(160 days)
The XABO Catheters are used for cerebrospinal fluid (CSF) shunting.
The XABO Catheters are manufactured using barium sulfate fillcone elastomer and are impregnated with clindamycin hydrochloride and rifampicin designed to be released over time from the exterior and inner lumen surface once implanted.
The XABO Ventricular Catheters will be offered in 18 cm in length with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. Lengths are marked in 1 cm intervals starting from the catheter tip, thus enabling the surgeon to qauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 16 flow holes around the catheter circumference.
Components supplied with the XABO Ventricular Catheter include a pre-loaded stainless steel stylet and depending on the confiquration may contain a deflector.
The XABO Peritoneal Catheters measure 60 cm or 120 cm in length, 1.2 mm in inner diameter, and 2.5 mm in outer diameter. There are no length markers or wall slits on the tip is open ended. The catheter may be trimmed to the proper length.
The XABO Catheters are designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System. Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System miniNAV valve, and the Miethke Shunt System (DSV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K110206/K030698/K011030).
The provided text focuses on the 510(k) premarket notification for the XABO Ventricular Catheter, XABO Peritoneal Catheter, and XABO Catheter Set. It primarily addresses the substantial equivalence of these devices to existing predicate devices. While it mentions performance bench testing and specific tests performed, it does not explicitly state specific acceptance criteria values or detailed study results that would allow for a complete fill of the requested table.
The document indicates that the devices were tested against "performance specifications" and that the results "confirm that the XABO Catheters meet performance specifications." However, the exact numerical or qualitative specifications themselves are not provided.
Therefore, the following information is extracted directly from the provided text, and where information is not explicitly stated, it is noted as "Not explicitly stated in the provided text."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Bench Testing (ISO 7197) | "Testing results confirm that the XABO Catheters meet performance specifications." (Specific specifications and results not provided). |
| Zone of Inhibition | "Comparison testing of the XABO Catheters and the predicate device show that they have the same characteristics." (Specific characteristics and results not provided). |
| Drug Content | "Comparison testing of the XABO Catheters and the predicate device show that they have the same characteristics." (Specific characteristics and results not provided). |
| Drug Release Kinetic | "Comparison testing of the XABO Catheters and the predicate device show that they have the same characteristics." (Specific characteristics and results not provided). |
| Crush Resistance | "Comparison testing of the XABO Catheters and the predicate device show that they have the same characteristics." (Specific characteristics and results not provided). |
| MRI Safety (ASTM F2213, F2182, F2119) | "the deflector is MR Conditional in 3-Tesla Magnetic Resonance Imaging systems per ASTM F2503." |
| Biocompatibility (ISO 1099-1, FDA Guidance "Use of International Standard ISO 10993-1") | Met requirements for Cytotoxicity, Sensitization/Reactivity, Genotoxicity, Implantation, Acute Systemic Toxicity, Sub-Chronic, Hemolysis, Pyrogenicity. Chronic and developmental/reproductive toxicity addressed by chemical characterization. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. The phrase "All testing was performed on the worst-case final finished device" could imply a limited number of samples, but a specific number is not given.
- Data Provenance: The studies are described as "Performance bench testing" and "Biocompatibility testing," suggesting laboratory-based testing, not human-patient data. The country of origin of the data is not specified. It is laboratory research, not retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as the testing described is bench testing and biocompatibility, not studies requiring expert interpretation of clinical data for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for the types of tests described (bench testing, biocompatibility).
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, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence through bench and biocompatibility testing, not AI-assisted human reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (catheter), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For performance bench testing, the "ground truth" would be the pre-defined engineering specifications and standards (e.g., ISO 7197) that the device must meet.
- For biocompatibility testing, the "ground truth" is compliance with international standards (ISO 1099-1) and FDA guidance, ensuring that the device's biological interactions are within acceptable limits.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device that requires a training set and ground truth establishment.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).