(183 days)
UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.
The UNIEVER Disposable Spinal Anesthesia Needles are available in an array of sizes, lengths, and bevel and tip designs. The UNIEVER Disposable Spinal Anesthesia Needle has a tightly fitting removable stylet that completely occludes the lumen to avoid tracking epithelial cells into the subarachnoid space. The needles are available with a sharp (cutting)-tip or a blunt-tip. UNIEVER Disposable Spinal Anesthesia Needles are also available with an introducer. Available sizes are 18G to 29G (K-3), and 22G to 29G (Pencil Point) for lengths of 30-150mm. The introducers are available in sizes of 18G-22G with needle lengths of 25-50mm.
This document is a 510(k) summary for the UNIEVER Disposable Spinal Anesthesia Needle. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than a clinical study evaluating diagnostic or prognostic accuracy. Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not directly applicable or available in this type of submission.
Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and performance, with limitations acknowledged:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from relevant standards or statements) | Reported Device Performance (from text) |
|---|---|---|
| Material/Design | Materials commonly used in medical devices (stainless steel, polycarbonate, polypropylene). | Manufactured with stainless steel, polycarbonate, and polypropylene. |
| Sterilization | Sterilized using ethylene oxide (EO). | Sterilized using ethylene oxide (EO). |
| Shelf Life | 5-year shelf life. | Has a 5-year shelf life. |
| Biocompatibility | Compliant with biocompatibility standards (sensitization, irritation, cytotoxicity, pyrogenicity), including additional endotoxin and particulate testing for CSF contact. | Evaluations and validations performed to demonstrate compliance to biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, and Pyrogenicity) and sterilization including additional endotoxin and particulate testing for CSF contact. |
| Performance (General) | Compliance with relevant voluntary safety standards, specifically ISO standards 594-1, 7864, and 9626. | Testing confirmed compliance with ISO 594-1, 7864, and 9626. |
| Intended Use | Intended for injection of local anesthetic into the subarachnoid cavity for pain management. | Shares the same indications for use as both predicates. |
Explanation of Limitations:
- The acceptance criteria are largely based on adherence to established international standards (ISO) and common practices for medical devices of this type, rather than specific performance metrics like sensitivity, specificity, or accuracy (which would be relevant for diagnostic AI devices).
- "Reported Device Performance" here refers to the direct statements of compliance or characteristics mentioned in the summary, not quantitative results from detailed performance studies. The document states "Tests were performed...demonstrated that the device is safe and effective" but does not provide the raw data or specific outcomes of these tests beyond affirming compliance with standards.
The following points address the remaining questions, but it's crucial to understand that a 510(k) summary for a spinal needle (a physical medical device, not an AI or diagnostic algorithm) does not typically involve the kind of performance studies common for AI/ML or diagnostic devices. Therefore, most of these fields will be marked "Not Applicable" or "Not Provided" in this context.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: This type of information is not relevant for a physical device like a spinal needle, which undergoes bench testing and compliance verification rather than "test sets" of patient data for diagnostic accuracy. The testing mentioned (ISO standards, biocompatibility) would involve material samples or device prototypes in controlled environments.
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)
- Not Applicable/Not Provided: Ground truth, in the sense of expert consensus on diagnostic interpretations, is not part of the evaluation for a spinal needle. Compliance with standards and biocompatibility are typically assessed by laboratory technicians, engineers, and toxicologists, rather than medical experts forming a "ground truth" on patient outcomes for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: Adjudication methods are used to resolve disagreements among experts in establishing ground truth for diagnostic studies. This is not relevant for the type of testing described in this 510(k) summary.
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
- Not Applicable: This is a physical medical device, not an AI/ML algorithm. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is entirely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm. Standalone performance as described is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Inferred: While "ground truth" in the diagnostic sense is not used, the "truth" for this device's performance would be established by:
- Compliance with International Standards: Adherence to physical, mechanical, and safety specifications outlined in ISO 594-1, 7864, and 9626.
- Biocompatibility Testing: Results from validated laboratory tests (e.g., in vitro or in vivo) demonstrating absence of cytotoxicity, sensitization, irritation, pyrogenicity, and acceptable endotoxin/particulate levels.
- Material Characterization: Verification that materials are as specified and commonly used in medical devices.
8. The sample size for the training set
- Not Applicable/Not Provided: There is no "training set" in the context of a physical medical device's 510(k) submission. This concept applies to AI/ML algorithms.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: As there is no training set, this question is not applicable.
§ 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).