(64 days)
The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.
The SIMS Portex Anesthesia Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks.
The catheter is available as 21g (O.D. .033"/I.D. .019"). The catheters have a nominal length of 38 inches. The catheters may include a stylete.
The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017).
The provided document, K994275, describes a 510(k) premarket notification for the SIMS Portex Anesthesia Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for a novel device, such as detailed performance metrics from a specific test set, expert adjudication, or MRMC studies, is not present in this document.
Instead, the document emphasizes equivalence through non-clinical data demonstrating that the new catheter performs equivalently to predicate devices for specific characteristics.
Here’s an analysis based on the provided text, addressing the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalency to Predicate) | Reported Device Performance |
|---|---|---|
| Dimensional Characteristics | Identical design and materials to current catheter for: |
- Inner Diameter (ID)
- Outer Diameter (OD)
- Length | Demonstrated equivalency to predicate devices. |
| Functional Characteristics | - Flow Rate - Leakage
- Eye Patency
- Tensile Strength
- Percentage Elongation
- Luer Taper
- Security of Connection of the catheter to the catheter connector
- Hub/Catheter Detachment | Demonstrated equivalency to predicate devices. |
| Material Safety | - ETO residuals (Ethylene Oxide sterilization residuals) - Biological Safety per ISO 10993 | Data submitted covers ETO residuals and biological safety per ISO 10993. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the way one would for a clinical study with patients or a specific set of images for an AI algorithm. The performance evaluation was based on non-clinical data comparing the new device's characteristics against predicate devices. The exact sample sizes for each physical or material test (e.g., number of catheters tested for flow rate, tensile strength, etc.) are not provided in this summary.
Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these non-clinical, bench-top type tests. The tests would likely have been conducted in a lab setting by the manufacturer (SIMS Portex Inc., likely in Keene, NH, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation was based on objective, quantifiable physical and material tests against manufacturer specifications and predicate device characteristics, not subjective interpretations by experts to establish a "ground truth" in a clinical diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the non-clinical, bench-top tests conducted.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an anesthesia catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is an anesthesia catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established specifications and performance characteristics of the predicate devices and recognized industry standards (e.g., ISO 10993 for biological safety). The new device's performance in dimensional, functional, and material safety tests was compared directly to these objective benchmarks to demonstrate substantial equivalence.
8. The sample size for the training set
This question is not applicable. The device is an anesthesia catheter and does not involve a training set as would be used for machine learning.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
§ 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).