(232 days)
A sterile, single-use hypodermic syringe, incorporating a safety mechanism designed to withdraw the needle back into the safety shield after use and lock it in this position. To be used for injecting medications or fluid into the patient by attached cannula or via IV therapy or to draw samples or fluids by the same means.
The Smartlock™ safety syringe is a sterile, single use hypodermic syringe incorporating an innovative safety mechanism. It is designed to withdraw the needle into the safety shield after use and to lock it in this position. The syringe consists of three parts: a safety shield, a barrel and a plunger. There is no rubber piston. The syringe is packaged fully assembled and no set-up action or pre-use motion is necessary. Needles are attached in the standard luerslip method and can be changed during a procedure, if necessary. The materials used in production are medical grade polypropylene and polyethylene. As the last of the medication is delivered, the plunger rim will disengage the safety clips from the shoulder. As the plunger is retracted (as if to refill), the needle will also retract. The plunger must be retracted fully until a "click" sound is heard and no movement is possible. Disposal is then simple and safe. The functioning of the 3ml, 5ml and 10ml Smartlock ™ Safety Syringes are identical in all respects, save the amount of fluid which can be aspirated.
The provided text describes the "Smartlock™ Safety Syringe" and presents information from a 510(k) submission, including a comparison to predicate devices and results from a clinical trial and a simulated use study. However, the document does not explicitly state acceptance criteria for the device. Instead, it aims to demonstrate substantial equivalence to existing predicate devices.
Therefore, the response below will focus on explaining how the studies demonstrate substantial equivalence, rather than directly fulfilling a "reported device performance" against "acceptance criteria" table as the document does not provide such a table.
1. Table of Acceptance Criteria and Reported Device Performance
As the provided document is a 510(k) summary, it focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and reporting performance against them. The "acceptance criteria" for a 510(k) would generally be the performance of the predicate device, which the new device aims to match or be non-inferior to.
The studies aim to show that the Smartlock™ safety syringe performs comparably to or better than the predicate devices in relevant aspects. The key performance metrics evaluated were:
| Acceptance Criteria (Implied by Predicate Device Performance) | Reported Device Performance (Smartlock™ Safety Syringe) |
|---|---|
| Clinical Performance (Syringe Functionality) | Substantially equivalent to Becton Dickinson Plastipak™ standard syringe in respect of comparable characteristics. Nurses ranked both types of syringes similarly and positively. Successful functioning of syringes confirmed by monitors and an independent auditor. |
| Safety Mechanism Usage / Effectiveness | Substantially equivalent to Becton Dickinson Safety-Lok™ safety syringe with respect to the rates of correct usage. The success rates in correctly using the Smartlock™ safety syringe did not significantly differ from the Safety-Lok™. "In-service" training sessions enhance the rate of correct usage for both safety syringes, with the Safety-Lok™ scoring slightly higher with this added training. The intention of the safety mechanism (needle retraction and locking) is fulfilled, rendering the syringe unusable after activation. |
| Physical and Operational Characteristics | Generally comparable in intended use, syringe size (5ml), type (single-use), and the principle of operation for 3ml, 5ml, and 10ml versions. Key differences exist in the number of parts (3 vs 6), materials (polypropylene/polyethylene vs silicone rubber in predicate), connection type (luerslip vs luerlock), scaling (read in reverse off plunger vs forward off barrel), and aspiration method. The safety feature operates by needle retraction and locking in one operation, activated manually after medication dispensing, similar in intent to the Safety-Lok™ pulling a shield over the needle. The Smartlock™ cannot be re-used, similar to the Safety-Lok™. Sterilization via EO gas (vs. Gamma radiation for Safety-Lok™ and EO gas for Plastipak™). |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Trial: The clinical trial involved nurses in three South African hospitals. The exact number of nurses or syringes evaluated is not specified.
- Simulated Use Study: The simulated use study was conducted at three separate American hospitals. The exact number of participants or simulated uses is not specified.
Both studies appear to be prospective in nature, as they involve monitoring and evaluations during actual or simulated use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Clinical Trial:
- Monitors: "Experienced personnel" monitored the actual use of syringes by nurses. No further specific qualifications or number of monitors are given.
- Auditor: An "independent auditor" evaluated the number of syringes which functioned successfully. No specific qualifications (e.g., medical background, experience years) or number of auditors are given.
- Simulated Use Study: No specific experts are mentioned for establishing ground truth, as the study focused on comparing correct usage rates between the two safety syringes among nurses who received instruction.
4. Adjudication Method for the Test Set
- Clinical Trial: There isn't an explicit "adjudication method" described in the sense of resolving disagreements between multiple expert reads. However, "experienced personnel" monitored use, and an "independent auditor" evaluated successful function, suggesting a form of review process.
- Simulated Use Study: The study assessed "success rates in correctly using" the syringes. The method of determining "correct usage" is not detailed, so no specific adjudication method is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a formal Multi-Reader, Multi-Case (MRMC) comparative effectiveness study, as typically performed for diagnostic imaging devices, was not conducted. The studies involved nurses (users/readers) but focused on their ability to correctly use the device and their subjective experience, rather than their diagnostic accuracy across multiple cases with and without AI assistance. The device is a syringe, not a diagnostic tool requiring interpretation by multiple readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This question is not applicable to the Smartlock™ Safety Syringe. This device is a physical medical instrument (a syringe), not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this product.
7. The Type of Ground Truth Used
- Clinical Trial: The ground truth for the clinical trial was the observed successful functioning of the syringes during actual use and the subjective experiences/ranking of nurses. This is performance and usability ground truth.
- Simulated Use Study: The ground truth for the simulated use study was the rate of correct usage of the safety mechanism by nurses, and potentially their subjective feedback, which falls under usability and performance.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this device. A training set is typically relevant for machine learning algorithms. As the Smartlock™ Safety Syringe is a physical medical device, not an AI or algorithm, the concept of a training set as described here does not apply.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).