MZT · Device, Heimlich Maneuver Assist

Anesthesiology · 21 CFR 868.5115 · Class 2

Overview

Identification

The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.

Classification Rationale

Class II (special controls) (“Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices”). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9.

Special Controls

*Classification.* Class II (special controls) (“Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices”). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9.

Therefore, the Quickair Choke Reliever is subject to the following special controls which when combined with the general controls of the act, will provide reasonable assurance of the safety and effectiveness of the device: 1. Labeling that includes instructions for reporting complications resulting from the use of the device directly to the manufacturer, as well as any applicable medical device reporting requirements (21 CFR 803). 2. Labeling for the lay user that includes adequate instructions for use including (i) a clear identification of the minimum victim size threshold (weight), as well as any device-specific limitations identified through application of design controls and (ii) instructions for use of the Heimlich maneuver. 3. Design controls that satisfactorily evaluate: - The potential for excessive generation and application of pressure to the abdomen that can result in damage to the internal organs. The generated pressures and their distributions over the abdomen should be assessed for safety and compared to the Heimlich maneuver in a variety of victim sizes and user strengths; - the initial and peak airway pressures and the duration of pressure application of the device as compared to the Heimlich maneuver; - bench testing to include static load, mechanical shock, fatigue and intraabdominal pressure simulation; and - human factors testing to demonstrate that the lay user is able to understand and follow the device instructions for use with respect to device placement and applied force. The testing should include a range of rescuer’s sizes, ages and educational levels, as well as an appropriate range of victim size and position.

Recent Cleared Devices (1 of 1)

Top Applicants

• Maet Industries, Inc. — 1 clearance