Product Classification

• Device: air filter portable apparatus
• Regulation Description: Air-handling apparatus for a surgical operating room.
• Definition: The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
• Physical State: A reusable mobile HEPA air filtration unit with a hose connecting to a disposable air delivery unit to be place at the surgical site.
• Technical Method: The system uses an air supply hose connected to nozzle design that is to be mounted, or applied to the incision drape in close proximity to the surgical site to provide direct air flow blowing over the surgical incision site that helps reduce the level of ambient airborne contamination.
• Target Area: Surgical site.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Product Code: ORC
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 878.5070
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc