Search Results
Found 1 results
510(k) Data Aggregation
(52 days)
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 syringes.
This 510(k) submission (K091474) for the Easy.Touch Insulin Syringe describes a device seeking substantial equivalence to a predicate device. The information provided focuses on the device's technical characteristics and bench testing, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories related to diagnostic study design or AI performance are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | For the injection of U100 insulin. | The device is intended for the injection of U100 insulin. |
| Biocompatibility | (Implicit: Must be safe for human contact and not cause adverse biological reactions) | Bench tests demonstrated biocompatibility. |
| Mechanical Testing | (Implicit: Syringe must function reliably, dispense accurately, and withstand expected forces) | Bench tests demonstrated appropriate mechanical performance. |
| Sterility | Must be sterile (sterile fluid path, EO sterilized), non-toxic, non-pyrogenic. | Supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic. |
| Substantial Equivalence | Device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device (Feel-ject Insulin Syringe K070917). | Bench tests demonstrated the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. |
| Device Characteristics | Calibrated hollow barrel, fixed needle, standard plunger/gasket, color-coded needle cap, available in 0.3ml/cc, 0.5ml/cc, 1ml/cc sizes. | The Easy.Touch insulin syringe consists of a calibrated hollow barrel, fixed needle, plunger and gasket of the same shape as conventional insulin syringes, color-coded orange cap, and available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. These are identical to the predicate device's technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the submission. The submission references "bench tests," which typically do not involve human subjects or a "test set" in the context of diagnostic performance. These tests relate to the physical and biological properties of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is not applicable for this type of device and testing. Ground truth determination by experts is relevant for diagnostic accuracy studies.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable. Adjudication methods are used in studies involving human interpretation or expert consensus for ground truth.
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
This information is not provided and is not applicable. This device is an insulin syringe, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the bench tests, the "ground truth" would be established by measurement standards and compliance with recognized industry standards and regulatory requirements for medical devices (e.g., ISO standards for sterility, biocompatibility, mechanical integrity). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical study.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device does not involve a "training set" as it's not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable.
Summary of the Study and Evidence:
The provided 510(k) summary for the Easy.Touch Insulin Syringe describes bench testing as the primary study performed to demonstrate substantial equivalence to a predicate device (Feel-ject Insulin Syringe K070917).
The study did not involve human subjects or clinical performance data in the typical sense of a diagnostic study. Instead, it focused on:
- Biocompatibility: Ensuring the materials are safe for human contact.
- Mechanical Testing: Verifying the syringe's functional integrity, such as plunger force, barrel integrity, and needle attachment.
- Sterility Testing: Confirming the device is sterile, non-toxic, and non-pyrogenic.
- EO Residues Testing: Ensuring no harmful ethylene oxide residues remain after sterilization.
The acceptance criteria for these tests would be defined by relevant national and international standards (e.g., ISO standards for medical devices) and FDA guidance for piston syringes. The reported performance is that these "tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
Therefore, the "study" that proves the device meets acceptance criteria is a series of bench tests evaluating the physical, chemical, and biological properties of the syringe against predetermined standards and in comparison to a legally marketed predicate device. The document implies compliance with these standards and equivalence based on the successful completion of these tests.
Ask a specific question about this device
Page 1 of 1