(125 days)
The Speedband Multiple Band Ligator is indicated for endoscopic ligation of anorectal hemorrhoids and esophageal varicies.
The major components of the Modified Speedband™ are the ligating handle and the ligating unit.
This 510(k) summary describes a medical device rather than an AI/ML algorithm or a diagnostic tool that would typically have acceptance criteria and performance metrics like sensitivity, specificity, or AUC. Therefore, much of the requested information is not applicable to this document.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it's not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety & Performance verified by laboratory testing | Satisfactory |
| Biocompatibility Assessment | Satisfactory results |
| Substantial Equivalence to predicate devices (Speedband™ and Wilson Cook Six Shooter) in materials, manufacturing process, and intended use. | Modified Speedband™ shares similar materials, manufacturing process, and intended use as predicate devices. |
| Equivalent in indications for use to predicate devices | Modified Speedband™ has equivalent indications for use as predicate devices. |
| Similar in design to predicate devices | Modified Speedband™ is very similar in design to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "laboratory testing," but does not provide details on the number of devices or units tested.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This document describes a physical medical device (ligator) and its mechanical/biocompatibility performance, not a diagnostic test requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for evaluating human interpretations in diagnostic studies. The testing described here is for physical device performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device, not an AI or diagnostic tool. No human reader study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the traditional sense for diagnostic tools). The "ground truth" for this device's performance would be established by engineering standards, material specifications, and regulatory requirements demonstrating its ability to safely and effectively ligate tissue. This would be verified through specific laboratory tests (e.g., tensile strength, biocompatibility assays).
8. The sample size for the training set
- Not Applicable. There is no "training set" for this type of medical device's performance testing. The principles of AI/ML training do not apply here.
9. How the ground truth for the training set was established
- Not Applicable. As there's no training set, this question is not relevant.
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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.
§ 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.