(180 days)
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.
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.
The provided submission does not contain specific acceptance criteria or a detailed study proving the device meets these criteria. Instead, it is a 510(k) summary focused on establishing substantial equivalence to predicate devices. The document outlines the intended use, device description, and a comparison table with predicate devices, but lacks quantitative performance metrics or a formal study design for evaluating the LEM Hemorrhoidal Ligators' performance against predefined acceptance criteria.
The core of this submission is a comparison of the new device (LEM Hemorrhoidal Ligators) to existing, legally marketed devices (O'Regan Ligator and Erchinger Hemorrhoidal Ligator) to demonstrate that it is "substantially equivalent." This means that the device is as safe and effective as the predicate devices.
Here's an analysis of the provided text in relation to your request, with explicit mention of what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicates | 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. (Matches predicate devices' intended use). |
| Material (Plastic) | Same as O'Regan | Plastic (Matches O'Regan Ligator, differs from Erchinger's surgical stainless steel). |
| Single Use | Same as O'Regan | Yes (Matches O'Regan Ligator, differs from Erchinger's reusability). |
| Method of Use | Functionally similar | Provides means to apply a ligature or elastic ring around the base of the hemorrhoidal nodule to cut off blood flow. Both models for use with forceps or suction. Features an angled distal cylinder to contain the nodule and an ergonomically-designed pistol handgrip with trigger to release the banding ring. (Functionally similar to predicates, with a difference in handgrip design from O'Regan). |
| Ergonomics | Improved over O'Regan | Ergonomically-designed pistol handgrip. (Described as a difference from O'Regan's syringe-like handle). |
| Reuseability | N/A (single use) | Single patient use. (Differs from Erchinger's reusable design). |
| Effectiveness (Clinical Outcome) | Not explicitly stated; implicitly assumed to be equivalent to predicates. | Not reported in provided text. The submission focuses on substantial equivalence based on design and intended use, not on specific clinical effectiveness data with acceptance criteria. |
| Safety | Not explicitly stated; implicitly assumed to be equivalent to predicates. | Not reported in provided text. The submission relies on the safety profile of predicate devices. |
Missing Information:
- Specific numerical or qualitative performance targets that the device had to meet (e.g., success rate of banding, complication rates, force required, band retention force, etc.).
- Actual performance data from a study against such criteria. The document only describes the device's features and its similarity to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not reported.
- Data Provenance: Not applicable / Not reported.
Explanation: This 510(k) summary does not describe a clinical performance study with a "test set" in the sense of patient data. The evaluation is based on a comparison to predicate devices, focusing on design, materials, and intended use. There is no mention of country of origin for any (non-existent) test data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There is no mention of a "test set" requiring ground truth established by experts.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe an MRMC study or any study comparing human readers' performance with or without AI assistance. This device is a mechanical ligator, not an AI-assisted diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
- Not applicable. This device is a mechanical medical instrument, not an algorithm. Therefore, a standalone (algorithm only) performance study is irrelevant.
7. Type of Ground Truth Used
- Not applicable. As there is no test set or clinical study described in detail, the concept of "ground truth" (e.g., pathology, outcomes data) for evaluation is not presented. The "ground truth" equivalent in a 510(k) is often the established safety and effectiveness of the predicate devices against which the new device is compared.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" with established ground truth.
Overall Conclusion:
The provided document is a 510(k) premarket notification summary. For such submissions, the primary "study" is often a comparison to predicate devices, demonstrating substantial equivalence rather than conducting a de novo clinical trial with specific performance acceptance criteria. The document focuses on demonstrating that the LEM Hemorrhoidal Ligators have the "same intended use" and "similar technological characteristics" to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. Therefore, many of the detailed study-related questions you posed are not applicable to the content of this specific regulatory submission.
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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.
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K070881
PAGE 2 OF 2
Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.
| ParameterDevice Name | LEM HemorrhoidalLigator | O'Regan Ligator | Erchinger HemorrhoidalLigator |
|---|---|---|---|
| Product Code | FHN | FHN | FHN |
| K Number | K963166 | K000297 | |
| CommonName | Hemorrhoidal ligator | Hemorrhoidal ligator | Hemorrhoidal legator: suctionligators |
| Intended Use | LEM hemorrhoidalligators are used to cutoff the blood flow tohemorrhoidal tissue bymeans of a ligature orring placed around thehemorrhoid base. | O'Regans ligiator areused to cut off the bloodflow to hemorrhoidaltissue by means of aligature or ring placedaround the hemorrhoidbase. | Hemorrhoidal ligators are usedto cut off the blood flow tohemorrhoidal tissue by meansof a ligature or ring placedaround the hemorrhoid base. |
| Material | Plastic | Plastic | Surgical Stainless steel |
| Single use | Yes | Yes | No |
| Method of use | Lem hemorroidal ligatorsare used to apply aligature or elastic ringaround the base of thehemorrhoidal nodule inorder to cut off the bloodflow to hemorrhoidaltissue. Two models foruse either with forceps orsuction. Both variants aresupplied with a separablecylindrical cone) to assistin loading the bands, anangled distal cylinder tocontain the nodule, andan ergonomically-designed pistolhandgrip, with trigger torelease the banding ring.re | O'Regan ligator providessuction and ligationcapability. An elasticband can be stretchedover the front end of theligator by means of thecone shaped loadingapparatus. The front endof the ligator is insertedthrough the anus deepwithin the rectum. Thenozzle is then withdrawngently as the device isangulated to point directlytowards the site to bebanded which is thentrapped and banded. | The hemorrhoid is grasped witha forceps or sucked into theligator head (suction forceps) Arubber ring is slipped over thevaricosity, causing tissuenecrosis and sloughing of thehemorrhoid |
| 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 (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
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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
Page of
17
§ 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.