The inx Medical Nexus™ Hemorrhoid 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 in hospitals, clinics, and doctors' offices.

Device Description

The inx Medical Nexus™ Hemorrhoid 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 inx Medical Nexus™ Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Nexus™ Hemorrhoid Ligator. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and statistical endpoints as might be found for a PMA device.

Therefore, the study design and acceptance criteria information as typically requested for performance evaluation of a novel medical device (especially AI/ML-driven) are not available in this document. The provided text outlines non-clinical performance testing against the predicate devices for features like drop resistance, environmental exposure, and suction generation, and asserts substantial equivalence rather than reporting on specific clinical performance metrics.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
Information on sample sizes for test sets, data provenance, or ground truth establishment by experts for clinical performance.
Adjudication methods or multi-reader multi-case comparative effectiveness studies.
Details on standalone algorithm performance for an AI component.
Training set details.

The focus is on demonstrating that the Nexus™ Hemorrhoid Ligator is substantially equivalent to existing predicate devices (Haemoband Multi-Ligator and O'Regan Ligator) in terms of indications for use, technology, mode of operation, materials, and environment of use, and that no new safety or efficacy considerations are raised.

However, here's an overview of the non-clinical testing conducted to support substantial equivalence, presented in a format that aligns with parts of your request for "acceptance criteria" where applicable to non-clinical tests:

Non-Clinical Performance Testing and Reported Device Performance

The "acceptance criteria" here are framed as pass/fail criteria for non-clinical engineering and material tests, demonstrating that the device functions as intended and is comparable to predicates.

Acceptance Criteria (Pass/Fail)	Reported Device Performance
Drop Test (ISO 60068-2-32): Device works after free fall	The proposed device passed the free fall testing.
Environmental Exposure (MIL-STD-810G Method 501.5, 502.5, 506.5): Meets performance specifications after exposure to high/cold temperature and humidity	The proposed device met the performance specifications after being exposed to the various conditions.
Biocompatibility of Materials: Materials identical to predicate Haemoband Multi-Ligator (K091519)	All materials which are in patient contact are identical to the predicate Haemoband Multi-Ligator (K091519).
Suction Applied: Vacuum generated equivalent to predicate O'Regan device (K963166)	The vacuum generated was determined to be equivalent to the predicate O'Regan - O'Regan Ligator (K963166).

Further Details (as per request, but information is limited/not applicable to clinical performance)

Sample size used for the test set and the data provenance: Not applicable. This was non-clinical engineering and material testing, not a clinical study involving patients or data sets. The "test set" would be the specific units of the device subjected to the environmental, drop, and suction tests. The document doesn't specify the number of units tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering specifications and comparison to predicate device characteristics, not expert clinical interpretation.
Adjudication method for the test set: Not applicable. This was engineering testing, not a study requiring adjudication of expert interpretations.
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: Not applicable. This device is a mechanical ligator, not an AI/ML diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm-driven device.
The type of ground truth used: For the non-clinical tests, the "ground truth" was based on established engineering standards (e.g., ISO, MIL-STD) for performance and direct comparison of material identity and functional equivalence (suction strength) to legally marketed predicate devices.
The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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JUL 1 1 2013

Premarket Notification 510(k) Section 5 - 510(k) Summary

inx Medical

510(k) Summary Page I of 5

Date prepared:	3-May-13
inx Medical1819 Clarkson Rd., Suite #206Chesterfield, MO 63017	Tel - 636-333-1010Fax - 636-333-1011
Official Contact:	James L. Vermeersch - President & CEO
Proprietary or Trade Name:	Nexus™ Hemorrhoid Ligator
Common/Usual Name:	Hemorrhoidal ligators
Classification Name/Code:	78 FHN - hemorrhoidal ligatorsCFR 876.4400, Class II
Device:	Multi-Ligator
Predicate Devices:	K091519 - Haemoband - Multi-LigatorK963166 - O'Regan - O'Regan Ligator

Device Description:

The inx Medical Nexus™ Hemorrhoid 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 inx Medical Nexus™ Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.

Indications for Use:

The inx Medical Nexus™ Hemorrhoid Ligator includes suction 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:

. Anal polyps
Grade IV hemorrhoids ●
Patients with perineal infection .

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inx Medical

510(k) Summary Page 2 of 5 3-May-13

Patients with perineal Crohn's Dz .
Patients with portal hypertension .
Use with caution when treating patients on anticoagulants i.e. Warfarin .

Predicate Device Comparison:

The inx Medical Nexus Hemorrhoid Ligator is viewed as substantially equivalent to the predicate devices because:

Indications -

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.
. Discussion - The indications for use are identical to the predicates Haemoband Multi-Ligator (K091519) and O'Regan - O'Regan Ligator (K963166)

Technology and Mode of Operation -

The internal mechanism for holding and banding the ligator bands is identical to the ♥ predicate Haemoband Multi-Ligator (K091519)
The incorporation of an internal suction / vacuum source is equivalent to the predicate . O'Regan - O'Regan Ligator (K963166)
Mode of operation that is banding hemorrhoidal tissue is identical to the predicates -. Haemoband Multi-Ligator (K091519) and O'Regan - O'Regan Ligator (K963166)
Discussion The technology and mode operation are identical to the combined predicates. .

