(87 days)
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No
The device description and performance studies focus on mechanical components and biocompatibility, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is indicated for the treatment of esophageal varices and anorectal hemorrhoids, which directly addresses medical conditions.
No
Explanation: The device is described as a "Multiple Band Ligator" used for treatment procedures (ligation/injection therapy for esophageal varices and band ligation for hemorrhoids), not for diagnosing conditions.
No
The device description clearly outlines physical hardware components (Ligating Unit, Handle Unit with Trip Wire and Scope Fastener, plastic spool, irrigation valve) and their mechanical functions, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Modified Superview is a device used directly on the patient's body during a medical procedure (ligation of esophageal varices and anorectal hemorrhoids). It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "treatment of esophageal varicies" and "band ligation treatment of anorectal hemorrhoids." This is a treatment, not a diagnostic test.
- Device Description: The description details a mechanical device used for applying bands, not for analyzing biological samples.
Therefore, based on the provided information, the Modified Superview is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation /injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.
Product codes
78 FHN, 78 KHN/78 MND
Device Description
The Microvasive Modified Superview is a Multiple Band Ligator composed of two major components.
- The Ligating Unit
The main component of the ligating unit is a cylinder which fits at the distal end of the endoscope. Elastic bands are stretched around the distal portion of the cylinder. - Handle Unit with Trip Wire and Scope Fastener
The main component of the Handle Unit is a plastic spool which turns only in the clockwise direction. A trip wire is attached to the plastic spool. When the plastic spool is rotated, the handle will make a distinct "click" sound, and one band will be fired automatically. The Handle Unit also incorporates a scope fastener to secure the handle onto the endoscope. An irrigation valve is located on the side of the Handle Unit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
esophageal, anorectal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Laboratory testing regarding characteristics was performed on the Modified Superview to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Superview with satisfactory results.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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SECTION 10 510(K) SUMMARY
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| > DATE: | March 15, 1999 | ||
|---|---|---|---|
| > COMMON/USUAL NAMES: | Hemorrhoidal Ligator, Esophageal Variceal Ligator | ||
| > TRADE/PROPRIETARY NAME: | Speedband Superview Multiple Band Ligator | ||
| > CLASSIFICATION NAME & | |||
| DEVICE CLASSIFICATION: | Class II | ||
| Name | Number | 21 CFR Ref | |
| Ligator, Homorrhoidal | 78 FHN | 876.4400 | |
| > DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | |||
| > OWNER/OPERATOR: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| > CONTACT PERSON: | Abby Lipman, Senior Regulatory Affairs Specialist |
DESCRIPTION OF DEVICE
The Microvasive Modified Superview is a Multiple Band Ligator composed of two major components.
1. The Ligating Unit
The main component of the ligating unit is a cylinder which fits at the distal end of the endoscope. Elastic bands are stretched around the distal portion of the cylinder.
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