K Number
K172811
Device Name
EsophyX Z, EsophyX2 HD
Date Cleared
2017-10-19

(31 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Empty

No
The device description explicitly states it is "all mechanical" and the performance studies confirm it is "purely mechanical" with no changes from the predicate devices. There is no mention of AI or ML in the document.

Yes
The device is indicated for the "treatment of symptomatic chronic gastroesophageal reflux disease," which directly addresses a medical condition, making it a therapeutic device.

No.
The text describes the device as a system for approximating and plicating tissue in the GI tract, indicated for the treatment of chronic gastroesophageal reflux disease. It is a surgical tool used for a therapeutic procedure (fundoplication), not for diagnosing a medical condition.

No

The device description explicitly states it is an "all mechanical, flexible fastener delivery device with user controls outside the patient's body" and lists various hardware components (plastics, aluminum, stainless steel, etc.). It also describes a physical mechanism for deploying fasteners. This clearly indicates it is a hardware-based medical device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • Device Function: The description clearly states that the EsophyX devices are used for transoral tissue approximation and full thickness plication in the GI tract. They are mechanical devices used in a surgical procedure to physically alter the gastroesophageal junction.
  • Lack of Specimen Analysis: There is no mention of the device collecting, preparing, or analyzing any biological specimens from the patient. Its function is entirely focused on manipulating and fastening tissue within the body.

Therefore, the EsophyX device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

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 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

ODE

Device Description

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

GI tract, gastroesophageal junction

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room environment; Prescription Use

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

Not Found

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

Not Found

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

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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K171307

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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.

1

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

2

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)

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

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 100
Redmond, 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 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

4

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.

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.

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.

5

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.

6

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.