Search Results

The SteriCap™ Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-ip luer syringe) for the administration of drugs.

The SteriCap® Mini Needle ("SteriCap®") and Needles ("Needles") are devices intended to provide a means of fluid injection and aspiration to and from the body. The devices are a single lumen needle. For SteriCap® Mini Needle, the needle has a spring-actuated sliding cap, which protects the needle prior to use. For Needles, the needle is covered by a removable clear cap.

The additional gauges and lengths of the product family included in this submission are 30G/31G/33Gx 6mm and 31G / 33G x 4 mm. The additional gauges and lengths of the Needle included in this submission are 29G/30G/31G x 13 mm and 33G x 8 mm.

The provided text describes the submission of a medical device, the SteriCap™ Mini Needle and Standard Needles, for 510(k) premarket notification. The FDA's decision is that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information about:

• A table of acceptance criteria and reported device performance related to an AI/ML or diagnostic imaging device.
• Sample sizes for test sets (beyond general mention of performance testing).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods for test sets.
• Whether an MRMC comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The text focuses on the physical characteristics and performance testing of a hypodermic needle, demonstrating its substantial equivalence to a predicate device. The performance data mentioned relates to:

• Dimensional and Physical Properties Verification (ISO 9626:2016, ISO 7864:2016)
• Needle quality (ISO 9626:2016, ISO 7864:2016)
• Color coding (ISO 6009:2016, ISO 7864:2016)
• Biocompatibility (ISO 10993-1, cytotoxicity, sensitization, irritation, acute systemic toxicity, materials mediated pyrogenicity)
• Sterility/Shipping and Shelf-life (ISO 11135:2014, ISO 10993-7, ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, ASTM F88/F88M-15)

These are standard tests for medical devices, particularly those involving materials, sterility, and physical properties, and are not related to AI/ML device performance or diagnostic accuracy.

Therefore, I cannot provide the requested information based on the given input, as it describes a physical medical device (hypodermic needle) and not an AI/ML-based diagnostic device.

Ask a specific question about this device

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.

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.

Ask a specific question about this device