(109 days)
Single use devices that are indicated for use as an accessory with BD Hypak Sterile Clean Fill (SCF) glass Prefilled Syringes 1 mL long to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The devices can be used on a wide range of patients including children and adults.
The Safe'n'Sound® Luer Lock Passive Delivery System is an anti-needlestick accessory for use with BD Hypak SCF glass Prefilled Syringes. It fits with needles 1" long maximum, and consists of a body assembly and a loose plunger rod.
The Safe'n'Sound® Luer Lock Passive Delivery System is and anti-needlestick accessory for use with BD Hypak SCF glass Prefilled Syringes and is intended to protect healthcare professionals, patients who self-inject doctor prescribed medication, and individuals that assist self-injecting patients, from accidental needlesticks. The device can be used on a wide range of patients including children and adults.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Standard/Acceptance Criteria | Reported Device Performance |
|---|---|
| Product functions as intended | Confirmed by bench testing |
| Biocompatibility (ISO 10993-5) | Meets requirements |
| Biocompatibility (ISO 10993-10) | Meets requirements |
| Safe to use | Confirmed by simulated clinical use testing |
| Effective in shielding needles | Confirmed by simulated clinical use testing |
| Substantially equivalent to predicate devices | Concluded based on functional testing, design, technology, performance, and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the bench testing or simulated clinical use testing. It generally states that "Bench testing has been performed" and "Simulated clinical use testing has been performed."
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, "simulated clinical use testing" suggests a prospective, controlled environment, rather than retrospective real-world data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned (bench testing, simulated clinical use testing) would likely involve technical personnel and possibly healthcare professionals for the simulated use, but specific details are absent.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance is provided. This device is a mechanical accessory, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a mechanical anti-needlestick accessory, not an algorithm or software.
7. The Type of Ground Truth Used
Based on the description of the testing, the "ground truth" for this device would be established through:
- Engineering specifications and objective measurements: For bench testing, ensuring the device components function as designed and meet specific technical parameters.
- Observational data/expert assessment: For simulated clinical use, verifying that the device effectively shields the needle and can be used safely and effectively by users in a controlled environment.
8. The Sample Size for the Training Set
This question is not applicable as the device is a mechanical accessory and does not involve AI/machine learning training sets.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a mechanical accessory and does not involve AI/machine learning training sets or associated ground truth establishment.
Summary of the Study Proving Device Meets Acceptance Criteria:
The device's performance was assessed through two primary types of studies:
- Bench Testing: This confirmed that the "product functions as intended" and demonstrated substantial equivalence to predicate devices in "general technological features and principle of operation." This testing would have involved evaluating mechanical integrity, activation mechanisms, and general functionality. Biocompatibility testing (meeting ISO 10993-5 and ISO 10993-10) was also performed as part of the bench tests.
- Simulated Clinical Use Testing: This testing confirmed that the device "could be used safely and effectively to shield needles inside the protection device after use." This likely involved users (potentially healthcare professionals or simulated users) performing injection actions with the device and verifying that the needle retraction/shielding mechanism activated correctly to prevent needlesticks.
Based on the results of these tests, the manufacturer concluded that "the Safe'n'Sound® Luer Lock Passive Delivery System is substantially equivalent to predicate devices currently marketed under the Food, Drug and Cosmetic Act" and "raises no new issues of safety or effectiveness."
§ 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).