Product Classification

• Device: sterilizer automated loading system
• Regulation Description: Steam sterilizer.
• Definition: Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.
• Physical State: The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and a sterilizer that sits on a loading car.
• Technical Method: Works in conjunction with a steam sterilizer
• Target Area: NA
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: PEC
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(k)
• Regulation Number: 880.6880
• 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

Recognized Consensus Standards

• 14-588 AAMI TIR17:2017/(R)2020
  Compatibility of materials subjected to sterilization
• 14-609 AAMI TIR17:2024
  Compatibility of materials subjected to sterilization

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc