The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). X-Tack is not intended for hemostasis of acute bleeding ulcers.

Device Description

The X-Tack™ Endoscopic HeliX Tacking System is a sterile, single-use device that enables the user to approximate soft tissue in the gastrointestinal (GI) tract using helix tacks and a 3-0 suture through a 2.8 mm or larger working channel of an endoscope (e.g. gastroscope or colonoscope).

OverStitch Suture Cinch
The Overstitch Suture Cinch device is comprised of thermoplastic and stainless steel materials and includes an implantable PEEK Cinch component designed to secure and cut the suture once tissue approximation is complete. It is the final step of the X-Tack procedure. The device functions by squeezing the handle and deploying the PEEK components, which form a press-fit onto the tail end of the suture to maintain suture position in situ.

AI/ML Overview

The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures. The device's performance was evaluated through non-clinical and animal testing to demonstrate substantial equivalence to a predicate device (K151802 - Resolution™ 360 Clip).

Here's an overview of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (X-Tack)	Predicate Device Performance (Resolution™ 360 Clip)
Endoscope compatibility	Scopes with a 2.8mm working channel.	Scopes with a 2.8mm working channel.
Working length	Gastric: 155 cm, Colon: 235 cm	Gastric: 160 cm, Colonic: 235 cm
Repositionable prior to deployment	Yes	Yes
Physician control over placement and final locking	Yes	Yes
Expected implant duration	Approximately 1 month or less, then implant is passed in stool.	Approximately 1 month or less, then implant is passed in stool.
Clip opening width	Not applicable. Device uses independent tacks, suture and cinch and is not limited by a clip opening dimension.	11 mm
Closure efficacy in animal study (at 4 weeks)	100% closure. Histologic evaluations of closure were consistent with wound healing.	100% closure. Histologic evaluations of closure were consistent with wound healing.
Sterilization Method	EO	EO
Usage	Single-use	Single-use
Implanted Materials	Helix Tack: 316L Stainless Steel; Cinch: VESTAKEEP i4 (PEEK); Suture: Polypropylene USP 3-0 Polypropylene; Copper Phthalocyanine Blue (Below 0.5WT%)	Capsule: 304 Stainless Steel; Arms: 17-7 PH SS; Tension breaker: Luran 968R (polystyrene); Yoke: F75 Cobalt Chrome
Biocompatibility	Tested per ISO 10993.	Tested per ISO 10993.
MR Compatibility	MR Conditional with 1.5 and 3 T MR scanners with spatial field gradient of 2500 Gauss/cm (extrapolated or less) and SAR of 2.0 W/kg for 15 minutes of continuous scanning	MR Conditional with 1.5 and 3T MR scanners with spatial field gradient of 2500 Gauss/cm (extrapolated or less) and SAR of 2.0 W/kg for 15 minutes of continuous scanning
Anchor retention, Suture tensile strength, Endoscope compatibility	Performed (details not specifically provided beyond "performed")	Not explicitly stated; assumed to be met due to predicate status
Usability and human factors, Packaging, Shelf-life, Distribution forces	Validated (details not specifically provided beyond "validated")	Not explicitly stated; assumed to be met due to predicate status

2. Sample size used for the test set and the data provenance:

Animal Study: 4 pigs and 40 defects (created in the stomach and colon) were used in a randomized, controlled animal study.
Data Provenance: The animal study was conducted to compare closure rates and healing between X-Tack and the predicate device. The location of the study (country of origin) is not specified. The study appears to be prospective, specifically designed for this comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document mentions "direct visualization and histological analysis" for evaluation in the animal study. However, it does not specify the number of experts, their qualifications, or their role in establishing ground truth.

4. Adjudication method for the test set:

The document does not specify any adjudication method (e.g., 2+1, 3+1). The evaluation was based on direct visualization and histological analysis in the animal study.

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:

No MRMC comparative effectiveness study was done as the device is a medical instrument (tacking system), not an AI-assisted diagnostic tool for human readers.

