EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Applicant
Endogastric Solutions, Inc.
Product Code
ODE · Gastroenterology, Urology
Decision Date
Apr 26, 2024
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The EndoGastric Solutions EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
Device Story
EsophyX Z+ is a single-use, sterile, all-mechanical, flexible fastener delivery system for Transoral Incisionless Fundoplication (TIF). Used in operating rooms by interventional gastroenterologists and surgeons. Device features a flexible shaft with proximal user controls and a distal fastener delivery mechanism. A separate endoscope, passed through the device's central lumen, provides visualization. The device mimics surgical tissue grasping, piercing, and suturing; it deploys permanent polypropylene SerosaFuse fasteners to create tissue folds, narrow the gastroesophageal junction, and reduce hiatal hernias. The procedure aims to treat chronic GERD by restoring the anti-reflux barrier. Benefits include minimally invasive, incisionless tissue approximation.
Clinical Evidence
Bench testing only. No clinical data presented. Performance testing included labeling verification, device force evaluation, fastener loading/deployment, and dimensional verification. All tests demonstrated passing results.
Technological Characteristics
Materials: acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane, nylon. Fasteners: polypropylene. Principle: mechanical fastener delivery. Energy: manual. Connectivity: none. Sterilization: Ethylene Oxide (ISO 11135, ISO 10993-7). Standards: ISO 10993-1 (biocompatibility), ISO 11607-1 (packaging), ISO 11737-1 (microbiological).
Indications for Use
Indicated for symptomatic chronic gastroesophageal reflux disease (GERD) patients requiring/responding to pharmacological therapy; indicated for transoral tissue approximation, full-thickness plication, and ligation in the GI tract; indicated to narrow the junction and reduce hiatal hernias ≤ 2cm. Patients with >2cm hernias eligible if reduced to ≤ 2cm via laparoscopic repair.
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
EsophyX Z Device with SerosaFuse Fasteners and Accessories (K172811)
Submission Summary (Full Text)
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April 26, 2024
EndoGastric Solutions, Inc. % John J. Smith Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Columbia Square Washington, District of Columbia 20004
Re: K240879
Trade/Device Name: EsophyX Z+ Device with SerosaFuse Fasteners and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODE Dated: March 29, 2024 Received: March 29, 2024
Dear John J. Smith:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
# Shanil P. Haugen -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K240879
Device Name
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Indications for Use (Describe)
The EndoGastric Solutions EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
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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## 510(K) SUMMARY
#### EndoGastric Solutions, Inc. EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
#### Submitter
EndoGastric Solutions, Inc. 18109 NE 76th Street Redmond, WA 98052 Phone: +1 408-705-5521 Facsimile: +1 425-650-7028 Contact Person: Shala Famil
Date Prepared: March 29, 2024
Name of Device: EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Classification Name: 21 CFR 876.1500, Endoscope and accessories - Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Regulatory Class: Il
Product Code: ODE
Predicate Device: EndoGastric Solutions, Inc., EsophyX Z Device with SerosaFuse Fasteners and Accessories (K172811)
#### Device Description
The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single-use, sterile system consisting of an all-mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile by ethylene oxide (EO). The delivery device is limited contact and materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon.
The permanent contact, implantable SerosaFuse tissue fasteners are constructed of injection molded polypropylene and are of a strength equivalent to 3-0 suture. The SerosaFuse Implantable Fastener Cartridge is dual-lever containing 20 fasteners in each lever, and is designed to be removable. Each fastener consists of a leading leg, interconnecting web and trailing leg. The fastener's unique design allows it to be loaded onto a stylet, passed into and down a small delivery lumen of the device and subsequently delivered through apposed tissue surfaces in the GI tract. When deployed in tissue, the fastener serves as a suture-like implantable.
The system is used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The EsophyX Z+ device deploys the SerosaFuse fastener during an endoscopic procedure. A separate commercial endoscope operating independently
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down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. The EsophyX Z+ device is capable of transoral tissue approximation, ligation, and full thickness plication in the GI tract. The process essentially mimics the standard surgical technique of grasping tissue and apposing/approximating the tissue, piercing, and suturing the tissue fold. Each of these steps is controlled at the device proximal end, though plication, ligation and gastroesophageal valve formation is accomplished at the distal end of the device.
## Intended Use / Indications for Use
The subject and predicate EsophyX devices are both intended for transoral tissue approximation, plication and fastening of tissue in the GI tract, for the endoluminal treatment of gastroesophageal reflux disease. The subject device's indications for use are as follows:
The EndoGastric Solutions EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic qastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
## Summary of Technological Characteristics
The technological characteristics of the EsophyX Z+ device are largely unchanged from the EsophyX Z predicate device, which was cleared in K172811. This 510(k) submission primarily proposes changes to the instructions for use and other device labeling. A table comparing the key features of the subject and predicate devices is provided below.
