(210 days)
The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon. For single use only.
Not Found
The provided 510(k) summary (K031236) for the Scandimed International Auto-Band Ligator is a clearance letter from the FDA. It declares the device substantially equivalent to legally marketed predicate devices.
Crucially, this document is a regulatory clearance letter and does not contain the details of a study proving the device meets specific acceptance criteria. This type of FDA clearance relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical trials to establish de novo performance criteria.
Therefore, I cannot provide the information requested in your bullet points because the provided text does not contain a study report or clinical trial data.
To clarify what this document does provide:
- Device Name: Scandimed International Auto-Band Ligator
- Intended Use: Used to band esophageal varices or hemorrhoids in the colon. For single use only.
- Regulatory Classification: Class II, Product Code: 78 MND
- Predicate Device: Not explicitly named in this letter, but implied by the "substantial equivalence" determination.
Without a detailed clinical study report, it's impossible to answer your specific questions regarding acceptance criteria, sample sizes, expert qualifications, ground truth, or comparative effectiveness.
§ 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.