OverStitch NXT Endoscopic Suturing System

K231553 · Apollo Endosurgery, Inc. · OCW · Jun 29, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K231553
• Device Name: OverStitch NXT Endoscopic Suturing System
• Applicant: Apollo Endosurgery, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Jun 29, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

The OverStitch NXT Endoscopic Suturing System is a single-use, sterile endoscopic accessory used for tissue approximation within the gastrointestinal tract. The system consists of a needle driver assembly, anchor exchange device, and accessories (e.g., tissue helix, suture cinch). It is mounted onto a single-channel endoscope using medical tape. The physician operates the device by squeezing the needle driver handle to actuate the needle, exchange suture-anchors, and perform stitching. A new 'MaxFlex' feature uses a pull string to control endoscope retroflexion. The device enables endoscopic suturing, which can benefit patients by allowing for minimally invasive tissue repair or closure. It is intended for use by clinicians in an endoscopic setting.

Clinical Evidence

No clinical data was required to demonstrate substantial equivalence. Evidence consists of bench testing (suture drag, tensile, torque, endoscope compatibility, reliability, bond strength), functional testing in an ex vivo model, and packaging integrity testing (ASTM F2096-11, ASTM F1980-21, ASTM D4169-22, ASTM F88/F88M-21). Biocompatibility was assessed per ISO 10933-1.

Technological Characteristics

Materials include thermoplastics, silicone, stainless steel, and other medical-grade materials. The device is a mechanical endoscopic accessory for suturing, featuring a needle driver assembly with a 'MaxFlex' pull-string for retroflexion control. It is compatible with single-channel endoscopes (8.8-9.8 mm OD). Sterilization is via Ethylene Oxide (EO). It is MR safe for 1.5T and 3T scanners under specified conditions.

Indications for Use

Indicated for endoscopic placement of suture(s) and approximation of soft tissue within the gastrointestinal tract using a single-channel endoscope.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• OverStitch™ Sx Endoscopic Suturing System (K210266)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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Page 1 of 3 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 [phone] www.bostonscientific.com

K231553

## 510(k) Summary

| Owner's Name & Address: | Boston Scientific Coporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Shene<br>Senior Regulatory Affairs Specialist<br>[phone]<br>[e-mail] |
| 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) and<br>accessories are intended for endoscopic placement of sutures<br>and approximation of soft tissue within the gastrointestinal tract<br>utilizing a single-channel endoscope. The system is comprised of<br>the Needle Driver Assembly and Anchor Exchange Device<br>(collectively referred to as ESS), and accessories such as the<br>Tissue Helix or NXT Tissue Helix Pro, Suture Cinch and Suture-<br>Anchor Assembly devices. All devices are sterile packaged and<br>designed for single use and are manufactured from various<br>thermoplastic, silicone, stainless steel and other medical grade<br>materials.<br><br>The OverStitch NXT ESS is designed for compatibility with single<br>channel endoscopes. The ESS is mounted onto the endoscope<br>using polyester medical tape for the endcap assembly. The<br>external catheter sheath has two working channels through which<br>the Anchor Exchange and OverStitch accessories can operate,<br>independent of the endoscope channel.<br><br>The handle of the Needle Driver Assembly is squeezed to actuate<br>the needle body and exchange the proprietary Suture-Anchor<br>Assembly with the Anchor Exchange to perform stitching<br>operations. |

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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.

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| Biocompatibility: | Biocompatibility testing and toxicological assessments were<br>performed on subject OverStitch NXT devices in accordance with<br>their risk category requirements, as defined in ISO 10933-1.<br>Testing included cytotoxicity, irritation and skin sensitization,<br>systemic toxicity, and material mediated pyrogenicity. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Performance Data: | Clinical testing was not required to demonstrate substantial<br>equivalence. |

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 Suturing<br>System is intended for endoscopic<br>placement of suture(s) and approximation<br>of soft tissue. | Same, with the exception of the<br>name. |
| Endoscope<br>Compatibility | Compatible with single channel<br>endoscopes having an outer diameter<br>range 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 with<br>spatial field gradient of 2500 Gauss/cm<br>(extrapolated or less) and SAR of 2.0 W/kg<br>for 15 minutes of continuous scanning | Same |

#### Summary Table of Equivalence Table 1: