(76 days)
The Neuron Therapeutics Inc., 14-Gauge Lumbar Puncture Set is indicated for temporary access to the lumbar subarachnoid region to drain cerebrospinal fluid (CSF) and other fluids of similar physical characteristics.
The Neuron Therapeutics 14-Gauge Lumbar Puncture Set, part number PN1000735, consists of a 14-Gauge Lumbar Catheter Kit, a Transparent Tegaderm™ Dressing, a Suture-less Catheter Anchor, and a Sterile Drape. These individual, sterile packaged components are provided in sealed tamper-evident packaging for single-use. The 14-Gauge Lumbar Catheter Kit, part number PN1000737, contains a single 30 cm coiled lumbar catheter with an inner diameter of 1.25 mm, an outer diameter of 1.74 mm and 35 fenestrations. The shorter length, larger diameter and higher number of fenestrations of the catheter allow for decreased flow resistance and higher liquid flow rates. The higher number of fenestrations decreases the possibility of occlusion of the catheter during use. The catheter is constructed of polyurethane to provide resistance to kinking or collapsing. The catheter has 13 location markings positioned at 1 cm intervals to assist the physician in identifying the location of the distal end of the catheter in the subarachnoid space. Special markings are provided to indicate the location of the catheter tip, the proximal fenestration and the coiled shaft as they exit from the needle tip. The 14-Gauge Lumbar Catheter Kit also contains a 15.0 cm, 14-gauge Extra-Thin Wall Touhy Needle and a 45 cm stainless steel flexible J-tip guidewire for inserting and guiding the catheter into the lumbar subarachnoid space. A 6-French Touhy-Borst Connector is also included for connection to equipment for patient monitoring or fluid collection.
This document is a 510(k) premarket notification for a medical device and therefore describes substantial equivalence, not a study demonstrating the device meets acceptance criteria. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device and does not require a PMA.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including specific details like sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies, cannot be extracted from this document as it is not a clinical study report.
The document focuses on:
- Device Identification: Proprietary name, trade name, common name, classification, regulatory class, product code.
- Contact Information: Manufacturer and representative.
- Statement of Substantial Equivalence: Comparing the Neuron Therapeutics device to a predicate device (CODMAN Lumbar External Drainage Catheter with Touhy Needle) based on intended use, design characteristics, and manufacturing methods.
- Indications for Use: Explicitly stated for temporary access to the lumbar subarachnoid region for draining cerebrospinal fluid and other fluids.
- Physical Description: Detailed description of the components of the 14-Gauge Lumbar Puncture Set, including materials, dimensions, and features.
- FDA Clearance Letter: Confirming the review and determination of substantial equivalence.
There is no information in this submission about:
- Acceptance Criteria Table or Reported Performance: This submission aims to show "substantial equivalence" to a predicate, not to meet specific performance criteria from a new study.
- Sample Sizes, Data Provenance, Experts, or Adjudication Methods for a Test Set: No new clinical test data or ground truth establishment is presented.
- MRMC Comparative Effectiveness Study: There is no mention of a study involving human readers or AI assistance.
- Standalone (Algorithm Only) Performance: This is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable in this context.
- Training Set Sample Size or Ground Truth Establishment for a Training Set: Not applicable.
§ 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).