(180 days)
Not Found
No
The device description and intended use focus on a mechanical process (applying a ligature) and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also explicitly marked as "Not Found".
Yes
The device is used to precisely apply a ligature to hemorrhoidal tissue, cutting off blood flow to treat and eliminate hemorrhoids, which directly addresses a medical condition.
No
The device is used to apply a ligature to hemorrhoidal tissue to cut off blood flow, leading to the elimination of the hemorrhoid. This is a therapeutic action, not a diagnostic one.
No
The device description explicitly states it is manufactured from plastic and includes physical components like a cylindrical cone, angled distal cylinder, and a pistol handgrip with a trigger, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The LEM Hemorrhoidal ligator is a surgical instrument used directly on the patient's body to treat hemorrhoids by applying a ligature. It does not analyze samples taken from the body.
The description clearly indicates a device used for a surgical procedure, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.
Product codes (comma separated list FDA assigned to the subject device)
FHN
Device Description
The Sapimed LEM Disposable hemorrhoidal ligators are used to apply a ligature or elastic ring around the base of the hemorrhoidal nodule in order to cut off the blood flow to hemorrhoidal tissue. The lack of blood supply will result in shrinkage, desiccation and elimination of the hemorrhoid. It is supplied in two models Model numbers A.5650 and A 5660. They are both manufactured from plastic and designed for single patient use. Both variants are supplied with a separable cylindrical cone (0 10mm) to assist in loading the bands, an angled distal cylinder to contain the nodule, and an ergonomicallydesigned pistol handgrip,with trigger to release the banding ring. The LEM has an angled design that allows the operator a clear view of the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hemorrhoidal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical personnel trained in proctology procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K070881
PAGE 1 OF 2
510(k) Summary
SEP 26 2007
SAPI MED S.P.A. Via Santi 25-Z.I. D4 Scalo Alessandria, ITALY 15100 Phone 39-013-1348109
Contact: Mrs. Paola Oddenino
Summary Prepared: February 28, 2007
Trade Name: LEM Hemorrhoidal Ligators
Common Name: Hemorrhoidal Ligators
Classification Name: ligator, Hemorrhoidal
Predicate Device Identification
| CFR21:876.4400 | ||
|---|---|---|
| Product Code:FHN | ||
| Device Class:II | ||
| Legally Marketed Device: | ||
| Company | Product | 510(k) # |
| Patrick J. O'Regan | O'Regan Ligator | K963166 |
| Erchinger Medizintechnik | Erchinger Hemrrohoidal ligator | K000297 |
Description:
The Sapimed LEM Disposable hemorrhoidal ligators are used to apply a ligature or elastic ring around the base of the hemorrhoidal nodule in order to cut off the blood flow to hemorrhoidal tissue. The lack of blood supply will result in shrinkage, desiccation and elimination of the hemorrhoid. It is supplied in two models Model numbers A.5650 and A 5660. They are both manufactured from plastic and designed for single patient use. Both variants are supplied with a separable cylindrical cone (0 10mm) to assist in loading the bands, an angled distal cylinder to contain the nodule, and an ergonomicallydesigned pistol handgrip,with trigger to release the banding ring. The LEM has an angled design that allows the operator a clear view of the procedure.
Intended Use:
The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
1
K070881
PAGE 2 OF 2
Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.
| Parameter
Device Name | LEM Hemorrhoidal
Ligator | O'Regan Ligator | Erchinger Hemorrhoidal
Ligator |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FHN | FHN | FHN |
| K Number | | K963166 | K000297 |
| Common
Name | Hemorrhoidal ligator | Hemorrhoidal ligator | Hemorrhoidal legator: suction
ligators |
| Intended Use | LEM hemorrhoidal
ligators are used to cut
off the blood flow to
hemorrhoidal tissue by
means of a ligature or
ring placed around the
hemorrhoid base. | O'Regans ligiator are
used to cut off the blood
flow to hemorrhoidal
tissue by means of a
ligature or ring placed
around the hemorrhoid
base. | Hemorrhoidal ligators are used
to cut off the blood flow to
hemorrhoidal tissue by means
of a ligature or ring placed
around the hemorrhoid base. |
| Material | Plastic | Plastic | Surgical Stainless steel |
| Single use | Yes | Yes | No |
| Method of use | Lem hemorroidal ligators
are used to apply a
ligature or elastic ring
around the base of the
hemorrhoidal nodule in
order to cut off the blood
flow to hemorrhoidal
tissue. Two models for
use either with forceps or
suction. Both variants are
supplied with a separable
cylindrical cone) to assist
in loading the bands, an
angled distal cylinder to
contain the nodule, and
an ergonomically-
designed pistol
handgrip, with trigger to
release the banding ring.
re | O'Regan ligator 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 which is then
trapped and banded. | The hemorrhoid is grasped with
a forceps or sucked into the
ligator head (suction forceps) A
rubber ring is slipped over the
varicosity, causing tissue
necrosis and sloughing of the
hemorrhoid |
| Packaged | Clean, non-sterile | Clean, non sterile | Clean, non-sterile |
Device Comparison Table: Predicate Product Comparison Chart
Similarities and differences between LEM Hemorrhoidal Ligators and Predicate Products
The LEM hemorrhoidal ligators have the same intended use as the predicate devices using a retrieval of the nodule through suction or forceps and the consequent banding of the nodule. The difference between the LEM hemorrhoidal ligator and the O'Regan ligator is the ergonomically designed handgrip rather than the syringe-like handle of the the O'Regan ligator. The Erchinger ligator is a reuseable stainless steel rather than a single use device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 6 2007
Sapimed S.P.A. c/o Ms. Yolanda Smith Smith Associates 1676 Village Green, Suite A CROFTON MD 21114
Re: K070881
Trade/Device Name: LEM Suction Hemorrhoidal Ligator Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: FHN Dated: August 21, 2007 Received: August 22, 2007
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006 FDA Centennial" around the edge. In the center of the logo is the acronym "FDA" in large, bold letters. Below the acronym are three stars. The logo is black and white and has a slightly distressed look.
Protecting and Promoting Public Health
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 107088)
Device Name: LEM Suction Hemorrhoidal Ligator
Indications for Use:
The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Jessen
sion Sign Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
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