(108 days)
The In6 Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.
The In6 Safety Syringe (3ml) is sterile, single-use, disposable, Non-reusable, Retractable, Piston Syringe, provided with needle attached in place., which is intended for the injection of medication into a patient, while minimizing the potential for accidental injury as a result of needle-stick (sharps injury).
In6 Safety Syringe (3ml) works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safely inside the empty syringe barrel for disposal.
The In6 Safety Syringe (3ml) consist of the following major components. 1. Plunger, 2. Barrel, 3. Piston, 4. O- Ring, 5. Spring, 6. Needle Hub, 7. U.V. Glue, 8. Cannula, 9. Needle Protector.
The provided text describes a 510(k) submission for the In6 Safety Syringe (3ml). It establishes substantial equivalence by comparing it to a predicate device and relies on bench testing and simulated use studies. However, the document does not include detailed acceptance criteria or the specific results of a study that proves the device meets those criteria in the format requested.
The document states:
- "In terms of Physical specification, Chemical specification, Biological Summary: specification & Sterilization Specification, the device conforms to applicable standards included ISO 7864, ISO 7886-1, ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards----etc."
- "Moreover, bench testing & simulated use study contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
This indicates that studies were performed, but the specific acceptance criteria and the numerical performance results are not detailed in this summary. Therefore, many of the requested fields cannot be populated from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Physical Specification | Conforms to ISO 7864, ISO 7886-1 | "demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Chemical Specification | Conforms to ISO 10993 series | "demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Biological Specification | Conforms to ISO 10993 series, USP Pyrogenic standards | "demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Sterilization Specification | Conforms to ISO 11607-1, ISO 11135 | "demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Sharps Injury Reduction | Designed to reduce risk of sharps injuries | "demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Syringe Reuse Prevention | Designed to reduce potential for syringe reuse | "demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Retraction Mechanism | Needle retracts safely inside empty syringe barrel for disposal | "bench testing & simulated use study contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
Missing Information (Not available in the provided text):
- Specific numerical thresholds for "conforms to standards" (e.g., specific force required for retraction, leakage rates, biocompatibility results).
- Detailed quantitative results from the "bench testing & simulated use study."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "bench testing & simulated use study" but does not give the number of syringes tested or the specifics of the test designs.
- Data Provenance: Not specified. It's likely from Taiwan, given the company's address, but not explicitly stated for the study data. The studies are described as "bench testing & simulated use study," which implies prospective data collection for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The studies appear to be primarily engineering/performance testing against established standards, rather than studies requiring expert medical interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the text. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.
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. This is a medical device (syringe) and not an AI/imaging diagnostic device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a medical device (syringe) with a mechanical safety feature, not an algorithm. So, this question is not applicable. The "standalone" performance would be the device's ability to retract the needle as designed, which was assessed via "bench testing & simulated use study."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance claims appears to be compliance with international standards (ISO, USP) and the intended mechanical function (needle retraction). This would be established through objective measurements and physical/chemical/biological tests.
8. The sample size for the training set:
- This is a medical device (syringe) with a mechanical safety feature, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no training set in the AI/ML sense for this 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).