(86 days)
The Comfort EZ™ disposable sterile insulin syringes are intended for injection of U100 insulin only.
The Comfort EZ™ 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 28 through 31 gauge needle sizes, in 0.3 ml/cc and 1 ml/cc capacities. 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.
The provided document is a 510(k) summary for the Comfort EZ™ Insulin Syringe, which is a medical device for the injection of U100 insulin. The submission aims to demonstrate substantial equivalence to a predicate device, the Feel-ject 2. Insulin Syringe.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the characteristics of the predicate device (Feel-ject Insulin Syringe) and relevant international standards. The Comfort EZ™ Insulin Syringe aims to be "identical" in these aspects to achieve substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (based on Predicate/Standards) | Reported Device Performance (Comfort EZ™) |
|---|---|---|
| Intended Use | For the injection of U100 insulin. | Identical |
| Method of Use | Standard procedure for syringe use (removing caps, measuring dosage, single use, sharps disposal). | Identical |
| Type | Type 8 of ISO8537:1991(E); syringe with fixed needle tube and fitted with protective end cap. | Identical |
| Barrel Marking Scale | Conforms to ISO 8537:1991(E). | Identical |
| Lubricant | Polydimethysiloxane. | Identical |
| Lubricant amount | 0.25 mg/cm2 max. | Identical |
| Barrel transparency | Haze 25% max. (2mm sheet). | Identical |
| Reuse | For only use (single use). | Identical |
| Biocompatibility | Conforms to ISO 10993-1. | Identical (Conforms to ISO 10993-1 through testing) |
| Materials | 1) Plastic parts: polypropylene; 2) Gasket: natural rubber; 3) Packing film: Polyethylene film. | Identical (Same materials as predicate) |
| Sterility | Sterilized by ethylene oxide gas SAL = 10-6. | Identical (Sterilized by EO SAL = 10-6) |
| Packaging (Primary) | Each syringe individually packaged in a Tyvek peel pouch. | (Implied identical for individual) |
| Packaging (Secondary) | 10 syringes in a poly bag; 10 poly bags in a cardboard box. | 10 syringes in a poly bag; 10 poly bags in a cardboard box (i.e., 100 syringes). |
| Mechanical Testing | Hub/needle bond strength (ISO 7894:1993). | Demonstrated conformance |
| Sterility Testing | ISO 11607 and ISO 11135, including EO residues (ISO 10997-7). | Demonstrated conformance |
| Standards Compliance | ISO 8537 Sterile, Single-Use Syringes, with or without Needle, for Insulin. | Conforms to ISO8537:1991(E) |
The overall performance criterion is "substantially equivalent" to the predicate device due to identical technological characteristics, materials, manufacturing methods, and conformance to relevant standards.
2. Sample size used for the test set and the data provenance
The document states that "Bench and standards compliance testing was performed." However, it does not specify the sample size for any of these tests.
Regarding data provenance:
- Biocompatibility: Conforms to ISO 10993-1. The list of tests (Cytotoxicity, Maximization, Intracutaneous Toxicity, Hemolysis, Systemic toxicity, Pyrogen Testing) implies lab testing.
- Mechanical testing: Hub/needle bond strength (ISO 7894:1993).
- Sterility testing: ISO 11607 and ISO 11135, including EO residues testing (ISO 10997-7).
- Standards Compliance: ISO 8537:1991(E).
The document is a US FDA 510(k) submission, and the predicate device is from Korea (Feel Tech). The location where the "bench and standards compliance testing" for the Comfort EZ™ syringe was performed is not explicitly stated, but it would typically be conducted by the manufacturer (Simple Diagnostics, based in Florida, USA) or a contracted lab. The data is retrospective in the sense that the tests were performed to demonstrate equivalence for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and submission. The "ground truth" for a mechanical device like an insulin syringe is based on objective measurements against established international consensus standards (like ISO standards) and material science, not expert interpretation of subjective data like images. Therefore, clinical experts or radiologists are not involved in establishing ground truth for performance testing.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in subjective assessments, which is not the nature of the bench and standards compliance testing performed for this device.
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 question is not applicable. This submission is for a physical medical device (insulin syringe), not an AI algorithm or a diagnostic tool that involves human readers or image interpretation. Therefore, no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as it pertains to AI algorithms, not physical medical devices like syringes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the test set in this context is based on:
- International Standards: e.g., ISO 8537 for syringes, ISO 10993 for biocompatibility, ISO 7894 for mechanical testing, ISO 11607 and ISO 11135 for sterility.
- Predicate Device Specifications: The characteristics, materials, and performance of the legally marketed Feel-ject 2. Insulin Syringe (K070917) form a primary basis for equivalence, implying its validated performance constitutes a "ground truth" for comparison.
- Objective Bench Test Results: Direct physical, chemical, and biological measurements demonstrating compliance with the above standards and equivalence to the predicate.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a physical medical device like an insulin syringe. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This question is not applicable as there is no 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).