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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AutoBand Ligator, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Test/Performance Metric	Acceptance Criteria	Reported Device Performance
Material Safety	Biocompatibility - Sensitization	Passed	Passed
	Biocompatibility - Irritation	Passed	Passed
	Biocompatibility - Cytotoxicity	Not cytotoxic	Cytotoxic
	Allergen Testing (ELISA)	Below detection limits	Below detection limits (for allergens clinically relevant to latex allergy)
Functional Performance	Band Deployment Performance	Improved	Improved (due to minor design changes)
Substantial Equivalence	Comparison to Predicate Device	Substantially equivalent in: Intended Use, Operating Principle, Performance, Technology, Energy Used, Packaging.	All criteria met for substantial equivalence to predicate device.

Note on Biocompatibility - Cytotoxicity: The document explicitly states the "Ligation Band material is cytotoxic when tested in accordance with ISO 10993-5:1999." This appears to be a deviation from a typical "passed" acceptance criterion for cytotoxicity in the conventional sense of indicating no cytotoxic effect. However, it's presented in the context of demonstrating substantial equivalence to the predicate device, which also stated its material was cytotoxic. This suggests that for this specific application (ligation bands contacting mucosal membranes for prolonged duration), a certain level of cytotoxicity might be considered acceptable or an inherent characteristic of the material, and the goal was to demonstrate that the new material is no worse than the predicate.

Study Details

The provided document describes non-clinical testing rather than a human clinical study. The device is a modification of an already approved device (K083556), and the submission focuses on demonstrating substantial equivalence.

1. Sample sizes used for the test set and the data provenance:
* Test Set Sample Size: Not explicitly stated for each specific bench test. The document mentions "bench testing of performance" and "laboratory biocompatibility testing."
* Data Provenance: The testing was conducted in a laboratory setting ("laboratory biocompatibility testing"). The country of origin of the data is not specified, but it can be inferred to be within the scope of the manufacturer's (EndoChoice, Inc. in Alpharetta, GA, USA) operations or contracted labs. It is retrospective in the sense that it's testing a finished product modification against established standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This was a non-clinical, laboratory-based study validating material properties and functional performance against technical specifications and international standards (ISO 10993-1, ASTM D6499-07, ASTM D74727-08), not human expert evaluation against a "ground truth" in the clinical imaging sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. This was a non-clinical, laboratory-based study.

4. 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:
* No. This is a medical device (ligation band) and not an AI/imaging diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a medical device, not an algorithm. However, the non-clinical functional verification testing can be considered "standalone" as it evaluates the device's intrinsic mechanical and material performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For biocompatibility: International standards (ISO 10993-1, ISO 10993-5:1999) and specific ASTM test methods (ASTM D6499-07, ASTM D74727-08) served as the "ground truth" or reference for evaluating material safety.
* For functional performance: Engineering specifications and expected performance characteristics (e.g., improved band deployment) of the modified components served as the "ground truth."

7. The sample size for the training set:
* Not applicable. This is a non-clinical study for a physical medical device, not an algorithm that requires a training set.

8. How the ground truth for the training set was established:
* Not applicable. There is no training set for this type of device submission.

Summary

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EndoChoice, Inc.

510(k) Summary AutoBand Ligator

1. Company Identification

EndoChoice, Inc. 11800 Wills Road Alpharetta, GA 30009 Telephone (678) 708 4743 FAX (678) 567 8218 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.

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 toband esophageal varices orhemorrhoids in the colon.	The AutoBand Ligator is used toband esophageal varices orhemorrhoids in the colon.
Operation	Varices are aspirated into the bandbarrel. Once in the correctposition, the band is then deployedover the varix (the elastic band willassure that blood flow into the varixis stopped).	Varices are aspirated into the bandbarrel. Once in the correctposition, the band is then deployedover the varix (the elastic band willassure that blood flow into the varixis stopped).
Ligator Wheel design	Automatic ReverseThe Ligator wheel isdesigned with start andstop positions to ensurethat no more than oneband is deployed at atime. When the band isdeployed, the wheel headwill go automatically to thestart position The Ligator wheel has alocking arm so that thetrigger cord is held in thecorrect position tofacilitate fully controlleddeployment of the band.	Automatic ReverseThe Ligator wheel isdesigned with start andstop positions to ensurethat no more than oneband is deployed at atime. When the band isdeployed, the wheel headwill go automatically to thestart position The Ligator wheel has alocking arm so that thetrigger cord is held in thecorrect position tofacilitate fully controlleddeployment of the band.
Band Barrel design	The transparent bandbarrel is loaded with thebands next to each other Only one cord in the bandbarrel is used to deploythe bands The band deploymentcord is supplied with smallglass pearl to ensure	The transparent bandbarrel is loaded with thebands next to each other Only one cord in the bandbarrel is used to deploythe bands The band deploymentcord is supplied with smallglass beads to ensure

See Table 1 below.

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EndoChoice, Inc.

AutoBand Multiple Band Ligator

	correct and effectivedeployment of the bands.	correct and effectivedeployment of the bands.
Ligator Body design	• Mounting of the wheel ison a flexible arm, whichallows the device to befirmly fixed on the scope;this ensures a high levelof stability and precisionduring the procedure	• Mounting of the wheel ison a flexible arm, whichallows the device to befirmly fixed on the scope;this ensures a high levelof stability and precisionduring the procedure
Number of bands	5, 6, 7, 8, or 10	Same
Materials	Band Barrel: AcrylicCord: NylonBand: Natural Latex RubberPearl: GlassLigator Body: PolycarbonateLoading wire: Stainless Steel	Band Barrel: AcrylicCord: NylonBand: Synthetic PolyisopreneBead: GlassLigator Body: PolycarbonateLoading wire: Stainless Steel
Patient Contact	Ligation Bands are surface devicescontacting mucosal membranes forprolonged duration.	Ligation Bands are surface devicescontacting mucosal membranes forprolonged duration.
Packaging	PET (Polyethylene Terephthalate)Blister Pack	PETG (Polyethylene TerephthalateGlycol) Blister Pack
Biocompatibility of Band	Ligation Bands material is cytotoxicwhen tested in accordance withISO 10993-5:1999	Tested for sensitization, irritation,and cytotoxicity. Ligation Bandmaterial is cytotoxic when tested inaccordance with ISO 10993-5:1999See Vol_014 Biocompatibility
Sterilization	Single UseNon-Sterile	Single UseNon-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 (800) 638-2041 or (301) 796-7100 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 ____________________________________________________________________________________________________________

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.