(87 days)
The Altaviz Needle Kit II is a convenience kit that includes:
A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe.
The Altaviz Needle Kit II is indicated for intravitreal use.
The Altaviz Needle Kit II is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The original version of this kit, the Altaviz Needle Kit, was cleared on December 5, 2022 (K222681), and the only difference between the Altaviz Needle Kit and the Altaviz Needle Kit II is the 29G injection needle included.
The tray of the Altaviz Needle Kit II is designed to securely store two separately packaged and previously sterilized needles: a single-use 29G injection needle and either a sterile 18G or 19G 5 micron filter needle. The tray lid provides protection and helps secure the needles during transport. No changes to the primary packaging of the needles or additional sterilization occurs prior to inclusion in the Altaviz Needle Kit II.
The 29G needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male connector (nozzle) of a piston syringe.
The 18G or 19G 5 micron filter needle is a sterile medical device for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate or ABS (respectively) designed to be connected with a male connector (nozzle) of a piston syringe. The filter needle is used to draw up fluids into a syringe.
The Altaviz Needle Kit II is a convenience kit consisting of a 29G injection needle and either an 18G or 19G 5 micron filter needle. The device is indicated for intravitreal use. The provided text outlines the substantial equivalence argument for this device, comparing it to a primary predicate (Altaviz Needle Kit) and an additional predicate (TSK Steriject 29G Hypodermic Needle). The acceptance criteria and the study proving the device meets these criteria are primarily focused on the performance of the individual components, specifically the 29G injection needle, for intravitreal use, as the "kit" itself is a convenience packaging of pre-sterilized, previously distributed needles.
Here's a breakdown of the information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance tests conducted to support the device's suitability for intravitreal use, specifically for the 29G injection needle. The text states that "Additional testing to intraocular acceptance criteria for the TSK 29G needle has been performed." and details these tests under "Performance Data".
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Particulate Matter | USP Particulate Matter in Injections | Meets specified limits for particulate matter in injections (general) | Passed |
| USP Particulate Matter in Ophthalmic Solutions | Meets specified limits for particulate matter in ophthalmic solutions (specific to eye) | Passed | |
| Biocompatibility/Irritation | ISO 10993-10 (Intraocular Irritation Testing) | No unacceptable intraocular irritation | Passed |
| Ethylene Oxide (EtO) Residuals | ISO 10993-7 | Residual EtO levels within specified safe limits | Assessed (and implicitly passed to support clearance) |
| Endotoxins | FDA guidance "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices" | Endotoxin levels within specified safe limits for intraocular devices | Tested (and implicitly passed to support clearance) |
Note on "Implicit" Acceptance Criteria: The document states that the tests were performed and "passed," implying that the device met the established acceptance criteria for those standards. The specific numerical limits for these standards (e.g., maximum particulate count, EtO limits, endotoxin levels) are not explicitly stated in this summary but are defined within the referenced ISO and USP standards and FDA guidance documents.
2. Sample Size and Data Provenance
- Sample Size for Test Set: The sample sizes for the specific performance tests (particulate, irritation, EtO residuals, endotoxins) are not explicitly stated in this document. These would typically be detailed in the full test reports referenced by the standards (e.g., ISO, USP).
- Data Provenance: Not explicitly stated from the provided text. The tests were performed to demonstrate compliance with international standards (ISO, USP) and FDA guidance, suggesting a controlled laboratory testing environment, but the country of origin of the data or whether it was retrospective/prospective is not specified. Given it's premarket notification, it's typically prospective testing.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable/not stated. For a medical device focused on physical and chemical characteristics, the "ground truth" is established by adherence to validated laboratory testing methods and compliance with established international standards (ISO, USP) and FDA guidance. The evaluation does not involve medical interpretation by experts in the same way an AI diagnostic algorithm for images would.
- Qualifications of Experts: Not applicable/not stated. The "experts" in this context would be the technicians and scientists performing the tests, qualified to conduct analyses according to the specified standards, but their specific qualifications are not detailed here.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1 consensus) is relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies need to be resolved. For laboratory performance testing against predefined standards, there is no "adjudication" in this sense; the results either meet the criteria or they do not.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is typically performed for AI-assisted diagnostic devices to evaluate how AI assistance impacts human reader performance. The Altaviz Needle Kit II is a physical medical device, not a diagnostic AI tool, so an MRMC study is not relevant.
6. Standalone Performance (Algorithm Only)
- Standalone Performance: No. This concept applies to AI algorithms. The performance evaluation here is of the physical device components themselves meeting safety and performance standards for their intended use.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth is established by objective laboratory measurements and tests against predefined, quantitative, and qualitative criteria within established international standards (ISO, USP) and FDA guidance. For example, the ground truth for particulate matter is the measured particulate count compared to the maximum allowable count, and for irritation, it's the observed biological response compared to predefined irritation scales.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI algorithm, so there is no "training set." The components of the kit are physical devices that undergo manufacturing and quality control processes to ensure consistency and compliance.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set.
§ 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).