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These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes

The Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and protected by blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected to the pen. The needle cap cover is intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

The Easy.Touch Pen Needle (K112789) is a relabeled version of the Feel Fine insulin pen needle (K080904) and is claimed to be substantially equivalent to it and Becton Dickenson Pen Needles (K100005, K051899). The submission provided a summary of performance testing to support this claim of substantial equivalence.

Here's an breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Bench testing included biocompatibility, compatibility with ISO Type A pens, mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as effective, and performs in a substantially equivalent manner to the previous predicate devices."
However, specific acceptance criteria values (e.g., minimum tensile strength, maximum leakage rate) and the precise reported device performance values are not detailed in the provided text. The claim is general, stating that the device "is as effective, and performs in a substantially equivalent manner."

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not specified. The document states "Bench tests were performed," but does not provide the number of units tested for each type of bench test.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by MHC Medical Products or its contracted labs, likely performed in the USA given the company's address. The data is retrospective in the sense that it's based on completed bench tests submitted for regulatory review.

3. Number of Experts and Qualifications for Ground Truth:

• This information is not applicable as the provided documentation describes a medical device, specifically a pen needle. The "ground truth" for such a device is established through objective physical, chemical, and biological performance testing (bench tests) against recognized standards and predicate device performance, not through expert consensus on interpretations like with diagnostic imaging.

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC study was not done. This type of study is typically performed for AI-powered diagnostic systems or decision support tools where human interpretation is involved. The Easy.Touch Pen Needle is a mechanical device, not a diagnostic or AI-assisted tool.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone algorithm study was not done. This is not an AI/algorithm-driven device. The performance refers to the physical and biological characteristics of the pen needle itself.

7. Type of Ground Truth Used:

• The ground truth used for evaluating the device's performance was based on objective bench test results against established engineering specifications, ISO standards (e.g., for ISO Type A pens), and the performance characteristics of legally marketed predicate devices. This includes measurements for mechanical integrity, material biocompatibility, and sterility.

8. Sample Size for the Training Set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing are based on established engineering principles and standards, not data training.

9. How Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

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For the injection of U100 insulin. The Easy.Touch disposable sterile insulin syringes are intended for injection of U100 insulin only.

The Easy Touch insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle. The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston svringes. This premarket notification is for additional needle gauges and lengths as compared to our previous submission, K091472.

The provided text describes the 510(k) summary for the Easy-Touch Insulin Syringe (K102178). This document is a premarket notification to the FDA for a medical device and is not a study proving device performance against specific acceptance criteria in the context of AI/ML or diagnostic imaging.

Therefore, many of the requested categories in your prompt are not applicable to the provided text. The device in question is a simple medical tool (insulin syringe), and the "study" referred to in the document is a series of bench tests to demonstrate substantial equivalence to predicate devices, not a clinical trial with human subjects or complex performance metrics.

Here's an attempt to answer the applicable parts of your request based on the provided information, with notes where information is not available or not relevant:

Acceptance Criteria and Device Performance for Easy-Touch Insulin Syringe (K102178)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document only mentions "Bench tests were performed."
• Data Provenance: Not specified, but given it's a bench test (laboratory testing), it's not applicable in the same way as clinical data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For a simple physical device like an insulin syringe, "ground truth" established by human experts in the context of diagnostics or AI is not relevant. The "truth" of its performance (e.g., sterility, mechanical function) is determined by standardized laboratory tests and measurements.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic evaluations. This device relies on objective physical and chemical testing.

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

• Not Applicable. This is not an AI/ML device or a diagnostic device where human readers would be involved.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

• Objective lab measurements and adherence to standards. The "ground truth" for a mechanical device like this is based on whether it meets predefined physical, chemical, and biological specifications (e.g., proper dimensions, lack of particulate matter, absence of microbial growth, proper dose delivery, biocompatibility).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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