AUTOBAND LIGATOR

K132535 · Endochoice, Inc. · MND · Aug 23, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K132535
• Device Name: AUTOBAND LIGATOR
• Applicant: Endochoice, Inc.
• Product Code: MND · Gastroenterology, Urology
• Decision Date: Aug 23, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AutoBand Multiple Band Ligator is used to band esophageal varices or hemorrhoids in the colon. The device is intended for single use only.

Device Story

AutoBand Multiple Band Ligator is a single-use endoscopic device for banding esophageal varices or hemorrhoids. System components include an applicator unit (barrel, handle, activation wheel, trigger wire, fixation arm), fixation strap, and pre-loaded ligation bands. Operated by a physician during endoscopy, the trigger wire is inserted through the endoscope biopsy port. Varices are aspirated into the barrel; the activation wheel deploys bands over the target tissue to stop blood flow. Mechanical design features include an automatic reverse wheel with start/stop positions to ensure single-band deployment and a locking arm for controlled trigger cord positioning. The device is non-sterile and intended for single use. Benefits include precise, controlled ligation of vascular lesions.

Clinical Evidence

No clinical data. Bench testing and laboratory biocompatibility testing were performed. Biocompatibility testing included irritation, sensitization, cytotoxicity (ISO 10993-5:1999), and systemic toxicity (ISO 10993-1). Synthetic Polyisoprene bands were tested via ELISA inhibition assay (ASTM D6499-07) and Allergen ELISA (ASTM D74727-08) to confirm absence of clinically relevant latex allergens. Functional verification testing confirmed performance of design changes.

Technological Characteristics

Materials: Band Barrel (Acrylic), Cord (Nylon), Band (Synthetic Polyisoprene), Bead (Glass), Ligator Body (Polycarbonate), Loading wire (Stainless Steel). Principle: Mechanical aspiration and band ligation. Energy: None (manual). Form factor: Endoscopic applicator with 5-10 band capacity. Connectivity: None. Sterilization: Non-sterile, single-use. Software: None.

Indications for Use

Indicated for patients requiring ligation of esophageal varices or hemorrhoids in the colon.

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

• Auto-Band Ligator (K083556)

Submission Summary (Full Text)

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EndoChoice, Inc.

:

# 510(k) Summary AutoBand Ligator

# 1. Company Identification

EndoChoice, Inc. 11800 Wills Road Alpharetta, GA 30009 Telephone [phone] FAX [phone] Establishment Registration: 300759133

AUG 2 3 2013

# 2. Contact Person

Daniel Hoefer Regulatory Affairs Manager

## 3. Device Name

Commercial name: AutoBand Multiple Band Ligator Classification name: Hemorrhoidal Ligator

# 4. Device Classification

Product Code: MND Regulation Number: 876.4400 Class: I I

# 5. Intended Use

The AutoBand Multiple Band Ligator is used to band esophageal varices or hemorrhoids in the colon. The device is intended for single use only.

#### Device Description 6.

The AutoBand Multiple Band Ligator device consists of the applicator unit (including the band barrel, handle, activation wheel, wheel grip, beaded string, interior stainless steel trigger wire, and fixation arm), a fixation strap, and the ligation bands that are mounted on the barrel.

The device is intended for single use and is supplied non-sterile. The ligation bands are intended for endoscopic placement in the esophagus or colon, with the trigger wire introduced through the biopsy port of the endoscope. Each AutoBand barrel is pre-loaded with seven bands. Models are manufactured for compatibility with either gastroscopes or colonoscopes. AutoBand model designations also are differentiated based on compatibility with different endoscope manufacturers.

# 7. Substantial Equivalence

The device submitted for review is a modification of the Auto-Band Ligator (K083556, Scandimed International).

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### AutoBand Multiple Band Ligator

EndoChoice, Inc.

Changes to the device include a modification in materials specification of the ligation bands. The unmodified bands are composed of natural latex rubber, while in the modified device they are synthetic Polyisoprene. In addition, the modified device includes minor design changes to the beaded deployment strand and the wire locking assembly arm; each of these mechanical changes is intended to improve ligation band deployment performance.

As a result of the modification to the band material, the labeling of the device no longer includes a caution statement that the device may cause allergic reactions due to the presence of natural latex rubber. The labeling now includes the statement "Not made with natural latex rubber."

