The EndoGastric Solutions EsophyX, HD Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the Gl 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 gastroesophageal 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,

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 gastroesophageal iunction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic qastroesophaqeal 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 Description

The EndoGastric Solutions EsophyX Device models (EsophyX2 HD and EsophyX Z, K171307) with SerosaFuse Fasteners and Accessories are a prescription use only, disposable, single use systems consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The devices are used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure.

The 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 tissue fasteners are constructed of injection molded polypropylene.

These transoral devices and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the devices' flexible shaft lumen provides visualization of the procedure at all times, from device insertion through extraction. Two fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed from the proximal device end, to the distal end down two separate channels via lumens in a flexible shaft where they are then in position ready for deployment into tissue. The operator, controlling the distal end of the devices through the mechanical controls at the proximal end of the devices, captures and positions a fold of tissue at the gastroesophageal junction. The fastener controls deploy both fasteners simultaneously in the EsophyX Z model, or individually in the EsophyX2 HD model, at the captured tissue position. This creates a permanent surgical partial fundoplication. Additional fasteners are used as needed to complete the valve restoration.

AI/ML Overview

This document is a 510(k) summary for the EsophyX®2 HD and EsophyX Z Fastener Delivery Devices, indicating substantial equivalence to previously cleared predicate devices. It focuses on a specification change rather than a new device with independent performance studies. Therefore, much of the requested information regarding new studies and performance data for acceptance criteria is not applicable in the context of this 510(k) submission.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria for a new device study because this submission is for a specification change to an already cleared device. The "performance" reported primarily indicates that the device's performance remains the same as the predicate device despite the specification change.

Acceptance Criteria (Implied for this submission): The device, with the modified specification for clamping pressure, must maintain the same safety and effectiveness profile as the previously cleared predicate devices.
Reported Device Performance: "As both submission devices are identical to the predicates devices, the performance characteristics remain the same as those cleared previously in submission K171307." The engineering specification change for clamping pressure "does not change either device's operation, safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission is for a specification change to an existing device. It explicitly states: "the EsophyX Z device/EsophyX2 HD devices (K171307) were used as the predicate without additional in vivo data needed for substantial equivalence as there are no changes made to the devices for this specification change proposal." Therefore, no new test set or data provenance details are provided for this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no new in vivo or clinical study was conducted for this specific submission, there is no mention of experts establishing ground truth for a new test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new clinical data or test set requiring adjudication was generated for this submission.

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

Not applicable. This device is a mechanical surgical tool, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human "readers" or AI assistance is irrelevant.

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

Not applicable. This device is a mechanical surgical tool, not an algorithm. Its operation inherently involves a human-in-the-loop (the surgeon).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for this submission. The study proving "substantial equivalence" relies on the previous clearance of the predicate devices. The basis for those original clearances (K171307) would have included performance data, but specific "ground truth" modalities for those past studies are not detailed in this document.

8. The sample size for the training set

Not applicable. This is a hardware device undergoing a specification change, not an AI algorithm requiring a training set.

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

Not applicable. As above, this is not an AI algorithm.

Summary of the Study Discussed (Pertaining to this 510(k) submission):

The "study" described in the document is a technical assessment concluding that a proposed engineering specification change to increase the upper design limit for the clamping pressure of the existing EsophyX®2 HD and EsophyX Z devices does not alter the device's fundamental operation, safety, or effectiveness.

Nature of the "Study": This was not a de novo clinical trial but rather an engineering evaluation and comparison to a previously cleared predicate device (K171307).
Basis for Conclusion: The conclusion is based on:
- The devices being "identical" to the predicates, except for the specific clamping pressure tolerance.
- The principles of operation remaining the same.
- Reference to consensus standards.
- Verification and validation testing remaining "unchanged."
- Biocompatibility testing being consistent.
- The literature supporting the specification change.
No New Clinical Data: The document explicitly states "without additional in vivo data needed for substantial equivalence as there are no changes made to the devices for this specification change proposal."

In essence, the "study" demonstrating that the device meets acceptance criteria for this 510(k) relies on the fact that the device (with the modified clamping pressure specification) is demonstrated to be substantially equivalent to a predicate device that has already proven its safety and effectiveness. The acceptance criteria effectively imply that the device with the new specification must perform equivalently to the predicate, and the provided document argues that this is indeed the case.

Summary

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October 19, 2017

EndoGastric Solutions, Inc. Steve J. Hoffman Corporate Compliance Officer 18109 NE 76th Street. Suite 100 Redmond, WA 98052

Re: K172811

Trade/Device Name: EsophyX Z Device with SerosaFuse Fasteners and Accessories EsophyX2 HD Device with SerosaFuse Fasteners and Accessories Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODE Dated: September 26, 2017 Received: October 4, 2017

Dear Steve J. Hoffman:

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. 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

OMB No. Form Approved: 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K172811 Device Name

EsophyX Z Device with SerosaFuse Fasteners and Accessories

EsophyX2 HD Device with SerosaFuse Fasteners and Accessories

Indications for Use (Describe)

EsophyX2 HD Device with SerosaFuse Fasteners and Accessories: The EndoGastric Solutions EsophyX, HD Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the Gl 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 gastroesophageal 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,

EsophyX Z Device with SerosaFuse Fasteners and Accessories: 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 gastroesophageal iunction 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)

7 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

EsophyX®2 HD and EsophyX Z Fastener Delivery Devices

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: _____________________________

Applicant Information [807.92(a)(1)]:

