(75 days)
The DR Safety Syringe is used to inject fluids into or withdraw fluids from the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
The DR Safety Syringe is a retractable type piston syringe, designed to aid in the prevention of needle stick injuries. This single-use, disposable syringe provided sterile and consists of the following components for 3ml and 5ml safety syringe: Barrel, Plunger, Stopper, Luer Assembly, hypodermic needle, Locking Ring and O-Ring.
0.5ml and 1ml safety syringe: Barrel, Plunger, Stopper, needle hub, needle tube, protective cap, Locking Ring and O-Ring
The DR Safety Syringe functions in a manner similar to standard syringes for fluid injection/withdrawal. After use, the health care professional fully depresses the plunger to engage the luer assembly/needle hub. Once the luer assembly/needle hub is engaged, pulling back the plunger causes the adapter and the attached needle to be withdrawn into the safety of the barrel. This retraction into the barrel of the syringe can be visually confirmed. Once this safety mechanism has been activated, the syringe is permanently disabled and the needle is completely secured within the barrel. Both the syringe and plunger are discarded in a Sharp's container.
The DR Safety Syringes are available for 0.5mL, 1mL, 3mL, 5mL.
The 0.5ml and 1ml DR Safety Syringes with fixed needle and 3ml, 5ml DR Safety Syringes with exchangeable needle are used to inject fluids into or withdraw fluids from the body. The DR Safety Syringes are designed to aid in the prevention of needle stick injuries
The provided text describes the 510(k) submission for the "DR Safety Syringe" and "Sterile Hypodermic Needle for Single Use." This document primarily focuses on demonstrating substantial equivalence to predicate devices through various performance tests and biocompatibility assessments, rather than presenting a clinical study with detailed acceptance criteria and performance data for an AI-powered medical device.
Therefore, I cannot fully answer your request according to the specific criteria you've asked for (e.g., acceptance criteria for AI performance, sample size for AI test sets, number of experts for AI ground truth, MRMC studies, standalone AI performance) because the provided document does not describe an AI medical device or a clinical study for one.
The document details the following for a physical medical device (syringe and needle):
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Acceptance Criteria & Device Performance (Physical Device):
- The document lists numerous bench and non-clinical tests conducted according to ISO standards (e.g., ISO 7886-1, ISO 7886-4, ISO 9626, ISO 7864, ISO 10993-1, ISO 23908) and FDA guidance for "Medical Devices with Sharps Injury Prevention Features."
- Specific performance criteria are implied by these standards (e.g., tolerance on graduated capacity, liquid leakage, air leakage, re-use prevention feature test, sterility, various limits for chemical extracts, dimensions, stiffness, bond strength, penetration force, corrosion resistance).
- The reported performance for each of these tests is stated as "All necessary bench and non-clinical testing were conducted... to support a determination of substantial equivalence" and "the test result demonstrate that DR Safety Syringe is safe" and "The nonclinical tests demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device."
- For biocompatibility, specific conclusions are provided (e.g., "did not show potential toxicity," "did not induce intracutaneous reactivity," "No evidence of causing skin sensitization," "no evidence of systemic toxicity," "No rabbit an individual rise in temperature of 0.5℃ or more," "had no influence on hemolytic properties," "had no effect on complement activity," "meets the requirement of thrombogenicity test").
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Sample Size:
- The document does not specify sample sizes for the individual bench or non-clinical tests. It states tests were conducted "according to" relevant ISO standards, which would typically define appropriate sample sizes for such tests.
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Data Provenance:
- Not applicable in the context of clinical data. This is bench testing of a physical device.
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Experts, Ground Truth, Adjudication, MRMC studies, Standalone AI, Training Set:
- These concepts are not relevant to the provided document, as it pertains to the regulatory submission of a physical medical device (syringe and needle) and its non-clinical performance and biocompatibility, not an AI/ML-driven device. There is no mention of AI, image interpretation, or clinical outcomes that would require human expert adjudication or MRMC studies. The ground truth for the device's performance is established by the specified ISO industrial standards and guidances.
In summary, the provided document details the non-clinical testing and biocompatibility assessments for a medical syringe and needle, demonstrating its adherence to established engineering and safety standards for substantial equivalence to existing devices. It does not provide information relevant to the performance evaluation of an AI-powered medical 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).