(90 days)
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No
The description focuses on the mechanical function of the device for ligating hemorrhoids and does not mention any computational or data-driven features indicative of AI/ML.
Yes
The device is described as a "combination" device intended to ligate hemorrhoids, which is a therapeutic intervention to treat a medical condition.
No
The device description indicates that the new device is a tool for ligating hemorrhoids. It enables the operating surgeon to "bring into view and ligate hemorrhoids." This describes a therapeutic or surgical procedure, not a diagnostic one. While it involves viewing the hemorrhoids, the primary function described is the treatment (ligation) rather than identifying or characterizing a disease for diagnosis.
No
The device description clearly details a physical instrument with tubes, an obturator, and a mechanism for applying elastic bands, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "bring into view and ligate hemorrhoids." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a tool used for a physical intervention (ligating tissue) within the anal canal and rectum. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a surgical instrument used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The new device has incorporated features of the above tools into one device, resulting in one instrument that can bring into view and ligate hemorrhoids, all at the same time, by the operating surgeon. No assistant is needed. The tool is a double barreled tube, the internal tube carrying a preloaded latex elastic band slightly protuding from the external tube. An obturator is inserted into the devise and after adequate lubrication, the tool is inserted into the anal canal and rectum. The obturator is then removed. The anatomical site for banding is chosen, by acurate positioning the tool, A long narrow, angled tenaculum, or any other grasping device is inserted into the tube, the chosen tissue is grasped and pulled into the tube. The inner tube is retracted with the operators thumb and the outer barrel pushes the elastic band off the internal barrel and the band lodges around the tissue.
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
anal canal and rectum
Indicated Patient Age Range
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Intended User / Care Setting
operating surgeon, outpatient basis in my office
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
The Solo Band Ligator has been succesfully used in approximately 100 hemorrhoid ligations on an outpatient basis in my office, .over the past two years. Other than greater ease of the procedure for the surgeon, no significant differences before, during or after the banding procedure, were observed by the surgeon or the patient.
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.
0
1960020
- Summary Report.
APR - 1 1996
510 (k) Summary
SURCRAFT, LC is claiming equivalence of the McGivney hemorrhoid ligator and the Hirschman anoscope and Brinkerhof rectal speculum.
The new device is therefor a socalled "combination" devise that claims to have the same intended uses as several different types of predicate devices
The new device has incorporated features of the above tools into one device, resulting in one instrument that can bring into view and ligate hemorrhoids, all at the same time, by the operating surgeon. No assistant is needed. The tool is a double barreled tube, the internal tube carrying a preloaded latex elastic band slightly protuding from the external tube. An obturator is inserted into the devise and after adequate lubrication, the tool is inserted into the anal canal and rectum. The obturator is then removed. The anatomical site for banding is chosen, by acurate positioning the tool, A long narrow, angled tenaculum, or any other grasping device is inserted into the tube, the chosen tissue is grasped and pulled into the tube. The inner tube is retracted with the operators thumb and the outer barrel pushes the elastic band off the internal barrel and the band lodges around the tissue.
The solo Band Ligator is simpler than the predicate devise and because of its design is easier to clean without hard to get to parts. There are no small openings that can clog up with debris, no springs, no adjustment screws.
Both tools accomplish the banding procedure well, but the Solo Band Ligator does it more accurately and under full manual and visual control of the operating surgeon. He does not have to depend on the assistant (who cannot see what he is doing) holding the tool at the critical moment when the instrument has to be fired. The Solo Band Ligator has been succesfully used in approximately 100 hemorrhoid ligations on an outpatient basis in my office, .over the past two years. Other than greater ease of the procedure for the surgeon, no significant differences before, during or after the banding procedure, were observed by the surgeon or the patient.
In view of all of the above I conclude that the Solo Band Ligator in its current configuration is functionally essentially equivalent to the predicate devise (Hemorrhoid Ligator) and structurely and functionally equivalent to the Anoscope and Rectal Speculum (Hirschman and Brinkerhof). Clinical results of the rubber band procedure with one or the other tool are identical. The new devise is easier to clean, provides a better view and is under solo operated control by the surgeon.