Search Results

AN-E epidural needle is intended for the transient delivery of anesthetics to provide neuraxial anesthesia or to facilitate placement of an epidural catheter.

AN-SI spinal needle and AN-SII spinal needle are intended for the transient delivery of anesthetics to provide neuraxial anesthesia.

The proposed device, Anesthesia conduction needles, including Epidural Needle for Single Use (AN-E), Spinal Needle for Single Use (AN-SI, AN-SII) was developed by LCCS Products Limited to meet urgent demands on prevention of cross- infection. Anesthesia conduction needles, is a kind of sterile and sharp hollow-device used for transferring anaesthetic to epidural cavities. The device can be used for introducing dedicated ducts into epidural cavities for convenience of injecting anaesthetic continuously. Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space. The needle tubing is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for neuraxial anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.The stylet hub is made of HDPE, the needle hub is made of resin, the raw material of the needle tubing and stylet is stainless steel, the jacket is PP, all the raw materials are biocompatible.

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

Device: AN-SI spinal needle, AN-SII spinal needle, AN-E epidural needle

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are primarily based on established international standards for medical needles and a comparison to a predicate device. The performance data is reported as meeting these standards and being similar to the predicate.

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

• Sample Size: The document does not explicitly state the specific numerical sample size used for the performance tests. It generally refers to "each size of the needles" being tested. For biocompatibility, it mentions "appendix B1 AN-E biocompatibility test and appendix B2 AN-SI biocompatibility test," implying samples of AN-E and AN-SI were tested.
• Data Provenance: The tests were conducted by the submitter (LCCS Products Limited) or their manufacturing partner, likely in China (Guangzhou, Guangdong, China is the submitter's representative address). The nature of the tests (material properties, dimension conformance) indicates they are likely laboratory-based prospective testing of manufactured devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable in this context. The review is for a Class II medical device (needles) primarily based on engineering performance standards and substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" is defined by industrial standards (ISO) and direct comparison to the predicate device specifications.

4. Adjudication Method

• N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert interpretation of images or clinical outcomes, to establish a "ground truth" when there's disagreement among experts. This type of study is not described for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. These studies are relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to measure diagnostic accuracy and efficiency. This device is an anesthesia conduction needle, which is a physical tool, not a diagnostic algorithm.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

• Yes, in a sense, the primary performance evaluation for this device is "standalone." The device (the needle itself) is tested directly against physical and material standards (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2) and compared to the predicate device's specifications. There is no "human-in-the-loop" component in the device's intended function that would require such a study design. The performance relates to its physical integrity and dimensional accuracy.

7. Type of Ground Truth Used

The ground truth used for this device evaluation is primarily:

• Industry Standards: International Organization for Standardization (ISO) standards (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2) define the acceptable physical and material properties.
• Predicate Device Specifications: The established characteristics (dimensions, materials, design) of the legally marketed predicate devices (IMD's Tuohy needle; Quincke needle; Pencil Point needle K070354).

8. Sample Size for the Training Set

• N/A. This is not an AI/ML device where a "training set" would be applicable. The development of the needle relies on engineering design and manufacturing processes, not machine learning.

9. How the Ground Truth for the Training Set Was Established

• N/A. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The design and manufacturing process would adhere to established engineering principles and standards.

Ask a specific question about this device

Anesthesia conduction needles are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

needles, including Epidural Needle for Single Use(AN-E), Spinal Needle for Single Use(AN-S), AN-SII), consist of needle tube, hub, stylet and jacket The product is mainly used for epidural and/or spinal block (also called as epidural and/or spinal anesthesia) in human bodies.
The needles have been categorized as following in detail:

1. AN-SI Spinal Needles (same to IMD's Quincke needle)
2. AN-SII Spinal Needle (same to IMD's Pencil point needle)
3. AN-E Epidural Needles (same to IMD's Tuchy needle)
   These needles are provided as sterile, single use devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needle. This is a simple hypodernic regional allestilesia trays (Mis). Anoonball concession of the aresthesia onduction needle. The later needie to hake the intral punction and election of local and the end anesthelics into the epidural space for longer pain relief.
   The Shanghai SA's anesthesia conduction needles – AN-SI, AN-SII, AN-SII, AN-E – are single use, sterile madical devices for like The Shanghal SA s anesulesia conductions. The cannula is stabilized during puncture with use of an Inner thanslent delively of ancollobo acting regioned its reached its analogical site for regional style. This stylet is within atter the ansociety (i.e., within minutes) by the professional ansether and the possible. The altestiesia. Then the arestheses our as opplied below the anesthesia conduction needle. The needle is Allondavely of dealer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The provided document is a 510(k) summary for Anesthesia Conduction Needles (K120475). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets specific acceptance criteria in the way typically expected for a medical device performance study, especially one involving AI or detailed clinical outcomes.

Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device (IMD's Tuohy needle, Quincke needle, Pencil Point needle K070354) through non-clinical performance and biocompatibility testing against recognized international standards.

Therefore, many of the requested fields regarding acceptance criteria, study design, expert involvement, and AI performance cannot be directly extracted from this document. I will fill in what is available and indicate when information is not present.

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable table format for device performance in a clinical setting with associated outcomes. Instead, it refers to conformity with international standards for device components and materials as the basis for performance.

Acceptance Criteria (Implicit from Standards Conformity) and Reported Device Performance:

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

This information is not provided in the document. The document refers to "Performance testing was conducted to verify that the proposed device met all design specifications," but does not detail the sample sizes, origin, or retrospective/prospective nature of this testing. This implies bench testing or material conformance rather than a clinical human subject study.

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 information is not applicable/provided. The device is an anesthesia conduction needle, and the testing described is non-clinical (material and structural compliance with standards, biocompatibility). There is no "ground truth" established by human experts in the context of diagnostic or interpretive performance for such a device in this document.

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

This information is not applicable/provided. As above, there is no diagnostic or interpretive test set that would require an adjudication method.

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 information is not applicable. The device is an anesthesia conduction needle (a physical medical instrument), not an AI-powered diagnostic or decision-support system. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm.

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

This information is not applicable. The device is a physical medical instrument, and the testing focuses on its physical and material properties, and sterility, against engineering standards.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of an AI algorithm described for this device. For the non-clinical testing, sample sizes are not explicitly stated in this summary.

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

This information is not applicable/provided. As there is no training set for an AI algorithm, this question is not relevant. For the non-clinical tests, the "ground truth" is adherence to the specified international standards.

Ask a specific question about this device