(136 days)
The hydrocephalus accessories are intended for use with Codman's Hydrocephalus Shunt Systems.
The Codman-Medos Connector is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 rite Type P. Pixation and coming with nonabsorbable sutures in a surgical application.
The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of 0.8 me rype b fixation and obling to 1.2 mm nominal I.D. silicone rubber tubing, and min fromman f.D. Billions fulls of the version in a surgical applical application.
The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device. When used with the shunting device, the ventriculostomy reservoir is also indicated for use as the proximal fluid pathway.
The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to The ACCO-FLO Three Way Ochniction our be unities into the right atium of the heart or the shunt cereorospinal had from the lateral vonthologime and fixation of approximately 1.3 mm peritoneal cavity, providing they are used in the joining aurrical application pentioneal cavily, providing they are about in the John's and surgical application.
The ACCU-FLO Connectors can be utilized as a component in systems designed to shunt The AOOO+ LO Ochhoolors our be anticles into the right atrium of the heart or the peritoneal cerebrospiral not from the joining and fixation of approximately 1.3 mm nominal I.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.
The Cerebral Catheter-Reservoir is indicated for use as a component of a shunting system to The Gerebral Vatheter-1000Non in Indication for see and cavities for the purpose of diagnostic studies, therapeutic drug administration, or the diversion of fluid.
The In-Line Shunt Filter is indicated for use to filter particles that are larger than approximately The in Line Gham Mis suspected and when shunting is the procedure of choice in the treatment of hydrocephalus.
The hydrocephalus accessories consist of connectors, reservoirs, and a filter. The connectors are made of stainless steel or plastic and are used in the joining and fixation of silicone rubber tubing. The reservoirs are made of silicone, stainless steel, and/or plastic and are used for the purpose of diagnostic studies or therapeutic drug administration. The filter is made of stainless steel and silicone and is used to filter particles.
This submission describes a collection of Central Nervous System Fluid Shunt and Components, including various connectors, reservoirs, and a shunt filter.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on the Magnetic Resonance (MR) safety of the devices. The acceptance criteria are implicit in adhering to established ASTM standards for MR safety. The reported performance demonstrates that the devices meet these standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Adherence to ASTM F 2052 (MR-related heating) | Testing performed to ASTM F 2052, results contribute to overall MR Conditional/Safe determination. No specific numerical value for heating provided, but implies within acceptable limits for 3 Tesla MR systems. |
| Adherence to ASTM F 2213 (MR-related force and torque) | Testing performed to ASTM F 2213, results contribute to overall MR Conditional/Safe determination. No specific numerical value for force/torque provided, but implies within acceptable limits for 3 Tesla MR systems. |
| Adherence to ASTM F 2119 (MR-related artifacts) | Testing performed to ASTM F 2119, results contribute to overall MR Conditional/Safe determination. No specific numerical value for artifacts provided, but implies within acceptable limits for 3 Tesla MR systems. |
| Adherence to ASTM F 2182 (MR-related heating, force, torque) | Testing performed to ASTM F 2182, results contribute to overall MR Conditional/Safe determination. No specific numerical value for heating, force, or torque provided, but implies within acceptable limits for 3 Tesla MR systems. |
| Overall MR Safety Classification (ASTM F 2503) | Devices described as "MR Conditional" or "MR Safe" in 3-Tesla Magnetic Resonance Imaging (MRI) systems, according to ASTM F 2503. Devices made of silicone and plastic were determined to be "MR Safe" because they do not contain metallic or conducting materials, indicating zero risk for these specific components. |
| No added risk to the patient when exposed to a 3 Tesla MR system | "The test results demonstrate that there is no added risk to the patient when exposed to a 3 Tesla MR system." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of units or individual components tested for each ASTM standard. It simply states "Bench testing was performed according to the following MRI standards: ASTM F 2052, ASTM F 2213, ASTM F 2119, and ASTM F 2182." and that "The devices that are made of silicone and plastic were evaluated and determined to be MR Safe". However, given the nature of MR safety testing for medical devices, it typically involves a representative sample of each unique device type, material, and configuration that could potentially interact with the MR environment.
- Data Provenance: The study is a retrospective bench-top study. The data provenance is internal to the manufacturer ("Bench testing was performed..."). There is no indication of country of origin of the data beyond the manufacturer's location (Raynham, MA, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For MR safety testing, ground truth is established by objective measurements based on scientific principles and standardized test methods (ASTM standards) rather than expert consensus. The experts involved would typically be engineers or technicians with expertise in magnetic resonance and materials science who conduct the tests and interpret the results according to the specified ASTM protocols.
4. Adjudication Method for the Test Set:
This information is not applicable/not provided for this type of bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret data (e.g., radiology images) and disagreement among readers needs resolution. Here, the "ground truth" is determined by direct physical measurements against established 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 submission is for a medical device (hydrocephalus shunt components) and their MR safety, not an AI or imaging diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used:
The ground truth used is based on objective physical measurements and adherence to internationally recognized ASTM standards for Magnetic Resonance safety (ASTM F 2052, ASTM F 2213, ASTM F 2119, ASTM F 2182, and ASTM F 2503). These standards define acceptable limits for device interaction with MR fields (e.g., heating, force, torque, artifacts).
8. The Sample Size for the Training Set:
Not applicable. This submission describes a physical medical device. There is no concept of a "training set" as would be found in machine learning or AI development. The device design and materials are based on established engineering principles and prior knowledge.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As stated above, there is no training set for a physical medical device like this in the context of MR safety testing. The "ground truth" for the device's characteristics and safety (before testing) is established through its design specifications, material properties, and manufacturing processes, which are then validated through bench testing.
§ 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).