The OverStitch NXT Endoscopic Suturing System (ESS) and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix or NXT Tissue Helix Pro, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The OverStitch NXT ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using polyester medical tape for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel.

The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.

AI/ML Overview

The document is a 510(k) summary for the OverStitch NXT Endoscopic Suturing System, indicating that clinical performance data was not required to demonstrate substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance or AI algorithm output. The acceptance criteria and performance data mentioned in section {5} refer to non-clinical bench testing, functional testing on an ex vivo model, and packaging integrity, as well as biocompatibility.

Here's the information derived from the document regarding the non-clinical performance:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria Category	Specific Tests/Evaluations	Reported Device Performance (Met Acceptance Criteria?)
Non-Clinical Performance Data	Conformance to product specifications and equivalence to predicate designs (K210266)	Yes
	Verification and validation for proposed system of devices	Yes
	Evaluation of individual functional and reliability requirements	Yes
	System compatibility	Yes
Performance Testing (Bench Testing)	Suture drag testing	Yes
	Tensile testing	Yes
	Torque testing	Yes
	Endoscope compatibility	Yes
	Sterility	Yes
	Reliability	Yes
	Bond strength	Yes
Functional Testing	Ex vivo model evaluation (under same test methods as predicate) for device function and intended use	Yes
Packaging Integrity	ASTM F2096-11	Yes
	ASTM F1980-21	Yes
	ASTM D4169-22	Yes
	ASTM F88/F88M-21	Yes
Biocompatibility	Cytotoxicity (per ISO 10933-1)	Yes
	Irritation (per ISO 10933-1)	Yes
	Skin sensitization (per ISO 10933-1)	Yes
	Systemic toxicity (per ISO 10933-1)	Yes
	Material mediated pyrogenicity (per ISO 10933-1)	Yes

2. Sample Size Used for the Test Set and Data Provenance

This document describes non-clinical testing. It does not provide specific sample sizes for the bench tests, ex vivo model, or packaging integrity tests. The provenance of the data is from Apollo Endosurgery Inc./Boston Scientific's own testing procedures. The tests are prospective in the sense that they were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable to the non-clinical and ex vivo testing described. There were no human expert evaluations in the context of clinical "ground truth" establishment for this submission as clinical data was not required.

4. Adjudication Method for the Test Set

Not applicable as it was non-clinical and ex vivo testing, not human expert adjudication.

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 study was conducted. This device is not an AI-assisted diagnostic or therapeutic device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (endoscopic suturing system), not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods (e.g., ASTM standards), and comparison to the predicate device's established performance parameters. For the ex vivo model, the ground truth was the expected device function and intended use observed in the model.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 29, 2023

Apollo Endosurgery Inc. James Shene Senior Regulatory Affairs Specialist 1120 South Capital of Texas Hwy., Suite 300 Austin, Texas 78746

Re: K231553

Trade/Device Name: OverStitch NXT Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCW Dated: May 26, 2023 Received: May 30, 2023

Dear James Shene:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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.

Cynthia Chang -S

for

Deborah Fellhauer Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K231553

Device Name

OverStitch NXT Endoscopic Suturing System

Indications for Use (Describe)

The OverStitch NXT Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston" and "Scientific" are stacked on top of each other. The text is in a blue serif font.

Page 1 of 3 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 (508) 382-4000 www.bostonscientific.com

