← Product Code [FHN](/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN) · K091519 # HAEMOBAND MULTI-LIGATOR (K091519) _Haemoband Surgical, Ltd. · FHN · Jul 28, 2009 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K091519 ## Device Facts - **Applicant:** Haemoband Surgical, Ltd. - **Product Code:** [FHN](/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN.md) - **Decision Date:** Jul 28, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4400 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. It is for use only by trained medical personnel. ## Device Story Handheld, disposable, single-use device for hemorrhoidal rubber band ligation. Features integrated suction to grasp hemorrhoidal tissue; pistol-style handgrip with trigger mechanism; preloaded with 4 non-latex rubber bands. Operates by applying suction to hold tissue, then deploying a band around the hemorrhoid base to induce necrosis and sloughing. Used in hospitals, clinics, and doctors' offices by trained medical personnel. Benefits include multi-band capacity and auto-reload functionality, streamlining the ligation procedure compared to single-band or reusable systems. ## Clinical Evidence No clinical data provided. Substantial equivalence established via bench testing and comparison of technological characteristics to predicate devices. ## Technological Characteristics Disposable, single-use handheld ligator. Materials certified to ISO 10993. Features integrated suction system and mechanical trigger for band deployment. Preloaded with 4 non-latex rubber bands. Mechanical operation; no electronic or software components. ## Regulatory 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 - Erchinger Medizintecknik - Ligator ([K000297](/device/K000297.md)) - SAPI MED S.p.a. - LEM ligator ([K070881](/device/K070881.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Premarket Notification 510(k) Section 5 - 510(k) Summary K091519 Haemoband ### 510(k) Summary Page 1 of 3 21-May-09 | Haemoband Surgical Ltd.
The Mount Business Park
2 Woodstock Link
Belfast BT6 8DD
Northern Ireland | |---------------------------------------------------------------------------------------------------------------| | Tel - 011-44-28-9073-7283
Fax - 011-44-28-9073-7282 | | JUL 2 8 2005 | | Official Contact: | | Colin Foster - Managing Director | | Proprietary or Trade Name: | | Multi-Ligator | | Common/Usual Name: | | Hemorrhoidal ligators | | Classification Name/Code: | | 78 FHN - hemorrhoidal ligators
21 CFR 876.4400 | | Device: | | Multi-Ligator | | Predicate Devices: | | K0000297 - Erchinger Medizintecknik - Ligator
K070881 - SAPI MED S.p.a. - LEM ligator | #### Device Description: The Haemoband Multi-Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The Haemoband Multi-Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with 4 preloaded non-latex rubber bands. #### Indications for Use: The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices. #### Patient Population: Individuals with hemorrhoids #### Environment of Use: Hospitals, clinics, and doctors' offices. #### Contraindications Do not use to treat: - . 4th degree or continuously prolapsed hemorrhoids - . Anal Polyps - In the presence of perineal infection, can be used after the infection has settled. . - Use with caution when treating patients on anticoagulants i.e. Warfarin . {1}------------------------------------------------ Premarket Notification 510(k) Section 5 — 510(k) Summary Haemoband ## 510(k) Summary Page 2 of 3 21-May-09 ## Summary of substantial equivalence: | 510(k) Numbers & Manufacturers | Proposed Device | Predicate Device | | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | K070881
SAPI MED S.p.a. | K000297
Erchinger Medizintechnik | | Device | Haemoband Multi-Ligator | LEM | Ligator | | Class | Class II | Class II | Class II | | Product Code | FHN | FHN | FHN | | CFR | 876.4400 | 876.4400 | 876.4400 | | Intended Use | The Haemoband Multi-Ligator
includes suction and ligation
capabilities. The ligator is used
to cut off the blood flow to
hemorrhoidal tissue by means of
a ligature or ring placed around
the hemorrhoid base. | 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
used to cut off the blood
flow to hemorrhoidal tissue
by means of a ligature or
ring placed around the
hemorrhoid base. | | Environment of Use | Hospitals, clinics, and doctors'
offices. | Not specified | Not specified | | Prescriptive | Yes trained medical personnel | Yes trained medical
personnel trained in
proctology | Yes trained medical
personnel trained in
proctology | | Principle of Operation | Apply a ligature or elastic ring
around the base of the
hemorrhoidal nodule in order to
cut off the blood flow to the
hemorrhoidal tissue. Has a
means to apply suction to hold
the hemorrhoidal tissue prior to
and during the ligature
procedure. Pre-loaded bands in a
pistol handgrip with trigger to
apply suction and release the
banding ring | Apply a ligature or elastic
ring around the base of the
hemorrhoidal nodule in
order to cut off the blood
flow to the hemorrhoidal
tissue. Has a means to
apply suction to hold the
hemorrhoidal tissue prior
to and during the ligature
procedure. Pre-loaded
bands in a pistol handgrip
with trigger to apply
suction and release the
banding ring | Hemorrhoid is grasped with
a forceps or sucked into the
ligator head (suction
forceps). A ring is slipped
over the varicosity, causing
tissue necrosis and
sloughing of the
hemorrhoid. | | Disposable | Single patient use, disposable | Single patient use,
disposable | Surgical stainless steel,
reusable | | Materials | Standard materials tested or
certified to ISO 10993
Bands identical to K000297 | Not known | Identical bands used in
proposed device. | | 510(k) Numbers &
Manufacturers | | K070881
SAPI MED S.p.a. | K000297
Erchinger Medizintechnik | | Device | Haemoband Multi-Ligator | LEM | Ligator | | Preloaded ready for
use | Yes | No but supplied with a
band loader | No | | Multi bands | Yes | No | No | | Auto reload | Yes | No | No | | Suction | Integrated | Yes | Yes | · . 62 {2}------------------------------------------------ Premarket Notification 510(k) Section 5 - 510(k) Summary Haemoband ## 510(k) Summary Page 3 of 3 21-May-09 It is our view that there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device. ## Substantial Equivalence The Haemoband Multi-Ligator is viewed as substantially equivalent to the predicate devices because: #### Indications - - Identical to predicate K070881 SAPI Med LEM . #### Technology - . - Similar technology used - - K000297 Erchinger o - K070881 SAPI Med o #### Materials - - The materials in patient contact are identical to predicate device or we have provided . ISO 10993 certification. ## Environment of Use - - Identical to predicate K000297 Erchinger . {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Haemoband Surgical Ltd. c/o Mr. Paul E. Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134-29158 # JUL 28 2009 Re: K091519 Trade/Device Name: Haemoband Multi-Ligator Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class; II Product Code: FHN Dated: May 21, 2009 Received: May 22, 2009 Dear Mr. Dryden: 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 (PMA), it may be subject to 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. 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); medical device reporting of medical {4}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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, Iadine M. Morris Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Indications for Use Statement 510(k) Number: (To be assigned) **510(k) Number:** Device Name: Haemoband Multi-Ligator Indications for Use: The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. It is for use only by trained medical personnel. Prescription Use XX . (Part 21 CFR 801 Subpart D) or Over-the-counter use (21 CFR 807 Subpart C) Page 1 of 1 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hula Remu (Division Sign Off) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number A --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K091519](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K091519) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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