(85 days)
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
SEZ Safety Syringe consists of 1) a calibrated hollow barrel which contains medication and, after use, confines 2) the needle, 3) a movable plunger which aspirates medication and, after injection, retracts the needle into the barrel, At the distal end of the barrel, there is a female connector(nozzle) for fitting 3) a male connector(hub) to which the needle is firmly attached by bonding material. The needle is securely protected by 5) a cap before use. For sealing purpose, 6) an o-ring, between barrel and hub, and a gasket, between barrel and plunger, are used. The function of the device is to deliver medication and, after injection, to destroy the needle in the barrel to prevent needlestick injury and possible reuse. The injection process is practically the same as that of the conventional, non-safety, syringes, that is, to aspirate medication from a vial and to deliver it to a patient. The disposal process is turn-pull-push operation, each step of which is clearly and unmistakably defined. By turning the knob of the plunger half round clockwise, hub is disassembled from the barrel. Then plunger is pulled backward until it stops, which retracts hub and needle into the barrel. Needle is tilted to one-side pushed by the rod at plunger head. Finally, the plunger is pushed forward to crumble the needle in the barrel. Needle and contaminated fluid are contained in the barrel safely and used syringe can be discarded in the sharps container.
The provided text describes the SEZ Safety Syringe, a device for intramuscular and subcutaneous injection that aims to prevent needlestick injuries. A 510(k) submission (K031163) was made to the FDA, asserting its substantial equivalence to the EXEL Secure Touch Safety Syringe (K011754).
Here's an analysis of the acceptance criteria and the study as described in the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device, emphasizing safety and effectiveness, especially in preventing needlestick injuries, and adherence to relevant standards. The "reported device performance" is primarily a statement of equivalence and clinical acceptability.
| Acceptance Criteria Category | Specific Criteria (Implicitly from Comparison Document) | SEZ Safety Syringe Performance (Reported in 510(k) Summary) |
|---|---|---|
| Intended Use | Safety hypodermic syringe for intramuscular and subcutaneous medication injection, aiding in needlestick injury prevention. | Identical to predicate device. |
| Principle of Operation | Safety feature activation: |
- Disassemble needle assembly by turning plunger.
- Retract needle into barrel and confine it. Break plunger before disposal. | Identical, except needle confinement is guaranteed by pushing the plunger forward before disposal (instead of breaking the plunger). This is presented as an equivalent mechanism. |
| Volume (ml/cc) | Available in 3 and 5 ml/cc. | Available in 3 ml/cc. (The 5ml/cc variant is not mentioned for SEZ, but 3ml/cc is present, implying a subset comparison for available sizes). |
| Nozzle Type | Male conical lock fitting with rotatable internally threaded collar. | Female conical lock fitting with rotatable internally threaded neck. (Presented as a design difference but not a functional deviation from safety/effectiveness). |
| Barrel Marking | Conforms to ISO 7886-1:1993(E) standard. | Identical to predicate device. |
| Reuse | Non-reusable. | Identical to predicate device. |
| Biocompatibility | Conforms to ISO 10993-1. | Identical to predicate device. |
| Materials | Specific plastic parts, gasket, o-ring, packing film, packing paper as listed for predicate. | Identical to predicate device materials. |
| Sterility | Sterilized by ethylene oxide gas, SAL = 10^-6. | Identical to predicate device. |
| Overall Safety & Effectiveness | Substantially equivalent to predicate device, including needlestick injury prevention. | "In all material respects, the SEZ Safety Syringe is substantially equivalent to the predicate device." "The results of the investigation showed that the SEZ Safety Syringe is clinically acceptable." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "A clinical investigation was performed in conformity with the requirements specified in Annex X of MDD93/42/EEC, and test for the comparison between SEZ Safety Syringe and the legally marketed predicate device was performed in accordance with 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA'."
- Sample Size: The exact sample size for the "clinical investigation" or "test for the comparison" is not specified in the provided text.
- Data Provenance: The MDD93/42/EEC (Medical Devices Directive) indicates European regulatory compliance, suggesting the clinical investigation likely took place in a country adhering to these regulations. The "Guidance for Industry and FDA" suggests the data was also considered for the US FDA submission. The text does not explicitly state if the study was retrospective or prospective, but clinical investigations typically imply a prospective approach.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. Clinical investigations for device comparison often involve assessments by nurses or other healthcare professionals, but their specific roles in establishing a "ground truth" (e.g., for injury events) or their qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
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
- MRMC Study: This is not applicable as the device is a mechanical safety syringe, not an AI-powered diagnostic or assistive technology for "human readers."
- Effect Size of AI assistance: Not applicable.
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 mechanical safety syringe, not an algorithm. Performance is assessed on its mechanical function and safety features in preventing injuries.
7. The Type of Ground Truth Used
For a mechanical safety device like a syringe, the "ground truth" typically involves:
- Performance Metrics: Successful activation of the safety mechanism, prevention of needlestick injuries, proper medication delivery, and ease of use.
- User Feedback/Observations: Direct observation of users (healthcare professionals) using the device, recording successful safety feature activation, and instances of failure or injury.
- Biocompatibility Testing: Lab-based testing to ensure no adverse biological reactions (conforms to ISO 10993-1).
- Physical Testing: Mechanical tests to confirm strength, durability, and compliance with standards (e.g., barrel marking to ISO 7886-1).
The provided text states: "The results of the investigation showed that the SEZ Safety Syringe is clinically acceptable." This implies the ground truth was established through direct observation and measurement of the device's performance in a clinical setting against established safety and functional criteria for syringes with sharps injury prevention features.
8. The Sample Size for the Training Set
This is not applicable as the device is a mechanical safety syringe and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device does not require a "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).