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510(k) Data Aggregation
(55 days)
Use of the CODMAN EDS 3 CSF External Drainage System (EDS 3) is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.
Use the External Drainage System Collection Bag with the CODMAN EDS 3 External Drainage System to measure and collect cerebrospinal fluid (CSF).
The Codman EDS 3 CSF External Drainage System (Codman EDS 3 System) is designed to drain cerebral spinal fluid (CSF) at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP) post trauma. The EDS 3 device is comprised of four (4) main parts: ventricular catheter, patient drain line, base frame drip chamber assembly, and a collection bag. Note: The collection bag is sold as part of the Codman EDS 3 System, as well as sold separately.
The principle of operation of the proposed Codman EDS 3 system is identical to the currently marketed Codman EDS 3 system. The ventricular catheter is placed into one of the ventricles in the brain or in the subarachnoid space and is then connected to the patient drainage line. CSF flows from the brain or lumbar region through the patient line and enters into the 100 mL graduated drip chamber assembly, where it is collected over a period of time to calculate a flow rate. The drip chamber assembly can then be raised or lowered along the base frame, thereby adjusting the differential pressure to achieve the appropriate flow rate. Once the drip chamber height is set, the collected CSF is then drained into the attached 700 mL collection bag.
The Codman EDS 3 CSF External Drainage System Collection Bag is a sterile, vented 700 mL capacity bag that is graduated in 50 mL increments for accurate measurement. A microbial-retentive atmospheric vent facilitates CSF flow into the bag. One bag is provided with the system and replacement bags are sold separately as an accessory to the drain.
The EDS 3 system is a complete, disposable unit that is provided sterile and is available with or without a ventricular catheter.
Here is a summary of the acceptance criteria and study information for the CODMAN EDS 3 CSF External Drainage System and Collection Bag, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| IV Pole Clamp Design Verification | The new IV Pole Clamp must hold at least the same amount of weight as the predicate device. | Pass - proposed device design met the acceptance criteria and is therefore substantially equivalent to the predicate device. |
| Collection Bag Design Verification | The new Collection Bag must connect to the EDS 3 system, be leak-free, and exhibit at least the same tensile strength as the predicate device. | Pass - proposed device design met the acceptance criteria and is therefore substantially equivalent to the predicate device. |
| Drainage Time Design Verification | The drainage time for the new system must meet design input specifications and be at least as fast as the predicate device. | Pass - proposed device design met the acceptance criteria and is therefore substantially equivalent to the predicate device. |
| Design Validation / Simulated Use | The finished product must meet all user inputs and needs and inputs of the predicate device. | Pass - proposed device design met the acceptance criteria and is therefore substantially equivalent to the predicate device. |
| Sterilization Assurance Level (SAL) | Achieve a SAL of 10-6 in accordance with ISO 11135-1:2014. | The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10-6. |
| Shelf Life | Device and packaging remain functional and maintain sterility for a specified period (3 years for EDS3 System and Collection Bags). | Aging studies established that the device and packaging remain functional and maintain sterility for up to 3 years. |
| Biocompatibility | Materials for non-patient contacting components are acceptable for intended use and meet ISO 10993-1:2009. | The proposed materials were determined to be acceptable for their intended use and the final device continues to meet the requirements of ISO 10993-1:2009. |
2. Sample Size for Test Set and Data Provenance
The document describes only bench testing for design verification and validation. It does not explicitly state a 'test set' in the context of patient data or clinical trials. The evaluation was primarily based on comparing the performance of the modified device components against the predicate device in a laboratory setting. No data provenance in terms of country of origin or retrospective/prospective study type is applicable here, as no human data was used.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The study involved bench testing and engineering verification, not a clinical study requiring expert consensus for ground truth establishment.
4. Adjudication Method for Test Set
Not applicable. There was no clinical test set requiring adjudication. The verification and validation activities were based on standardized engineering and performance testing methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission relies on bench testing demonstrating substantial equivalence to a predicate device, not on comparative clinical performance with human readers.
6. Standalone Algorithm Performance
Not applicable. This device is a medical drainage system, not an AI or algorithm-based device.
7. Type of Ground Truth Used
The "ground truth" for this submission was established through engineering design specifications, industry standards (e.g., ISO 11135-1:2014, ISO 10993-1:2009), and performance of the legally marketed predicate device. The modified components' performance was compared against these established benchmarks.
8. Sample Size for the Training Set
Not applicable. There was no machine learning or AI component, thus no training set was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
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