(265 days)
The BD™ Spinal Needles are intended to gain entry into or puncher the spinal cavity permitting injection (including anesthesia)/withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures.
This device is intended for adult and pediatric patients.
The BD™ Spinal Introducer Needle is intended for placement or introduction of spinal needles.
This device is intended for adult and pediatric patients.
The BD Quincke Spinal Needle, BD Whitacre Spinal Needle are available in various gauges and needle lengths. The needle consists of a hollow needle (cannula) bonded to a clear hub at one end and a specific needle-point type (Quincke or Whitacre) at the other end. The stylet has a handle, which is color-coded and correlates to the gauge size.
The BD Spinal Needle Introducer consists of a needle, needle hub and needle shield and is available in various gauges. The needle consists of a hollow needle (cannula) bonded to a translucent colored hub (per gauge) at one end and a specific needle-point type at the other end. The introducer needle is optional aid through which a spinal needle can be inserted.
The BD Quincke Spinal Needle, BD Whitacre Spinal Needle and BD Spinal Needle Introducer devices are single use, sterile needles which, incorporate the ISO 594-1 and ISO 594-2 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use).
The document is a 510(k) summary for the BD Quincke Spinal Needle, BD Whitacre Spinal Needle, and BD Spinal Introducer Needle. It describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Testing (All per ISO 594 unless specified) | |
| Fluid leakage by Pressure Decay | Met ISO 594 requirements |
| Subatmospheric pressure air leakage | Met ISO 594 requirements |
| Stress cracking | Met ISO 594 requirements |
| Resistance to separation from axial load | Met ISO 594 requirements |
| Resistance to separation from unscrewing | Met ISO 594 requirements |
| Resistance to overriding | Met ISO 594 requirements |
| Stylet Pull Force (per BD internal requirements) | |
| - Quincke Needle 18G | ≥ 8 lbf |
| - Quincke Needle 20G | ≥ 5 lbf |
| - Quincke Needle 22G | ≥ 5 lbf |
| - Quincke Needle 23G | ≥ 5 lbf |
| - Quincke Needle 25G | ≥ 3.5 lbf |
| - Quincke Needle 26G | ≥ 3.5 lbf |
| - Quincke Needle 27G | ≥ 3.5 lbf |
| - Whitacre Needle 22G | ≥ 5 lbf |
| - Whitacre Needle 24G | ≥ 5 lbf |
| - Whitacre Needle 25G | ≥ 5 lbf |
| - Whitacre Needle 27G | ≥ 5 lbf |
| Handle/Hub Separation Force (per BD internal requirements) | Handle must not disengage when held upside down (Met requirements) |
| Needle Shield/Hub Separation Force (per BD internal requirements) | Needle shield must not disengage from hub when held upside down (Met requirements) |
| Cannula Pull Force (Bond between hub and needle) | Met ISO 7864:2016 requirements |
| Biocompatibility Testing (All per ISO 10993-1:2018 unless specified) | |
| Cytotoxicity | Non-cytotoxic (Per ISO 10993-5:2009) |
| Sensitization | Non-sensitizer (Per ISO 10993-10:2010) |
| Intracutaneous Reactivity | Non-irritant (Per ISO 10993-10:2010) |
| Acute Systemic Toxicity | Non-toxic (Per ISO 10993-11:2017) |
| Material-Mediated Pyrogenicity | Non-pyrogenic (Per ISO 10993-11:2017 and USP) |
| Chemical Characterization | Acceptable extractables/leachables profile (Per ISO 10993-18:2005) |
| Additional Testing | |
| Hemolysis | Non-hemolytic (Per ISO 10993-4:2017) |
| LAL Endotoxin | 2.15 EU/device (Per USP, met limits) |
| Particulate Matter | Met limits (Per USP ) |
| Neurotoxicity Assessment | No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the functional and biocompatibility tests. It indicates that the tests were performed according to specified ISO standards and internal requirements. Data provenance is not specified beyond the fact that these are non-clinical/design verification tests performed by BD. There is no indication of country of origin for any data or whether it is retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The tests performed are engineering and biocompatibility evaluations of physical device properties, not assessments requiring expert interpretation of clinical data in the same way an AI/ML device would.
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a 510(k) submission for conventional medical devices (needles), not an AI-assisted device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an algorithm-based device.
7. Type of Ground Truth Used
The "ground truth" for the performance criteria in this submission is based on established engineering standards (e.g., ISO 594, ISO 7864, ISO 10993, USP) and internal company requirements for device functionality and safety. The performance is measured against these objective, predefined criteria rather than a subjective "ground truth" established by experts or clinical outcomes in the context of diagnostic accuracy.
8. Sample Size for Training Set
Not applicable. This is not an AI/ML device, therefore, there is no training set.
9. How Ground Truth for Training Set Was Established
Not applicable. There is no training set.
§ 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).