(125 days)
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No
The summary describes a mechanical ligating device with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The "Speedband Multiple Band Ligator" is indicated for endoscopic ligation of hemorrhoids and esophageal varices, which are medical treatments, thus making it a therapeutic device.
No
The device is a ligator, used for treatment (ligation of hemorrhoids and varices), not for diagnosing conditions.
No
The device description explicitly mentions "major components are the ligating handle and the ligating unit," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "endoscopic ligation of anorectal hemorrhoids and esophageal varicies." This describes a procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description of the components (ligating handle and ligating unit) aligns with a device used for a physical procedure, not for analyzing a biological sample.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Speedband Multiple Band Ligator is a therapeutic device used for a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Speedband Multiple Band Ligator is indicated for endoscopic ligation of anorectal hemorrhoids and esophageal varicies.
Product codes
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Device Description
The major components of the Modified Speedband™ are the ligating handle and the ligating 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
anorectal, esophageal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing regarding characteristics was performed on Modified Speedband™ to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Speedband™ with satisfactory results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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FEB 1 3 1997
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.
| > COMMON/USUAL NAMES: | Hemorrhoidal Ligator, Esophageal Variceal Ligator |
|---|---|
| > TRADE/PROPRIETARY NAME: | Speedband™ Multiple Band Ligator |
| > CLASSIFICATION NAME & | |
| DEVICE CLASSIFICATION: | Class II |
| > CONTACT PERSON: | Lisa M. Quaglia, Senior Regulatory Affairs Specialist |
INDICATIONS FOR USE
The Speedband Multiple Band Ligator is indicated for endoscopic ligation of anorectal hemorrhoids and esophageal varicies.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the Modified Speedband™ is substantially equivalent to the currently-marketed Speedband™ and the Wilson Cook Six Shooter. These devices share similar materials, manufacturing process, and intended use. The major components of the Modified Speedband™ are the ligating handle and the ligating unit.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on Modified Speedband™ to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Speedband™ with satisfactory results.
CONCLUSION
Boston Scientific Corporation believes that Modified Speedband™ is substantially equivalent to the currently-marketed Speedband™ as well as the Wilson Cook Six Shooter. The Modified Speedband™ is equivalent in its indications for use, while being very similar in design and
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materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Modified Speedband™ will meet the minimum requirements that are considered acceptable for its intended use.