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Retrograde Intubation Set

Page Type
Product Code
Definition
A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800).
Physical State
Retrograde intubation sets may be comprised of guide wire and ventilating or non-ventilating intubation catheters.
Technical Method
An introducer in the cricothyroid membrane allows a guide wire to pass through to be retrieved from the patient mouth or nose. The intubating catheter is inserted along the guide wire to the depth of the cricothyroid membrane. The endotracheal tube is advanced over the intubating catheter into the trachea to access airways that are difficult to intubate and ventilate.
Target Area
Cricothyroid membrane, trachea, oral, nasal, upper airway
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5095
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5095 Retrograde intubation device

§ 868.5095 Retrograde intubation device.

(a) Identification. A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (§ 868.5090), syringe (§ 880.5860 of this chapter), and hemostats (§ 878.4800 of this chapter).

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

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:

(i) Wire guide tensile, flex, fracture, and corrosion testing;

(ii) Catheter tensile strength testing at likely points of failure;

(iii) Catheter kink radius testing;

(iv) Compatibility of device components that interact, including compatibility in connection, disconnection, and ability to transfer fluids;

(v) Dimensional validation;

(vi) Accuracy testing of markings; and

(vii) Validation of the maximum airway pressure.

(2) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(3) The device must be demonstrated to be biocompatible.

(4) Labeling must include:

(i) Instructions for use; and

(ii) Package labels that clearly identify the minimum compatible size of endotracheal tube.

[86 FR 73678, Dec. 28, 2021]

Retrograde Intubation Set

Page Type
Product Code
Definition
A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800).
Physical State
Retrograde intubation sets may be comprised of guide wire and ventilating or non-ventilating intubation catheters.
Technical Method
An introducer in the cricothyroid membrane allows a guide wire to pass through to be retrieved from the patient mouth or nose. The intubating catheter is inserted along the guide wire to the depth of the cricothyroid membrane. The endotracheal tube is advanced over the intubating catheter into the trachea to access airways that are difficult to intubate and ventilate.
Target Area
Cricothyroid membrane, trachea, oral, nasal, upper airway
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5095
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5095 Retrograde intubation device

§ 868.5095 Retrograde intubation device.

(a) Identification. A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (§ 868.5090), syringe (§ 880.5860 of this chapter), and hemostats (§ 878.4800 of this chapter).

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

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:

(i) Wire guide tensile, flex, fracture, and corrosion testing;

(ii) Catheter tensile strength testing at likely points of failure;

(iii) Catheter kink radius testing;

(iv) Compatibility of device components that interact, including compatibility in connection, disconnection, and ability to transfer fluids;

(v) Dimensional validation;

(vi) Accuracy testing of markings; and

(vii) Validation of the maximum airway pressure.

(2) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(3) The device must be demonstrated to be biocompatible.

(4) Labeling must include:

(i) Instructions for use; and

(ii) Package labels that clearly identify the minimum compatible size of endotracheal tube.

[86 FR 73678, Dec. 28, 2021]