requirements for special devices described in ISO 10993-7 have been considered to determine the EO residual limits as well as the appropriate endotoxin levels of devices with ophthalmic use.

9. Non Clinical Test (807.92(b)(1))

Performance

The design of the Terumo Injection Filter Needle has been validated by Terumo Europe N.V. in accordance with the Design Control Requirements and recognized

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word "TERUMO", creating a sense of motion and direction.

consensus standards that have been established for hypodermic needles under FDA product code QYM and 21CFR Section 880.5570:

ISO 7864:2016 "Sterile hypodermic needle for Single use"

ISO 9626:2016 "Stainless steel needle tubing for the manufacturing of medical devices"

ISO 80369-7: 2017 "Small bore connectors for liquids & gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

ISO 6009:2016 "Stainless steel needle tubing for the manufacturing of medical devices"

ISO 11607-1:2019 "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems"

USP <788> Particulate matter in injections

USP <789> Particulate matter in ophthalmic solutions

USP <71> Sterilitv test

Biocompatibility

The Terumo Injection Filter Needle are categorized following the definitions in EN ISO 10993-1:2020 as external communicating devices that can contact tissue, bone or dentin or that can indirectly contact the blood path up to 24 hours (short term exposure).

The biological evaluation for the Terumo Injection Filter Needle has been performed taking into consideration its the materials of construction and manufacturing process. The raw materials used for the manufacturing of the Terumo Injection Filter Needle were carefully selected and consequently the chosen materials are suitable to be used for production of this product for human use. The raw materials comply with the required internal specifications (with reference to standards and/or guidance if applicable) and applicable legislation and have passed all necessary tests during incoming inspection.

Chemical extraction on the finished product has been performed in accordance with EN ISO 10993-18:2020. Toxicological assessment was made according EN ISO 10993-17:2009 for the elemental impurities above the AET and concluded that no toxicological risk were posed.

Moreover, considering FDA Guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing within a risk management process" the following biological endpoints are addressed: cytotoxicity, sensitization, irritation including intracutaneous reactivity and ocular and intraocular irritation, acute systemic toxicity, material-mediated pyrogenicity, and haemocompatibility.

Sterilization and shelf life

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is sans-serif and the letters are bold.

The sterility of the Terumo Injection Filter Needle is assured by using a validated sterilization method qualified in accordance with ISO 11135:2014 "Sterilization of Health Care Products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".

The physical validation of the sterilizer is conducted to verify the temperature and humidity in the sterilization load and the pressure in the sterilizer during the whole cycle.

The biological validation is performed in accordance with ISO 11135:2014 Annex B "Conservative determination of lethal rate of the sterilization process - Overkill approach" part B.1.2.a "Half cycle approach". This resulted in a holding time of 120 min for the sterilization cycle to assure a SAL of at least 10° according to the requirements of ISO 11135:2014.

The products can therefore be labelled sterile in accordance with EN 556-1:2001/AC1:2006 "Sterilization of medical devices - Requirements for medical devices to be labelled STERILE - Part 1: Requirements for terminally sterilized medical devices".

In accordance with ISO 10993-7:2008/Amd.1:2019: "Biological evaluation of medical devices - Part 7: Ethylene Oxide sterilization residuals", taking into consideration special situations as described in section 4.3.6 from the standard.

The limits for the bacterial endotoxin testing LAL (Limulus Amebocyte Lysate) performed as part of the release criteria are aligned with the requrements described in FDA'S Guidance "Guidance Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices".

Accelerated aging is performed based on ASTM F1980: "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" to support 5 years shelf life.

10. Clinical Test (807.92(b)(2))

This 510(k) does not include data from clinical tests.

11. Conclusion (807.92(b)(3))

In summary, the Terumo Injection Filter Needle, manufactured by Terumo Europe, being the subject of this 510(k), is substantially equivalent to its predicate device:

K-Pack II Needle 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x -1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall (K192057) manufactured by Terumo Europe N.V.
The differences in the intended use/Indications for Use and the technological characteristics, do not raise any new or different issues of safety or effectiveness. The Terumo Injection Filter Needle is as safe and effective, and performs as well as the legally marketed predicate device.

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).