(90 days)
The Codman HAKIM Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The Codman HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainages of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The Codman HOLTER Lumboperitoneal (LP) Shunt is indicated for shunting cerebrospinal fluid when the lumboperitoneal route is the procedure of choice in the treatment of communicating hydrocephalus.
The Codman HOLTER Atrial Catheters are indicated for use to shunt cerebrospinal fluid, when shunting of cerebrospinal fluid to the atrium is the procedure of choice in the treatment of hydrocephalus.
The Codman HOLTER Ventricular Catheters are indicated for use to gain access to the ventricles for diagnostic purposes and in the treatment of hydrocephalus.
The Codman Medos Ventricular Catheter is indicated 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 UNI-SHUNT System is indicated for use as a one-piece ventriculo-peritoneal shunt system for the palliative treatment of hydrocephalus. No other use is recommended.
The Codman BACTISEAL Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Codman HAKIM Precision and Programmable Valves:
The Codman HAKIM Precision and Programmable Valves are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. Both the Codman HAKIM Precision and Programmable Valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The Codman HAKIM Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges. The Codman HAKIM Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman HAKIM Programmable Valves can be adjusted to 18 different opening pressure settings.
Codman HOLTER Catheters:
The HOLTER Catheter, is a barium-impregnated silicone rubber open-ended catheter. Two stainless steel Type "A" Fixation and Joining Connectors are included with each catheter to use in rejoining the catheter if it has been cut for lengthening or revision. The HOLTER Catheter, Salmon Design, is a barium-impregnated silicone rubber catheter. Four longitudinal slits (90° apart) near the closed distal tip of the catheter are for drainage of cerebrospinal fluid. Two stainless steel Type "A" Connectors are included with each catheter to use in rejoining the catheter if it has been cut for lengthening or revision.
Codman Medos Ventricular Catheter:
The Medos Ventricular Catheter is made from barium-impregnated silicone tubing. The catheter is 140 mm in length and is supplied with 24 inlet holes, 3 rows of 8 holes, at the proximal end. The catheter, with stainless steel stylet and right angle adapter, is supplied sterile.
UNI-SHUNT® System:
The UNI-SHUNT® system with Reservoir incorporates a double dome access port to facilitate injections and aspirations of CSF samples. It is a continuous length of barium-impregnated silicone tubing with an access reservoir made of self-sealing silicone which can be punctured with a 25 gauge or smaller Huber type needle.
Codman BACTISEAL Catheters:
The BACTISEAL Catheters are made of radiopaque (barium-impregnated) silicone tubing and are supplied sterile. BACTISEAL Catheters are subjected to a treatment process by which the silicone tubing is impregnated with rifampin and clindamycin hydrochloride. The catheter is 14 cm in length and is supplied with 24 inlet holes (3 rows of 8 holes) at the proximal end. Depth marks have been added to the catheter (one dot at 5 cm and two dots at 10 cm). A stainless-steel stylet and right angle adapter are packaged with the ventricular catheter. The peritoneal catheter has a beveled tip at one end and the other end of the catheter has a flat tip. The catheter is 120 cm long and may be trimmed to the proper length.
This document, K172022, primarily discusses the substantial equivalence of updated Codman Hydrocephalus Shunt Systems to previously cleared predicate devices. The changes noted are related to labeling updates for MRI compatibility and compliance with ISO 7197 standards for pressure flow characteristics. The performance data provided is entirely from bench testing; there are no human studies (clinical or multi-reader multi-case) described for proving device performance.
Therefore, many of the requested elements regarding human studies (like MRMC studies, expert ground truth adjudication, and clinical study sample sizes) are not applicable to this specific submission as presented in the document.
Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are based on bench testing for various aspects of the device, primarily related to MRI safety and conformity to specific ISO and ASTM standards.
| Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 7197 | Characterize the pressure flow characteristics of the device per ISO 7197. | Pass – Pressure and Flow characteristic results added to the product IFUs. |
| ASTM F647 | Characterize the long-term stability of the implantable shunt assemblies per ASTM F647. Mean difference of Post stability – pre-stability testing (P-Q post bursting pressure) must not be greater than 10 mmH2O at each pressure setting tested and must comply with PQ characteristic specifications in the IFU. | Pass – average difference less than 10mm H2O and results comply with characteristics provided in the IFU. |
| ASTM F2119 | Image Artifact information was collected for the devices in both 1.5T and 3.0T MR environments. For each device, scans were made in three planes (sagittal, coronal, and axial) for using both gradient and spin echo sequences. Our labeling lists the worst-case image artifact for gradient echo sequencing. (Implied acceptance: artifacts are within acceptable limits for safe imaging and adequate information for labeling). | Pass – results added to MR Information in the product IFUs. |
| ASTM F2182 | The acceptance criterion for this test was to characterize the implanted device increase in temperature after 15 minutes of continuous scanning (in both 1.5 T and 3.0 T MR environments). (Implied acceptance: temperature increase is within safe limits for human use). | Pass - results added to MR Information in the product IFUs. |
| ASTM F2052 | This test assessed if the amount of magnetically induced force on the device is less than or equal to the force on the device due to gravity. The magnetically induced force for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environment, thus supporting the MR Conditional claim. The maximum acceptable spatial gradient was determined on the basis of the component with the largest deflection, and is listed in our labeling. (Implied acceptance: magnetically induced force is not clinically significant such that it dislodges the device or causes harm). | Pass - results added to MR Information in the product IFUs. |
| ASTM F2213 | This test assessed if the amount of magnetically induced torque on the device is less than or equal to the gravitational torque. The magnetically induced torque for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environments, thus supporting the MR Conditional claim. (Implied acceptance: magnetically induced torque is not clinically significant such that it dislodges the device or causes harm, particularly with rotation). | Pass - results added to MR Information in the product IFUs. |
Study Details for Device Performance
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of devices tested. The document refers to "the devices" being tested.
- Data Provenance: The studies are bench tests, meaning they were conducted in a laboratory setting. There is no information about country of origin for the data or whether it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in this context, would typically refer to clinical diagnosis or expert annotations for an AI/diagnostic device. This submission describes physical device testing against engineering standards. The "ground truth" is defined by the technical specifications outlined in the ASTM and ISO standards and the performance of the device against those specifications. No human experts were involved in establishing the "ground truth" for the bench tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is bench testing against specified engineering criteria, there is no need for human adjudication of test results.
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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. The document explicitly states "No clinical studies were required". This device is a hydrocephalus shunt system, not an AI, diagnostic imaging, or reader-assisted device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device (shunt system), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these bench tests are the established engineering and safety specifications defined by the relevant ASTM and ISO standards (e.g., maximum allowable temperature increase, force/torque limits, pressure flow characteristics).
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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).