(213 days)
The B. Braun Perican Ultra needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.
The B. Braun Perican Ultra needle is a single use, disposable anesthesia needle (18 Ga.) with Tuohy (curved) bevel. The needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter. The proposed needle is composed of a hollow stainless steel cannula with 1 cm depth markings along the length of the cannula. The cannula is also designed with small 'echogenic' etched markings intended to enhance visibility of the needle when using an ultrasound imaging device. The cannula are secured to the winged polycarbonate hub using an epoxy resin and plastic spacer. The Perican Ultra needle is provided with a plastic stylet, which is pre-assembled inside the needle cannula. The hub is designed with a Luer adapter to facilitate attachment of the needle to anesthetic administration devices, such as a syringe.
Here's an analysis of the Perican™ Ultra Needle based on the provided 510(k) Premarket Notification:
The document does not describe a study involving an AI/Machine Learning device. It concerns a medical device, specifically an anesthesia conduction needle. Therefore, many of the requested categories related to AI performance, ground truth, experts, and training/test sets are not applicable.
However, I can extract the acceptance criteria and the methods used to demonstrate the device meets those criteria for this non-AI medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement | Acceptance Criteria (Test) | Reported Device Performance |
|---|---|---|
| Visual Specifications | - Needles are free of hooks, burrs, cracks, damage, occlusion, foreign contamination discoloration, excessive roughness. |
- Inspected for presence of echogenic markings. | "Results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device and is substantially equivalent to the predicate devices." (Implies visual specifications were met and echogenic markings were present and acceptable). |
| Dimensional Specifications | The following dimensions are within specification according to the product drawing: - Cannula outer diameter
- Cannula inner diameter
- Cannula length
- Distance to first depth marking
- Depth marking width
- Tip Gap of Stylet | "Results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device and is substantially equivalent to the predicate devices." (Implies dimensional specifications were met). |
| Associated Device Testing | - Needle permits a 20 Ga. catheter to freely pass through the cannula. - Needle performs adequately with sideport valve assembly (i.e., extension tubing) and threading assist guide attached. | "Results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device and is substantially equivalent to the predicate devices." (Implies adequate performance with associated devices). |
| Ultrasound Visibility | - Needle is visible under ultrasound. | The device includes "'echogenic' etched markings intended to enhance visibility of the needle when using an ultrasound imaging device." And "Results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device and is substantially equivalent to the predicate devices." (Implies ultrasound visibility was enhanced and acceptable). |
| Functional Testing | - The Luer of the needle meets the requirements of ISO 594-1 and ISO 594-2. - Needle is free of occlusions and permits flow of fluid.
- Needle assembly withstands a minimum pressure without leaking.
- Needle withstands bending without breaking.
- Needle is sufficiently stiff.
- Cannula to hub joint has sufficient tensile strength.
- Stylet fit in cannula is sufficient.
- Stylet to stylet hub has sufficient tensile strength. | "Results of functional performance and biocompatibility testing demonstrate that the Perican Ultra needle is substantially equivalent to the predicate devices." (Implies all functional tests were successfully passed). |
| Sterilization | - SAL 10^-6 - EO Residual Levels
- LAL Bacterial Endotoxin Testing | "Results of functional performance and biocompatibility testing demonstrate that the Perican Ultra needle is substantially equivalent to the predicate devices." (Implies all sterilization requirements were met). |
| Biocompatibility | Cytoxicity, Intracutaneous Reactivity, Sensitization, Rabbit Pyrogenicity, Systemic Toxicity, USP Physicochemical Tests for Plastics, Corrosion, Acidity/Alkalinity according to ISO 10993-1:2009. | "Based on similarities to the predicate device and biocompatibility test results, the Perican Ultra needle materials of construction are considered biocompatible for their clinical application." (Implies all biocompatibility tests were passed successfully). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each performance test. It only states that functional performance testing was "completed" and "results of testing demonstrate that the Perican Ultra needle performs similarly to the predicate device." The data provenance (country of origin, retrospective/prospective) is not mentioned, as these are typically bench-top and lab-based engineering tests rather than clinical studies with patient data.
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. The "ground truth" for this device's performance is established by engineering and laboratory test standards (e.g., ISO standards, dimensional measurements, functional performance metrics), not expert human interpretation of data for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for studies where human interpretation or consensus is required to establish a gold standard. For this device, objective measurements and adherence to established engineering standards serve as the "ground truth."
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/Machine Learning device, and therefore no MRMC study, human reader improvement with AI, or effect size is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/Machine Learning device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is based on:
- Adherence to international standards (ISO 9626:1991/Amd. 1:2001, ISO 7864:1993, ISO 594-1:1986, ISO 594-2:1998, ISO 10993-1:2009), which define acceptable performance characteristics.
- Objective measurements of physical and functional properties (e.g., cannula dimensions, Luer taper fit, tensile strength, pressure resistance).
- Visual inspection criteria.
8. The sample size for the training set
Not applicable. This is not an AI/Machine Learning device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set in the context of machine learning for this device.
§ 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).