| | EsophyX Z+<br>(Subject Device) | EsophyX Z<br>(Predicate Device, K172811) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 876.1500, Endoscope and<br>accessories (Class II) | 21 CFR 876.1500, Endoscope and<br>accessories (Class II) |
| Product Code | ODE (Endoscopic Suture/Plication<br>System, Gastroesophageal Reflux<br>Disease (Gerd)) | ODE (Endoscopic Suture/Plication<br>System, Gastroesophageal Reflux<br>Disease (Gerd)) |
| Intended Use | The EsophyX Z+ device is intended<br>for transoral tissue approximation,<br>plication and fastening of tissue in<br>the GI tract, for the endoluminal<br>treatment of gastroesophageal<br>reflux disease. | The EsophyX Z device is intended<br>for transoral tissue approximation,<br>plication and fastening of tissue in<br>the GI tract, for the endoluminal<br>treatment of gastroesophageal<br>reflux disease. |
| | EsophyX Z+ | EsophyX Z |
| | (Subject Device) | (Predicate Device, K172811) |
| Indications for Use | The EndoGastric Solutions<br>EsophyX Z+ Device with<br>SerosaFuse Fasteners and<br>Accessories is indicated for use in<br>transoral tissue approximation, full<br>thickness plication and ligation in<br>the GI tract and is indicated for the<br>treatment of symptomatic chronic<br>gastroesophageal reflux disease in<br>patients who require and respond to<br>pharmacological therapy. It is also<br>indicated to narrow the junction and<br>reduce hiatal hernia ≤ 2cm in size in<br>patients with symptomatic chronic<br>gastroesophageal reflux disease.<br>Patients with hiatal hernias larger<br>than 2cm may be included, when a<br>laparoscopic hiatal hernia repair<br>reduces the hernia to 2cm or less. | The EndoGastric Solutions<br>EsophyX Z+ Device with<br>SerosaFuse Fasteners and<br>Accessories is indicated for use in<br>transoral tissue approximation, full<br>thickness plication and ligation in<br>the GI tract and is indicated for the<br>treatment of symptomatic chronic<br>gastroesophageal reflux disease in<br>patients who require and respond to<br>pharmacological therapy. It is also<br>indicated to narrow the junction and<br>reduce hiatal hernia ≤ 2cm in size in<br>patients with symptomatic chronic<br>gastroesophageal reflux disease.<br>Patients with hiatal hernias larger<br>than 2cm may be included, when a<br>laparoscopic hiatal hernia repair<br>reduces the hernia to 2cm or less. |
| User Population | Interventional Gastroenterologists<br>and Surgeons | Interventional Gastroenterologists<br>and Surgeons |
| Technological<br>Characteristics | The system is a prescription use<br>only, disposable, single-use, sterile<br>system consisting of an all<br>mechanical, flexible fastener<br>delivery device with user controls<br>outside the patient's body. The<br>transoral device and tissue<br>fasteners are provided sterile (EO).<br>The tissue fasteners are equivalent<br>to 3.0 suture and are permanent<br>implants. | The system is a prescription use<br>only, disposable, single-use, sterile<br>system consisting of an all<br>mechanical, flexible fastener<br>delivery device with user controls<br>outside the patient's body. The<br>transoral device and tissue<br>fasteners are provided sterile (EO).<br>The tissue fasteners are equivalent<br>to 3.0 suture and are permanent<br>implants. |
| Major Components | EsophyX Z+ Fastener Delivery<br>Device<br>SerosaFuse Fastener Cartridge and<br>Fasteners | EsophyX Z Fastener Delivery<br>Device<br>SerosaFuse Fastener Cartridge and<br>Fasteners |
| Accessories | Endoscope Compatibility Tool | Endoscope Compatibility Tool |
| Safety Features | Safety features include safe sharps<br>storage, fastener delivery lockout,<br>and prevention of tissue over-<br>plication | Safety features include safe sharps<br>storage, fastener delivery lockout,<br>and prevention of tissue over-<br>plication |
| Biocompatibility | Meets the requirements of ISO<br>10993-1 | Meets the requirements of ISO<br>10993-1 |
| Sterilization | Ethylene Oxide; meets<br>requirements of ISO 10993-7 | Ethylene Oxide; meets<br>requirements of ISO 10993-7 |
| | EsophyX Z+<br>(Subject Device) | EsophyX Z<br>(Predicate Device, K172811) |
| Standards with<br>which the Device<br>Complies | ISO 11135 | ISO 11135 |
| | ISO 11607-1 | ISO 11607-1 |
| | ISO 11737-1 | ISO 11737-1 |
## SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
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#### Performance Data
Non-clinical testing was conducted to demonstrate that the EsophyX Z+ device is as safe and effective as the predicate device:
- Labeling verification .
· Benchtop performance testing, including evaluation of device forces, fastener loading and deployment, and dimensional verification
In all instances, the EsophyX Z+ device functioned as intended and demonstrated passing results.
## Conclusions
The EsophyX Z+ device is as safe and effective as the predicate EsophyX Z device (K172811). The EsophyX Z+ device has the same intended uses and indications, and similar technological characteristics and principles of operation as its predicate device. In addition, the minor differences between the EsophyX Z+ device and its predicate devices raise no new issues of safety or effectiveness. Thus, the EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is substantially equivalent.
