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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

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.

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For the spinal administration of anesthetic agents to provide regional anesthesia.

The Spinal Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub. The Spinal Needle will be provided as a sterile, single use, disposable device. The Spinal Needle will be available in a variety of lengths and gauges.

Here's an analysis of the provided text regarding the "Spinal Needle" device and its regulatory submission:

Summary: The provided document demonstrates a substantial equivalence determination for a Spinal Needle. However, it explicitly states that no bench testing or clinical studies were conducted by Epimed International, Inc. for this submission. The basis for acceptance is solely the device being identical to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. No test set was used for this submission.
• Data Provenance: Not applicable. No data was generated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not applicable. No ground truth was established by experts for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring adjudication was used.

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

• MRMC Study: No. This device is a physical medical instrument (spinal needle), not an AI diagnostic tool. Therefore, an MRMC study is not relevant, nor was one performed.
• Effect Size of Human Reader Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: No. This device is a physical medical instrument, not an algorithm. Therefore, a standalone performance study is not applicable, nor was one performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable. No specific ground truth establishment was conducted for this submission. The "ground truth" for regulatory purposes here is the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. No training set was used. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

• Ground Truth Establishment: Not applicable. No training set was used.

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