(91 days)
ExtaviPro™ Sterican™ 30G Hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
ExtaviPro™ Sterican™ 30G hypodermic needles are comprised of a steel cannula that is sharpened to a point at one end. The other end is bonded to a vellow color-coded female Luer Lock hub designed for attachment to a corresponding male connector, such as a syringe. A protective cap must be removed before injection.
Here's an analysis of the acceptance criteria and study information for the ExtaviPro™ Sterican™ 30G device based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (hypodermic needle). Unlike AI/software devices, the acceptance criteria and performance evaluation for this type of hardware device fundamentally differ. There are no AI/ML components, human-in-the-loop scenarios, or ground truth establishment in the traditional sense of AI studies. Instead, the evaluation focuses on meeting established engineering standards and functional performance specific to the physical device.
Acceptance Criteria and Device Performance
| Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|
| Conformance to ISO 7864:1993(E) - Sterile hypodermic needles for single use | Needles passed functional testing demonstrating safety and effectiveness, meeting the requirements of this standard. |
| Conformance to ISO 9626:1991/Amd. 1:2001(E) - Stainless steel needle tubing for the manufacture of medical devices | Needles passed functional testing demonstrating safety and effectiveness, meeting the requirements of this standard. |
| Conformance to ISO 594-1 - Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 1: General requirements | Needles passed functional testing demonstrating safety and effectiveness, meeting the requirements of this standard (specifically related to the Luer lock hub). |
| Conformance to ISO 594-2 - Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 2: Lock fittings. | Needles passed functional testing demonstrating safety and effectiveness, meeting the requirements of this standard (specifically related to the Luer lock hub). |
| Sterility and pyrogen-free status | Device is sterile and pyrogen-free (as stated in description). This is maintained through the same validated sterilization process and primary packaging as the predicate device. |
| Shelf life of at least one year | Demonstrated through tests performed on samples after accelerated aging. |
| Equivalence in safety and effectiveness to predicate device (Sterican™ Needles, K072247) | The device passed all functional tests, uses the same materials, manufacturing processes, and sterilization processes as the predicate device. It is concluded to be as safe, effective, and to perform as well as the predicate device. |
Study Details (Interpreted for a Hardware Medical Device)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices (e.g., "N=100 needles"). However, the tests were performed on "samples" before EtO-Sterilization and after 3 sterilization cycles, as well as after accelerated aging. This implies a sufficient number of samples were used to meet the statistical requirements of the listed ISO standards.
- Data Provenance: The tests were conducted internally by B. Braun Melsungen AG, a German company ("B. Braun Melsungen AG Dr. Stefan Seidel... Germany"). This would be considered internal company data. The source is retrospective in the sense that the testing was completed prior to the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the AI/ML sense. "Ground truth" for this device is established by objective measurements against engineering standards (e.g., cannula dimensions, hub connection strength, flow rates). These are not determined by expert consensus in the same way as diagnosing medical images. The expertise lies in the engineers performing and interpreting the physical and chemical tests according to the standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert opinions, which isn't relevant for objective physical measurements against engineering standards. The results of the tests are binary (pass/fail) based on predefined criteria in the ISO standards.
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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 hypodermic needle, a physical medical instrument, not an AI or software-based diagnostic tool. There are no "human readers" or "AI assistance" involved in its functional evaluation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective engineering standards and measurements. The "ground truth" for this device relates to its physical properties and functional performance as defined by international standards (ISO 7864, ISO 9626, ISO 594-1, ISO 594-2). For example, a needle's bending strength is measured against a specified force, not determined by expert opinion.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established:
- Not applicable. There is no "training set" or "ground truth" establishment in the context of AI/ML for this 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).