(153 days)
The OVUS Capless Safety Needle, when used with a standard commercially available syringe, is intended to inject fluids into, or withdraw fluids from, parts of the body, including the applications of hypodermic injection, veinipuncture, and drawing of arterial blood. The needle is retracted after use to prevent accidental needle sticks.
The OVUS Capless Safety Needle is a retractable needle system that provides anti-sharps protection. The device is made of the following components: (1) a slotted plastic housing, (2) a needle with a tab on the hub that protrudes from the slot in the housing when installed, (3) a spring that fits over the metal needle shaft, (4) a collar bonded to the proximal end of the housing to prevent the needle from sliding out, (5) a locking pin to prevent reuse (tamper-proof version only), and (6) a dust cover for the distal end of the device. The housing has a slot that allows the tab on the needle hub to slide toward the distal end and into the extended position with the needle fully exposed. At each end of the slot there is a short perpendicular slot that serves to lock the needle/tab in either the fully retracted or fully extended position. When extended, the spring is compressed and would tend to retract the needle unless it were locked in the extended position.
This 510(k) summary describes a medical device, the OVUS Capless Safety Needle, which is a retractable needle system designed to prevent accidental needle sticks. The summary focuses on establishing "substantial equivalence" to predicate devices rather than providing specific acceptance criteria and detailed study results in the manner typically found for AI/software-based devices.
Therefore, for aspects like acceptance criteria, sample sizes, expert qualifications, and detailed performance metrics, the available document does not contain the granular information usually requested for AI device studies.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds or benchmarks. Instead, it describes a comparative evaluation against predicate devices based on "functionality outcome measures" and "safety" ratings from participants in simulated-use studies. The reported device performance is qualitative and comparative.
| Acceptance Criterion (Implicit) | Reported Device Performance (OVUS Capless Safety Needle) |
|---|---|
| Functionality (vs. Needle-Pro) | - Preferred in all but one of six functionality measures in one study. |
| - Preferred in 3/6 functionality measures in another study. | |
| - Statistical significance obtained for 4/6 and 1/6 measures respectively. | |
| Functionality (vs. VanishPoint) | - Preferred on only 1/6 functionality measures. |
| - Differences were very small and none were significant. | |
| Safety (vs. Needle-Pro) | - Rated higher on safety. |
| - Equivalence established in both studies in primary analysis. | |
| Safety (vs. VanishPoint) | - Expressed a slight (non-significant) preference for the safety feature. |
| Substantial Equivalence | - Demonstrated substantial equivalence to predicate devices based on performance data from simulated-use studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of participants or the number of simulated uses in the "simulated-use studies." It refers to "participants in the three studies."
- Data Provenance: Not specified. Given the context of a US FDA submission, it is highly likely the studies were conducted in the United States, but no explicit country of origin is mentioned. The studies were prospective simulated-use studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the traditional sense of ground truth for an AI/diagnostic device. The "ground truth" here is the user experience and safety perception during simulated use, as rated by the participants themselves. These participants are not described as "experts" creating a definitive ground truth label, but rather as users evaluating the device.
4. Adjudication Method for the Test Set
Not applicable. The study involved participants rating the devices, and the results were likely aggregated and analyzed statistically. There's no mention of an "adjudication method" in the context of resolving discrepancies in expert labeling or diagnoses.
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
The study described is not an MRMC comparative effectiveness study focused on human reader improvement with AI assistance. It is a simulated-use comparison of a new medical device (a safety needle) against predicate devices, focusing on user-reported functionality and safety. This device is not an AI/software as a medical device (SaMD).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device (safety needle), not an algorithm or AI. Its performance is intrinsically linked to human interaction during its use.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on user ratings and perceptions of functionality and safety during simulated use. It is not an objective, independently verified ground truth like pathology or outcomes data, but rather subjective feedback from the study participants.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no concept of a "training set" for an algorithm. The development and testing likely involved engineering and design iterations, but not algorithm training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned 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).