Date Prepared:	August 26, 2017
Name:Address:	EndoGastric Solutions, Inc.18109 NE 76th St. Suite 100Redmond, WA 98052
Phone:	425-307-9200
Fax:	425-307-9201
Contact Person:	Steven J Hoffman
Phone Number:	425.307.9226
Office:	425.307.9200
Facsimile Number:	425.307.9201

Device Information [807.92(a)(2)]:

Device Trade Name:	EsophyX® Z Device with SerosaFuse Fasteners and Accessories
	EsophyX₂ HD Device with SerosaFuse Fasteners and Accessories
Common Name:	Endoscopic Clip Applier, Implantable Fastener and Accessories
Classification Name(s):	Endoscope and Accessories
Product Code/ Regulation:	ODE / 21 CFR 876.1500
Classification:	Class II

Predicate Device(s) [807.92(a)(3)]:

EndoGastric Solutions, EsophyX2 HD, EndoGastric Solutions, EsophyX Z, K171307

Device Description: [807.92(a)(4)]:

The subject EsophyX devices are unchanged from the currently cleared devices. The principles of operation for the devices are the same and also remain unchanged from the prior clearance. The indications for use for both models are identical.

The device is limited contact and materials include acrylic/polycarbonate plastics, machined

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510(k) Summary (Continued):

aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon.

The permanent contact, implantable tissue fasteners are constructed of injection molded polypropylene.

Intended Use / Indications for Use [807.92(a)(5)]:

Both EsophyX2 HD and Z Fastener Delivery Devices with SerosaFuse Fasteners and accessories are intended for transoral tissue approximation. plication and fastening of tissue in the GI tract, for the endoluminal treatment of gastroesophageal reflux disease.

The Indications for Use for both products is as follows:

The EndoGastric Solutions EsophyX Device models (EsophyX2 HD and EsophyX Z) with SerosaFuse Fasteners and Accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and are 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 gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic qastroesophaqeal 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 the Technological Characteristics compared to the Predicate Device [807.92(a)(6)]:

Both EsophyX models are cleared for the same indications for use with the subject devices unchanged from the corresponding predicates (please reference K171307). Both devices use the same method of loading fasteners at the proximal end of the device and moving them down to the distal end in preparation of deployment. Tissue is retracted, secured in position, plicated and fastened in the same manner. Both use the TIF procedure.

As with the identical predicate device, the EsophyX Z differs in design in the operator controls on the proximal end when compared to the EsophyX2HD. In the EsophyX2 HD, posterior and anterior fasteners can be deployed using individual controls. In the EsophyX Z device, these controls have been automated with a mechanical trigger, which deploys both fasteners at the same time.

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510(k) Summary (Continued):

Further, the EsophyX Z device/EsophyX2 HD devices (K171307) were used as the predicate without additional in vivo data needed for substantial equivalence as there are no changes made to the devices for this specification change proposal. Therefore, the devices have the same indications for use and are identical technologically.

No technological differences exist between the subject and predicate devices.

Performance Data on which Substantial Equivalence is Based [807.92(b)(1) and (2)]:

As both submission devices are identical to the predicates devices, the performance characteristics remain the same as those cleared previously in submission K171307.

As previously cleared in the referenced submission, both products are purely mechanical, have no device specific guidance documents, consensus standards are referenced, verification and validation testing remains unchanged as well as biocompatibility testing. In all instances, both devices function as intended and operation observed continues as designed.

Because there are no device changes, the safety and effectiveness profiles for both devices remain identical to the predicate devices.

The engineering specification change to increase the upper, design specification limit for the clamping pressure of the current devices' operational feature which temporarily clamps apposed tissue until a fastener is deployed to hold tissue together is proposed to provide a moderate increase in margin due to variations in the manufacturing process. This could cause the clamping pressure to exceed the currently cleared specification due to minor variations in the control system drag within each device. This specification change is supported by literature.

Based on the data presented in the literature, we attest the product specification change for the EsophyX2 HD and EsophyX Z devices does not change either device's operation, safety or effectiveness.

Conclusions Drawn from Performance Data [807.92(b)(3)]:

With the only change compared to the predicate EsophyX devices' clearance is a change to the product specification allowing a moderate increase in the upper limit of the temporary Tissue Mold clamping pressure occurring during each fastener deployment, no change is seen in the performance of either subject device.

As the subject devices and the predicate devices are the EsophyX2 HD and EsophyX Z are as safe and effective as the predicate EsophyX2 HD and EsophyX Z devices. Both devices have the same intended uses and indications, technological characteristics, and principles of operation as their predicate devices. The specification change does not alter the intended therapeutic use of the devices and does not affect safety and effectiveness when used as labeled. Device performance data remains the same and is therefore as safe and effective as the predicate devices. Thus, the EsophyX2 HD and EsophyX Z are substantially equivalent to their predicates.

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Additional Information [807.92(d)]:

None.

Concluding Statements:

As the proposed and predicate devices remain the same in design and use, the proposed EsophyX2 HD and EsophyX Z are as safe and effective as the predicate devices. All devices have the same intended use and indications, technological characteristics, and principles of operation.

The specification change to increase the margin for the upper clamping pressure limit does not alter the intended therapeutic use of the device and does not affect its safety and effectiveness when used as labeled. Device performance data, i.e., tissue clamping performance, remains the same and is therefore as safe and effective as the predicate devices. Thus, the proposed devices are substantially equivalent to the predicates.

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.