(239 days)
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 This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for neuraxial anesthesia.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 The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.The stylet hub is made of HDPE, the needle hub is made of resin, the raw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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Conformance |
|---|---|---|
| Design Characteristics | - Diameters: Similar to predicate device cannulas (AN-SI, AN-II: 20g-27g; AN-E: 15g-20g) | - "The diameters of the AN-SI, AN-II and AN-E are 20g-27g, 22g-27g and 15g-20g successively, the diameters of the needles of this 510k submission are similar to the diameters of the cannulas covered by the predicate devices." (Page 2) |
| - Lengths: Tested for each size, appropriate for different patient groups and clinical applications | - "The lengths of the AN-SI, AN-II and AN-E are 25mm-200mm, 60mm-200mm and 50mm-150mm successively, different lengths used for different group of patient... Each size of the needles is tested following the ISO 9626, the test results show that each size of the needles meets the criteria of the standard." (Page 2) | |
| - Tip Specifications: Identical to predicate device tips | - "Tip specifications: the tips of the needles are identical to the tips of the predicate devices." (Page 2) | |
| Material Properties | - Stiffness: Meets ISO 9626 criteria | - "Plus the properties of stiffness and resistance to breakage are tested and the results are in the criteria of the ISO 9626." (Page 2) - "Each size of the needles is tested following the ISO 9626, the test results show that each size of the needles meets the criteria of the standard." (Page 3) |
| - Resistance to Breakage: Meets ISO 9626 criteria (and general standard requirements) | - "Plus the properties of stiffness and resistance to breakage are tested and the results are in the criteria of the ISO 9626." (Page 2) - "The results of the test of resistance to breakage show the needles of each size meet the standard requirements." (Page 3) | |
| - Biocompatibility: Raw materials comply with predicate device and standards (HDPE for stylet hub, resin for needle hub, stainless steel for tubing/stylet, PP for jacket) | - "all the raw materials are biocompatible." (Page 1) - "the AN-E, each size of AN-SI and AN-SII is composed of the same raw material...identical type and duration of patient contact." (Page 3) - Specific raw materials listed (K-Resin KR03, SUS 304) and certified as identical to predicate device's materials by the manufacturer of the predicate. (Page 5) | |
| Performance Standards | - Stainless Steel components: Conforms to ISO 9626 | - "Stainless Steel components: ISO 9626" (Page 2) - "ISO 9626:-1991/Amd. 1:2001(E) 'Stainless steel needle tubing for the manufacture of medical devices.'" (Page 3) - "Each size of the needles is tested following the ISO 9626, the test results show that each size of the needles meets the criteria of the standard." (Page 3) |
| - Hub: Conforms to ISO 594-1 and ISO 594-2 | - "Hub: ISO 594-1 and ISO 594-2" (Page 2) - "ISO 594-1:1986, 'Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part 1: General Requirements.'" (Page 3) - "ISO 594-2:1998 'Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Pant 2: Lock fittings.'" (Page 3) | |
| - Hub to Needle Bond Strength: Conforms to ISO 7864 | - "Hub to Needle Bond Strength: ISO 7864" (Page 2) - "ISO 7864:1993(E) 'Sterile hypodermic needles for single use.'" (Page 3) | |
| Sterilization | - Equivalent to predicate device (materials, packaging, and sterilization processes are the same) | - "Sterilization is equivalent to predicate device since the materials, packaging, and sterilization processed are the same." (Page 3) |
| Manufacturing Methods | - Identical to predicate device | - "Anesthesia conduction needles are processed using the identical manufacturing methods as the IMD's Tuohy needle; Quincke needle; Pencil Point needle" (Page 3) |
| Substantial Equivalence | - Demonstrates similarity and substantial equivalence to predicate devices (IMD's Tuohy needle; Quincke needle; Pencil Point needle K070354) in formation, technical characteristics, and function, including direct statement of substantial equivalence by the FDA. | - The entire submission aims to prove this. The conclusion states: "The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are similar, as well as substantially equivalent to the predicate devices." (Page 5) - "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (FDA 510(k) Clearance Letter, Page 6) |
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.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).