K231553

510(k) Summary

Owner's Name & Address:	Boston Scientific Coporation300 Boston Scientific WayMarlborough, MA 01752
Contact Person:	James SheneSenior Regulatory Affairs Specialist(512) 852-3793james.shene@apolloendo.com
Date:	June 26, 2023
Trade Name:	OverStitch™ NXT Endoscopic Suturing System
Common Name:	Endoscopic Tissue Approximation Device
Product Code:	OCW
Classification:	Class II (21 CFR 876.1500)
Classification Name	Endoscope and Accessories
Predicate Devices:	K210266 - OverStitch™ Sx Endoscopic Suturing System
Device Description	The OverStitch NXT Endoscopic Suturing System (ESS) andaccessories are intended for endoscopic placement of suturesand approximation of soft tissue within the gastrointestinal tractutilizing a single-channel endoscope. The system is comprised ofthe Needle Driver Assembly and Anchor Exchange Device(collectively referred to as ESS), and accessories such as theTissue Helix or NXT Tissue Helix Pro, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged anddesigned for single use and are manufactured from variousthermoplastic, silicone, stainless steel and other medical gradematerials.The OverStitch NXT ESS is designed for compatibility with singlechannel endoscopes. The ESS is mounted onto the endoscopeusing polyester medical tape for the endcap assembly. Theexternal catheter sheath has two working channels through whichthe Anchor Exchange and OverStitch accessories can operate,independent of the endoscope channel.The handle of the Needle Driver Assembly is squeezed to actuatethe needle body and exchange the proprietary Suture-AnchorAssembly with the Anchor Exchange to perform stitchingoperations.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue.

age 2 of 3

The OverStitch NXT Endoscopic Suturing System is intended for Indications for Use: endoscopic placement of suture(s) and approximation of soft tissue. Technological Characteristics: Modifications to design and materials as compared to the predicate device cleared via K210266 are as follows: . "MaxFlex" Feature: a new feature, integrated into the needle driver assembly, that incorporates the use of a "pull string" to provide physicians with the ability to further control the retroflexion capabilities of their endoscope. . Endoscope Attachment Method : the method and materials used to attach the needle driver to the endoscope were updated. . Design/Material Modifications: New materials and design modifications were implemented in order to improve product durability and the manufacturability of the device. Non-Clinical Performance Data: Appropriate product testing was performed on the subject device to evaluate conformance to product specifications and equivalence to the predicate designs. Verification and validation for the proposed system of devices was conducted in accordance with written protocols, previously applied to the predicate device. All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility. Performance Testing Bench testing of the ESS, Tissue Helix Pro (alone and in combination with anchor-sutures and cinch devices) included suture drag testing, tensile testing, torque testing, endoscope compatibility, sterility, reliability and bond strength. Functional Testing An ex vivo model was utilized under the same test methods as the predicate to evaluate the device function and intended use. Packaging Integrity Packaging Integrity was confirmed by repeating testing in accordance with ASTM F2096-11, ASTM F1980-21, ASTM D4169-22 and ASTM F88/F88M-21. Acceptance criteria were met in each of the studies listed above.

The results confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised with the new device.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for Boston Scientific. The logo is in blue and consists of the words "Boston" on the top line and "Scientific" on the bottom line. The font is a serif font, and the letters are bold.

Biocompatibility:	Biocompatibility testing and toxicological assessments wereperformed on subject OverStitch NXT devices in accordance withtheir risk category requirements, as defined in ISO 10933-1.Testing included cytotoxicity, irritation and skin sensitization,systemic toxicity, and material mediated pyrogenicity.
Clinical Performance Data:	Clinical testing was not required to demonstrate substantialequivalence.

Basis of Substantial Equivalence: Based on a comparison of indications for use and technological characteristics, the proposed devices have demonstrated substantial equivalence to their predicates.

	Predicate OverStitch Sx ESS (K210266)	OverStitch NXT Device
Indications for Use	The OverStitch Sx Endoscopic SuturingSystem is intended for endoscopicplacement of suture(s) and approximationof soft tissue.	Same, with the exception of thename.
EndoscopeCompatibility	Compatible with single channelendoscopes having an outer diameterrange of 8.8 to 9.8 mm	Same
Working Length	Maximum working length of 110 cm	Same
Sterilization Method	EO	Same
Shelf Life	3 years	1 year
Usage	Single-use	Same
Biocompatibility	Tested per ISO 19993.	Same
MR Compatibility	Safe with 1.5 and 3 T MR scanners withspatial field gradient of 2500 Gauss/cm(extrapolated or less) and SAR of 2.0 W/kgfor 15 minutes of continuous scanning	Same

Summary Table of Equivalence Table 1:

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.