(65 days)
The TERUMO® Micro tapered pen needle is intended for use with a pen injector device for the subcutaneous injection of insulin. It is indicated for general use and for pediatric patients.
The Terumo® Micro tapered pen needle is comprised of a stainless steel needle pointed at both ends with a 28gauge outer diameter at the vial end and tapers to a 33gauge outer diameter at the needle tip i.e. patient end. The tapered length is 3.5mm from the tip. The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device). It is designed to fit type A universal insulin pen injectors. The exposed patient-end needle length is 3/16" (5mm). The needle tip is covered by a colored plastic protective cap which is covered by a clear outer plastic cap. Just prior to use, the outer plastic cap is removed and retained for recapping once the injection is completed. The colored cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer cap so it can be safely removed from the pen injector and disposed of immediately. This pen needle device is individually packaged and sterilized. It is a disposable device intended for single use only.
The provided text describes the Terumo Micro tapered pen needle and its FDA 510(k) clearance, but it does not contain a specific performance study with detailed acceptance criteria and reported results. Instead, it states that the device was "tested in accordance with ISO 11608-2: 2000" and that "None of the data raises any new issues of safety and effectiveness." It also mentions "injection force and penetration resistance" as other tested parameters.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment cannot be extracted directly from the provided text for a device that is not an AI/ML diagnostic system.
However, I can infer some information based on the context of a medical device submission and ISO standards.
Here's a breakdown of the available information and what cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Inferred from ISO 11608-2:2000) | Reported Device Performance |
|---|---|---|
| Needle Dimensions | Adherence to specified gauges (28G vial end, 33G patient end), tapered length (3.5mm), exposed length (3/16" / 5mm). | The device is described as having these dimensions. |
| Needle Sharpness/Penetration Force | Within acceptable limits to ensure patient comfort and proper injection. (ISO 11608-2 covers this for pen needles). | "Penetration resistance" was tested. No specific values or criteria reported. |
| Injection Force | Within acceptable limits for ease of use. (ISO 11608-2 covers this for pen needles). | "Injection force" was tested. No specific values or criteria reported. |
| Compatibility with Pen Injectors | Fits type A universal insulin pen injectors securely. (ISO 11608-2 would cover this). | "Designed to fit type A universal insulin pen injectors." No specific test results reported. |
| Sterility | Meets sterility requirements as a single-use, disposable device. | Stated as "individually packaged and sterilized." No specific test results reported. |
| Leakage | No leakage during use. (ISO 11608-2 would cover this). | Not explicitly mentioned but would be a part of general performance testing under ISO. |
| Material Biocompatibility | Materials are biocompatible for medical use. | Materials (stainless steel needle, plastic hub/caps/packaging) are mentioned as "similar to the predicate devices." No specific test results reported. |
| Risk Analysis | No new or different issues of safety and effectiveness for usage by adults or children. | "A risk analysis was conducted and there were no new or different issues of safety and effectiveness identified." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The device is manufactured by Terumo Corporation in Japan, but where the testing was conducted or the origin of any clinical data (if applicable, which isn't clear here) is not stated. The submission was prepared by Terumo Medical Corporation in Maryland, USA.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not applicable. This device is a pen needle, not an AI/ML diagnostic device that requires expert ground truth for classification tasks. Performance testing likely involved engineering measurements and potentially usability testing, but not expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant. The comparison is against predicate devices based on design and performance standards, not human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 3. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance would be established by engineering specifications, direct physical measurements, and adherence to established international standards (ISO 11608-2:2000) for pen needles. This includes criteria for dimensions, force, sterility, material properties, and compatibility. It also relies on the safety and effectiveness profile of the predicate devices.
8. The Sample Size for the Training Set
- Not applicable. 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. See point 8.
§ 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).