(14 days)
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Treatment of pharyngocutaneous fistulas following laryngectorny or laryngoesophagectorny.
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Management of cervical esophageal and hypopharyngeal strictures and fistulas resulting from a variety of causes including surgery, radiation, advanced malignancy, trauma, and ingestion of caustic agents.
The Montgomery Salivary Bypass Tube is a silicone tube with a funnel-shaped end for use in treating esophageal strictures and fistulas. The tube is available is sizes 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, and 20mm (outside diameter).
This document is a 510(k) summary for a medical device called the "Montgomery Radiopaque Salivary Bypass Tube." It describes the product, its intended use, and indicates that it passed cytotoxicity testing.
However, the provided text does not contain any information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any details about a study evaluating its effectiveness or a comparative effectiveness study involving AI or human readers.
Therefore, I cannot fulfill your request for information about acceptance criteria, device performance, study details, expert involvement, or ground truth establishment based on the provided input. This document focuses on the regulatory submission aspects for a traditional medical device, not a diagnostic or AI-driven system that would typically have such performance metrics reported.
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JU 25 1996
SMDA Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Product: Montgomery Radiopaque Salivary Bypass Tube
Description: The Montgomery Salivary Bypass Tube is a silicone tube with a funnel-shaped end for use in treating esophageal strictures and fistulas. The tube is available is sizes 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, and 20mm (outside diameter).
Indication For Use:
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Treatment of pharyngocutaneous fistulas following laryngectorny or laryngoesophagectorny.
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Management of cervical esophageal and hypopharyngeal strictures and fistulas resulting from a variety of causes including surgery, radiation, advanced malignancy, trauma, and ingestion of caustic agents.
Predicate Device: Montgomery Salivary Bypass Tube.
Testing: Finished device samples passed cytotoxicity testing and were determined to be nonreactive and non-cytotoxic based on Elution Test, USP 23.
PRESIDENT
Submitted by:
Stuart K. Montgomery, President
Date:
7/10/96
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.