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510(k) Data Aggregation
(567 days)
Senso Medical Depth Electrodes are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
The SENSO SEEG Electrode is a smooth electrode with a diameter of 0.8 - 2 mm with a rounded tip. Different configurations exist with diameters of 0.8, 1.1, 1.27, and 2.0 mm. The electrode contacts are made from stainless-steel that can be 1.5mm, 2.0, and 3.0 mm long, with a total exploration length varying from (22 - 82 mm) according to the electrode reference. The total length of the electrodes range from 360 mm to 410 mm long depending on the number of contacts and total exploration length of the electrodes. The electrodes come in 3 main configurations, but can be customized to the parameters mentioned above based on the application need.
This FDA 510(k) summary provides information on the SENSOSEEG Depth Electrodes. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in the typical format of a diagnostic algorithm's performance study.
This document is a premarket notification for a medical device (depth electrodes), not a diagnostic algorithm. Therefore, the "acceptance criteria" and "study" described are focused on the device's physical and functional properties, and its substantial equivalence to predicate devices, rather than on diagnostic performance metrics like accuracy, sensitivity, or specificity common to AI/ML software.
The acceptance criteria are implied by the comparison to predicate devices and the non-clinical testing performed.
Here's an attempt to categorize the information based on your request, keeping in mind the nature of this submission:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (depth electrodes), the "acceptance criteria" are related to its design specifications, material properties, and functional performance, rather than diagnostic accuracy. The "reported device performance" is largely demonstrated by showing equivalence to legally marketed predicate devices through bench testing and material comparison.
| Acceptance Criterion (Implied) | Reported Device Performance (as demonstrated by comparison and testing) |
|---|---|
| Intended Use (Temporary recording, monitoring, stimulation of electrical brain signals) | Identical to all predicate devices (DIXI Medical Microdeep Depth Electrode (K170959), Ad-tech depth electrodes (K964644), PMT Depthalon Electrodes (K802152)). |
| Clinical Application (Placement in subsurface brain for recording, monitoring, stimulation) | Identical to DIXI Medical and Ad-tech depth electrodes. |
| Contraindications (Patients at risk for infection or unsafe surgical procedures) | Identical to Ad-tech depth electrodes. |
| Single-patient use, Disposable | Identical to all predicate devices. |
| Provided Sterile | Identical to all predicate devices; EO Sterilization validated. |
| Environment of Use (Intraoperative and Neurological monitoring locations) | Identical to all predicate devices. |
| Duration of Use (< 30 days) | Identical to all predicate devices. |
| Electrode Contact Material (Stainless steel) | Different from primary predicate (Platinum / Iridium) but identical to secondary predicate (PMT Depthalon Electrodes) and also explicitly stated as being in common with other brain implant devices. This difference is deemed not to raise new safety concerns. |
| Maximum Stimulation Charge Density (< 30 µC/cm2) | Identical to secondary predicate (Ad-tech depth electrodes). (Primary predicate N/A, PMT Not available online). |
| Number of electrode contacts (4-16) | Similar to predicate ranges (DIXI: 5-18; Ad-tech: up to 16; PMT: up to 16). |
| Electrode Material (Stainless Steel) | Different from primary predicate (Platinum Iridium) but identical to secondary predicate (PMT Depthalon, partially identical to Ad-tech which uses both Platinum Iridium and Stainless Steel). This difference is mitigated by demonstrating safety. |
| Electrode jacket (TPU) | Identical to DIXI Medical and Ad-tech depth electrodes. (PMT Not available online). |
| Electrode body diameter (brain contact) (0.8 mm to 2 mm) | Equivalent to predicate devices. While DIXI Medical is 0.8 mm and Ad-tech is 1.57 mm (Macro), and PMT is 0.8 mm to 1.8 mm, the document states "Design Verification Testing proves the equivalency. A comparative testing with Ad depth electrodes proves the equivalency." This implies the range is acceptable and supported by testing. |
| Stylet | Identical to all predicate devices. |
| Electrode contact length (1.5 - 3 mm Macro) | Similar. While DIXI is 2 mm and PMT is 2.0mm and 5.0mm, the SENSO SEEG's smaller contact length is deemed not to raise safety concerns, similar to other marketed devices (e.g., SPENCER® PROBE DEPTH ELECTRODES K041604 with <1.5 mm). |
| Overall length (360 - 400 mm) | Different from predicates (DIXI: 500 mm, 1000 mm; Ad-tech: < 660 mm; PMT: 27 mm). Longer length is accommodated by additional contacts and user preference. Safety and performance evaluated in design verification testing. |
| Electrode contact surface (Ring contact built from a folded (coiled) exposed wire) | Different in manufacturing technology (weaving/braiding vs. crimping/welding) but results in a "ring contact" similar to predicates. The difference in technology is stated not to raise concern over safety. |
| Non-clinical Performance Tests (Mechanical, electrical, functional, biocompatibility, packaging, shelf life, transit, EO sterilization) | Performed to assure safety and effectiveness and conformance to design specifications. These tests collectively demonstrate the device meets its functional and safety requirements, aligning with predicate devices. |
Since this is a medical device approval and not a diagnostic AI/ML algorithm submission, the following points are not applicable or not explicitly detailed in this 510(k) summary:
- 2. Sample sized used for the test set and the data provenance: Not applicable in the context of device design and bench testing. The "test set" would be the prototypes or production samples undergoing engineering verification and validation testing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for a physical device refers to engineering specifications and material standards, not expert medical opinion on an image.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.
- 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 device is an electrode, not an AI assistance tool for human interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this type of device is established by engineering specifications, material standards (e.g., ISO standards for biocompatibility), and established performance benchmarks derived from predicate devices.
- 8. The sample size for the training set: Not applicable for device testing.
- 9. How the ground truth for the training set was established: Not applicable for device testing.
The "study that proves the device meets the acceptance criteria" is the set of Non-clinical testing performed as listed on page 12 of the document:
- Verification testing (mechanical, electrical, and functional testing)
- Biocompatibility Testing
- Packaging, shelf life and transit testing
- EO Sterilization Validation
These tests ensure the device performs as intended, is safe for its indicated use, and is substantially equivalent to predicate devices, thereby meeting the necessary acceptance criteria for a 510(k) clearance. The details of these tests (e.g., number of samples, specific methodologies) are typically found in the full 510(k) submission, not in the summary document.
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