(197 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, material properties, and sterilization of a manual injection needle with an integrated filter. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an injection filter needle, which is used for the administration of therapeutic fluids but is not itself a therapeutic device. Its function is to facilitate the injection process, not to provide therapy.
No
The device is described as an "Injection Filter Needle" intended for "treatment - injection of fluids into parts of the body". Its function is to deliver substances, not to diagnose conditions.
No
The device description clearly outlines physical components like a stainless steel cannula, luer connector, and integrated filter, indicating it is a hardware device, not software-only.
Based on the provided information, the Terumo Injection Filter Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "inject fluids into parts of the body below the surface of the skin and into the vitreous." This describes a device used for direct administration of substances into the body, which is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a sterile injection needle with a filter. This aligns with a device used for administering fluids, not for analyzing samples taken from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on the physical properties of the needle, filter efficiency in preventing particles, packaging, biological safety, and sterilization. These are relevant to a device used for injection, not for diagnostic testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Terumo Injection Filter Needle does not fit this definition.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QYM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin and into the vitreous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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 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 Particulate matter in injections
USP Particulate matter in ophthalmic solutions
USP Sterility test
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.
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
§ 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).
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
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.
-
- Device Name (807.92(a)(2))
-
- Predicate Devices (807.92(a)(3))
-
- Reason for Submission
-
- Device Description (807.92(a)(4))
-
- Indications for Use (807.92(a)(5))
-
- Comparison of the intended use and the technological characteristics between the proposed and predicate device
-
- Substantial Equivalence Comparison (807.92(a)(6))
-
- Non Clinical Test (807.92(b)(1))
- Clinical Test (807.92(b)(2)) 10.
-
- 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 Manager
Tel. (+32) 16 38 13 02
Fax (+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
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)
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 | NEEDLE
GAUGE | NEEDLE
LENGTH | NEEDLE
BEVEL | CANNULA
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.
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 Needle
30G x 1/2" ETW
5µm filter | Predicate device:
K-Pack II Needle
27G x 1/2" ETW, 27G x 1/2" UTW,
30G x 1/2" ETW and 30G x 1/2" Ultra
Thin Wall
(K192057) | Comments |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Terumo Injection Filter
Needle is a sterile medical device
for single use intended to inject
fluids. | The K-Pack II Needles being
Hypodermic Single Lumen Needles are
sterile medical devices for single use
intended to inject fluids into, or
withdraw fluids from, parts of the body
below the surface of the skin. | SE |
| Indications for Use | For general application - for
treatment - injection of fluids into
parts of the body below the
surface of the skin and the
vitreous. | Indications for Use: No specific
indications for use identified | SE |
| Prescription
or
OTC (over the
counter) | Prescription | Prescription | Same |
| Characteristics | Subject Device:
Terumo Injection Filter Needle
30G x 1/2" ETW
5µm filter | Predicate device:
K-Pack II Needle
27G 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 Steel
Hub - PMMA/ Masterbatch
Adhesive - Acrylic Glue
Lubricant - Silicone
(Polydimethylsiloxane)
Filter component - 5µm mesh
woven polyamide filter | Cannula - Stainless Steel
Hub - Polypropylene/
Masterbatch
Adhesive – Epoxy Glue
Lubricant - Silicone
(Polydimethylsiloxane) | SE
The materials introduced with the
subject device 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.
Biocompatibility testing on the
finished device supports the
adequacy of the selected materials. |
| Design/
Constructions | Same as predicate but with the
added feature of a filter welded
in the hub | The device consists of a cannula
attached to a hub. | SE
The subject device additionally has
a filter welded in the hub with pore
size of 5 µm which its function is
supported by filter efficiency testing. |
| Specifications | 30G x 1/2"
Extra Thin Wall
Regular Bevel
Filter Pore Size 5 µm | 30G x 1/2"
Extra Thin Wall
Regular Bevel | Same needles specifications in
accordance with ISO 7864.
The subject device additionally has
a filter welded in the hub with pore
size of 5 µm which its function is
supported by filter efficiency testing. |
| Principle of
Operation | Manual. | Manual | Same operation principle.
Manual use in accordance with ISO
7864. |
| Characteristics | Subject Device:
Terumo Injection Filter Needle
30G x 1/2" ETW
5µm filter | Predicate device:
K-Pack II Needle
27G x 1/2" ETW, 27G x 1/2" UTW,
30G x 1/2" ETW, 30G x 1/2" UTW
(K192057) | Comments |
| | | | Connection with syringes in
accordance with ISO 80369-7. |
| Unit packaging | Blister pack consisting of printed
paper and film. | Hard pack consisting of cap and case. | SE |
| | | | Packaging evaluation in
accordance with ISO 11607-1. |
| | | | SE |
| Sterilization | EO to SAL 10-6 | EO to SAL 10-6 | Same sterilization validation
process in accordance with ISO
11135. |
| | | | Bacterial endotoxin limits and EO
residual limits (ISO 10993-7) are
set taking into consideration special
devices (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 and USP . -
- -Filter efficiency is evaluated considering the test methods described in USP and USP .
- 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 Particulate matter in injections
USP Particulate matter in ophthalmic solutions
USP 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.