(264 days)
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No
The device description details a mechanical ligator for hemorrhoids and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is intended for the treatment of hemorrhoids, which is a medical condition. It directly acts on the body to alleviate or treat a disease.
No
Explanation: The device is described as a ligator for the treatment of hemorrhoids, which involves placing elastic bands on tissue. Its function is to perform a medical procedure (treatment), not to diagnose a condition.
No
The device description clearly describes a physical medical device made of polypropylene with suction and ligation capabilities, intended for the treatment of hemorrhoids. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "hemorrhoid ligator" for the treatment of hemorrhoids. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a device used to physically place elastic bands on tissue within the rectum. This is a mechanical intervention, not a diagnostic test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The O'Regan, Ligator or Hemorrhoid Ligator is a device for the treatment of hemorrhoids.
Product codes
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Device Description
The O'Regan, Ligator or Hemorrhoid Ligator is a device for the treatment of hemorrhoids. The technique involves placing elastic bands on tissue in the rectum in the vicinity of the hemorrhoids. The bands are placed high enough in the rectum to be above the sensitive area so that any discomfort from the procedure is minimized.
The device provides suction and ligation capability. An elastic band can be stretched over the front end of the ligator by means of the cone shaped loading apparatus. The front end of the ligator is inserted through the anus deep within the rectum. The nozzle is then withdrawn gently as the device is angulated to point directly towards the site to be banded. A mark on the outside of the device provides a measure as to the level inside the rectum where the band is to be placed. The device is designed to be used without a proctoscope, but the site to be banded is initially identified by inserting a viewing device such as a sigmoidoscope or proctoscope. The opening at the front end of the device allows only a fairly conservative amount of tissue to be trapped within the chamber. The device can be used single handedly.
The device will be made available in a package, labelled clean but not sterile for one time use only. Rubber bands will not be included but are readily available from medical suppliers. The device is made of polypropylene with no colour additive.
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
rectum
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)
As can be seen from the summary of the clinical data provided, the bands can be placed as accurately or more accurately by this technique. The size of the bite of tissue banded is also more constant and more precise than with other methods. If the band for some reason is not optimal, it can be fairly readily displaced with the examining gloved finger.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
MAY - 5 1997
Image /page/0/Picture/1 description: The image shows the text 'K963166 Page 1 of 2'. The text is written in a bold, handwritten style. The phrase 'Page 1 of 2' indicates that this is the first page of a two-page document.
"510(K) Summary" as required by 807.92(C)
Name: Patrick J. O'Regan Address : 912 - 750 West Broadway Vancouver, B. C. ער 1988 (604) 876-9926 Fax: 872-7533 Ph :
Patrick J. O'Regan Contact Person:
August 2, 1996 Date:
Hemorrhoid Ligator Common Name:
Proprietory Name: O'Regan Ligator
The O'Regan, Ligator or Hemorrhoid Ligator is a Description: device for the treatment of hemorrhoids. The treatment of hemorrhoids by elastic band ligation is credited to Blaisdell who described the technique in the late 1950's, and in the early 1960's Barron popularized this treatment after his reports in the medical literature. The technique involves placing elastic bands on tissue in the rectum in the vicinity of the hemorrholds. The bands are placed high enough in the rectum to be above the sensitive area so that any discomfort from the procedure is minimized.
A number of different devices have been available to date. Some of the devices such as the Goltner Ligator rely on a suction technique to draw the tissue into the chamber and an expanded elastic band is placed around the trapped tissue in the chamber thus cutting off it's blood supply and causing the tissue to The resultant healing proves beneficial and helps to necrose. shrink hemorrhoids and restore the anatomy towards normal confiquration. Other devices such as the McGivney Ligator are used in conjunction with a forceps which is used to draw tissue into the chamber before banding.
The present device provides suction and ligation capability. An elastic band can be stretched over the front end of the ligator by means of the cone shaped loading apparatus. The front end of the ligator is inserted through the anus deep within the rectum. The nozzle is then withdrawn gently as the device is angulated to point directly towards the site to be banded. The site to be banded will have been previously identified by means of examination with a sigmoldoscope, a proctoscope or such an instrument. A mark on the outside of the device will provide a measure as to the level inside the rectum where the band is to be placed. Thus by angling the device acutely in the direction of the tissue to be banded and by measuring the distance from the outside, the band can be placed accurately on the appropriate tissue.
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Page 2 of 2
K963166
The opening at the front end of the device allows only a fairly conservative amount of tissue to be trapped within the chamber and subsequently allow banding of this said amount. The aperture has been found by trial and error to be optimal and conservative. This aperture is in fact smaller than that used on any of the other hemorrhoidal ligators available on the market. This ligator is intended to be used only as a hemorrhoid ligator. This device differs mainly in one respect from other devices available to date. Whereas other devices are designed to be used with the aid of a proctoscope or similar viewing instrument and the band is placed under direct vision, the present device is designed to be used without a proctoscope. As mentioned above the site to be banded is initially identified by inserting a viewing device such as a sigmoidoscope or proctoscope. The present device does not require that a proctoscope or anoscope be used in conjunction with the device.
As can be seen from the summary of the clinical data provided, the bands can be placed as accurately or more accurately by this The size of the bite of tissue banded is also more technique. constant and more precise than with other methods. If the band for some reason is not optimal, it can be fairly readily displaced with the examining gloved finger. The device can be used single handedly, as a proctoscope or an assistant is not necessary to perform the procedure.
The device will be made available in a package, labelled clean but not sterile for one time use only. Rubber bands will not be included but are readily available from medical suppliers. The device will be produced by Columbia Plastics Itd. Custom Injection Molding, 19320-60th Avenue, Surrey, B. C. V35 8E5. The device is made of polypropylene with no colour additive.
I hearby certify that, in my capacity as owner and developer of the O'Regan Ligator, I believe to the best of my knowledge, that all data and information submitted in the premarked notification are truthful and accurate and that no material facts have been omitted.
(Signature) ( Name ) (Date)
(Premarket Notification 510k Number)