Search Results

The safety pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.

HE Model: Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

HS Model: Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

The proposed device, Safety Pen Needle, is a sterile, non-pyrogenic, single-use device, which is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. It incorporates a sharps injury prevention feature, which can reduce the occurrence of accidental needle sticks.

The proposed device is provided with two models, i.e. HE Model and HS Model. HE Model has an attached safety shield, which can automatically lock in place and reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. HS Model has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of accidental needle sticks from both ends of the needle.

Both of HE Model and HS Model contain main body, needle tube, front shield, rear shield, big spring, turning tube, container (outer cap) and peel tab (sealing paper). Both ends of the needle tube (i.e. the patient end and the pen connection end) is lubricated by silicone oil. The needle tube and the needle hub are bonded by glue. The container sealed with the peel tab constitutes the sterile barrier system. The common components of both models are almost the same in materials and structure and size, and the only difference is the structure of the rear shield. The biggest difference between the two models is that HS Model contains a small spring additionally and has a relatively more complex structure.

The provided text is a 510(k) summary for a medical device (Safety Pen Needle). It describes the device, its intended use, comparison to a predicate device, and non-clinical testing conducted to demonstrate substantial equivalence.

However, the text does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving the device meets those criteria, particularly for a software-based AI/ML device. The document pertains to a physical medical device (pen needle) and relies on standard performance testing and simulated clinical use for safety features, not AI/ML performance metrics.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC). The document lists "Requirements" (standards) and "Results" (Pass/Fail) for various physical and biological tests, but these are not the AI/ML performance metrics you asked for.
• Sample size used for the test set and data provenance (for AI/ML). The document mentions 500 subject devices for a "simulated clinical use study" of the safety feature, but this is not an AI/ML test set.
• Number of experts used to establish ground truth and their qualifications. This is not relevant to a physical pen needle's mechanical testing.
• Adjudication method for the test set. Not relevant.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done. Not relevant, as this is for a physical device, not an AI assisting human readers.
• If a standalone (algorithm only) performance study was done. Not relevant.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.). The "ground truth" for the physical device's safety feature was a lack of needle-stick injuries and protective feature failure in a simulated environment.
• The sample size for the training set. Not applicable for a physical device.
• How the ground truth for the training set was established. Not applicable.

In summary, the provided document describes the regulatory submission for a physical medical device and does not contain the information requested about the acceptance criteria and study for an AI/ML powered device.

Ask a specific question about this device

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."

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.

Ask a specific question about this device