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The Sterile Hypodermic Needles for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

The proposed device, Sterile Hypodermic Needles For Single Use, consists of a needle tube, needle hub and protective cap. The needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the color complies with ISO 6009.The protective cap is made of PP and does not contact the patient. The conical fitting of Sterile Hypodermic Needles For Single Use is a luer that can be used with other medical devices which have 6% conical fitting. It is provided sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials. And the Hypodermic Needles For Single Use are individually packaged in a sterile Sterile barrier.

This document is a 510(k) summary for a medical device (Sterile Hypodermic Needles for Single Use). It details the substantial equivalence of the proposed device to a predicate device, focusing on non-clinical performance and biocompatibility.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with a set of international and national standards, which dictate the performance and safety requirements for sterile hypodermic needles. The "reported device performance" is essentially the statement that the device complies with these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study conducted to prove the device meets the acceptance criteria is a non-clinical performance testing study. This type of study demonstrates equivalence by showing that the proposed device performs comparably to a legally marketed predicate device against established performance and safety standards.

1. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual test (e.g., how many needles were tested for seal strength, how many samples for biocompatibility). It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, for each listed standard (ISO, ASTM, USP), there are usually defined sample size requirements for the tests prescribed within that standard.
• Data Provenance: The document implies that the testing was performed by or for Zhejiang Kindly Medical Device Co., Ltd., based in Zhejiang Province, China. The testing appears to be retrospective, as it was completed before the 510(k) submission. No specific country of origin is mentioned for the data itself beyond the company's location.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: For this type of medical device (sterile hypodermic needles) and the nature of the non-clinical performance testing, "ground truth" is not established by human experts in the way it would be for AI/imaging diagnostics. Instead, the ground truth is defined by the objective, quantified pass/fail criteria outlined in the referenced international standards (e.g., flow rate requirements, needle stiffness, biocompatibility limits). The "experts" involved are presumed to be the qualified laboratory personnel conducting the tests and interpreting the results against the standard's specifications. Their qualifications are not explicitly stated.

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

• None (Not Applicable): Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially for evaluating diagnostic performance (e.g., radiology reads where multiple experts might disagree). This non-clinical study relies on objective, measurable parameters against established standard criteria, so human adjudication in this sense is not relevant.

4. 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:

• No (Not Applicable): An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers interpret medical images or data. This submission is for a physical medical device (hypodermic needles), not an AI diagnostic tool. Therefore, no MRMC study was performed.

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

• No (Not Applicable): This question also pertains to AI algorithm performance. A hypodermic needle does not involve an algorithm, nor does it have "human-in-the-loop performance" in the sense of a software-assisted task.

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

• Standard-defined Objective Criteria: The ground truth for this device is based on the objective, measurable pass/fail criteria specified within the referenced international standards (ISO, ASTM, USP). For example, a needle must meet specific force requirements for penetration, sterility levels, or biocompatibility limits as defined by these standards. This is fundamentally different from a diagnostic ground truth (e.g., confirmed pathology diagnosis for an image).

7. The sample size for the training set:

• Not Applicable: This device is a physical product, not a machine learning model. Therefore, there is no "training set." The performance is validated through direct physical and chemical testing.

8. How the ground truth for the training set was established:

• Not Applicable: As there is no training set, this question is not relevant.

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The Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the enidural catheter into the epidural space.

The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.

The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.

The proposed device, Epidural Anesthesia Needles are available in a series combination of needle size and length. The needle tubing is stabilized during puncture with use of an inner stylet. The stylet is withdrawn after the epidural anesthesia needle its anatomical site for neuraxial anesthesia. Then an epidural catheter is introduced into epidural cavities for convenience of injecting anesthetic continuously.

The proposed device, Spinal Anesthesia Needles are available in a series combination of needle size and length. The spinal anesthesia needle has a tightly fitting removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic. The needles are available in Sprotte and Quincke two type.

The proposed device, Combination Anesthesia Needle are instruments for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or continuous infusion of local anesthetics into the epidural space for subsequent pain relief if required. The needles are a matched set. The epidural needle and the spinal needle are locked by conical fitting that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the epidural needle to prevent accidental displacement.

Here's the information about the acceptance criteria and study as extracted from the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, specific sample sizes for these non-clinical tests are not provided in the given text. The data provenance is also not explicitly stated beyond referring to international and US standards. It can be inferred that these non-clinical tests were conducted in a laboratory setting. The study is retrospective in the sense that it relies on existing predicate devices for comparison and established standards, rather than new prospective human trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The study relies on compliance with recognized standards and non-clinical testing rather than expert-derived ground truth based on patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve human interpretation of results requiring adjudication. It focused on objective performance against technical standards.

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

No MRMC comparative effectiveness study was done. This document pertains to the clearance of medical needles, which are physical devices, not an AI or imaging diagnostic tool that would typically involve human readers.

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

This question is not applicable as the submission is for physical medical needles, not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests appears to be defined by:

• Compliance with established international and US standards (e.g., ISO, ASTM, USP).
• Comparison to predicate devices in terms of technical characteristics and performance (e.g., biocompatibility test results like "No Cytotoxicity").

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device requiring a training set.

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

This information is not applicable as this is not an AI/machine learning device.

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