(a) Identification. An enzyme packed cartridge is an ex vivo prescription device that is used in enzymatic hydrolysis of macronutrients into their essential nutrient forms at the time of delivery. The device consists of an outer casing containing an inert polymer with a covalently bound enzyme through which nutritional formula is directed. The device fits in line with enteral feeding systems.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient contacting components of the device must be demonstrated to be biocompatible.

(2) In vivo testing must be performed and must demonstrate that the device causes neither an adverse tissue response nor adverse performance.

(3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:

(i) Mechanical testing to demonstrate that the device can withstand clinical forces;

(ii) Flow rate and leakage testing to demonstrate that the device does not impede the flow of enteral formula;

(iii) Demonstration of enzymatic effect on intended macronutrient;

(iv) The amount of enzyme that exits the cartridge must be characterized;

(v) Validation that the device does not adversely impact the nutritional composition of enteral formula; and

(vi) Validation that the device does not impede flow alarms on enteral feeding pumps.

(4) Human factors testing must be performed to characterize use error risks.

(5) Performance data must support shelf life by demonstrating package integrity and device functionality over the identified shelf life.

(6) Labeling must include the following:

(i) A detailed summary of in vivo testing pertinent to use of the device, including device-related adverse events;

(ii) A detailed summary of compatible formulas that is supported by non-clinical testing, including the expected enzymatic conversion as a percentage;

(iii) Detailed instructions on how to place the device into an enteral feeding circuit;

(iv) A warning regarding the possibility for misconnections; and

(v) Expiration date or shelf life.

(7) Patient labeling must be provided and must include:

(i) Relevant warnings, precautions, adverse effects, and complications;

(ii) A description of the device and how it operates;

(iii) Instructions on how to correctly use the device; and

(iv) The benefits and risks associated with the use of the device.

[82 FR 47971, Oct. 16, 2017]