Breathing System Heater

Design Assumptions:

The disposable device is designed for single patient use in general respiratory procedures by general clinical staff for up to 30 days.

The device will contain extruded and injection molded plastic parts assembled with connectors at each end. The molded parts will include a device for circuit heating, likely a coil or some other element, and a thermostat device for communicating temperature to the controller, connected by a proprietary adapter. The device controller is assumed to be relatively simple for calculations in this report, assuming the device will have minimum and limited control options.

Being made up of a wide range of parts, each designed to interact with the other and including electronic controls with firmware or software, the developer should expect to spend over $300k on non-recurring engineering (NRE) costs, with no less than 15% of that being dedicated toward a proof-of-concept for feasibility evaluation before the start of design for manufacturability.

The device is not exempt from design controls and will require design traceability documentation to be compliant with regulations. The developer should expect this work to add up to 10-20% to the program's nonrecurring engineering costs. 

Regulation Assumptions:

The regulation number for such a device is 868.5270. This regulation number covers moderate-risk Class II devices. Product code BZE falls under this regulation number. At least eight market-approved 510(k) devices are associated with this classification code. 

The developer could expect to spend between $45k-$70k in regulatory compliance support, including the possible need for a pre-submission. FDA fees for a small business entity may range between $8k-$35k for adult-indicated devices, depending on the regulatory pathway — 510(k) submission or De Novo request.

This device product code is eligible for Third Party Review. The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process in which accredited third parties can review eligible low-to-moderate risk medical devices.

Risk assessments for this device should include an in-depth look at material cracking, leak, and temperature performance, which account for half of the over 600 reported complaints for devices of this product code.

Testing Assumptions:

FDA-recognized consensus standards recommended for testing:

• 1-134 ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
• 1-135 ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
• 1-136 ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
• 1-137 ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
• 1-138 ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

Connection tests may also be applicable depending on the type of assembly.

The developer should prepare to spend well over $100k on testing for this device to prove substantial equivalence to an existing device 510(k) and more if they intend to prove uniquely different technological advancements, which require a De Novo filing. 

Ease of Manufacturing:

While extrusions and injection molded technology providers are abundant, vent tubing and heated circuit manufacturers may be scarce. Should the developer create custom circuits, components like circuit coils and thermostats are readily available as standard Original Equipment Manufacturer (OEM) items. Incorporating a smooth wall or corrugated tube may pose some challenges.