Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for Industry | Guideline Explorer

Description

This document supersedes theGuidance for the Content of Premarket Notifications for Disposable, Sterile, Ear, Nose and Throat Endoscope Sheaths with Protective Barrier Claims, which was issued on October 21, 1996

Scope & Applicability

Product Classes

4

Ear, Nose, and Throat Endoscope Sheaths

Subject of the guidance document for marketing clearance; Guidance for manufacturers seeking marketing clearance for these protective barriers.; Guidance for manufacturers seeking marketing clearance of these protective barriers.

Mediastinoscope and accessories

21 CFR 874.4720, Class II

Otoscope

21 CFR 874.4770, Class I(exempt)

Endoscope sheath

sterile, disposable covering for various types of ENT endoscopes

Stakeholders

3

Manufacturer

Entity responsible for submitting NDINs

Sponsor

Entity responsible for submitting applications under section 524B

Physician

Allowed value for reporter qualification

Regulatory Context

Attributes

5

Substantial equivalence

Regulatory standard for 510(k) clearance; demonstration required for 510(k) submission; regulatory standard for 510(k) clearance; Comparison of subject device parameters to predicate 510(k) submission numbers.

virus titer

Measured to determine the concentration of the challenge virus.

Detection Limit

Analytical procedure validation characteristic

Sterility assurance level

support the use of the proposed cycle and the desired sterility assurance level

Sterility status

Required information on the package label.

Identified Hazards

Hazards

3

Transmission of pathogens

purpose of a sheath is to help prevent transmission

virus transmission

The risk the sheath is intended to prevent as a protective barrier.

Pathogenic organisms

Includes viruses like HIV and HBV that the sheath must protect against.

Related CFR Sections (8)

21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
21CFR874.4760§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a) Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic ligRead full regulation →
21CFR874.4680§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a) Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light sourcRead full regulation →
21CFR874.4710§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a) Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreRead full regulation →
21CFR874.4720§ 874.4720 Mediastinoscope and accessories.
(a) Identification. A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly andRead full regulation →
21CFR874.4770§ 874.4770 Otoscope.
(a) Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.Read full regulation →
21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

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