(104 days)
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
The StaClear Syringe is a single-use piston syringe intended for use by healthcare professionals for general-purpose fluid aspiration/injection. Its operation is manual. The StaClear Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. It uses standard syringe components with a low-particulate gas plasma crosslinked silicone coating called TriboLink-Si. The StaClear Syringe is suitable for ophthalmic use.
The StaClear Syringe is offered in the following configurations:
- SC250AN – Consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap.
- SC250LS – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-slip connector, plunger, and plunger stopper.
- SC250LL – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-lock connector, plunger, and plunger stopper.
The provided document is an FDA 510(k) clearance letter for the StaClear Syringe, which is a medical device, not an AI/ML algorithm. Therefore, many of the requested fields, such as "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth," and information about training sets, are not applicable to this type of device and therefore not present in the document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to established performance standards for syringes.
Here's the information that can be extracted from the provided text regarding acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance
The document lists various ISO and USP standards as the basis for performance evaluation. The "Acceptance Criteria" are implied to be compliance with these standards, and the "Reported Device Performance" is stated as "Identical" or "Compliant" with these standards.
| Attribute/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Syringe Performance (ISO 7886-1) | Compliance with ISO 7886-1:2017 | Identical to predicate; Device maintains performance per ISO 7886-1 after 5-years of aging. |
| - Cleanliness | Pass | Identical |
| - Acidity and Alkalinity | Pass | Identical |
| - Extractable Metals | IOL limits per ISO 11979-5 | Identical |
| - Lubricant | Pass | Identical |
| - Tolerance on Graduations | Pass | Identical |
| - Stopper Detachment | Pass | Identical |
| - Dead Space | Pass | Identical |
| - Air and Liquid Leakage Past Stopper | Pass | Identical |
| - Plunger Force | Pass | Identical |
| - Fit of Stopper | Pass | Identical |
| Needle Performance (SC250AN only) (ISO 7864 & ISO 9626) | Compliance with ISO 7864:2016 & ISO 9626:2016 | Identical to predicate; Device maintains performance per ISO 7864, ISO 9626 after 5-years of aging. |
| - Cleanliness | Pass | Identical |
| - Acidity and Alkalinity | Pass | Identical |
| - Extractable Metals | IOL limits per ISO 11979-5 | Identical |
| - Tolerance on Length | Pass | Identical |
| - Tube Defects | Pass | Identical |
| - Lubricant | Pass | Identical |
| - Point Defects | Pass | Identical |
| - Needle Penetration Force | Pass | Identical |
| - Bond Between Tube and Hub | Pass | Identical |
| - Patency of Lumen | Pass | Identical |
| - Materials | Pass | Identical |
| - Surface Finish | Pass | Identical |
| - Size Designation | Pass | Identical |
| - Outside Diameter | Pass | Identical |
| - Stiffness | Pass | Identical |
| - Resistance to Breakage | Pass | Identical |
| - Resistance to Corrosion | Pass | Identical |
| Luer Connector Performance (SC250LS and SC250LL only) (ISO 80369-7) | Compliance with ISO 80369-7:2021 | Compliant with established performance standards; Device maintains performance per ISO 80369-7 after 5-years of aging. |
| - Materials | Pass | Compliant |
| - Dimensional Requirements | Pass | Compliant |
| - Fluid Leakage | Pass | Compliant |
| - Air Leakage | Pass | Compliant |
| - Stress Cracking | Pass | Compliant |
| - Separation Force | Pass | Compliant |
| Luer-Lock only (ISO 80369-7) | Compliance with ISO 80369-7:2021 | Compliant with established performance standards. |
| - Unscrewing Torque | Pass | Compliant |
| - Resistance to Overriding | Pass | Compliant |
| Particulate Testing | Compliance with USP & USP | Identical to predicate; Device performs as intended. |
| - Particulate Matter in Injections (USP ) | Pass | Identical |
| - Particulate Matter in Ophthalmic Solutions (USP ) | Pass | Identical |
| Biocompatibility | Compliance with ISO 10993-1 for external communicating device with prolonged tissue contact | Biocompatible for intended use. |
| Sterility | Sterilized to SAL 10⁻⁶; Endotoxin per USP with IOL limits; Sterility per USP | Sterilized to SAL 10⁻⁶; Endotoxin levels meet IOL limits; Device maintains sterility per USP after 5-years of aging. |
| Shelf Life | Maintain performance and sterility for 5 years | Testing demonstrates performance and sterility maintained over 5 years after accelerated aging. |
| Packaging | Compliance with ISO 11607-1:2019 for sterile barrier | Compliant with established requirements per ISO 11607-1:2019. (For Tyvek Pouch packaging) |
| - Sterile Barrier Integrity | Pass (e.g., using bacterial aerosol followed by sterility tests per USP ) | Maintained. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for testing each attribute. The data provenance (country of origin, retrospective/prospective) is also not provided. The testing is described as "non-clinical testing" and "performance testing performed as per the design control system," suggesting in-house, prospective testing.
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 is a physical medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the device's performance is objective measurements against established engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring adjudication of interpretations.
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 a physical medical device and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance refers to the device's adherence to specified standards in direct testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to recognized international and national standards for medical devices, specifically:
- ISO standards (e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993-1, ISO 11607-1) which define performance characteristics, materials, and testing methodologies.
- USP standards (e.g., USP , USP , USP , USP ) which define testing for particulate matter, sterility, and endotoxins.
- ASTM standards (e.g., ASTM D4169, ASTM F1980) for packaging and accelerated aging.
These standards provide objective, measurable criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve a training set as would an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device and does not involve 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).