(27 days)
Intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
Spectrum® VentriClear™ II Ventricular Drainage Catheter Set includes a silicone 2.8 mm (9 Fr.) ventricular catheter available in a 33 cm length with numbered markings and 16 sideports. VentriClear™ II is impregnated with minocycline and rifampin. This device is supplied sterile and is intended for one-time use.
The provided document describes a Special 510(k) Premarket Notification for a medical device (Spectrum® VentriClear™ II Ventricular Drainage Catheter). This type of submission is for modifications to a legally marketed device and primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing. It is not an AI/ML device, and therefore the requested information such as MRMC studies, effect size of human readers with AI assistance, or standalone algorithm performance, and training set details are not applicable to this submission.
Here's a breakdown of the acceptance criteria and study information that is relevant and available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria with specific threshold values for each test. Instead, it refers to the tests generally assuring "reliable design and performance" and conforming to "requirements necessary for its use." The performance results are described in a qualitative manner.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Properties | |
| HPLC testing | Results provide reasonable assurance that the device conforms to requirements. |
| Tensile testing | Results provide reasonable assurance that the device conforms to requirements. |
| Biocompatibility | Results provide reasonable assurance that the device conforms to requirements. |
| Fluid Management | |
| Liquid leakage testing | Results provide reasonable assurance that the device conforms to requirements. |
| Burst pressure testing | Results provide reasonable assurance that the device conforms to requirements. |
| Gravity flow rate testing | Results provide reasonable assurance that the device conforms to requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the described tests (HPLC, Tensile, Liquid Leakage, Burst Pressure, Biocompatibility, Gravity Flow Rate). The data provenance is also not specified, but given that these are physical performance tests of a manufactured medical device, they would typically be conducted in a laboratory setting by the manufacturer (Cook Incorporated) rather than involving human patient data from a specific geographical origin. These tests are prospective in nature, as they are conducted on newly manufactured or modified devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical device (catheter), not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is determined by physical and chemical testing against engineering specifications and industry standards.
4. Adjudication method for the test set
Not applicable, as ground truth is not established through expert consensus or interpretation. The performance is assessed against predefined physical/chemical standards.
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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
The "ground truth" for the performance of this device is established through:
- Engineering Specifications and Standardized Test Methods: Each test (HPLC, Tensile, Leakage, Burst Pressure, Flow Rate, Biocompatibility) would have pre-defined acceptance criteria based on established engineering principles, material science, and relevant industry standards for medical devices of this type.
- Predicate Device Performance: The primary method of demonstrating "substantial equivalence" is by showing that the modified device performs comparably to the legally marketed predicate device (Cook Spectrum® Ventricular Drainage Catheter Set - K011812) in terms of these physical and chemical properties.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).