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510(k) Data Aggregation
(197 days)
Terumo Injection Filter Needle (NF-3013RBKE05M)
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.
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.
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 and USP | Performance verified against these standards. | Substantially Equivalent (SE). |
| Filter Efficiency | Test methods described in USP and USP | 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 ** (Particulate matter in injections) and **USP ** (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.
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