Materials -

The materials in patient contact are identical to predicate device Haemoband Multi-Ligator . (K091519)
Discussion The materials are identical to the predicate. ♥

Environment of Use -

Identical to predicate Haemoband Multi-Ligator (K091519) and O'Regan O'Regan . Ligator (K963166)
. Discussion - The environments of use are identical to the predicates.

Differences -

There are no differences between the predicates and the proposed device which would raise any new safety or risks and thus can be found to be substantially equivalent,

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K131282
Page 3 of 5

inx Medical

remarket Notification 510(

510(k) Summary

510(k) Manufacturer	Proposed Device	Predicate Device
Device Name	Nexus™ Hemorrhoid Ligator	HaemobandMulti-Ligator	O'Regan LigatorO'Regan
Product Code	FHN	K091519	K963166
CFR	876.4400	876.4400	876.4400
Indications for Use	The inx Medical Nexus™ Hemorrhoid 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 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.	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.	Hospitals, clinics, and doctors' offices.	Hospitals, clinics, and doctors' offices.
Prescriptive	Yes, for use by trained medical personnel	Yes, for use by trained medical personnel	Yes, for use by trained medical personnel
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 an internal 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	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 manual means to apply suction to hold the hemorrhoidal tissue prior to and during the ligature procedure.
Method of suction	Manually via an internal syringe type method to generate suction	Connected to an external vacuum source	Manually via a syringe type method to generate suction
510(k) ManufacturerDevice Name	Proposed Device	Predicate Device
Procedure options	Nexus™ Hemorrhoid LigatorWith or without the use of a proctoscope	K091519HaemobandMulti-LigatorWith or without the use of a proctoscope	K963166O'ReganO'Regan LigatorWith or without the use of a proctoscope
Number of ligation bands pre-loaded	3-4	3-4	Not specified
Disposable	Single patient use, disposable	Single patient use, disposable	Single patient use, disposable
Material biocompatibility	Materials identical to K091519	Identified and cleared in K091519	N/A
Auto reload	Yes	Yes	No
Non-clinical Performance Testing	Environmental conditionsMechanical Drop testLigator release and reloadVacuum / suction generated	Environmental conditionsMechanical Drop testLigator release and reload	Vacuum / suction generated
Standards	None under section 514	None under section 514	None under section 514

PDF Page 29 of 114

Page 5.3

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K131282
Page 4 of 5

inx Medical

Premarket Notification 510(k)
Section 5 - 510(k) Summary

510(k) Summary

Page 5.4 PDF Page 30 of 114

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510(k) Summary

Page 5 of 5 3-May-13

Non-clinical Testing Summary -

We have performed a number of tests appropriate for the proposed device. These tests include:

Drop

Standard test method of free fall per ISO 60068-2-32 .
. Pass / fail criteria is that the device works
Discussion The proposed device passed the free fall testing. .

Environmental (Hot / Cold / Humidity Exposure)

Standard test methods for exposure followed the listed procedures
- MIL-STD-810G Method 501.5, Procedure 1 (60℃ High Temperature Test 0 Storage)
  - MIL-STD-810G Method 502.5, Procedure I (-20℃ Cold Temperature Test o Storage)
- MIL-STD-810G Method 506.5, Procedure 1 (Humidity Test Storage) o
Pass / fail criteria was that they would meet the performance specifications.
. Discussion - The proposed device met the performance specifications after being exposed to the various conditions.

Biocompatibility of Materials -

Materials are identical to the predicate Haemoband Multi-Ligator (K091519). .
- Parts which are Surface communicating, Mucosal contact, limited duration which o would be Ligator components.
- Parts which are Surface communicating, Mucosal contact, and prolonged duration o would be the ligator bands.
Discussion All materials which are in patient contact are identical to the predicate . ● Haemoband Multi-Ligator (K091519).

Suction Applied -

Bench testing was performed to measure the applied vacuum generated by the device . which was compared to the predicate O'Regan device.
Discussion The vacuum generated was determined to be equivalent to the predicate ● O'Regan - O'Regan Ligator (K963166).

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2013

inx Medical % Paul E. Dryden President ProMedic. Inc. 1819 Clarkson Rd., Suite #206 Chesterfield, MO 63017

Re: K131282

Trade/Device Name: Nexus™ Hemorrhoid Ligator Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: FHN Dated: May 15, 2013 Received: May 16, 2013

Dear Paul E. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Paul E. Dryden

You must comply with all the Act's requirements, including, but not limited to: registration and I va mact och pr . mart 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements model. ab its 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 115809.http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin Fisher -S

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number:

K131282 (To be assigned)

Nexus™ Hemorrhoid Ligator Device Name:

Indications for Use:

The inx Medical Nexus™ Hemorthoid 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 in hospitals, clinics, and doctors' offices.

Prescription Use XX	or	Over-the-counter use
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beniamin 2013.07.

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131282 510(k) Number

PDF Page 26 of 114

Page 4.2

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.