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The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injector pen.

The 31 gauge Disetronic PenFine® Injection Pen Needles are the same sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens as the 29 and 30 gauge Disetronic PenFine® Injection Pen Needles. The only difference is in the thickness of the cannula.

The provided text describes a 510(k) submission (K982399) for a 31 gauge Disetronic PenFine® injection Pen Needle. This is a medical device, specifically a hypodermic single lumen needle, and the submission focuses on demonstrating substantial equivalence to existing predicate devices, not on proving new clinical performance. Therefore, many of the typical acceptance criteria and study details for AI/device performance are not applicable here.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a medical device like this, acceptance criteria typically involve demonstrating safety and effectiveness by meeting engineering specifications, biocompatibility standards, and functional requirements comparable to predicate devices. The document doesn't provide a table of specific numerical acceptance criteria from the submission. Instead, the "performance" demonstrated is substantial equivalence to legally marketed predicate devices based on design and functional testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical performance data involving patient samples or diagnostic accuracy. The performance data mentioned refers to engineering and functional testing. There is no information on sample size or data provenance (country of origin, retrospective/prospective) for such a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The submission is for a physical medical device (injection pen needle), not a diagnostic algorithm or AI system that requires expert-established ground truth on a test set of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There is no "test set" in the context of evaluating diagnostic performance or classifying data points for ground truth.

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

This is not applicable. MRMC studies are used for evaluating diagnostic imaging systems or AI systems that assist human readers. This submission is for an injection pen needle.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is an injection pen needle, which is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This is not applicable. For a physical device like an injection pen needle, "ground truth" would relate to its physical properties, sterility, and functional performance, verified through laboratory testing and engineering standards, not through methods like expert consensus on medical images or pathology results.

8. The sample size for the training set

This is not applicable. There is no "training set" for an injection pen needle. The device is manufactured based on design specifications and quality control.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set, there is no ground truth for it to be established.

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The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen.

The Disetronic PenFine® Injection Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens. They will be offered with a 29 and 30 gauge needle in an 8, 10 and 12 mm length.

The PenFine® Pen Needle is comprised of a siliconized stainless steel cannula welded into in a polyethyleneterapthalate (PETP) hub. A polyethylene protective cap snaps onto the hub over the needle. This assembly fits into a K-Resin outer protective container which provides the sterile barrier along with the peel tab.

The PenFine® has a patented design feature that differs from currently available pen needles. Existing pen needles must be screwed onto the threaded male extension of the injection pen. The PenFine® uses a single motion "snap on" mechanism.

The needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the Injection Pen. The back end of the cannula punctures the rubber injection port on the drug reservoir in the Injection Pen. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug is ready to be injected.

When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The Injector Pen automatically delivers the drug through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

This document is a 510(k) summary for the Disetronic PenFine® Injection Pen Needle. It establishes substantial equivalence to existing predicate devices but does not provide a study to prove acceptance criteria. Instead, it relies on "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." Therefore, many of the requested fields cannot be filled.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document states: "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." This implies that the acceptance criteria are met by virtue of being equivalent to existing, approved devices and conforming to standards, but the specific criteria and their measured performance are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document only vaguely mentions "Performance data has been generated".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of device (injection pen needle) does not typically involve expert review for "ground truth" in the way a diagnostic imaging device would. Performance is typically assessed through engineering tests and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

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 device is a pen needle, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a pen needle, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated or applicable in the traditional sense for this device. Performance would likely be measured against engineering specifications, biocompatibility standards, and sterility testing, rather than a clinical "ground truth." The "ground truth" in this context is adherence to established standards for mechanical performance, sterility, and material safety.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. This device is a physical medical device, not a machine learning model.

Summary of what is provided in the document regarding validation:

The document relies on "design equivalency and the functional and safety testing" to establish substantial equivalence to predicate devices (Novo Nordisk NovoFine 30 Injection Pen Needles and Becton Dickinson B-D Micro-Fine, Ultra-Fine and Ultra-Fine II Injection Pen Needles).

The core of the "proof" for this device's acceptance seems to be:

• Comparison to Currently Marketed Devices: The Disetronic PenFine® Injection Pen Needles are stated to be substantially equivalent to established products on the market.
• Technological Characteristics: The document claims "The technological characteristics are the same as the predicate devices."
• Performance Data: It broadly states that "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." This implies that the device was tested against relevant industry standards (e.g., for needle sharpness, sterility, flow rates, compatibility with pens, material safety) and met the requirements, thus demonstrating equivalency to already approved devices.

In essence, this 510(k) summary indicates that the device meets acceptance criteria by demonstrating conformance to established standards and substantial equivalence to existing, approved devices, rather than through a novel clinical study with explicit acceptance metrics and performance results. Specific numerical performance metrics or detailed study methodologies are not included in this summary.

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