(114 days)
The Pencan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.
The Spinocan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.
The B. Braun Pencan Spinal Needle consists of a polycarbonate hub bonded to a stainless steel cannula with pencil-point tip. The hub of the Pencan spinal needle incorporates a viewing window for visualization of cerebrospinal fluid. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 22 Ga. to 27 Ga. Needles that are 24 Ga .- 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.
The B. Braun Spinocan Spinal Needle consists of the same polycarbonate hub as the Pencan needles. The hub is bonded to a stainless steel cannula with Quincke bevel. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 18 Ga. to 27 Ga. Needles that are 25 Ga. - 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the B. Braun Medical Inc. Pencan, Spinocan Spinal Needles and Spinal Introducer Needles:
Based on the provided 510(k) summary (K112515), the device in question is a medical needle, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.
The acceptance criteria and study focus on demonstrating substantial equivalence to predicate devices through performance testing against established international standards and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ISO 9626:1991/Amd. 1:2001(E): "Stainless steel needle tubing for the manufacture of medical devices." | "Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for needle tubing.) |
| ISO 7864:1993(E): "Sterile hypodermic needles for single use." | "Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for sterile hypodermic needles.) |
| ISO 594-1:1986: "Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part1: General Requirements." | "Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for Luer taper fittings, confirming proper connection with other medical equipment.) |
| ISO 594-2:1998: "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings." | "Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for Luer lock fittings, ensuring secure connections.) |
| ISO 10993-1:2009: "Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process" (Biocompatibility) | "Biocompatibility testing... demonstrates that the materials used in the construction of the proposed needles are safe for their intended use." (Confirms the materials are biologically suitable for patient contact.) |
| Substantial Equivalence to Predicate Devices | The proposed Pencan and Spinocan needles are deemed "similar" to predicate devices (K932569, K820047, K011122) in intended use, needle cannula, tip design, and dimensions, with primary differences being hub geometry, non-solution contacting materials, and additional gauges/lengths. Compliance with performance standards further supports equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not an AI/ML device study. The "testing" refers to physical and material performance evaluations against established standards, not a clinical trial with patient data. Therefore, concepts like "test set" or "data provenance" in the context of clinical data are not applicable here. The data provenance would be the internal testing laboratories of B. Braun Medical Inc. or contracted testing facilities that conducted the performance and biocompatibility tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of medical device submission. Ground truth for physical device performance is established by objective measurements against engineering and material science standards (e.g., tensile strength, flow rate, biocompatibility assays), not expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical outcomes where there might be disagreement. For a physical device demonstrating compliance with standards, the results are objectively measured.
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 device and therefore no MRMC study involving human readers with AI assistance was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. Its performance is inherent to its physical design and materials.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by the international standards themselves (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, ISO 10993-1). The device must meet the specified test methods and criteria outlined in these standards. For biocompatibility, the chemical and biological properties of the materials, as tested according to ISO 10993 guidelines, serve as the ground truth.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device and does not involve a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device and does not involve a training set.
In summary, for K112515, the "study" demonstrating the device meets acceptance criteria consists of:
- Performance testing against established international standards (ISO).
- Biocompatibility testing in accordance with ISO 10993-1.
- Comparison to predicate devices to demonstrate substantial equivalence based on similar design, materials, and intended use, and successful performance against the aforementioned standards.
The B. Braun Pencan and Spinocan Spinal Needles and Spinal Introducer Needles are traditional medical devices, and their regulatory pathway focuses on demonstrating safety and effectiveness through compliance with recognized standards and substantial equivalence to legally marketed predicate devices, rather than through AI/ML-specific validation studies.
§ 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).