(637 days)
The CHIRANA® Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.
The CHIRANA® Insulin Syringes are a 0.3mL, 0.5mL, or 1.0mL syringes designed for subcutaneous injection of a desired dose of insulin. The CHIRANA® Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, and 12.7mm). The CHIRANA® Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.
The provided document is a 510(k) summary for the CHIRANA Insulin Syringes. It details the device's characteristics, indications for use, and performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria and detailed study results for an AI/ML-based device in the format requested.
The document discusses the physical characteristics, materials, and mechanical performance testing of an insulin syringe, which is a traditional medical device, not a software-driven or AI/ML-enabled diagnostic or therapeutic device. The performance testing section refers to standards for sterile single-use syringes, hypodermic syringes, and needles, as well as biocompatibility and sterilization validations. These are typical assessments for a Class II physical medical device.
Therefore, I cannot fully complete the requested table and answer all questions related to AI/ML device performance validation, as the information is not present in the provided text.
However, I can extract information relevant to a physical medical device's performance assessment where applicable, and highlight what is missing based on the prompt's requirements for an AI/ML device.
Information that is applicable to a traditional medical device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
For a physical device like an insulin syringe, acceptance criteria relate to physical and functional properties, manufacturing standards, and safety. The document states compliance with recognized ISO standards. While specific numerical acceptance criteria (e.g., maximum force to inject, specific flow rates) are not explicitly listed in a table, the document implies that the device met the requirements of these standards.
| Acceptance Criteria Category (Implied by Standards) | Reported Device Performance (Implied by Compliance) |
|---|---|
| ISO 8537 (Sterile single-use syringes, with or without needle, for insulin) | Device demonstrated conformance to this standard. |
| ISO 7886-1 (Sterile hypodermic syringes for single use Part 1: Syringes for manual use) | Device demonstrated conformance to this standard. |
| ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices) | Device demonstrated conformance to this standard. |
| ISO 7864 (Sterile hypodermic needles for single use) | Device demonstrated conformance to this standard. |
| Biocompatibility (per ISO 10993-1) | Cytotoxicity, Sensitization, Irritation, Intracutaneous Reactivity, Subacute/Sub-chronic Toxicity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility testing were conducted and implied to meet criteria. |
| Particulate Matter (per USP ) | Met USP acceptance criteria. |
| Sterilization Validation (per ISO 11135) | Validated to SAL=10^-6. |
| Package Integrity (per ASTM D4169-16) | Testing conducted on final, packaged, sterile devices (implied to pass). |
| Shelf-Life Single Unit (per ASTM F1980-16) | Validated for 5 years. |
| Shelf-Life Multi-Unit (Closure integrity test) | Validated for 2 years and four months. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of number of units tested. For mechanical testing, this would typically be a specific number of syringes/needles per test type.
- Data Provenance: Not applicable in the context of "data provenance" for patient data in an AI/ML model. The testing is for manufactured physical goods. The testing was performed by "Empirical Testing Corp." (a consultant listed for the submitter).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable (N/A). This is a physical device, not one requiring expert interpretation of complex data for ground truth establishment. Validation relied on adherence to engineering and material standards.
4. Adjudication Method for the Test Set:
- Not applicable (N/A). Adjudication (e.g., 2+1, 3+1) is a common practice for complex medical image interpretation or clinical outcome assessment in AI/ML studies to establish a consensus ground truth. For a physical device, compliance with established test methods and specifications is directly assessed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, not performed. This type of study is specific to AI/ML imaging or diagnostic devices where human readers' performance with and without AI assistance is evaluated. This device is a physical syringe.
6. Standalone (Algorithm Only) Performance:
- Not applicable (N/A). This refers to the performance of a software algorithm without human interaction. The CHIRANA Insulin Syringe is a physical device.
7. Type of Ground Truth Used:
- Not applicable in the AI/ML sense. For this physical device, "ground truth" would be defined by the specifications in the relevant ISO and ASTM standards (e.g., dimensional tolerances, material properties, injection force, leak rates, sterility assurance level). The device's performance was measured against these engineering standards. The phrase "expert consensus, pathology, outcomes data" is generally used for clinical ground truth in AI/ML or diagnostic studies.
8. The Sample Size for the Training Set:
- Not applicable (N/A). This concept pertains to machine learning models. For a physical device, there isn't a "training set" in the AI/ML sense. Training involves manufacturing processes and quality control.
9. How the Ground Truth for the Training Set was Established:
- Not applicable (N/A). As above, this is an AI/ML concept.
In summary: The provided document describes the substantial equivalence review for a traditional medical device (insulin syringe) and details its compliance with relevant engineering and quality standards. It does not provide the information typically requested for demonstrating the performance of an AI/ML-driven medical 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).