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510(k) Data Aggregation
(53 days)
CellFX**®** System
The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Pulse Biosciences® CellFX® System is a proprietary platform technology. The CellFX System consists of the CellFX Console, CellFX Handpiece, CellFX Treatment Tips, and CellFX Software. The CellFX System delivers nanosecond duration electrical pulses that disrupt the function of cells leading to cell death, while sparing non-cellular tissue. The CellFX System delivers a series of timed, nanosecond electrical pulses (referred to as a "Cycle") to ablate and resurface tissue areas in dermatologic conditions.
The CellFX Console is capable of delivering short electric pulses at amplitudes up to 15 kV and pulse widths up to 700 ns. The electrical energy pulses are applied directly to targeted tissue using sterile Treatment Tips with stainless steel microneedles. The treatment parameters are selected by the user through a user interface on the Touchscreen Display of the CellFX Console.
The provided text describes the CellFX® System and its substantial equivalence to a predicate device, focusing on safety and performance, particularly concerning higher energy settings. However, it does not contain specific acceptance criteria with numerical targets, nor does it present a human reader study (MRMC) or a standalone algorithm performance study. The device is a physical electrosurgical system, not an AI/ML-driven diagnostic tool, which explains the absence of some of the requested information.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria for performance metrics. Instead, it refers to general statements of acceptance met during various tests.
| Acceptance Criteria (Stated Generally) | Reported Device Performance |
|---|---|
| Device performs as intended | All test articles met the acceptance criteria for device performance. The performance testing for the CellFX System (Console, Handpiece and Tip) verified that the CellFX System performed as intended and met product specifications. |
| Safety (e.g., no acute adverse events, acceptable healing, no effect on draining lymph nodes or non-target organs) | All CellFX treatments were successfully completed with no acute procedural adverse events. Pathology results support the safety of the CellFX System as there was acceptable healing of treated sites, no effect on draining lymph nodes or nontarget organs. The animal study data confirmed that the device performs as intended and does not raise safety concerns. |
| Performance (e.g., treatment zones achieving degeneration and necrosis of active treatment sites while epidermis remained intact) | The treatment zones met the acceptance criteria and successfully achieved degeneration and necrosis of active treatment sites while the epidermis remained intact in the majority of the treatment sites. The device performed as intended. |
| Biocompatibility | Biocompatibility testing was not required as there were no changes to the device compared to the predicate that would impact biocompatibility. (Implies predicate device previously met biocompatibility criteria) |
| Electrical safety and electromagnetic compatibility (EMC) | The CellFX System complies with IEC 60601-1, IEC 60601-1-2, 60601-2-2, IEC 60601-1-6, IEC 62366, and IEC 62304. All electrical safety and EMC tests passed. |
| Software Verification and Validation | Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance. Completed software testing supports the safety and effectiveness of the device. Cybersecurity controls implemented to mitigate risk. Considered a "moderate" level of concern. |
2. Sample Size and Data Provenance
The only clinical-like study mentioned is an animal study.
- Sample Size (Test Set): 15 Yucatan mini-pigs.
- Data Provenance: Prospective animal study (Yucatan mini-pigs). The country of origin is not specified but is implicitly under US regulatory purview given the FDA submission.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Not applicable as this was an animal study evaluating device performance and safety, not a diagnostic accuracy study requiring human expert interpretation of images or clinical data for ground truth. Ground truth would have been established through pathological examination and observation of healing in the animal models.
4. Adjudication Method for the Test Set
Not applicable. The animal study evaluated physiological and pathological responses to the device treatment, not a diagnostic outcome requiring adjudication of expert opinions. The assessment of pathological outcomes would typically involve veterinary pathologists.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The device is an electrosurgical system for ablation and resurfacing, not a diagnostic imaging or AI-assisted diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this device.
6. Standalone Performance Study (Algorithm Only)
No, a standalone (algorithm only) performance study was not done. This device is a physical electrosurgical system, not a software algorithm or AI model designed for standalone diagnostic or analytical performance. Its "performance" refers to its physical operation and biological effects.
7. Type of Ground Truth Used
For the animal study:
- Pathology: Evaluation of treatment zones (degeneration and necrosis), epidermal integrity, and effects on draining lymph nodes and non-target organs.
- Outcomes Data: Observation of acute procedural adverse events and healing.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would relate to engineering design, testing, and validation, not data-driven model training.
9. How Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, there is no "training set" in the context of an AI/ML model for this type of device. The device's performance characteristics are established through engineering design, bench testing, and in vivo studies, where "ground truth" for these measurements is based on physical and biological principles.
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