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Esophageal, Mucosal, Electrical Characterization

Page Type
Product Code
Definition
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Physical State
The device consists of a probe, cables, and other processing equipment to record and display the electrical characteristics of the esophageal tissue.
Technical Method
The device goes into the esophagus and comes in contact with the tissue. Through sensors or other means, the electrical characterization of the tissue is recorded and later displayed.
Target Area
Esophagus
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.1450
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.1450 Esophageal tissue characterization system

§ 876.1450 Esophageal tissue characterization system.

(a) Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.

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

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

(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.

(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.

(6) Performance data must validate the reprocessing instructions for any reusable components of the device.

(7) Labeling must include:

(i) Specific instructions regarding the proper placement and use of the device;

(ii) Instructions for reprocessing of any reusable components; and

(iii) An expiration date for single use components.

[86 FR 68399, Dec. 2, 2021]

Esophageal, Mucosal, Electrical Characterization

Page Type
Product Code
Definition
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Physical State
The device consists of a probe, cables, and other processing equipment to record and display the electrical characteristics of the esophageal tissue.
Technical Method
The device goes into the esophagus and comes in contact with the tissue. Through sensors or other means, the electrical characterization of the tissue is recorded and later displayed.
Target Area
Esophagus
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.1450
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.1450 Esophageal tissue characterization system

§ 876.1450 Esophageal tissue characterization system.

(a) Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.

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

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

(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.

(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.

(6) Performance data must validate the reprocessing instructions for any reusable components of the device.

(7) Labeling must include:

(i) Specific instructions regarding the proper placement and use of the device;

(ii) Instructions for reprocessing of any reusable components; and

(iii) An expiration date for single use components.

[86 FR 68399, Dec. 2, 2021]