| Device |
mechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with applicator |
| Definition |
Intended for use at the patient’s point of care by clinicians to prepare an autologous skin cell suspension for application to prepared treatment areas indicated for repigmentation in patients with stable vitiligo. |
| Physical State |
The cell harvesting device is comprised of a bundled set of prep instruments, application tools, processing and carrier solutions packaged as a single, sterile, stand-alone, disposable (single-use kit). The device may include: (1) a processing unit for tissue incubation, rinsing, and filtering; (2) prep instruments: syringe, blunt needle, disposable scalper, spray nozzle, cell strainer; and (3) processing and carrier solutions: enzyme, sterile water, buffer. The cell suspension may be applied using a syringe outfitted with a spray nozzle or dripped from the syringe. |
| Technical Method |
Processing of a split-thickness skin sample using enzymatic and mechanical disaggregation to create a cell suspension. |
| Target Area |
The device output cell suspension is applied to a resurfaced depigmented lesion area and skin donor site that have been prepared by a healthcare provider for treatment |
| Review Panel |
Hematology |
|---|
| Product Code | QWY |
|---|
| Premarket Review |
CBER Division
(CBER)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