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

Not applicable, as this is a physical medical device and not an algorithm.

7. The type of ground truth used:

For the animal study: Direct visualization and histological analysis of the defects were used to determine closure rates and healing.

8. The sample size for the training set:

Not applicable, as this device's performance was evaluated through non-clinical (bench) and animal testing, not through machine learning training data.

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

Not applicable, as there was no training set for a machine learning algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

December 15, 2020

Apollo Endosurgery, Inc. Natalie Allen Regulatory Affairs Specialist 1120 S. Capital of Texas Hwy Austin, Texas 78749

Re: K201808

Trade/Device Name: X-Tack Endoscopic HeliX Tacking System Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL, OCW Dated: November 5, 2020 Received: November 6, 2020

Dear Natalie Allen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201808

Device Name

X-Tack Endoscopic HeliX Tacking System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo for Apollo Endosurgery. The logo features a stylized human figure with a blue circle for a head and a blue spiral for a body. The text "apollo" is written in blue, sans-serif font to the right of the figure. Below "apollo" is the word "endosurgery" in a smaller, blue, sans-serif font.

1120 S. Capital of TX Hwy, Bldg. 1, Ste. 300 Austin, Texas 78746 USA
Phone: 512.279.5100 FAX: 512.279.5105

510(k) Summary

Owner's Name & Address:	Apollo Endosurgery1120 S. Capital of Texas Hwy.Building 1, Suite 300Austin, TX 78746
Contact Person:	David M. Hooper, PhDVice President, Quality and Regulatory AffairsPhone: (512) 279-5100Email : david.hooper@apolloendo.com
Date:	December 10, 2020
Trade Name:	X-Tack™ Endoscopic HeliX Tacking System
Common Name:	Endoscopic Tissue Approximation Device
Product Code:	PKL, OCW
Classification:	Class II (21 CFR 876.4400)
Classification Name	Hemorrhoidal Ligator
Predicate Devices:	K151802 - Resolution™ 360 Clip
Device Description	X-Tack™ Endoscopic HeliX Tacking SystemThe X-Tack™ Endoscopic HeliX Tacking System is a sterile,single-use device that enables the user to approximate soft tissuein the gastrointestinal (GI) tract using helix tacks and a 3-0 suturethrough a 2.8 mm or larger working channel of an endoscope (e.g.gastroscope or colonoscope).
	OverStitch Suture CinchThe Overstitch Suture Cinch device is comprised of thermoplasticand stainless steel materials and includes an implantable PEEKCinch component designed to secure and cut the suture oncetissue approximation is complete. It is the final step of the X-Tackprocedure. The device functions by squeezing the handle anddeploying the PEEK components, which form a press-fit onto thetail end of the suture to maintain suture position in situ.
	Indications for Use: The X-Tack™ Endoscopic HeliXTacking System is intended for approximation of soft tissue inminimally invasive gastroenterology procedures (e.g. closure andhealing of ESD/EMR sites, and closing of fistula, perforation orleaks). X-Tack is not intended for hemostasis of acute bleedingulcers

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Image /page/4/Picture/0 description: The image shows the logo for Apollo Endosurgery. The logo features a stylized figure of a person with a spiral body and a circular head, all in blue. To the right of the figure is the word "apollo" in blue, with the word "endosurgery" in a smaller font size underneath it, also in blue.

