| Device |
mechanical and enzymatic autologous skin processor for cell suspension, with applicator |
| Definition |
Intended to enable clinicians to prepare an autologous skin cell suspension for application to burn injuries for use when autografting is indicated for definitive wound closure. |
| 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. |
| 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 burn injury wound bed and skin donor site that have been prepared by a healthcare provider to receive application of a skin autograft. |
| Review Panel |
Hematology |
|---|
| Product Code | QCZ |
|---|
| Premarket Review |
Center for Biologics Evaluation & Research (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? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
