(421 days)
The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
The proposed devices, Pen Needles, are a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. The proposed devices include two models, i.e. Easydrip Pen Needle and Easydrip Plus Pen Needle. Both models have the same construction, operation methods and similar materials. Both models consist of needle tubing, needle tip shield, needle base, needle container, sealing dialysis paper, glue and silicone oil. The needle base of the device can be screwed onto compatible insulin pens. The only minor differences between the Easydrip and Easydrip Plus models are the outer shape and the material of the Needle tip shield. The Easydrip Needle tip shield is slightly shorter in length and more tapered than the Easydrip Plus Needle tip shield. The material of construction of the Easydrip Needle tip shield is polyethylene, while the Easydrip Plus Needle tip shield is polypropylene.
The Pen Needles are offered in various gauge sizes and needle lengths. The proposed devices are irradiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-9.
The provided text is a 510(k) Summary for a medical device (Easydrip Pen Needle, Easydrip Plus Pen Needle). It describes the device's features, intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.
However, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, ground truth, MRMC study, etc.) is primarily relevant to studies validating the performance of Artificial Intelligence (AI) or machine learning (ML) models in medical diagnosis or image analysis.
The document provided, K193422, is for a physical medical device (a pen needle), not an AI/ML powered device. Therefore, the concepts of "acceptance criteria for an AI model," "training set," "test set ground truth established by experts," "MRMC study," or "standalone algorithm performance" are not applicable to this type of device submission.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing and biocompatibility testing to demonstrate the physical and biological safety and performance of the pen needle against established medical device standards (e.g., ISO standards).
Here's how I can address your prompt based on the provided document, interpreting "acceptance criteria" and "study" in the context of a physical medical device:
Acceptance Criteria and Study for the Easydrip Pen Needle / Easydrip Plus Pen Needle
The acceptance criteria for the Easydrip Pen Needle and Easydrip Plus Pen Needle are primarily based on their conformance to international standards for hypodermic needles and insulin pen needles, along with demonstrating physical performance and biocompatibility comparable to a legally marketed predicate device.
1. A table of acceptance criteria and the reported device performance:
Since this document describes bench testing against technical standards and a predicate device, the "acceptance criteria" are the requirements set forth in those standards and the "reported device performance" is the statement of "Passed."
| Test (Acceptance Criteria Based On) | Reported Device Performance (Result) |
|---|---|
| Physical/Functional Performance: | |
| Materials (ISO 9626 specified tubing materials) | Passed |
| Dimensions (Fit test apparatus as per ISO 11608-2 item 7.2) | Passed |
| Flow rate through the needle (Annex A to ISO 11608-2) | Passed |
| Binding force between needle base and needle tubing (ISO 11608-2 Clause 9) | Passed |
| Needle tip appearance (ISO 11608-2 4.5) | Passed |
| Needle tubing flawlessness (ISO 7864:1993, 11.3) | Passed |
| Size of inside and outside diameter and puncturing force | Passed (Implicitly, covered by other tests) |
| Dislocation of measuring point patient end (ISO 11688-2 Table 2, Clause 8) | Passed |
| Functional compatibility with needle-based injected systems (ISO 11608-2 Clause 11) | Passed |
| Ease of assemble and disassembly (ISO 11608-2 Clause 11 requirements) | Passed |
| Biocompatibility: | |
| Cytotoxicity (ISO 10093-5) | Passed / No cytotoxicity |
| Sensitization (ISO 10993-10) | Passed / No evidence of sensitization |
| Irritation (ISO 10993-10) | Passed / No evidence of skin irritation |
| Hemocompatibility (ISO 10993-4, ASTM F765) | Passed / No evidence of hemolysis |
| System toxicity (acute) (ISO 10993-11) | Passed / No systemic toxicity |
| Pyrogen (USP 40.NF 35 Pyrogen Test) | Passed / No pyrogen |
| Particulate Matter (USP Method 1) | Passed |
| Sterilization: | |
| Sterility Assurance Level (SAL) (Radiation sterilization, ISO 11737-2:2012) | Achieved an SAL of 10-6 |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not explicitly state specific sample sizes for each test. For physical device testing against ISO standards, sample sizes are typically determined by the standard itself (e.g., lot sampling plans) or by statistical justification to achieve confidence in meeting the specifications.
- Data Provenance: The tests were performed as part of the submission by Sandstone Medical (Suzhou) Inc., located in China. These are non-clinical bench tests, not human data. The document implies these are prospective tests conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable as this is a physical medical device, not an AI/ML-powered device requiring expert adjudication for "ground truth." The "ground truth" for these tests are the objective measurements and technical requirements specified by the international standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 10993 series, USP standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests are deterministic based on physical measurements and chemical/biological analyses against specified criteria, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI/ML devices where reader performance (e.g., radiologists interpreting images) is assessed with and without AI assistance. This document is for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used:
The "ground truth" for this device's performance is defined by:
- Compliance with established international technical standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 10993 series).
- Objective physical and chemical measurements (e.g., flow rate, binding force, dimensions, cytotoxicity, pyrogenicity).
- Predicate device comparison: demonstrating that the proposed device performs "as safe and effective as" the predicate device, implying that the predicate's established safety and effectiveness serve as a benchmark.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).