(203 days)
The Easy Point™ Needle is intended for use with syringes for general purpose fluid injection and/or aspiration, and venipuncture to obtain blood collection. The EasyPoint™ Needle aids in the prevention of needlestick injuries.
The EasyPoint™ Needle is intended for general purpose percutaneous injection or aspiration of fluids and venipuncture to obtain blood collection. The device contains a sharps injury prevention feature (needlestick prevention feature-chamber) that covers the entire needle after use. Initially available in sizes of 23G and 25G x 1" and 25G x 5/8" for use with 3mL syringes or smaller.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the EasyPoint™ Needle:
This device is a Class II medical device (Needle, Hypodermic, Single Lumen), and the submission is a 510(k) Premarket Notification (K133635), indicating a pre-market pathway based on substantial equivalence to existing predicate devices, rather than a de novo approval or PMA which would typically involve more extensive clinical studies and a focus on specific performance metrics. Therefore, the "acceptance criteria" here primarily refer to demonstrating safety and effectiveness by being substantially equivalent to the predicate devices and meeting relevant engineering standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Engineering Performance | ISO 594-1 (Luer fittings) | Performed according to applicable design requirements. | Passed. |
| ISO 594-2 (Luer fittings) | Performed according to applicable design requirements. | Passed. | |
| ISO 7864 (Sterile hypodermic needles) | Performed according to applicable design requirements. | Passed. | |
| ISO 7886 (Sterile hypodermic syringes) | Performed according to applicable design requirements. | Passed. | |
| ISO 9626 (Stainless steel needle tubing) | Performed according to applicable design requirements. | Passed. | |
| Liquid Leakage | Performed according to applicable design requirements. | Passed. | |
| Air Leakage | Performed according to applicable design requirements. | Passed. | |
| Dead Space | Performed according to applicable design requirements. | Passed. | |
| Needle Puncture Force | Performed according to applicable design requirements. | Passed. | |
| Functionality Force | Additional performance tests developed by Retractable Technologies, Inc. | Passed. | |
| Deactivation Force | Additional performance tests developed by Retractable Technologies, Inc. | Passed. | |
| Chamber Strength/Rigidity | Additional performance tests developed by Retractable Technologies, Inc. | Passed. | |
| Cannula/Hub Bond Strength | Additional performance tests developed by Retractable Technologies, Inc. | Passed. | |
| Biocompatibility | ISO 10993 | Acceptable results. | Passed. |
| Sterilization | ISO 11137 (Sterilization of healthcare products — Radiation) | Sterilization Validation performed to ensure sterility (SAL 10⁻⁶). | Passed. |
| Human Factors/Usability | Demonstrated safe and effective use by healthcare workers in a simulated use scenario. | Performed safely and effectively. | Passed. |
| Substantial Equivalence | Comparison to predicate devices (VanishPoint® Syringe and BD PrecisionGlide® single lumen needle) based on intended use, technology, and performance. | Devices are substantially equivalent; no new issues of safety and effectiveness raised. | Conclusion reached by applicant and affirmed by FDA. |
2. Sample Size Used for the Test Set and Data Provenance:
- Engineering Testing: The text does not specify the exact sample sizes for each engineering test (e.g., how many needles were tested for liquid leakage). It generally states that "Performance testing... was performed according to applicable design requirements" and "Additional performance tests were developed."
- Simulated Use Study: The text does not specify the exact sample size (number of healthcare workers) for the simulated use study.
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Retractable Technologies, Inc. The nature of the studies (engineering, simulated use) suggests prospective data collection for the purpose of this submission.
- Biocompatibility & Sterilization: These are standard laboratory tests, and sample sizes are typically defined by the specific ISO standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Engineering Testing: Ground truth is established by the defined engineering standards (ISO) and the measurement systems used. No external experts are mentioned for establishing ground truth beyond standard engineering practices.
- Simulated Use Study: The study involved "a variety of healthcare workers." The number and specific qualifications (beyond "healthcare workers") are not provided. The ground truth here would be the observed safe and effective use of the device by these users.
4. Adjudication Method for the Test Set:
- Not applicable in the traditional sense for this type of submission. The performance against engineering standards is objective. For the simulated use study, the assessment would likely be observational, without a formal adjudication committee as might be found in a clinical trial.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic imaging devices where multiple readers interpret cases to assess diagnostic accuracy with and without AI assistance. The EasyPoint™ Needle is a medical device for fluid injection, aspiration, and blood collection, not a diagnostic imaging tool.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable. This device is a manual device (hypodermic needle) with a passive safety mechanism. There is no "algorithm" or AI component to assess standalone performance for. The "safety feature" is mechanical and integrated into the design.
7. Type of Ground Truth Used:
- Engineering Testing: Defined by international standards (ISO) and internal test protocols.
- Biocompatibility: Defined by ISO 10993 standards and laboratory results.
- Sterilization: Defined by ISO 11137 standards and validation results.
- Simulated Use Study: Observational assessment of safe and effective use by target users (healthcare workers).
8. Sample Size for the Training Set:
- Not applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.
§ 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).