(198 days)
The Lumbar Drainage Catheter Kit is indicated for temporary access to the lumbar subarachnoid region and, when used with other Codman devices, is designed to drain cerebrospinal fluid (CSF) as a means of reducing increased intracranial volume and pressure.
The Lumbar Drainage Catheter Kit consists of an 80cm lumbar catheter having an inner diameter of .76mm. The catheter has 13 tantalum location markings to assist the surgeon. The initial mark is located at 11.4 cm with a mark every 1cm thereafter for 10cm, and additional marks at 15cm and 20cm. Also included are a cm-marked 14 gauge thin wall Touhy needle with optional stabilizing wings; a 100 cm Teflon coated, flexible tip guidewire with an outer diameter of 0.5mm; a plastic female Luer-Lok connector, with barbed end and plastic Luer-Lok cap, that is installed on the distal end of the catheter in preparation for connection to monitoring equipment or fluid collection equipment; and a soft suture tab for holding the catheter in position.
The provided document (K964923) is a 510(k) premarket notification for a medical device called the "CODMAN Lumbar Drainage Catheter Kit." This type of submission is for establishing substantial equivalence to a predicate device, not for presenting a study proving the device meets specific performance acceptance criteria in the way a clinical trial for a new drug or a novel medical device might.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device.
Here's why the document doesn't have the requested information and what it does provide:
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Acceptance criteria and reported device performance (Table): Not applicable. The submission asserts substantial equivalence based on similar materials, intended use, design, manufacturing, packaging, and sterilization to a predicate device (Cordis Lumbar Catheter Accessory Kit, K855058). There are no specific performance metrics or acceptance criteria for a "study" reported in this document.
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Sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how training set ground truth was established: None of this information is present because this is a 510(k) submission based on substantial equivalence, not a clinical performance study. The core argument is that the new device is so similar to an already approved device that new clinical performance data is not required to establish safety and effectiveness.
What the document does communicate:
- Proprietary Name: CODMAN Lumbar Drainage Catheter Kit
- Common Name: Lumbar Drainage Catheter Kit
- Classification Name: Central nervous system fluid shunt and component (Class II, 21 CFR §882.5550)
- Predicate Device: Cordis Lumbar Catheter Accessory Kit (K855058)
- Basis for Substantial Equivalence: Similar materials, intended use, design, manufacture, packaging, and sterilization.
- Indications for Use: Temporary access to the lumbar subarachnoid region and, in conjunction with other Codman devices, to drain cerebrospinal fluid (CSF) to reduce increased intracranial volume and pressure.
- Physical Description of the Device: Detailed components and dimensions of the catheter, needle, guidewire, connector, and suture tab.
In summary, this 510(k) notification is a regulatory document to clear a medical device for market based on its similarity to an existing device, rather than a report detailing a study with specific acceptance criteria and performance results.
§ 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).