LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660

K070881 · Sapimed S.P.A. · FHN · Sep 26, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070881
• Device Name: LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
• Applicant: Sapimed S.P.A.
• Product Code: FHN · Gastroenterology, Urology
• Decision Date: Sep 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

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. Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.

Device Story

LEM Hemorrhoidal Ligators are single-patient-use plastic devices for hemorrhoid treatment; used by trained proctology personnel in clinical settings. Device components include a separable cylindrical cone for band loading, an angled distal cylinder to contain the hemorrhoidal nodule, and an ergonomically designed pistol handgrip with a trigger mechanism. Operation involves capturing the hemorrhoidal nodule via suction or forceps; the operator uses the angled design for clear visualization of the procedure; the trigger releases an elastic banding ring around the base of the nodule. This ligation cuts off blood supply, inducing tissue shrinkage, desiccation, and elimination. The device provides a mechanical alternative to existing reusable or syringe-style ligators.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Plastic construction; single-use; manual mechanical actuation; angled distal cylinder design; pistol-grip handle with trigger release; non-sterile.

Indications for Use

Indicated for medical personnel trained in proctology procedures to treat hemorrhoidal tissue by cutting off blood flow via ligature or ring placement at the hemorrhoid base.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• O'Regan Ligator (K963166)
• Erchinger Hemorrhoidal ligator (K000297)

Submission Summary (Full Text)

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K070881
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## 510(k) Summary

SEP 26 2007

SAPI MED S.P.A. Via Santi 25-Z.I. D4 Scalo Alessandria, ITALY 15100 Phone [phone]

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.

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K070881
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Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.

| Parameter<br>Device Name | LEM Hemorrhoidal<br>Ligator | O'Regan Ligator | Erchinger Hemorrhoidal<br>Ligator |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FHN | FHN | FHN |
| K Number | | K963166 | K000297 |
| Common<br>Name | Hemorrhoidal ligator | Hemorrhoidal ligator | Hemorrhoidal legator: suction<br>ligators |
| Intended Use | LEM hemorrhoidal<br>ligators are used to cut<br>off the blood flow to<br>hemorrhoidal tissue by<br>means of a ligature or<br>ring placed around the<br>hemorrhoid base. | O'Regans ligiator are<br>used to cut off the blood<br>flow to hemorrhoidal<br>tissue by means of a<br>ligature or ring placed<br>around the hemorrhoid<br>base. | Hemorrhoidal ligators are used<br>to cut off the blood flow to<br>hemorrhoidal tissue by means<br>of a ligature or ring placed<br>around the hemorrhoid base. |
| Material | Plastic | Plastic | Surgical Stainless steel |
| Single use | Yes | Yes | No |
| Method of use | Lem hemorroidal ligators<br>are used to apply a<br>ligature or elastic ring<br>around the base of the<br>hemorrhoidal nodule in<br>order to cut off the blood<br>flow to hemorrhoidal<br>tissue. Two models for<br>use either with forceps or<br>suction. Both variants are<br>supplied with a separable<br>cylindrical cone) to assist<br>in loading the bands, an<br>angled distal cylinder to<br>contain the nodule, and<br>an ergonomically-<br>designed pistol<br>handgrip, with trigger to<br>release the banding ring.<br>re | O'Regan ligator provides<br>suction and ligation<br>capability. An elastic<br>band can be stretched<br>over the front end of the<br>ligator by means of the<br>cone shaped loading<br>apparatus. The front end<br>of the ligator is inserted<br>through the anus deep<br>within the rectum. The<br>nozzle is then withdrawn<br>gently as the device is<br>angulated to point directly<br>towards the site to be<br>banded which is then<br>trapped and banded. | The hemorrhoid is grasped with<br>a forceps or sucked into the<br>ligator head (suction forceps) A<br>rubber ring is slipped over the<br>varicosity, causing tissue<br>necrosis and sloughing of the<br>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.

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## 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

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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 [phone] or [phone]

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

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# 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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