K Number
K201808
Device Name
X-Tack Endoscopic HeliX Tacking System
Date Cleared
2020-12-15

(167 days)

Product Code
Regulation Number
876.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The summary describes a mechanical device for tissue approximation and does not mention any computational or algorithmic components indicative of AI/ML.

Yes
The device is described as enabling the approximation of soft tissue to aid in the healing of various gastrointestinal issues, which directly contributes to the treatment or mitigation of a disease or condition.

No

The device is described as an "Endoscopic HeliX Tacking System" intended for "approximation of soft tissue" and "closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks." These functions are therapeutic, not diagnostic.

No

The device description explicitly details physical components made of thermoplastic and stainless steel, including an implantable PEEK Cinch component, indicating it is a hardware device, not software-only.

Based on the provided information, the X-Tack™ Endoscopic HeliX Tacking System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is for "approximation of soft tissue in minimally invasive gastroenterology procedures." This describes a surgical or procedural intervention, not a test performed on samples taken from the body to diagnose or monitor a condition.
  • Device Description: The device is described as a system for "approximating soft tissue in the gastrointestinal (GI) tract using helix tacks and a 3-0 suture." This is a mechanical device used for tissue repair.
  • Function: The device's function is to secure and cut suture to maintain tissue position. This is a physical action on tissue, not an analysis of biological samples.
  • Anatomical Site: The device is used directly within the "Gastrointestinal (GI) tract." IVDs typically analyze samples from the body (like blood, urine, tissue biopsies) in a laboratory setting.
  • Performance Studies: The performance studies described involve animal models and focus on "closure rates and healing," which are outcomes related to the physical repair of tissue defects.

In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The X-Tack system does not fit this definition. It is a therapeutic/surgical device used to physically repair tissue.

N/A

Intended Use / Indications for Use

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.

Product codes

PKL, OCW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal (GI) tract

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Closure efficacy in animal study: 100% closure at 4 weeks. Histologic evaluations of closure were consistent with wound healing.

Predicate Device(s)

K151802

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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

1

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

2

Indications for Use

510(k) Number (if known) K201808

Device Name

X-Tack Endoscopic HeliX Tacking System

Indications for Use (Describe)

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.

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 Endosurgery
1120 S. Capital of Texas Hwy.
Building 1, Suite 300
Austin, TX 78746 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David M. Hooper, PhD
Vice President, Quality and Regulatory Affairs
Phone: (512) 279-5100
Email : 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 System
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. |
| | Indications for Use: 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 |

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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-TackPredicate
Principle of Operation• Device is inserted into an endoscope
and deployed at target site.
• Helix tacks are deployed
independently around the defect.
• Implanted construct closes the defect
through metallic anchors and suture
tension.• Device is inserted into an endoscope
and deployed at target site.
• Clips are deployed independently
around the defect.
• Implanted construct consists of
metallic 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

| Endoscope

compatabilityScopes with a 2.8mm working channel.Scopes with a 2.8mm working channel.
Working lengthGastric: 155 cm
Colon: 235 cmGastric: 160 cm
Colonic: 235 cm
Respositionable prior
to deploymentYesYes
Physician control
over placement and
final lockingYesYes
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 widthNot applicable. Device uses
independent tacks, suture and cinch
and is not limited by a clip opening
dimension.11 mm
Closure efficacy in
animal study100% closure at 4 weeks.
Histologic evaluations of closure were
consistent with wound healing.100% closure at 4 weeks.
Histologic evaluations of closure were
consistent with wound healing.
Sterilization MethodEOEO
UsageSingle-useSingle-use
Implanted MaterialsHelix Tack: 316L Stainless Steel
Cinch: VESTAKEEP i4 (PEEK)
Suture: Polyproylene
USP 3-0 Polypropylene
Copper Phthalocyannine Blue (Below
0.5WT%) in accordance with 21 CFR
74, 3045Capsule: 304 Stainless Steel
Arms: 17-7 PH SS
Tension breaker: Luran 968R
(polystyrene)
Yoke: F75 Cobalt Chrome
BiocompatibilityTested per ISO 19993.Tested per ISO 19993.
MR CompatibilityMR 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 scanningMR 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