June 9, 2021 U.S. Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993‐0002 RE: Amendment to BP170122/287 – PMA Panel-Track Supplement - RECELL® Label Expansion Revised IFU Dear Document Control Center: AVITA Medical is submitting the IFU documentation required to address the Agency’s revision request received via email from Nevitt Morris on June 9, 2021. The existence of this submission and the data and other information that it contains are confidential and not subject to disclosure as provided in 21 CFR 814.9. Please contact Sandra Aprahamian at 661‐749‐9422, by email at [email protected] if there are any questions regarding this submission. Sincerely, Sandra Aprahamian Director, Regulatory Affairs AVITA Medical 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 P +1(661) 367-9170 | f +1 (661) 367-9180 | avitamedical.com INSTRUCTIONS FOR USE RECELL® Autologous Cell Harvesting Device The RECELL Autologous Cell Harvesting Device (RECELL Device) should be used only by licensed healthcare professionals trained in the use of the device. Warning: The RECELL Autologous Cell Harvesting Device is internally powered by four non‐replaceable AA batteries (1.5V). The device should not be used in the presence of flammable anesthetic mixtures. Do not incinerate batteries on disposal. The performance of the device may be affected by sources of electromagnetic radiation and if any malfunctions are noted, all possible sources of electromagnetic radiation must be removed before further use. Caution: Federal law restricts this device to sale by or on the order of a physician. AW‐IFU030‐7 1 THIS PAGE INTENTIONALLY LEFT BLANK AW‐IFU030‐7 2 TABLE OF CONTENTS TABLE OF CONTENTS ...................................................................................................................... 3 A BACKGROUND ..................................................................................................................... 5 DEVICE DESCRIPTION ................................................................................................................. 5 INDICATIONS FOR USE ............................................................................................................... 5 CONTRAINDICATIONS ................................................................................................................ 5 WARNINGS ................................................................................................................................. 6 PRECAUTIONS ............................................................................................................................ 7 SPECIAL PATIENT POPULATIONS ............................................................................................ 7 ADVERSE REACTIONS ................................................................................................................. 7 MEANING OF SYMBOLS .......................................................................................................... 8 DOSAGE .................................................................................................................................... 10 HOW SUPPLIED ........................................................................................................................ 10 STORAGE .................................................................................................................................. 10 DISPOSAL .................................................................................................................................. 11 B CLINICAL DATA SUMMARY ................................................................................................. 12 RECELL COMBINED WITH MESHED SKIN GRAFT FOR TREATMENT OF ACUTE BURN INJURIES (FULL‐THICKNESS AND MIXED‐DEPTH BURNS) ...................................................................................................................... 12 RECELL FOR TREATMENT OF ACUTE BURN INJURIES (DEEP PARTIAL‐THICKNESS BURNS) .......................... 21 C TREATMENT ....................................................................................................................... 25 REQUIREMENTS ....................................................................................................................... 25 RECELL® DEVICE SET‐UP ........................................................................................................ 25 BURN WOUND BED PREPARATION ....................................................................................... 29 SKIN SAMPLE HARVESTING ................................................................................................... 30 PREPARING CELL SUSPENSION USING THE RECELL DEVICE ..................................................... 32 D AFTERCARE ........................................................................................................................... 40 SUBSEQUENT DRESSINGS ..................................................................................................... 40 AFTERCARE PRECAUTIONS ................................................................................................... 40 SCAR MANAGEMENT ........................................................................................................... 41 E SYSTEM SPECIFICATIONS .................................................................................................... 42 OPERATION AND STORAGE CONDITIONS ............................................................................. 42 INTENDED USE ENVIRONMENT ............................................................................................ 42 ESSENTIAL PERFORMANCE ................................................................................................... 42 COMPONENT STERILIZATION AND TESTING ......................................................................... 42 AW ‐IFU030‐7 3 F ELECTROMAGNETIC COMPATIBILITY .................................................................................... 43 G TROUBLESHOOTING ............................................................................................................. 44 AW‐IFU030‐7 4 A BACKGROUND DEVICE DESCRIPTION RECELL® is a single‐use, stand‐alone, battery‐operated, autologous cell harvesting device containing enzymatic and delivery solutions, sterile surgical instruments, and actuators. The RECELL Device enables a thin split‐thickness skin sample to be processed to produce a RES® Regenerative Epidermal Suspension for immediate delivery onto a prepared wound bed. The cell suspension contains a mixed population of cells, including keratinocytes, fibroblasts, and melanocytes, obtained from the disaggregation of the skin sample. The preservation of melanocytes is important for restoring natural pigmentation to the recipient area. Additionally, sub‐populations of keratinocytes critical for re‐epithelialization have been identified in RES including basal keratinocytes, suprabasal keratinocytes, and activated keratinocytes. The Enzyme used to process the cells is a biological agent and as such may have slight variations in color and texture. INDICATIONS FOR USE The RECELL Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL Device is used by an appropriately‐licensed healthcare professional at the patient’s point of care to prepare autologous RES® Regenerative Epidermal Suspension for direct application to acute partial‐thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full‐thickness thermal burn wounds in pediatric and adult patients. CONTRAINDICATIONS • RECELL is contraindicated for the treatment of wounds clinically diagnosed as infected or with necrotic tissue present in the wound bed. • RECELL is contraindicated for the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate solution (Hartmann’s Solution). • The skin sample collection procedure specified for use of RECELL should not be used with patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone‐iodine, or chlorhexidine solutions. AW‐IFU030‐7 5 WARNINGS • Autologous use only. • Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. • RECELL is provided to the healthcare professional sterile and is intended for single use. • Do not reuse, freeze, or re‐sterilize device components. • Handle using aseptic technique. • Do not use RECELL or device components if packaging is damaged or there are signs of tampering. • Do not use RECELL or device components beyond the stated expiration date indicated on the adhesive Lot # and Expiration Date labels on the outer box packaging. • Choose a skin sample donor site that shows no evidence of surrounding cellulitis or infection. • For optimum cell viability, the skin sample should be processed immediately after harvesting. • If a skin sample is harvested and processed according to these instructions, it should require between 15 and 30 minutes of contact with the Enzyme. Contact in excess of 60 minutes is not recommended. • The Enzyme is derived from animal tissue and, although strict controls have been implemented in the manufacturing process to minimize the risk of pathogen contamination, a small risk of contamination exists and absolute freedom