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Ear, Nose, And Throat Stereotaxic Instrument

Page Type
Product Code
Definition
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Physical State
Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer.
Technical Method
The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor.
Target Area
Ear, nose and throat
Regulation Medical Specialty
Neurology
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).

Ear, Nose, And Throat Stereotaxic Instrument

Page Type
Product Code
Definition
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Physical State
Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer.
Technical Method
The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor.
Target Area
Ear, nose and throat
Regulation Medical Specialty
Neurology
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).