The modified device is identical in terms of intended use, operating principle, performance, technology, energy used, and packaging.

| SUBSTANTIAL EQUIVALENCE COMPARISON WITH PREDICATE DEVICES | | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Auto-Band Ligator (Latex) | AutoBand Ligator (Non-latex) |
| 510(k) number | K083556 | Pending |
| Indications for Use | The Auto-Band Ligator is used to<br>band esophageal varices or<br>hemorrhoids in the colon. | The AutoBand Ligator is used to<br>band esophageal varices or<br>hemorrhoids in the colon. |
| Operation | Varices are aspirated into the band<br>barrel. Once in the correct<br>position, the band is then deployed<br>over the varix (the elastic band will<br>assure that blood flow into the varix<br>is stopped). | Varices are aspirated into the band<br>barrel. Once in the correct<br>position, the band is then deployed<br>over the varix (the elastic band will<br>assure that blood flow into the varix<br>is stopped). |
| Ligator Wheel design | Automatic Reverse<br>The Ligator wheel is<br>designed with start and<br>stop positions to ensure<br>that no more than one<br>band is deployed at a<br>time. When the band is<br>deployed, the wheel head<br>will go automatically to the<br>start position The Ligator wheel has a<br>locking arm so that the<br>trigger cord is held in the<br>correct position to<br>facilitate fully controlled<br>deployment of the band. | Automatic Reverse<br>The Ligator wheel is<br>designed with start and<br>stop positions to ensure<br>that no more than one<br>band is deployed at a<br>time. When the band is<br>deployed, the wheel head<br>will go automatically to the<br>start position The Ligator wheel has a<br>locking arm so that the<br>trigger cord is held in the<br>correct position to<br>facilitate fully controlled<br>deployment of the band. |
| Band Barrel design | The transparent band<br>barrel is loaded with the<br>bands next to each other Only one cord in the band<br>barrel is used to deploy<br>the bands The band deployment<br>cord is supplied with small<br>glass pearl to ensure | The transparent band<br>barrel is loaded with the<br>bands next to each other Only one cord in the band<br>barrel is used to deploy<br>the bands The band deployment<br>cord is supplied with small<br>glass beads to ensure |

See Table 1 below.

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### EndoChoice, Inc.

#### AutoBand Multiple Band Ligator

| | correct and effective<br>deployment of the bands. | correct and effective<br>deployment of the bands. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ligator Body design | • Mounting of the wheel is<br>on a flexible arm, which<br>allows the device to be<br>firmly fixed on the scope;<br>this ensures a high level<br>of stability and precision<br>during the procedure | • Mounting of the wheel is<br>on a flexible arm, which<br>allows the device to be<br>firmly fixed on the scope;<br>this ensures a high level<br>of stability and precision<br>during the procedure |
| Number of bands | 5, 6, 7, 8, or 10 | Same |
| Materials | Band Barrel: Acrylic<br>Cord: Nylon<br>Band: Natural Latex Rubber<br>Pearl: Glass<br>Ligator Body: Polycarbonate<br>Loading wire: Stainless Steel | Band Barrel: Acrylic<br>Cord: Nylon<br>Band: Synthetic Polyisoprene<br>Bead: Glass<br>Ligator Body: Polycarbonate<br>Loading wire: Stainless Steel |
| Patient Contact | Ligation Bands are surface devices<br>contacting mucosal membranes for<br>prolonged duration. | Ligation Bands are surface devices<br>contacting mucosal membranes for<br>prolonged duration. |
| Packaging | PET (Polyethylene Terephthalate)<br>Blister Pack | PETG (Polyethylene Terephthalate<br>Glycol) Blister Pack |
| Biocompatibility of Band | Ligation Bands material is cytotoxic<br>when tested in accordance with<br>ISO 10993-5:1999 | Tested for sensitization, irritation,<br>and cytotoxicity. Ligation Band<br>material is cytotoxic when tested in<br>accordance with ISO 10993-5:1999<br><br>See Vol_014 Biocompatibility |
| Sterilization | Single Use<br>Non-Sterile | Single Use<br>Non-Sterile |

#### Non-clinical testing 8.

The modified device has undergone both bench testing of performance and laboratory biocompatibility testing for Irritation, Sensitization, Cytotoxicity, and System toxicity, in accordance with ISO 10993-1. In addition, the materials in the synthetic Polyisoprene bands were tested in accordance with the ELISA inhibition assay (ASTM D6499-07) and the Allergen ELISA (ASTM D74727-08), with result showing that allergens clinically relevant to latex allergy are not present to within detection limits.

Other design changes resulted in completion of non-clinical functional verification testing.

# 9. Conclusion

The modified AutoBand Ligator is substantially equivalent to the unmodified predicate device listed above.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.

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

August 23, 2013

EndoChoice, Inc. % Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta, GA 30009

Re: K132535

Trade/Device Name: AutoBand Ligator Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: MND Dated: August 9, 2013 Received: August 13, 2013

Dear Daniel Hoefer,

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. 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 (reporting of

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Page 2 - Daniel Hoefer

medical 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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -S

for

Benjamin 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

510(k) Number (if known): K132535

Device Name: AutoBand Ligator

Indications for Use:

The AutoBand Ligator is used to band esophageal varices or hemorrhoids in the colon.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/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 In Vitro Diagnostic Devices (OIVD)

# Herbert P. Lerner -S

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