(188 days)
The SteriCap™ Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs.
The SteriCap™ Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in sizes ranging from 23G - 33G. The distal end of the needle has a spring-loaded needle cap, which protects the needle prior to use.
This document describes the premarket notification (510(k)) for the SteriCap Mini Needle, which is a medical device. The information provided heavily focuses on the safety and performance of this physical medical device and its equivalence to a predicate device, rather than a "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered medical device, which would typically involve clinical performance metrics like sensitivity, specificity, AUC, etc.
Therefore, many of the requested items related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document as it concerns a hypodermic needle.
However, I can extract information related to the performance data provided to support the substantial equivalence of the SteriCap Mini Needle, which serves as the "acceptance criteria" and "device performance" in this context.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The product line extension met all specified criteria and did not raise new safety or performance questions." This indicates a pass/fail criteria for each test, implying the device performs as expected according to established standards for hypodermic needles. The document lists the types of testing performed rather than specific numerical acceptance criteria or measurements.
| Acceptance Criteria (Type of Test) | Reported Device Performance (Implied) |
|---|---|
| Needle Cap Sliding Force | Met specified criteria (Implied: Passed) |
| Twist Lock Release Force | Met specified criteria (Implied: Passed) |
| Dimensional and Physical Properties Verification (ISO 594-1 & 2) - Luer compatibility | Met specified criteria (Implied: Passed) |
| Bond and Material Strength Verification (ISO 594-1 & 2; ISO 7864) - Needle cap bond strength | Met specified criteria (Implied: Passed) |
| Bond and Material Strength Verification (ISO 594-1 & 2; ISO 7864) - Needle to luer hub bond strength | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Needle OD | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Needle ID | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Overall and Exposed Needle Length Verification | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Needle stiffness | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Bending-breakage resistance | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Resistance to corrosion | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Limits for acidity and alkalinity | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Limits for extractable metals | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Needle cleanliness | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Coring | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Needle point sharpness | Met specified criteria (Implied: Passed) |
| Needle quality (ISO 9626, ISO 7864) - Needle patency | Met specified criteria (Implied: Passed) |
| Color coding (ISO 6009, ISO 7864) | Met specified criteria (Implied: Passed) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document. The performance data section vaguely states "The following performance data were provided in support of the substantial equivalence." without giving specific sample numbers for each test.
- Data Provenance: Not specified in terms of country of origin. This would typically be laboratory test data, not patient-derived data, for a hypodermic needle. The document implies these are "in-house" or contract lab tests designed to meet ISO standards.
- Retrospective or Prospective: Not applicable. These are physical component tests, not clinical studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The "ground truth" for a physical device like a needle is established by engineering specifications, validated test methods (often international standards like ISO), and material properties, not by human experts adjudicating images or cases.
4. Adjudication method for the test set
- Not Applicable. See point 3. Testing involves objective measurements against predefined engineering specifications.
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
- Not Applicable. This is a physical medical device (hypodermic needle), not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- Engineering Specifications and International Standards: The 'ground truth' or benchmark for the SteriCap Mini Needle's performance is based on established ISO standards (e.g., ISO 594-1 & 2, ISO 7864, ISO 9626, ISO 6009) and the physical and mechanical properties expected of hypodermic needles.
8. The sample size for the training set
- Not Applicable. This refers to an AI/ML algorithm's training data. This document is about a physical device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary, this document is a 510(k) submission for a conventional medical device (hypodermic needle) and describes its performance based on engineering and material testing against established international standards, not a clinical study of 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).