(49 days)
The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, postoperatively, for the relief of pain. The Polyurethane Infusion Catheters are intended for use in the hospital or by an ambulatory patient.
The Polyurethane Infusion Catheter consists of two design options: Alpha Cath™ open end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked. Multi Drip® closed end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing has a series of tiny ports along the distal portion of the catheter which are designed to spread medication along an infusion zone.
The provided FDA 510(k) K061356 for the "Polyurethane Infusion Catheter" does not contain information on acceptance criteria, a specific study proving the device meets acceptance criteria, or any of the detailed analytical performance metrics typically associated with AI/ML device studies. This document is a traditional 510(k) submission for a medical device that predates the widespread adoption and specific regulatory guidance for AI/ML-driven medical devices.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable or not present in this document.
The primary method of demonstrating safety and effectiveness for this device is substantial equivalence to predicate devices, focusing on material change from PVC to medical-grade polyurethane while maintaining the same intended use.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document does not specify quantitative acceptance criteria or performance metrics for the Polyurethane Infusion Catheter in the way an AI/ML device would. The "performance" assessment is qualitative, stating that the device is "substantially equivalent" to existing predicate devices based on its design and material change.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This 510(k) does not describe a clinical performance study with a test set of data. The submission is based on the technological comparison and substantial equivalence to existing devices.
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 / Not Provided. As no specific performance study or test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No test set or related adjudication method is mentioned.
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 / Not Provided. This is not an AI/ML device, and no MRMC study is described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. The concept of "ground truth" as it applies to AI/ML performance evaluation is not relevant to this type of device submission. The device's "truth" is its functional design and material properties, which are compared to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not an AI/ML device, and therefore, no training set or machine learning model is utilized.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set for an AI/ML model, this information is not relevant.
Summary of the K061356 submission:
The submission focuses on a material change for an existing "Infusion Catheter" from PVC to medical-grade polyurethane. The primary argument for market clearance is substantial equivalence to previously cleared predicate devices (K021964, K042246, K003915, K993691). The manufacturer asserts that the new polyurethane catheters are "the same as the current Alpha Cath™ and Multi Drip™ Infusion Catheters except that the catheter material has been changed." The intended use remains identical: "for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain."
Safety and effectiveness are presumed based on the predicate devices, with the material change being the primary technical difference addressed by the submission, usually supported by biocompatibility and functional testing data (though specific test results are not detailed in this summary).
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.