(67 days)
The Soaker Catheter is intended to be used as follows:
- With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and
- As a stand alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous.
The Soaker Catheter is identical to the predicate IntraOp Catheter (K991543). This premarket notification adds an additional model to the Soaker Catheter family of catheters. The Soaker Catheter consists of a Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries Medical) with the insertion of a hollow fiber membrane in the inner diameter of the distal end of the catheter. The catheter has a closed end tip with multiple holes arranged radially along the lateral surface at the distal end of the device.
The provided text is a 510(k) summary for the "Soaker Catheter." This document focuses on demonstrating substantial equivalence to pre-existing devices, not on proving performance against specific acceptance criteria through a study. Therefore, the information required to answer most of your questions (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types for test and training sets) is not present in the provided text.
The document is a regulatory submission for a medical device, which typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than conducting new performance studies that would establish acceptance criteria for novel functionalities.
Here's a breakdown of what can be extracted and why other information is missing:
1. A table of acceptance criteria and the reported device performance
- Information Not Found: The document does not specify quantitative acceptance criteria or report performance data against such criteria. Its entire premise is based on substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Found: No mention of a "test set" or any clinical study from which such data would originate. The submission states the device's materials are "identical" to predicate devices and biological testing is in conformance with ISO 10993, but it doesn't describe a specific performance study in humans.
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)
- Information Not Found: Not applicable, as there's no described "test set" requiring ground truth establishment by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Found: Not applicable, as there's no described "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
- Information Not Found: This is a physical catheter, not an AI-powered diagnostic device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Found: This is a physical catheter, not an algorithm. Standalone performance as typically understood for AI/software is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Not Found: Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Information Not Found: Not applicable. There is no "training set" in the context of an AI/machine learning model. The device's design is based on existing, legally marketed catheters.
9. How the ground truth for the training set was established
- Information Not Found: Not applicable.
Summary of what the document does provide regarding device characteristics and regulatory pathway:
- Device Name: Soaker Catheter
- Common Name: Anesthetic Catheter
- Classification Name: Anesthesia Conduction Catheter
- Predicate Devices:
- Key Aspect of Substantial Equivalence: The Soaker Catheter is described as "identical" to the predicate IntraOp Catheter (K991543), with this submission adding an additional model (S1205: 20 GA with 12.5 cm (5.0 in.) infusion segment) to the existing S0605 model (20 GA with 6.5 cm (2.5 in.) infusion segment). The new model is "virtually identical" to the predicate 2.5-inch Soaker Catheter except for the longer infusion segment.
- Material Equivalence: "All materials in the catheter are identical in formulation to materials currently being used in other products with the same or similar uses and have a long history of use in those devices." (Section 3.1)
- Biological Testing: "Biological testing is in conformance with ISO 10993 Part 1 for fluid path components." (Section 3.2)
- Drug Compatibility: No specific drugs are referenced, and no drugs are included with the catheter. (Section 4.1)
- Intended Use:
- With I-Flow Corporation's PainBuster, ON-Q, and Nerve Block pain management kits.
- As a stand-alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous. (Section 5.1 & Indication for Use statement)
In essence, this 510(k) asserts that the Soaker Catheter is substantially equivalent to existing, legally marketed devices. It does not present new performance data against specific acceptance criteria, but rather relies on the established safety and effectiveness of its predicate devices and the similarity of its design and materials.
§ 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).