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 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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Haemoband Multi-Ligator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving device performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, a specific study proving device performance, sample sizes for test/training sets, expert consensus details, or MRMC studies.

The document primarily details the device description, indications for use, comparison with predicate devices to establish substantial equivalence in terms of technology, materials, and intended use.

Here's a breakdown of what can be extracted and what is missing based on the provided text:

1. A table of acceptance criteria and the reported device performance

Missing. The 510(k) summary does not define specific performance acceptance criteria or report device performance against them. It focuses on establishing substantial equivalence to predicate devices, implying that if it is equivalent, its performance is acceptable.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Missing. No specific test set or clinical study data is mentioned in this 510(k) summary. The submission relies on a comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing. Ground truth establishment is not relevant as no test set or clinical study is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. Not applicable; no test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Missing. This device is a mechanical ligator, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effects are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing. Not applicable; this is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing. Not applicable; no ground truth is established for device performance in the context of this 510(k) submission.

8. The sample size for the training set

Missing. Not applicable; no training set for an algorithm is mentioned.

9. How the ground truth for the training set was established

Missing. Not applicable; no training set is mentioned.

Summary based on available information:

The Haemoband Multi-Ligator obtained 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (K0000297 - Erchinger Medizintechnik - Ligator and K070881 - SAPI MED S.p.a. - LEM ligator). The "study" for this submission is implicitly the comparison presented in the "Summary of substantial equivalence" table.

Table of Acceptance Criteria and Reported Device Performance:

Feature/Criterion (Implied by Substantial Equivalence Claim)	Haemoband Multi-Ligator Performance (Claimed)	Basis for Claim	Actual Acceptance Criterion from Study	Specific Reported Performance Data
Intended Use	Cut off blood flow to hemorrhoidal tissue by means of a ligature/ring.	Identical to predicate K070881 SAPI Med LEM.	Not explicitly defined, relies on predicate's established use.	Not quantifiable in this document.
Technology / Principle of Operation	Apply ligature, suction to hold tissue, pre-loaded bands, pistol handgrip.	Similar to K000297 Erchinger and K070881 SAPI Med.	Not explicitly defined, relies on predicate's established mechanism.	Not quantifiable in this document.
Materials (Patient Contact)	Standard materials tested/certified to ISO 10993; bands identical to K000297.	Identical to predicate device or ISO 10993 certified.	Biocompatibility standards (ISO 10993).	Compliance with ISO 10993 (certification mentioned).
Environment of Use	Hospitals, clinics, doctors' offices.	Identical to predicate K000297 Erchinger.	Not explicitly defined, relies on predicate's established use environment.	Not quantifiable in this document.
Safety and Effectiveness	No significant differences affecting safety or effectiveness compared to predicates.	Conclusion drawn from substantial equivalence comparison (technology, materials, intended use).	No specific quantitative safety/effectiveness criteria are provided in the 510(k) summary for this device as part of a formal study.	No specific reported performance data from a dedicated study is included.

Key takeaway: This 510(k) submission does not include a clinical study with acceptance criteria and measured performance in the way a robust device performance study or AI algorithm validation would. Instead, it demonstrates that the Haemoband Multi-Ligator is "substantially equivalent" to already legally marketed devices, implying that its safety and effectiveness are comparable.

Summary

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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 Park2 Woodstock LinkBelfast BT6 8DDNorthern Ireland
Tel - 011-44-28-9073-7283Fax - 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 ligators21 CFR 876.4400
Device:
Multi-Ligator
Predicate Devices:
K0000297 - Erchinger Medizintecknik - LigatorK070881 - 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:

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 .

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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
		K070881SAPI MED S.p.a.	K000297Erchinger 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-Ligatorincludes suction and ligationcapabilities. The ligator is usedto cut off the blood flow tohemorrhoidal tissue by means ofa ligature or ring placed aroundthe hemorrhoid base.	The LEM Hemorrhoidalligators are used to cut offthe blood flow tohemorrhoidal tissue bymeans of a ligature or ringplaced around thehemorrhoid base.	Hemorrhoidal ligators areused to cut off the bloodflow to hemorrhoidal tissueby means of a ligature orring placed around thehemorrhoid base.
Environment of Use	Hospitals, clinics, and doctors'offices.	Not specified	Not specified
Prescriptive	Yes trained medical personnel	Yes trained medicalpersonnel trained inproctology	Yes trained medicalpersonnel trained inproctology
Principle of Operation	Apply a ligature or elastic ringaround the base of thehemorrhoidal nodule in order tocut off the blood flow to thehemorrhoidal tissue. Has ameans to apply suction to holdthe hemorrhoidal tissue prior toand during the ligatureprocedure. Pre-loaded bands in apistol handgrip with trigger toapply suction and release thebanding ring	Apply a ligature or elasticring around the base of thehemorrhoidal nodule inorder to cut off the bloodflow to the hemorrhoidaltissue. Has a means toapply suction to hold thehemorrhoidal tissue priorto and during the ligatureprocedure. Pre-loadedbands in a pistol handgripwith trigger to applysuction and release thebanding ring	Hemorrhoid is grasped witha forceps or sucked into theligator head (suctionforceps). A ring is slippedover the varicosity, causingtissue necrosis andsloughing of thehemorrhoid.
Disposable	Single patient use, disposable	Single patient use,disposable	Surgical stainless steel,reusable
Materials	Standard materials tested orcertified to ISO 10993Bands identical to K000297	Not known	Identical bands used inproposed device.
510(k) Numbers &Manufacturers		K070881SAPI MED S.p.a.	K000297Erchinger Medizintechnik
Device	Haemoband Multi-Ligator	LEM	Ligator
Preloaded ready foruse	Yes	No but supplied with aband loader	No
Multi bands	Yes	No	No
Auto reload	Yes	No	No
Suction	Integrated	Yes	Yes

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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 .

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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

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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

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Indications for Use Statement

510(k) Number:

(To be assigned)

510(k) Number:

Device Name:

Haemoband Multi-Ligator

Indications for Use:

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

Regulation Number and Section

§ 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.