(30 days)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
- Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative;
- Monitor CSF chemistry, cytology, and physiology;
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with: - Severe head injury
- Subarachnoid hemorrhage graded III, IV. or V preoperatively
- Reyes syndrome or similar encephalopathies
- Hydrocephalus
- Intracranial hemorrhage
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.
The Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:
- Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
- Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
The main system section located on the mounting panel includes: - Mounting bracket for height adjustment of system
- Optional self-adjusting cord with lock for adjustment of system height
- Main system stopcock with optional transducer attachment location
- Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking bracket
- Two drainage line slide clamps for flow monitoring and sampling
- Drainage bag connection line
- Needleless Injection Site (Interlink or Smartsite)
- Instructions for Use
The system does not contain any latex components.
Here's an analysis of the acceptance criteria and supporting study for the Becker External Drainage and Monitoring System, based on the provided FDA 510(k) summary:
This device is not an AI/ML device, so many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection | Meet volumetric capacity and approximate volumetric graduations. | The Becker EDMS device met the acceptance criteria for visual and dimensional inspection. |
| Leakage of Drainage Bag | Withstand inversion without leaking. | The Becker EDMS device met the acceptance criteria for drainage bag leakage. |
| Flow Initiation Pressure | (Not explicitly stated, but implies a specific pressure range) | The Becker EDMS device met the acceptance criteria for flow initiation pressure. |
| Drainage Bag Seal Weld | No leaks in the drainage bag. | The Becker EDMS device met the acceptance criteria for drainage bag seal weld. |
| Tensile Strength of Drainage Bag Inlet Port | (Not explicitly stated, but implies meeting a minimum strength) | The Becker EDMS device met the acceptance criteria for tensile strength of drainage bag inlet port. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each specific bench test. However, the testing was conducted as part of the design verification process for a modified component (the disposable drainage bag) within the Becker EDMS. The data provenance is from bench testing, which is a controlled laboratory environment, not derived from human patients or specific geographical regions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies were bench tests evaluating physical properties and functional performance against engineering specifications, not clinical outcomes requiring expert interpretation of medical data.
4. Adjudication Method for the Test Set
This information is not applicable as the studies were bench tests against predetermined engineering specifications, not studies involving subjective interpretation of data that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical device, not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests was based on engineering specifications and design requirements for the physical properties and functional performance of the modified drainage bag.
8. The Sample Size for the Training Set
This information is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no training set for this type of device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The device is the "Becker External Drainage and Monitoring System" (Becker EDMS), with specific modifications to its disposable drainage bag component. The study proving the device meets acceptance criteria was a series of "Performance Data - Bench" tests.
The modifications to the disposable bag primarily involved changes in its design (approximate volume capacity of 600ml with approximate volumetric markings in 50mL increments, an inlet port, an outlet port, and a hydrophobic/anti-microbial vent).
The performance testing was conducted in accordance with a risk assessment of these changes, which determined that dimensional verification and design verification testing of the bag were necessary. The specific tests performed included:
- Visual and Dimensional Inspection: To ensure the printed graduations met volumetric capacity.
- Leakage of Drainage Bag: To confirm the bag could withstand inversion without leaking.
- Flow Initiation Pressure: To record the pressure at which fluid flow begins.
- Drainage Bag Seal Weld: To ensure the bag's seals were intact and leak-free.
- Tensile Strength of Drainage Bag Inlet Port: To evaluate the durability of the connection point.
The results of all these bench tests showed that the Becker EDMS device met the specified acceptance criteria for each test. Based on these successful results, the manufacturer concluded that the changes introduced by the modified disposable bag do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence to the predicate device (Medtronic PS Medical Becker External Drainage and Monitoring System, K984053).
No animal or clinical testing was deemed necessary for these specific modifications, as the determination of substantial equivalence was based solely on the design verification bench testing.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).