FDA creates two new 510(k) clearance categories

FDA down-classified colon capsule imaging systems and intravascular administration sets to Class II, meaning devices in those categories will no longer be subject to long clinical trials and other PMA requirements. They will be approved via the 510(k) process instead, according to the May 16 final order in the Federal Register.

Upon approval, Given Imaging's ($GIVN)--now part of Covidien ($COV)--PillCam Colon 2 capsule endoscopy system and Anesthesia Safety Product's AirPurge System were not substantially equivalent to any devices on the market, so they were automatically classified into Class III.

Earlier this year FDA approved both companies' request to reclassify their devices into Class II, because "there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use."

The final orders are significant because they establish both devices as predicate devices, meaning that devices "deemed substantially equivalent" to them will be approved via the 510(k) process and must comply with the special controls described in the order.

Colon capsule imaging systems are "designed to visualize the colon for the detection of polyps. It is intended for use only in patients who had an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible," says the order.

An intravascular administration set is "a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid." Examples include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air, and safety control mechanisms to address hazardous situations, according to the order.

Both orders become effective June 16. Companies submitting applications for either product type will then face an easier approval pathway.

- read the final order creating the intravascular administration set category in the Federal Register
- read the final order creating the colon capsule imaging system category in the Federal Register

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