(250 days)
The BIOTOP DJT-A Safety Syringe (3cc/mL) serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.
The BIOTOP DJT-A Safety Syringe is a single-use hypodermic syringe that is very similar to a traditional syringe, except it possesses an integral needle retracting mechanism. Upon employing traditional syringe injection techniques, the needle can be manually retracted back inside the syringe barrel.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the BIOTOP DJT-A Safety Syringe:
Note: This document is a 510(k) Summary, which is a premarket notification for medical devices. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific performance acceptance criteria through extensive clinical trials as might be required for a PMA (Premarket Approval). Therefore, the "acceptance criteria" here are framed within the context of demonstrating equivalence.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence to DuoProSS™) | Reported Device Performance (BIOTOP DJT-A Safety Syringe) |
|---|---|
| Similar parts, design, material, operating procedure, and intended use to DuoProSS™. | Similar to DuoProSS™ in parts, design, material (PP plastic, lubricant, needle), operating procedure, and intended use. |
| Similar performance data under all conditions and stress as DuoProSS™. | "Performed bench testing revealed similar performance data, under all conditions and stress." |
| As safe and effective in its performance as DuoProSS™ in simulated field tests. | "Simulated field test suggests that the DJT-A is as safe and effective in its performance as the DuoProSS™." |
| Limits accidental needlestick injuries. | "The safety mechanism may limit accidental needlestick injuries..." |
| Helps to prohibit syringe reuse. | "...as well as help to prohibit syringe reuse." |
| Sterile and aseptic. | Sterile and aseptic, employing ethylene oxide (EO) sterilization. |
| Biocompatible. | Biocompatibility testing performed. |
| Meets requirements outlined in "Supplementary Guidance on Premarket Notification for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA." | All required testing (Bench, biocompatibility, sterility, substantial equivalence, simulated clinical testing) employed according to the FDA guidance document. |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated. The document mentions "Performed bench testing" and "simulated field test" without providing specific sample sizes for these tests.
- Data Provenance: The submitting company is BIOTOP Technology Co., Ltd. from Taiwan. The testing was conducted as part of their 510(k) submission. It's implied these were prospective tests conducted to support the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. The ground truth for performance was established through bench testing and simulated field testing, where the device's technical specifications and functional performance were compared to a predicate device. There is no mention of human expert evaluation in the establishment of ground truth for these tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is typically used for clinical studies involving human interpretation or subjective evaluations. The described performance testing (bench and simulated field tests) are objective measurements without the need for human adjudication in this context.
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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:
- Not applicable. This device is a mechanical safety syringe, not an AI software or diagnostic imaging device. Therefore, MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The performance described is "standalone" in the sense that the device itself was tested, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was the performance of the predicate device (M.K. Meditech's DuoPro Safety Syringe) and the established engineering and safety standards (as per FDA guidance for sharps injury prevention features). The BIOTOP DJT-A Safety Syringe's performance was compared against these.
- Specifically for the safety features, the ground truth relates to the physical mechanism effectively limiting accidental needle sticks and prohibiting reuse, which would be evaluated against engineering specifications and industry standards for safety syringes.
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The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model. There is no "training set" in the context of device development as described here.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this type of device submission.
§ 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).