(49 days)
Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist seff-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
The proposed device, NovaGuard SA Pro Safety System, is a non-sterile, single use anti needlestick accessory for pre-filled ISO standard glass syringes that are 1ml long with a max needle length of 5/8". The NovaGuard SA Pro Safety System consist of three components, syringe holder, sleeve and spring. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the injection, the needle is then covered by the sleeve protecting the user from potential sharps needle stick injury. There is a visual, tactile and audible recognition that the device safety feature has activated.
The provided document describes the NovaGuard SA Pro Safety System, an accessory for pre-filled syringes designed to prevent needlestick injuries. The submission is a 510(k) premarket notification, which means the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All testing met the required acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test. It only identifies the types of performance tests conducted and confirms they were measured against "internal performance standards."
| Acceptance Criteria (Not explicitly stated, assumed to be met) | Reported Device Performance (Implied) |
|---|---|
| Syringe assembly force: (Assumed internal standard) | Passed (met internal performance standards) |
| Pre-activation disassembly force (force applied to RNS): (Assumed internal standard) | Passed (met internal performance standards) |
| Pre-Activation Disassembly Force Test (force applied to cannula): (Assumed internal standard) | Passed (met internal performance standards) |
| Clip impact test (Integrated clip feature test): (Assumed internal standard) | Passed (met internal performance standards) |
| Drop Test - Post-activation with PFS: (Assumed internal standard) | Passed (met internal performance standards) |
| Drop Test - Pre-activation with PFS: (Assumed internal standard) | Passed (met internal performance standards) |
| Activation Security: (Assumed internal standard) | Passed (met internal performance standards) |
| RNS replacement: (Assumed internal standard) | Passed (met internal performance standards) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any of the performance tests.
The data provenance is not explicitly stated, but based on the context of a 510(k) submission from West Pharmaceutical Services, Inc., an American company, the testing would likely have been conducted in the United States (or by a contracted lab) and would be prospective (i.e., conducted specifically for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve experts establishing ground truth in the traditional sense (e.g., diagnosing medical conditions). The ground truth for performance testing of a mechanical device like this is determined by engineering specifications and objective measurements against predefined internal standards for force, impact resistance, and functionality. Therefore, this information is not applicable.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective mechanical/performance evaluations, not subjective assessments requiring adjudication.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is a factor. The NovaGuard SA Pro Safety System is a mechanical safety device. The document explicitly states: "The proposed device, NovaGuard SA Pro Safety System, modifications did not affect the device design impacting activation of the safety prevention feature therefore based upon their risk analysis a simulated use study was deemed not necessary." This indicates that even a human factors or simulated use study was considered unnecessary due to the nature of the modifications.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on engineering specifications and internal performance standards for mechanical integrity and functionality, rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic medical devices.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" in the context of this mechanical device. This concept applies to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, there is no ground truth for it.
In summary:
The document describes performance testing for a mechanical safety device, the NovaGuard SA Pro Safety System, which focuses on demonstrating its functional safety and mechanical integrity. The relevant "acceptance criteria" are the internal performance standards against which the device was tested, and the "study" is a series of bench tests. The submission argues for substantial equivalence based on these tests and the minor nature of the design modifications compared to the predicate device. Notably, no clinical or simulated use studies were deemed necessary for this 510(k) clearance due to the nature of the device and its modifications.
§ 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).