(14 days)
Not Found
Not Found
No
The device description and intended use describe a physical silicone tube for treating strictures and fistulas. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved.
Yes
The device is described for the "treatment" and "management" of various medical conditions, clearly indicating a therapeutic purpose.
No
The device is described as a treatment and management tool for strictures and fistulas, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "silicone tube" and mentions physical sizes (8mm, 10mm, etc.), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential transfusions, or to monitor therapeutic measures.
- Device Description and Intended Use: The description clearly states the device is a "silicone tube" used for the "Treatment of pharyngocutaneous fistulas" and "Management of cervical esophageal and hypopharyngeal strictures and fistulas." This involves direct physical intervention within the body to manage anatomical issues.
- Lack of Specimen Examination: There is no mention of the device being used to examine any biological specimens (blood, tissue, etc.) outside of the body.
The Montgomery Salivary Bypass Tube is a therapeutic device used to manage physical conditions within the body, not a diagnostic device used to analyze specimens for information about a patient's health state.
N/A
Intended Use / Indications for Use
-
Treatment of pharyngocutaneous fistulas following laryngectorny or laryngoesophagectorny.
-
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.
Product codes
Not Found
Device 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngocutaneous, cervical esophageal, hypopharyngeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Finished device samples passed cytotoxicity testing and were determined to be nonreactive and non-cytotoxic based on Elution Test, USP 23.
Key Metrics
Not Found
Predicate Device(s)
Montgomery Salivary Bypass Tube.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
-
Treatment of pharyngocutaneous fistulas following laryngectorny or laryngoesophagectorny.
-
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