(273 days)
The B. Braun Perifix catheters are regional anesthesia catheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration are epidural. The catheters may remain indwelling for up to 72 hours.
The B. Braun Contiplex catheters are regional anesthesia catheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The catheters may remain indwelling for up to 72 hours.
The B. Braun Perifix and Contiplex catheters are regional anesthesia catheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management. Routes of administration include epidural and perineural (peripheral nerve block). There is no difference in the catheter design of the Perifix catheter when compared to the Contiplex catheter (i.e. the catheters are the same). The only difference between the Perifix and Contiplex catheter is the intended route of administration; Perifix catheters are marketed for use in epidural anesthesia, while Contiplex catheters are marketed for use in peripheral nerve block procedures.
The B. Braun Perifix and Contiplex catheters consists of a hollow polyamide tube with depth markings thermo-diffused into the polyamide tube. The catheters are available in both 19 and 20 Ga. diameters. The Perifix/Contiplex catheters are available in an open-tip configuration (no side ports) as well as a closed-tip configuration (with side ports). The closed-tip catheters have a rounded closed-tip with three side ports for distribution of anesthetics and analgesics.
The catheters include depth markings to identify the depth of insertion during use. The tip of the catheter (proximal to the patient) is also marked to signify the end of the catheter.
The provided document describes the B. Braun Perifix and Contiplex Catheters, which are regional anesthesia catheters. The information focuses on demonstrating their substantial equivalence to a predicate device (B. Braun Regional Anesthesia Catheter, K042488) for 510(k) clearance, rather than presenting a study proving a device meets specific acceptance criteria in the context of clinical performance or AI algorithm effectiveness.
Therefore, many of the requested categories in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission, as it concerns the substantial equivalence of a medical device based on design, materials, and functional performance, not an AI algorithm or a clinical effectiveness study.
However, I can extract the relevant information regarding acceptance criteria and reported device performance from the document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test / Requirement | Reported Device Performance (as stated in the document) |
|---|---|---|
| Dimensional Specifications | Catheters meet dimensional requirements for outer diameter, inner diameter, overall length, and depth markings. | "Catheters meet dimensional requirements for outer diameter, inner diameter, overall length and depth markings" (Table 1) |
| Functional Testing | Flexibility | "Results of testing demonstrate that the Perifix and Contiplex catheters are substantially equivalent to the predicate device." (Implies flexibility requirements were met.) |
| Markings are legible | "Markings are legible" (Table 1) | |
| Catheter tubing is translucent | "Catheter tubing is translucent" (Table 1) | |
| Catheter achieves flow rate requirements | "Catheter achieves flow rate requirements" (Table 1) | |
| Catheter resists kinking | "Catheter resists kinking" (Table 1) | |
| Catheter permits flow of fluid when attached to catheter connector | "Catheter permits flow of fluid when attached to catheter connector" (Table 1) | |
| Catheter withstands fluid pressure without leakage | "Catheter withstands fluid pressure without leakage" (Table 1) | |
| Catheter withstands minimum tensile force when attached to connector | "Catheter withstands minimum tensile force when attached to connector" (Table 1) | |
| Catheter body withstands minimal tensile force | "Catheter body withstands minimal tensile force" (Table 1) | |
| Catheter has sufficient elongation properties | "Catheter has sufficient elongation properties" (Table 1) | |
| Associated Device Testing | Catheter passes through appropriate size procedural needle without being damaged | "Catheter passes through appropriate size procedural needle without being damaged" (Table 1) |
| Catheter passes freely through the threading assist guide | "Catheter passes freely through the threading assist guide" (Table 1) | |
| Catheter passes freely through sideport valve assembly | "Catheter passes freely through sideport valve assembly" (Table 1) | |
| Sterilization | Sterility Assurance Level (SAL) 10-6 | "SAL 10-6" (Table 1) |
| Ethylene Oxide (EO) residual levels met per ISO 10993-7 | "EO residual levels met per ISO 10993-7" (Table 1) | |
| LAL bacterial endotoxin levels met per USP and USP | "LAL bacterial endotoxin levels met per USP and USP " (Table 1) | |
| Biocompatibility | Cytotoxicity, Intracutaneous Reactivity, Sensitization, Rabbit Pyrogenicity, Systemic Toxicity, Subchronic Systemic Toxicity, Genotoxicity (bacterial reverse mutation, mouse lymphoma, mouse peripheral blood micronucleus), Implantation, Chemical Characterization of Materials (Exaggerated Extraction and Simulated Use) | "The tests completed with the Perifix and Contiplex catheters are provided in Table 2: Biocompatibility Tests." and "Based on test results, the Perifix and Contiplex catheter materials of construction are considered substantially equivalent to the predicate device." (Implies all listed tests were met). |
Here's an explanation of why other requested information is not applicable and what information the document DOES provide instead:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This document describes a 510(k) submission for a physical medical device, not an AI algorithm. The "tests" mentioned are engineering and biocompatibility tests performed on the device itself (e.g., measuring dimensions, tensile strength, flow rate, chemical residues), not a "test set" of patient data for an algorithm. There is no mention of a "test set" in the context of patient data.
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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):
- N/A. As above, no "test set" of patient data is being evaluated with experts for ground truth. The "ground truth" for these tests are objective measurements (e.g., did the catheter break at X force, did it pass Y flow rate).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for this type of device submission.
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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:
- N/A. This is a physical medical device, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the functional and dimensional tests, the "ground truth" is based on engineering specifications and physical properties measurements.
- For sterilization and biocompatibility tests, the "ground truth" is based on compliance with specific ISO and USP standards (e.g., SAL 10-6, ISO 10993-7 for EO residuals, USP and for endotoxins).
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The sample size for the training set:
- N/A. There is no "training set" as this is not an AI algorithm.
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How the ground truth for the training set was established:
- N/A. There is no "training set" as this is not an AI algorithm.
Summary of the Study (as described in the document):
The document describes a regulatory submission (510(k) Premarket Notification) for the B. Braun Perifix and Contiplex Catheters. The "study" presented is a series of performance tests conducted by the manufacturer to demonstrate substantial equivalence to a predicate device (B. Braun Regional Anesthesia Catheter, K042488).
- Objective: To demonstrate that the new catheters do not raise different questions of safety or effectiveness compared to the predicate device, despite minor differences in design, dimensions, and materials.
- Methodology: The manufacturer performed a range of tests categorized into:
- Dimensional Specifications: Checking outer diameter, inner diameter, overall length, and depth markings against requirements.
- Functional Testing: Evaluating properties like flexibility, legibility of markings, translucency, flow rate, kinking resistance, fluid pressure resistance, tensile strength (catheter-connector and body), and elongation properties.
- Associated Device Testing: Ensuring compatibility with procedural needles, threading assist guides, and sideport valve assemblies.
- Sterilization: Verifying SAL, EO residual levels, and LAL bacterial endotoxin levels according to relevant standards.
- Biocompatibility: Performing a comprehensive suite of tests recommended by ISO 10993-1, including cytotoxicity, intracutaneous reactivity, sensitization, pyrogenicity, systemic toxicity (single and subchronic), genotoxicity, implantation, and chemical characterization.
- Results: The document states that the results of these tests (functional performance, biocompatibility, and chemical testing) demonstrate that the Perifix and Contiplex catheters are "substantially equivalent" to the predicate device and "do not raise different questions of safety or effectiveness." The specific quantitative results for each test are typically detailed in the full 510(k) submission, but this summary document only provides the conclusion of compliance.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).