NEXUS HEMORRHOID LIGATOR
Device Facts
| Record ID | K131282 |
|---|---|
| Device Name | NEXUS HEMORRHOID LIGATOR |
| Applicant | Inx Medical |
| Product Code | FHN · Gastroenterology, Urology |
| Decision Date | Jul 11, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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. It is for use only by trained medical personnel in hospitals, clinics, and doctors' offices.
Device Story
Nexus™ Hemorrhoid Ligator is a handheld, single-use, disposable device for rubber band ligation of hemorrhoids. Device features a pistol handgrip with a trigger mechanism; incorporates an internal syringe-type suction source to hold hemorrhoidal tissue. Operator (physician/trained medical personnel) uses device in hospitals, clinics, or doctors' offices, optionally with a proctoscope. Suction is applied to draw tissue into the ligator head; trigger release deploys a pre-loaded non-latex rubber band around the hemorrhoid base to restrict blood flow. Device supports auto-reloading of 3-4 bands. Clinical benefit is the non-surgical ligation of hemorrhoidal tissue.
Clinical Evidence
Bench testing only. Testing included mechanical drop testing (ISO 60068-2-32), environmental exposure (MIL-STD-810G for temperature and humidity), and vacuum/suction performance comparison against the O'Regan predicate. Biocompatibility of materials was confirmed as identical to the Haemoband predicate.
Technological Characteristics
Handheld, disposable, single-use device. Materials identical to K091519. Features internal syringe-type manual suction mechanism and pistol-grip trigger for band release. Pre-loaded with 3-4 non-latex rubber bands. No electronic components or software. Sterilization method not specified.
Indications for Use
Indicated for individuals with hemorrhoids requiring rubber band ligation. Contraindicated for patients with anal polyps, Grade IV hemorrhoids, perineal infection, perineal Crohn's disease, or portal hypertension. Use with caution in patients on anticoagulants (e.g., Warfarin).
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
Submission Summary (Full Text)
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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 Medical<br>1819 Clarkson Rd., Suite #206<br>Chesterfield, MO 63017 | Tel - 636-333-1010<br>Fax - 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 ligators<br>CFR 876.4400, Class II |
| Device: | Multi-Ligator |
| Predicate Devices: | K091519 - Haemoband - Multi-Ligator<br>K963166 - 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 | Haemoband<br>Multi-Ligator | O'Regan Ligator<br>O'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) Manufacturer<br>Device Name | Proposed Device | Predicate Device | |
| Procedure options | Nexus™ Hemorrhoid Ligator<br>With or without the use of a proctoscope | K091519<br>Haemoband<br>Multi-Ligator<br>With or without the use of a proctoscope | K963166<br>O'Regan<br>O'Regan Ligator<br>With 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 conditions<br>Mechanical Drop test<br>Ligator release and reload<br>Vacuum / suction generated | Environmental conditions<br>Mechanical Drop test<br>Ligator release and reload | Vacuum / suction generated |
| Standards | None under section 514 | None under section 514 | None under section 514 |
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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
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