(163 days)
The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatic applications (children under 12 years, infants and neonates) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and peripheral blocks. The duration of use should not exceed 72 hours.
The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catherer is made of flexible, nylon tubing. The catheter is open-ended catheter with finished tip. The tipe 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 catherer is available in 24g (O.I). 0.022"/I.D. 0.012") size. The catheters have a nominal length of 36 inches. The catheter includes a stylet.
The catheters are provided with a catheter connector to provide a means of administration of anesthetics and/or analgesics. They are provided sterile as a component of a continuous anesthesia conduction catheter mini tray.
The provided text describes a 510(k) premarket notification for the Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with a specific study design and data.
Therefore, most of the requested information cannot be directly extracted from this document, as it outlines a regulatory submission process based on non-clinical data and comparison to predicates.
Here's an attempt to answer based on the available information, noting where data is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense for each performance metric, as it's a 510(k) submission relying on substantial equivalence to predicate devices. Instead, it states that the device's characteristics "fall within the values of the predicate Portex catheters and the B. Braun catheter."
The "reported device performance" is essentially that it performs equivalently to predicate devices across various non-clinical tests.
| Performance Metric | Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance |
|---|---|---|
| Dimensional Characteristics | Within values of predicate devices (K962696, K924541) | Data submitted demonstrates equivalence to predicate devices. |
| Flow Rate | Within values of predicate devices | Data submitted demonstrates equivalence to predicate devices. |
| Compression Resistance | Within values of predicate devices | Data submitted demonstrates equivalence to predicate devices. |
| Hub/Catheter Detachment | Within values of predicate devices | Data submitted demonstrates equivalence to predicate devices. |
| Deflection Resistance | Within values of predicate devices | Data submitted demonstrates equivalence to predicate devices. |
| Modulus of Elasticity | Within values of predicate devices | Data submitted demonstrates equivalence to predicate devices. |
| Tensile Strength | Within values of predicate devices (K924541) | Data submitted demonstrates equivalence to predicate devices. |
| Elongation | Within values of predicate devices (K924541) | Data submitted demonstrates equivalence to predicate devices. |
| Biocompatibility | Materials identical to predicate (K992471), ink identical to predicate (K935927) | Data submitted demonstrates equivalence (materials and ink). |
| Sterilization | Identical to predicate (K992471) | Data submitted demonstrates equivalence. |
| Packaging | Identical to predicate (K992471) | Data submitted demonstrates equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample sizes for the non-clinical tests (e.g., how many catheters were tested for flow rate, tensile strength, etc.).
- Data Provenance: The data is presented as "Non-Clinical Data" submitted by Smiths Medical ASD, Inc., located in Keene, NH, USA. The document doesn't specify if the testing was done internally or by a third-party, nor does it explicitly state the country of origin of the raw data. It is inherently prospective in the sense that the sponsor conducted these tests specifically for this 510(k) submission on the new device.
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)
- This question is not applicable as the submission relies on non-clinical engineering and material testing data, not expert-adjudicated clinical data to establish a "ground truth" for a test set. The "ground truth" here is the performance metrics themselves, measured against engineering specifications or comparison to predicate devices, not subjective expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for the same reasons as #3. There was no clinical test set requiring expert 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
- This question is not applicable. This is a submission for a physical medical device (catheter), not an AI/software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission are the measured physical, mechanical, and material properties of the device, confirmed through standard engineering and laboratory testing, and compared against the known properties of the predicate devices. This includes dimensional characteristics, flow rate, mechanical resistances (compression, deflection), material strengths (tensile, elongation), and material compatibility (biocompatibility).
8. The sample size for the training set
- This question is not applicable. There is no "training set" in the context of this 510(k) submission, which is based on demonstrating substantial equivalence through non-clinical testing, not machine learning or AI.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as #8.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).