Terumo Injection Filter Needle (NF-3013RBKE05M)

K230951 · Terumo Europe N.V. · QYM · Oct 18, 2023 · General Hospital

Device Facts

• Record ID: K230951
• Device Name: Terumo Injection Filter Needle (NF-3013RBKE05M)
• Applicant: Terumo Europe N.V.
• Product Code: QYM · General Hospital
• Decision Date: Oct 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Sterile, single-use hypodermic needle; stainless steel cannula (0.3 mm OD, 12 mm length) with integrated 5µm mesh filter in PMMA hub; manual operation; connects to standard luer-lock syringes; filter prevents particulate injection; used by clinicians for subcutaneous and intravitreal fluid injections; EO sterilized; packaged in paper/film blister.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via ISO 7864, ISO 9626, ISO 80369-7, USP <788>, USP <789>, and ISO 11607-1. Biocompatibility addressed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, and haemocompatibility. Sterilization validated per ISO 11135.

Technological Characteristics

Cannula: Stainless steel; Hub: PMMA/Masterbatch; Adhesive: Acrylic glue; Lubricant: Silicone (polydimethylsiloxane); Filter: 5µm woven polyamide mesh. Dimensions: 30G x 1/2" (12mm). Connectivity: ISO 80369-7 compliant luer connector. Sterilization: Ethylene oxide (SAL 10^-6).

Indications for Use

Indicated for injection of fluids into parts of the body below the surface of the skin and into the vitreous.

Regulatory Classification

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.

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)

Submission Summary (Full Text)

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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).

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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 ([e-mail]) or phone [phone] 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

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# 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) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size:20px">☒</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> |
| <div style="display:flex; align-items:center;"><div><span style="font-size:20px">☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

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#### Terumo Europe NV

Researchpark Haasrode 1520 Interleuvenlaan 40 3001 Leuven, Belgium Tel.: [phone] Fax: [phone]

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. [phone] Fax [phone]

Date prepared:

October 2023

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

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# 510(k) SUMMARY

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

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

| Prepared for: | TERUMO EUROPE N.V.<br>Interleuvenlaan 40,<br>3001 Leuven,<br>BELGIUM |
|-------------------------------|--------------------------------------------------------------------------------------------------|
| Prepared by/Contact person: | Mrs. L. Decoster – Regulatory Affairs Manager<br>Tel. [phone]<br>Fax [phone] |
| 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

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)

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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 | NEEDLE<br>GAUGE | NEEDLE<br>LENGTH | NEEDLE<br>BEVEL | CANNULA<br>WALL |
|----------------|-----------------|------------------|-----------------|-----------------|
| 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.

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# Table 2 - Intended Use/Indications for Use

| Characteristics | Subject Device:<br>Terumo Injection Filter Needle<br>30G x 1/2" ETW<br>5µm filter | Predicate device:<br>K-Pack II Needle<br>27G x 1/2" ETW, 27G x 1/2" UTW,<br>30G x 1/2" ETW and 30G x 1/2" Ultra<br>Thin Wall<br>(K192057) | Comments |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Terumo Injection Filter<br>Needle is a sterile medical device<br>for single use intended to inject<br>fluids. | The K-Pack II Needles being<br>Hypodermic Single Lumen Needles are<br>sterile medical devices for single use<br>intended to inject fluids into, or<br>withdraw fluids from, parts of the body<br>below the surface of the skin. | SE |
| Indications for Use | For general application - for<br>treatment - injection of fluids into<br>parts of the body below the<br>surface of the skin and the<br>vitreous. | Indications for Use: No specific<br>indications for use identified | SE |
| Prescription<br>or<br>OTC (over the<br>counter) | Prescription | Prescription | Same |
| Characteristics | Subject Device:<br>Terumo Injection Filter Needle<br>30G x 1/2" ETW<br>5µm filter | Predicate device:<br>K-Pack II Needle<br>27G x 1/2" ETW, 27G x 1/2" UTW,<br>30G x 1/2" ETW, 30G x 1/2" UTW<br>(K192057) | Comments |
| Manufacturer | Terumo Europe N.V. | Terumo Europe N.V. | Same manufacturer |
| Materials | Cannula - Stainless Steel<br>Hub - PMMA/ Masterbatch<br>Adhesive - Acrylic Glue<br>Lubricant - Silicone<br>(Polydimethylsiloxane)<br>Filter component - 5µm mesh<br>woven polyamide filter | Cannula - Stainless Steel<br>Hub - Polypropylene/<br>Masterbatch<br>Adhesive – Epoxy Glue<br>Lubricant - Silicone<br>(Polydimethylsiloxane) | SE<br>The materials introduced with the<br>subject device comply with the<br>required internal specifications (with<br>reference to standards and/or<br>guidance if applicable) and<br>applicable legislation and have<br>passed all necessary tests during<br>incoming inspection.<br>Biocompatibility testing on the<br>finished device supports the<br>adequacy of the selected materials. |
| Design/<br>Constructions | Same as predicate but with the<br>added feature of a filter welded<br>in the hub | The device consists of a cannula<br>attached to a hub. | SE<br>The subject device additionally has<br>a filter welded in the hub with pore<br>size of 5 µm which its function is<br>supported by filter efficiency testing. |
| Specifications | 30G x 1/2"<br>Extra Thin Wall<br>Regular Bevel<br>Filter Pore Size 5 µm | 30G x 1/2"<br>Extra Thin Wall<br>Regular Bevel | Same needles specifications in<br>accordance with ISO 7864.<br>The subject device additionally has<br>a filter welded in the hub with pore<br>size of 5 µm which its function is<br>supported by filter efficiency testing. |
| Principle of<br>Operation | Manual. | Manual | Same operation principle.<br>Manual use in accordance with ISO<br>7864. |
| Characteristics | Subject Device:<br>Terumo Injection Filter Needle<br>30G x 1/2" ETW<br>5µm filter | Predicate device:<br>K-Pack II Needle<br>27G x 1/2" ETW, 27G x 1/2" UTW,<br>30G x 1/2" ETW, 30G x 1/2" UTW<br>(K192057) | Comments |
| | | | Connection with syringes in<br>accordance with ISO 80369-7. |
| Unit packaging | Blister pack consisting of printed<br>paper and film. | Hard pack consisting of cap and case. | SE |
| | | | Packaging evaluation in<br>accordance with ISO 11607-1. |
| | | | SE |
| Sterilization | EO to SAL 10-6 | EO to SAL 10-6 | Same sterilization validation<br>process in accordance with ISO<br>11135. |
| | | | Bacterial endotoxin limits and EO<br>residual limits (ISO 10993-7) are<br>set taking into consideration special<br>devices (ocular). |
| Shelf life | 5 years | 5 years | Same shelf life. |

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# Table 3 - Technological characteristics

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# 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

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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

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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.