Page 2 of 3 1120 S. Capital of TX Hwy, Bldg. 1, Ste. 300 Austin, Texas 78746 USA Phone: 512.279.5100 FAX: 512.279.5105

K201808

Technological Characteristics: The X-Tack™ Endoscopic Helix Tacking System shares technological characteristics similar to the predicate device. These characteristics include: ● Equivalent intended use . Endoscopic delivery of closure device ● Manufactured from materials commonly utlilized for implant devices used in the gastrointestinal (GI) tract . Similar design concept in that a force is delivered by the implant to approximate soft tissue. ● Sterilized using an ethylene oxide (EO) process Equivalent performance in a randomized, controlled animal ● study, specifically evaluating the closure and healing of defects over the course of one month, as evaluated through direct visualization and histological analysis. Basis of Substantial Equivalence: Non-clinical testing was performed to verify anchor retention, suture tensile strength, and endoscope compatbilitity. Testing was performed to validate usability and human factors, packaging, shelf-life and the ability of the device to withstand distribution forces. The sterilization cycle and biocompatibility of the device were validated per recognized ISO standards. MR testing was performed to establish the conditions underwich the device could be safety scanned, as well as the heating and artefact that could be expected during MRI scanning. MR testing included scanning to determine induced forces, followed by laboratory tests to verify safety under maximum scan conditions. A randomized study involving 4 pigs and 40 defects (created in the stomach and colon), was done to compare the closure rates and healing between X-Tack and the predicate. That study demonstrated that the closure rates associated with X-Tack were equivalent to the predicate and that X-Tack enabled larger defects to be closed. Histological analysis of defects showed both devices resulted in healing of defects.

Based on the non-clinical and animal testing, the device is as safe and effective, and performs as well or better than the legally marketed predicate device.

	X-Tack	Predicate
Principle of Operation	• Device is inserted into an endoscopeand deployed at target site.• Helix tacks are deployedindependently around the defect.• Implanted construct closes the defectthrough metallic anchors and suturetension.	• Device is inserted into an endoscopeand deployed at target site.• Clips are deployed independentlyaround the defect.• Implanted construct consists ofmetallic arms and spring tension.

Summary Table of Equivalence

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Image /page/5/Picture/0 description: The image contains the logo for Apollo Endosurgery. The logo features a stylized human figure with a circular head and a flowing, curved body. To the right of the figure, the word "apollo" is written in a bold, sans-serif font, with "endosurgery" written in a smaller font directly below it. The logo is rendered in a light blue color.

1120 S. Capital of TX Hwy, Bldg. 1, Ste. 300
Austin, Texas 78746 Austin, Texas 78748
SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA SA S 12.279

Endoscopecompatability	Scopes with a 2.8mm working channel.	Scopes with a 2.8mm working channel.
Working length	Gastric: 155 cmColon: 235 cm	Gastric: 160 cmColonic: 235 cm
Respositionable priorto deployment	Yes	Yes
Physician controlover placement andfinal locking	Yes	Yes
Expected implantduration.	Approximately 1 month or less, thenimplant is passed in stool.	Approximately 1 month or less, thenimplant is passed in stool.
Clip opening width	Not applicable. Device usesindependent tacks, suture and cinchand is not limited by a clip openingdimension.	11 mm
Closure efficacy inanimal study	100% closure at 4 weeks.Histologic evaluations of closure wereconsistent with wound healing.	100% closure at 4 weeks.Histologic evaluations of closure wereconsistent with wound healing.
Sterilization Method	EO	EO
Usage	Single-use	Single-use
Implanted Materials	Helix Tack: 316L Stainless SteelCinch: VESTAKEEP i4 (PEEK)Suture: PolyproyleneUSP 3-0 PolypropyleneCopper Phthalocyannine Blue (Below0.5WT%) in accordance with 21 CFR74, 3045	Capsule: 304 Stainless SteelArms: 17-7 PH SSTension breaker: Luran 968R(polystyrene)Yoke: F75 Cobalt Chrome
Biocompatibility	Tested per ISO 19993.	Tested per ISO 19993.
MR Compatibility	MR Conditional with 1.5 and 3 T MRscanners with spatial field gradientof 2500 Gauss/cm (extrapolated orless) and SAR of 2.0 W/kg for 15minutes of continuous scanning	MR Conditional with 1.5 and 3T MRscanners with spatial field gradientof 2500 Gauss/cm (extrapolated orless) and SAR of 2.0 W/kg for 15minutes of continuous scanning

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.