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510(k) Data Aggregation
(71 days)
Disposable insulin syringe is a device intended for medical purpose for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
Disposable insulin syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The proposed device of Disposable Insulin Syringe is a syringe with needle, consisting of a calibrated hollow barrel, a movable plunger, the needle cover and end cap. The needle is fixed on the syringe. The syringe is designed for manual use.
The proposed device of Disposable Insulin Syringe is available in 0.3ml (U-100), 0.5ml (U-40, U-100), 1ml (U-40, U-100) volumes.
The proposed device is provided sterilized.
The provided document describes a 510(k) premarket notification for a Disposable Insulin Syringe (K110421). This is a medical device and not an AI/ML software device, therefore, many of the requested criteria (like ground truth, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable.
The acceptance criteria and the study that proves the device meets them are based on bench tests against established international standards for such devices.
Here's a breakdown of the requested information, adapted for a medical device rather than an AI/ML product:
Acceptance Criteria and Device Performance for Disposable Insulin Syringe (K110421)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reference Standard | Reported Device Performance |
|---|---|---|
| Syringe for Insulin | ISO 8537:2007 (Sterile single-use syringes, with or without needle, for insulin) | "The test results demonstrated that the proposed device complies with... ISO 8537:2007" |
| Needle Tubing Material | ISO 9626:1991/Amendment 1:2001 (Stainless steel needle tubing for the manufacture of medical devices) | "The test results demonstrated that the proposed device complies with... ISO 9626:1991/Amendment 1:2001" |
| Sterile Hypodermic Needles | ISO 7864:1993 (Sterile hypodermic needles for single use) | "The test results demonstrated that the proposed device complies with... ISO 7864:1993" |
| Overall Design Specifications | N/A (Internal Design Specifications) | "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the bench tests. It refers generally to "Bench tests." As this is a physical medical device, not an AI model, "data provenance" in the typical AI sense (country of origin, retrospective/prospective) is not directly applicable. The "tests" are likely physical tests conducted on a sufficient number of manufactured units to ensure compliance with the specified ISO standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is Not Applicable (N/A). For medical devices like insulin syringes, "ground truth" is established through adherence to internationally recognized performance and safety standards (e.g., ISO standards) and regulatory requirements, not through expert consensus on medical images or patient outcomes. The "experts" involved are typically engineers, quality assurance personnel, and regulatory specialists who interpret and apply these standards.
4. Adjudication Method for the Test Set:
This is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, typically for AI/ML performance evaluation. For bench testing of a physical medical device, the results are objective measurements against defined criteria in the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was Not Applicable (N/A). This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the nature of this physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone study was Not Applicable (N/A). This concept applies to AI algorithms. The "standalone performance" of this device is its ability to meet the physical and functional requirements of the ISO standards when tested in a laboratory setting.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is defined by the specifications within the cited ISO international standards (ISO 8537:2007, ISO 9626:1991/Amendment 1:2001, ISO 7864:1993). These standards define physical properties, dimensional tolerances, material requirements, sterility, and functional performance (e.g., fluid delivery accuracy, needle sharpness, leak-proof integrity). Compliance with these standards serves as the "ground truth" for device safety and effectiveness.
8. The Sample Size for the Training Set:
This is Not Applicable (N/A). This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This is Not Applicable (N/A). As there is no training set for a physical medical device like this, no ground truth needed to be established for it.
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