(90 days)
The B. Braun Perifix ONE® Pediatric Catheter is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery for pediatric patients within the subgroups of Child (2 to 12 years of age) and Adolescent (12 to 21 years of age). Routes of Administration include epidural and perineural (peripheral nerve block) with a duration of use no longer than 72 hours.
B. Braun's Perifix ONE® Pediatric Catheter is a coextruded anesthesia conduction catheter consisting of an inner layer of polyamide and an outer layer of polyurethane. The catheters will be available in 20 Ga. and 24 Ga. diameters. The 20 Ga. catheter will have a length of 1010 millimeters and the 24 Ga. catheter will have a length of 720 millimeters. The catheters are designed in a rounded closed tip configuration with six side ports for distribution of anesthetics and analgesics. Both catheters will have depth markings beginning within 2 millimeters from the tip of the catheter and ending at approximately 180 millimeters from the tip. The product is an individually packaged, sterile, non-pyrogenic, single use disposable device.
This document is a 510(k) premarket notification for a medical device called the "Perifix ONE® Pediatric Catheter, 20 Ga. and 24 Ga." It focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.
Here's a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: This document does not define specific performance acceptance criteria for the device itself (e.g., sensitivity, specificity, accuracy for a diagnostic device) or report performance metrics from a study that would demonstrate it meets such criteria. The "tests" mentioned are likely bench tests to demonstrate equivalence in materials, design, and manufacturing process, not clinical performance measures.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided: This document does not describe a "test set" in the context of clinical performance evaluation (e.g., patient data for an AI algorithm). The safety and effectiveness of the device were demonstrated through "a variety of tests" to show substantial equivalence to predicate devices, which typically refer to bench or engineering tests, not a clinical study involving a test set of 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)
- Cannot be provided: There is no mention of a "test set" requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: There is no mention of a "test set" requiring adjudication.
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
- Cannot be provided: This document describes a physical medical device (catheter) and its substantial equivalence to existing devices. It does not involve AI or human "readers" in the context of a diagnostic or interpretive task. Therefore, an MRMC study is not relevant, and no information on AI assistance is available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided: This device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided: As this is not a diagnostic device or an AI algorithm, the concept of "ground truth" in this context is not applicable. The "ground truth" for showing the device works would be its physical properties, biocompatibility, and ability to deliver anesthetics/analgesics, which are typically assessed through engineering and bench testing, not expert consensus on diagnostic interpretations.
8. The sample size for the training set
- Cannot be provided: There is no training set for this device, as it is a physical product and not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Cannot be provided: There is no training set or ground truth in this context.
Summary of Relevant Information from the Document:
The document concerns the Perifix ONE® Pediatric Catheter, 20 Ga. and 24 Ga. The submission is a 510(k) Premarket Notification seeking to demonstrate substantial equivalence to existing predicate devices.
- Demonstration of Safety and Effectiveness: "The Perifix ONE® Pediatric Catheter has been subjected to a variety of tests to demonstrate substantial equivalence to the three predicate devices and to demonstrate the safety and effectiveness of the proposed device." While these "tests" are mentioned, no specific details about their nature, methods, results, or acceptance criteria (in terms of clinical performance) are provided in the extracted text. These tests typically include biocompatibility, sterility, material strength, flow rates, and other engineering specifications to ensure the device performs as intended and is safe.
In conclusion, this document is a regulatory submission focused on proving substantial equivalence for a physical medical device, not a study evaluating acceptance criteria or performance of an AI or diagnostic tool. Therefore, much of the requested information is not applicable or available within the provided text.
§ 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).