(29 days)
The Sol-M Luer Lock Syringe is intended for aspiration of medications and fluids into the body.
The Sol-M Luer Lock Syringe is used to aspirate and inject fluid/medication into the body. The syringe is a sterile, single-use, 3-part syringe with luer lock conical connection. The Sol-MTM Luer Lock Syringe consists of the following components: Barrel, Plunger, Gasket. In addition to being used manually, the Sol-MTM Luer Lock Syringe can also work with a powerdriven syringe pump, with the luer lock tip connected to the IV administration line to deliver specific volume of fluid/medication. The syringe is individually blister packaged, and EtO sterilized with SAL of 10-6. The Sol-M™ Luer Lock Syringe is provided in 1, 3, 5, 10, 20, 30, and 60ml volume.
The provided text describes the Sol-M Luer Lock Syringe (K222744) and its acceptance criteria, particularly focusing on its suitability for use with power-driven syringe pumps.
Here's an analysis of the provided information, framed by your requested criteria:
The study primarily focuses on demonstrating the suitability of the Sol-M Luer Lock Syringe for use with power-driven syringe pumps, referring to ISO 7886-2 as the key standard.
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the device was tested according to ISO 7886-2:2020. The acceptance criteria are implicitly those defined by this standard. The reported performance is that the device met these criteria.
| Acceptance Criteria Category (based on ISO 7886-2) | Reported Device Performance |
|---|---|
| Critical Dimensions (for fit in pump) | Met acceptance criteria |
| Short-term Flow Rate Error (with pump) | Met acceptance criteria |
| Pump Forces (required to move plunger) | Measured and made available |
| Syringe Compliance (fluid displaced) | Met acceptance criteria |
| Manual Use (ISO 7886-1) | Previously demonstrated |
| Material/Design/Indications | Unchanged from predicate |
| Shelf Life (3 years) | Verified in testing |
| Biocompatibility | Leveraged from predicate |
| Sterilization | Unchanged from predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of syringes used for each test (e.g., for critical dimensions, flow rate, compliance tests). It only refers to "testing per ISO 7886-2."
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer, Sol-Millennium Medical Inc. The country of origin of the data is generally where the manufacturer performs their testing, which for Sol-Millennium Medical Inc. is based in Suwanee, Georgia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a bench testing (non-clinical) submission involving a physical medical device (syringe). "Ground truth" in this context refers to standardized measurements and performance specifications outlined in ISO 7886-2, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation of data where consensus is needed to establish a "ground truth" or resolve disagreements. For bench testing against a standard like ISO 7886-2, objective measurements are taken, compared against predefined limits, and either pass or fail.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading images) and the AI aims to improve their performance. This submission is for a physical medical device (syringe) and focuses on engineering performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is for a physical medical device, not an algorithm or AI. The testing described is "standalone" in the sense that the syringe's performance is measured directly, not in conjunction with human interpretation of its output.
7. Type of Ground Truth Used
The "ground truth" for the test set is established by international standards and specifications, specifically ISO 7886-2:2020 (for use with power-driven syringe pumps) and ISO 7886-1:2017 (for manual use). These standards define acceptable ranges for dimensional requirements, flow rate error, pump forces, and syringe compliance.
8. Sample Size for the Training Set
Not applicable. There is no AI/algorithm component requiring a training set mentioned in this submission. This is a traditional medical device (syringe) bench test.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 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).