Search Results

BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are indicated for the administration of anesthesia or analgesia into the epidural space, or to introduce a dedicated catheter for continuous administration of anesthesia or analgesia into the epidural space. They can also be used to introduce a spinal needle to perform a combined spinal and epidural procedure.

These devices are intended for adult and pediatric patients.

BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are single use, sterile needles which incorporate an ISO 594-1/-2 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 over the needle. The cannula is bonded to the hub at one end. The BD Perisafe™ Epidural needles also contain a plastic stylet handle and are available in various needle lengths. The needle hubs are ISO 594-1 and ISO 594-2 compliant connectors. The stylet handle for the BD Perisafe™ Epidural needles is color coded and correlate to the gauge size per ISO 6009:2016.

The provided text is a 510(k) summary for the BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle. It describes the subject device, its indications for use, and compares it to a predicate device to demonstrate substantial equivalence.

Based on the information provided, this document deals with the regulatory clearance of a medical device (epidural needles) and not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and effect sizes, are not applicable to this submission.

The acceptance criteria and performance data provided are for physical and biological characteristics of the medical device, not for an AI algorithm's diagnostic or predictive performance.

Here's an attempt to answer the questions based only on the provided document, highlighting when the information is not applicable or not present for AI/ML-specific inquiries:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison table between the subject device and the predicate device across various aspects, including functional testing and biocompatibility testing. The "Substantially Equivalent" column indicates that the subject device met the acceptance criteria by demonstrating equivalence or acceptable performance based on established standards or internal requirements.

Notes:

• The asterisks (*) indicate that for "Stylet Pull Force," "Handle/Hub Separation Force," and "Needle Shield/Hub Separation Force," the subject device had internal requirements and performed additional testing because the predicate device did not specify these tests, and there were design differences that necessitated these tests to ensure safety and effectiveness.
• "N/A" in the "Substantial Equivalence" column for some biocompatibility and additional tests indicates that these specific tests were performed by the subject device's manufacturer but were not explicitly specified for the predicate device in the comparison table. This implies the subject device met these criteria, contributing to substantial equivalence based on a broader assessment including materials equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as this is not an AI/ML-enabled device. The testing described focuses on physical and biological performance of the device itself (e.g., fluid leakage, material strength, biocompatibility), not on data-driven performance. The sample sizes for the functional and biocompatibility tests are not explicitly stated in this summary.

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. This is not an AI/ML-enabled device and no ground truth from expert readers/reviewers was established for its performance. The "ground truth" for this device's performance is based on established engineering standards (ISO standards, USP standards) and internal testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML-enabled device and no human adjudication process for performance was involved.

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 not an AI/ML-enabled device. No MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-enabled device. There is no algorithm to test in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is derived from:

• International Standards: ISO (International Organization for Standardization) standards (e.g., ISO 594, ISO 9626, ISO 10993, ISO 7864) for functional, mechanical, and biocompatibility properties.
• United States Pharmacopeia (USP) Standards: (e.g., USP, USP, USP) for specific biological and purity tests.
• Internal Requirements: For tests not explicitly covered by external standards but deemed critical by the manufacturer (e.g., Stylet Pull Force, Handle/Hub Separation Force, Needle Shield/Hub Separation Force). The rationale for these internal tests is provided, linking them to specific risks (e.g., user inconvenience, inability to use product, needle-stick injury).

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

Ask a specific question about this device

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.

Ask a specific question about this device