(22 days)
- With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and 1.
- As a stand alone device to provide continuous or intermittent delivery of local anesthetics 2. or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, percutaneous or perineural.
The Soaker Catheter has a closed end tip with multiple holes arranged radially along the lateral surface along the infusion segment at the distal end of the device. A membrane in the inner diameter of the catheter promotes even distribution along the infusion segment. This special 510(k) proposes a slight design change that has the membrane along the outside diameter of the catheter instead of the inside diameter.
The provided text is a Special 510(k) for a "Soaker Catheter" from I-Flow Corporation (K022869). This document describes a design change to an existing device, specifically moving a membrane from the inside to the outside diameter of the catheter.
Based on the nature of this submission (a Special 510(k) for a minor design change to an already cleared device), the typical detailed clinical studies and performance evaluations against specific acceptance criteria, as might be seen for a novel device or a device making substantial performance claims, are not present in this document.
Instead, the submission relies on demonstrating substantial equivalence to the predicate device (the earlier Soaker Catheter, K991543 and K994374). The justification for this substantial equivalence is that the "new Soaker Catheter utilizes the exact same technology for promoting even distribution along the infusion segment." This implies that the performance characteristics, and thus the "acceptance criteria," are inherently met by virtue of the device being functionally identical to the previously cleared version.
Therefore, many of the requested elements for a detailed study proving device meets acceptance criteria are not applicable (N/A) in this specific 510(k) summary.
Here's the breakdown of the information as requested, with explanations for why certain elements are N/A:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Maintain "even distribution along the infusion segment" (same as predicate device) | Utilizes "exact same technology for promoting even distribution along the infusion segment," therefore performance is considered equivalent to predicate |
| Biocompatibility (same materials as predicate) | Assumed to be the same and met as the predicate device (no mention of material change) |
| Sterility (same as predicate) | Assumed to be the same and met as the predicate device |
| Functional integrity (no adverse effects from design change) | Design change (membrane position) does not alter fundamental functional mechanism |
Explanation: This 510(k) is for a minor design modification where the manufacturer asserts that the fundamental technology and performance are unchanged. Therefore, explicit, quantitative acceptance criteria and a study dedicated to proving these new criteria are not typically provided in such a submission. The "acceptance" is that the device performs equivalently to its predicate, which has already been deemed safe and effective.
2. Sample size used for the test set and the data provenance
N/A. No specific test set or clinical data is presented for this Special 510(k) based on the provided text. The submission focuses on the engineering change and its lack of impact on existing performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. No ground truth establishment by experts is described in this document.
4. Adjudication method for the test set
N/A. No test set or adjudication method is described in this document.
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
N/A. This is a medical device (catheter), not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a medical device (catheter), not an algorithm. Standalone performance studies in this context are not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. No ground truth is specified or needed for this type of device modification under a Special 510(k) that claims substantial equivalence based on an identical functional principle.
8. The sample size for the training set
N/A. As this is a physical medical device and not a machine learning model, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
N/A. Not applicable, as there is no training set for a physical medical device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).