(198 days)
The Altaviz Intravitreal Syringe is intended for use by heath care professionals for general purpose fluid aspiration/injection. It is indicated for general and intravitreal use in adult patients.
The Altaviz Intravitreal Syringe is a three-piece sterile, single use, hypodermic syringe with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assembly consists of a lubricated polycarbonate barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the Altaviz Intravitreal Syringe incorporates a scale graduated in units of milliliters and is provided sterile by an irradiation sterilization method. The only difference between the Altaviz Intravitreal Syringe and the BD 1mL Luer-Lok Syringe is that the Altaviz Intravitreal Syringe is routinely tested to, and must meet, additional requirements to support intraocular use including endotoxin and particulate matter. The Altaviz Intravitreal Syringe is provided sterile by irradiation sterilization.
The provided FDA 510(k) clearance letter and summary for the Altaviz Intravitreal Syringe does not describe acceptance criteria, a study that proves the device meets specific acceptance criteria, or any information related to AI or ground truth as requested in the prompt.
The document states that "performance testing was also conducted and results confirmed that the Altaviz Intravitreal Syringe complies with the requirements of ISO 80369-7 (...) and ISO 7886-1 (...)". These ISO standards contain technical specifications and test methods for the performance of syringes. However, the document does not provide the specific acceptance criteria (e.g., maximum force, leakage rates, etc.) derived from these standards or the actual performance results of the Altaviz Intravitreal Syringe against those criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is the information that can be extracted or inferred to the best of my ability, highlighting where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material/Design Conformance: | |
| Barrel (Polycarbonate) | Identical to predicate |
| Barrel Lubricant (Silicone) | Identical to predicate |
| Plunger Rod (Polypropylene) | Identical to predicate |
| Stopper (Polyisoprene Rubber) | Identical to predicate |
| Stopper Lubricant (Silicone) | Identical to predicate |
| Sterilization: | |
| Sterilization Method (Gamma Irradiation) | Identical to predicate |
| Sterility Assurance Level (SAL) 10⁻⁶ | Identical to predicate |
| Shelf Life: | |
| 5 Years | Identical to predicate |
| Particulate Matter (for intravitreal use): | |
| USP Particulate Matter in Injections and USP Particulate Matter in Ophthalmic Solutions requirements | "Passed" (Specific values not provided) |
| Performance (ISO 80369-7 & ISO 7886-1): | |
| Requirements of ISO 80369-7 (Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications) | "Complies" (Specific acceptance criteria/values not provided) |
| Requirements of ISO 7886-1 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | "Complies" (Specific acceptance criteria/values not provided) |
| Biocompatibility: | |
| Cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity, hemolysis. | Conducted on predicate device (K941562) |
| Subacute toxicity (Chemical characterization and toxicological risk assessment). | "Performed" (Specific results not detailed beyond "ocular study...demonstrated that the device was not considered inflammatory to intraocular tissues of the rabbit.") |
Information not available in the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document only mentions "Particulate testing", "Performance testing", and "Non-Clinical Biocompatibility Testing" without detailing sample sizes or provenance of the test subjects/samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is not an AI/imaging device requiring expert adjudication for ground truth. The testing relates to physical and biological performance characteristics of a syringe. The ocular study was performed in rabbits, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical and chemical tests (e.g., particulate matter, ISO standards compliance), the "ground truth" is defined by the specific parameters and thresholds set within the respective standards (USP , ISO 80369-7, ISO 7886-1).
- For biological tests (biocompatibility, ocular study), the "ground truth" is determined by established biological safety standards, material characterization, and the observed responses in the animal model.
8. The sample size for the training set
- Not applicable. This is not an AI device needing a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device needing a training set.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).