(322 days)
The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures.
These devices are intended for adult and pediatric patients.
The BD® Spinal Introducer NRFit™ Needle is intended for placement or introduction of spinal needles.
This device is intended for adult and pediatric patients.
The BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle are single use, sterile needles which incorporate an ISO 80369-6 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use).
Each type of needle consists of a hollow, stainless steel cannula, a translucent, polypropylene hub and a polypropylene shield. The cannula is bonded to the hub at one end and there is a specific needle point (Quincke or Whitacre) at the other end. The BD® Spinal Introducer NRFit™ Needle is only available with a Quincke needle point. The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle also contain a stylet and are available in various needle lengths. The stylet consists of a solid, stainless steel wire bonded to a polypropylene handle. All three needles are available in various gauges.
The needle hubs for all three needles are ISO 80369-6 compliant connectors. The needle shields are yellow to indicate that the device is intended to only connect to ISO 80369-6 compatible devices. The stylet handle for the BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle and the needle hub of the BD® Spinal Introducer NRFit™ Needles are color coded and correlate to the gauge size per ISO 6009:2016.
The provided text describes the 510(k) Premarket Notification for the "BD® Quincke Spinal NRFit™ Needle, BD® Whitacre Spinal NRFit™ Needle and BD® Spinal Introducer NRFit™ Needle". This document outlines the device specifications and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
It's important to note that this 510(k) summary focuses on medical devices (needles), not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria (such as test set provenance, expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document. The study described is a series of non-clinical, laboratory-based performance tests and biocompatibility evaluations.
Here's the information extracted from the document that is applicable to the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests and indicates that the subject device "met all predetermined acceptance criteria for the above-listed performance tests." Specific quantitative acceptance criteria or detailed results (e.g., exact measured values) are not provided in this summary; rather, it states that the device successfully met the criteria as per various ISO standards and internal requirements.
| Test Type | Acceptance Criteria (as per standard/requirement) | Reported Device Performance |
|---|---|---|
| Functional Testing | ||
| Fluid leakage by Pressure Decrease | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Subatmospheric pressure air leakage | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Stress cracking | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Resistance to separation from axial load | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Resistance to separation from unscrewing | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Resistance to overriding | Per ISO 80369-6:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Stylet Pull Force | Per internal requirements | Met criteria (performed in an equivalent manner to predicate device) |
| Handle/Hub Separation Force | Per internal requirements | Met criteria (performed in an equivalent manner to predicate device) |
| Needle Shield/Hub Separation Force | Per internal requirements | Met criteria (performed in an equivalent manner to predicate device) |
| Cannula Pull Force (Bond between hub and needle) | Per ISO 7864:2016 | Met criteria (performed in an equivalent manner to predicate device) |
| Cannula Deflection/Stiffness | ISO 9626:2001 (for subject device), ISO 9626:2016 (for predicate) | Met criteria (performed in an equivalent manner to predicate device) |
| Cannula Breakage | ISO 9626:2001 (for subject device), ISO 9626:2016 (for predicate) | Met criteria (performed in an equivalent manner to predicate device) |
| Biocompatibility Testing | ||
| Cytotoxicity | Per ISO 10993-5:2009, Non-cytotoxic | Non-cytotoxic |
| Sensitization | Per ISO 10993-10:2010, Non-sensitizer | Non-sensitizer |
| Intracutaneous Reactivity | Per ISO 10993-10:2010, Non-irritant | Non-irritant |
| Acute Systemic Toxicity | Per ISO 10993-11:2017, Non-toxic | Non-toxic |
| Material-Mediated Pyrogenicity | Per ISO 10993-11:2017 and USP, Non-pyrogenic | Non-pyrogenic |
| Chemical Characterization | Per ISO 10993-18:2005, acceptable extractables/leachables profile | Acceptable extractables/leachables profile |
| Additional Testing | ||
| Hemolysis | Per ISO 10993-4:2017, Non-hemolytic | Non-hemolytic |
| LAL Endotoxin | Per USP, 2.15 EU/device | Met limits (2.15 EU/device) |
| Particulate Matter | Per USP , Met limits | Met limits |
| Neurotoxicity Assessment | No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article | No signs of systemic toxicity or neurological impairment |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in terms of exact numbers of devices tested for each criterion. The document refers to testing "Per ISO" standards, which would define the sample sizes required for compliance.
- Data Provenance: The testing was non-clinical (laboratory testing) and conducted by Becton, Dickinson and Company. No geographic origin or retrospective/prospective nature is specified as it's not applicable to materials and performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to the testing for these medical devices. Ground truth, in this context, is established by adherence to recognized international standards (ISO, USP) for physical and biocompatibility properties, not by expert human interpretation of data like in AI/ML studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This concept is not applicable. The testing involves objective physical and chemical measurements against predetermined pass/fail criteria established by international 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:
This is not applicable. This document is for physical medical devices (needles), not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This document is for physical medical devices (needles), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests relies on established international standards (ISO, USP) for physical properties (e.g., fluid leakage, tensile strength) and biological responses (e.g., cytotoxicity, hemocompatibility). For example, "Non-cytotoxic" per ISO 10993-5 is the ground truth.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is a traditional medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
This is not applicable. There is no "training set" as this is a traditional medical device, not an AI/ML algorithm.
§ 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).