(226 days)
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 The stylet is withdrawn after the epidural anesthesia needle its anatomical site for neuraxial anesthesia.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 The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic.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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Epidural Anesthesia Needles | |
| Needle Gauge | 14G |
| Needle Length | 65mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, 150mm (Proposed device), 30~160mm (Predicate) |
| Sterile | EO Sterilized, 10-6 |
| Single Use | Single Use |
| Needle Tip | Tuohy (Proposed device), Huber, Hustead and Crawford (Predicate) |
| Label/Labeling | Conform with 21 CFR 801 |
| Biocompatibility: Cytotoxicity | No Cytotoxicity |
| Biocompatibility: Intracutaneous Reactivity | No Intracutaneous Reactivity |
| Biocompatibility: Skin Sensitization | No Sensitization |
| Biocompatibility: Acute Systemic Toxicity | No Systemic Toxicity |
| Biocompatibility: Hemolysis | No Hemolysis |
| Biocompatibility: Pyrogen | No Pyrogen |
| Spinal Anesthesia Needles | |
| Needle Gauge | 18G |
| Needle Length | 40mm, 50mm, 65mm, 70mm, 80mm, 90mm, 120mm (Proposed device), 30~150mm (Predicate) |
| Sterile | EO Sterilized, 10-6 |
| Needle Tip | Quincke and Pencile (Proposed device), Sharp and blunt (Predicate) |
| Single Use | Single Use |
| Label/Labeling | Conform with 21 CFR 801 |
| Biocompatibility: Cytotoxicity | No Cytotoxicity |
| Biocompatibility: Intracutaneous Reactivity | No Intracutaneous Reactivity |
| Biocompatibility: Skin Sensitization | No Sensitization |
| Biocompatibility: Acute Systemic Toxicity | No Systemic Toxicity |
| Biocompatibility: Hemolysis | No Hemolysis |
| Biocompatibility: Pyrogen | No Pyrogen |
| Combined Anesthesia Needles | |
| Epidural Needle Gauge and Length | 14G |
| Spinal Needle Gauge and Length | 22G |
| Sterile | EO Sterilized, 10-6 |
| Single Use | Single Use |
| Label/Labeling | Conform with 21 CFR 801 |
| Biocompatibility: Cytotoxicity | No Cytotoxicity |
| Biocompatibility: Intracutaneous Reactivity | No Intracutaneous Reactivity |
| Biocompatibility: Skin Sensitization | No Sensitization |
| Biocompatibility: Acute Systemic Toxicity | No Systemic Toxicity |
| Biocompatibility: Hemolysis | No Hemolysis |
| Biocompatibility: Pyrogen | No Pyrogen |
| General acceptance criteria for all device types (implied by compliance to standards) | |
| Stainless Steel Needle Tubing | Complies with ISO 9626:1991 AMD 1:2001 |
| Sterile Hypodermic Needles for Single Use | Complies with ISO 7864:1993 |
| Conical fittings (Luer) Part 1: General requirements | Complies with ISO 594-1:1986 |
| Conical fittings (Luer) Part 2: Lock fittings | Complies with ISO 594-2:1998 |
| Ethylene oxide sterilization residuals | Complies with ISO 10993-7:2008 |
| Seal strength of flexible barrier materials | Complies with ASTM F88/88M-09 |
| Internal pressurization failure resistance of unrestrained packages | Complies with ASTM F1140/1140M-13 |
| Bacterial Endotoxins Test | Complies with USP38-NF33 |
| Biological evaluation of medical devices (in vitro cytotoxicity) | Complies with ISO 10993-5:2009 |
| Biological evaluation of medical devices (irritation and delayed-type hypersensitivity) | Complies with ISO 10993-10:2010 |
| Biological evaluation of medical devices (systemic toxicity) | Complies with ISO 10993-11:2006 |
| Biological evaluation of medical devices (interactions with blood) | Complies with ISO 10993-4: 2002/Amd 1: 2006 |
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.
§ 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).