(292 days)
The Savisafe Safety Device 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 self-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, Savisafe Safety Device is a non-sterile, single use anti-needlestick accessory for pre-filled ISO standard glass syringe that are 1ml with a needle length of 1/2". The proposed device consists of four components:(1) Syringe sleeve, (2) Syringe holder, (3) Plunger rod. (4) Spring. The proposed device has a five-year shelf life.
Here's a breakdown of the acceptance criteria and study information for the Savisafe Safety Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria for many of the tests. Instead, it states that the device "complies with the requirements" or that "the proposed device is substantial equivalence with the predicate device." Where specific findings are reported, they are included.
| Acceptance Criteria Category | Specific Test/Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. |
| Irritation (ISO 10993-10:2010) | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | |
| Sensitization (ISO 10993-10:2010) | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | |
| Safety Feature Performance | Safety Feature Activation Force Test (ISO 23908:2011) | The test results showed that the proposed device is substantially equivalent to the predicate device. |
| Safety Feature Override Force Test (ISO 23908:2011) | The test results showed that the proposed device is substantially equivalent to the predicate device. | |
| Activation Reaction | Conducted to meet the design specification. (Specific result not detailed, but implied successful.) | |
| Access to the sharp in safe mode | Conducted to meet the design specification. (Specific result not detailed, but implied successful.) | |
| Compatibility Performance | Tests with compatible pre-filled syringe | Demonstrated the compatibility between the proposed device and the pre-filled syringe. (Specific result not detailed, but implied successful.) |
| Durability/Transport | Simulated Transportation (ASTM D4169:2022) | Demonstrated the proposed device could function as intended after transportation. (Specific result not detailed, but implied successful.) |
| Simulated Clinical Study | Effect of safety feature (FDA Guidance Aug 9, 2005) | The test results demonstrated that the subject device complies with the requirements. (Specific result not detailed, but implied successful in preventing sharps injury under simulated conditions.) |
| Overall Conclusion | As safe, as effective, and performs as well as or better than predicate device. | The conclusion drawn from the non-clinical tests demonstrates that the proposed device, Savisafe Safety Device is as safe, as effective, and performs as well as or better than the legally marketed predicate device UltraSafe Passive PLUS Needle Guard (K123743). Additionally, the device is considered substantially equivalent to the predicate device based on the comparison of technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual non-clinical performance test. It mentions that tests were conducted "both on the proposed device and the predicate device" for the Safety Feature Performance tests.
The provenance of the data is not specified (e.g., country of origin, retrospective or prospective). Given that this is a 510(k) submission from a Chinese company, the testing was likely conducted in accordance with international standards, but the specific location of the test labs is not provided. All studies mentioned are non-clinical (laboratory/simulated), so "retrospective or prospective" doesn't strictly apply in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The studies conducted are non-clinical performance tests (biocompatibility, mechanical performance, simulated clinical use), not studies involving expert interpretation of medical images or clinical outcomes. Therefore, there's no "ground truth" established by medical experts in the traditional sense for these types of device performance tests.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple human readers or reviewers are making interpretations (e.g., of medical images) and their disagreements need to be resolved to establish a ground truth. The tests described are objective, non-clinical performance evaluations.
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:
This is not applicable as the device is a medical accessory (safety device for syringes), not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI in the document, nor are human readers involved in the performance evaluation described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable since the device is a mechanical safety accessory, not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the non-clinical performance tests, the "ground truth" is defined by adherence to established test standards and design specifications. For example:
- Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as determined by the specified ISO standards.
- Safety Feature Performance: The ability to activate and prevent override as per ISO 23908:2011 and deemed "substantially equivalent" to the predicate device.
- Simulated Clinical Study: Compliance with the requirements of FDA Guidance "Medical Devices with Sharps Injury Prevention Features."
This isn't "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather objective measurement against predefined engineering and biocompatibility criteria.
8. The Sample Size for the Training Set:
This is not applicable. There is no "training set" as this device is a mechanical safety accessory and does not involve machine learning or AI that would require training data.
9. How the Ground Truth for the Training Set was Established:
This is not applicable since there is no training set.
§ 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).