The EndoGastric Solutions EsophyX® 2 HD Device with SerosaFuse 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 junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

Device Description

The EndoGastric Solutions EsophyX® 2 HD Device with SerosaFuse Fasteners and Accessories consists of an all mechanical, flexible fastener delivery device with user controls outside the patient's body and sterile polypropylene fasteners delivered transorally through a flexible shaft into the GI tract via a common delivery mechanism comprised of three elements: a stylet, a pusher rod, and a delivery tube. All three fastener delivery elements run the length of the delivery device. The stylet runs down the inside of the lumen of the delivery tube and the pusher rod rides over the length of the stylet. The stylet is designed to pierce and hold the desired tissue plication in place and guide the fastener into position. There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded mechanically onto the stylet via a replaceable fastener cartridge containing ten fasteners for each channel. To load, the fastener cartridge lever is depressed, which snaps a fastener onto the stylet. The fastener is then pushed down the stylet from the proximal handle assembly to the distal tissue port via the pusher rod where it is then ready to be deployed into the tissue. When the desired tissue approximation/ plication is achieved, the pusher rod is used to push the fastener into the tissue, quided by the stylet which precedes it into the tissue. The leading leq of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing the leading leg of the fastener to disengage from the stylet and the fastener then seats across the desired tissue plication. A new fastener is loaded proximally in the device at the loading port, after retracting the pusher rod. The loading and fastening procedure can be repeated. The device is provided sterile and is a single use device.

AI/ML Overview

The provided document is a 510(k) summary for the EndoGastric Solutions EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for algorithm performance as would be expected for an AI/ML device.

Therefore, much of the requested information cannot be extracted from this document, as it pertains to AI/ML device evaluation, which is not the subject of this 510(k) submission. This submission is for a physical medical device.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Meet design specifications and user needs.	Verification and validation testing demonstrates the device meets product specifications and user requirements.
Meet biocompatibility requirements.	Biocompatibility testing provides evidence the device meets biocompatibility requirements.
Compatible with high-definition endoscopes.	Verified and validated to be compatible with high definition endoscopes.
Maintain the same indications for use as the predicate device.	Same indications for use as predicate.
Maintain the same operating principle as the predicate device.	Same operating principle as predicate.
Maintain the basic design with a larger shaft diameter (60Fr versus 54Fr) compared to the predicate device.	Incorporates the same basic design with a larger shaft diameter (60Fr versus 54Fr).

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

This information is not available in the provided document. The document refers to "verification and validation testing" which included "dimensional, mechanical, and performance testing" but does not specify sample sizes for these tests, nor the nature of the data or its provenance.

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):

This information is not applicable as this is not an AI/ML device requiring expert-established ground truth for a test set.

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

This information is not applicable as this is not an AI/ML device requiring adjudication of a test set.

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:

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not explicitly stated in terms of "ground truth" as it would be for an AI/ML device. For a physical device, performance evaluation typically involves engineering specifications, compatibility testing, and simulated use.

8. The sample size for the training set:

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 30, 2014

EndoGastric Solutions, Inc. % Michael A Daniel Consultant Daniel & Daniel Consulting, LLC Contact Address

Re: K142113

Trade/Device Name: EsophyX®2 HD 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: September 12, 2014 Received: September 15, 2014

Dear Michael A Daniel ,

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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. 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 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 yours.

Benjamin R. Fisher -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K142113

Device Name

EndoGastric Solutions EsophyX® 2 HD Device with SerosaFuse Fasteners and Accessories

Indications for Use (Describe)

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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Section 7. Premarket Notification 510(k) Summary

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 2, 2014
Name:Address:	EndoGastric Solutions, Inc.18109 NE 76th St. Suite 100Redmond, WA 98052
Phone:	425-307-9200
Fax:	425-307-9201
Contact Person:	Michael A Daniel, Consultant
Phone Number:	(415) 407-0223
Office:	(775) 392-2970
Facsimile Number:	(775) 392-2972

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

Device Trade Name:	EsophyX®2 HD Device with SerosaFuse Fasteners andAccessories
Common Name:	Endoscopic Clip Applier, Implantable Fastener andAccessories
Classification Name(s):	Endoscope and Accessories
Product Code/ Regulation:	ODE / 21 CFR 876.1500
Classification:	Class II

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

The predicate device is the EndoGastric Solutions EsophyX2 System cleared via 510(k) # K092400.

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

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510(k) Summary Continued:

There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded mechanically onto the stylet via a replaceable fastener cartridge containing ten fasteners for each channel. To load, the fastener cartridge lever is depressed, which snaps a fastener onto the stylet. The fastener is then pushed down the stylet from the proximal handle assembly to the distal tissue port via the pusher rod where it is then ready to be deployed into the tissue. When the desired tissue approximation/ plication is achieved, the pusher rod is used to push the fastener into the tissue, quided by the stylet which precedes it into the tissue. The leading leq of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing the leading leg of the fastener to disengage from the stylet and the fastener then seats across the desired tissue plication. A new fastener is loaded proximally in the device at the loading port, after retracting the pusher rod. The loading and fastening procedure can be repeated.

The device is provided sterile and is a single use device.

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

The EndoGastric Solutions EsophyX® , HD Device with SerosaFuse Fasteners and Accesories 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 gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic qastroesophaqeal reflux disease.

Summary of the Technological Characteristics compared to the Predicate Device [807.92(a)(6)]:

No change is being made to the fundamental technology and operating principle of the previously cleared EsophyX2 System used in this submission as a predicate device (K092400). The EsophyX 2 HD device is identical to this predicate device, only differing by the overall shaft diameter of the device. which has been increased to accommodate high definition (HD) endoscopes. The indications for use is unchanged. In summary:

same indications for use;
same operating principle;
incorporates the same basic design with a larger shaft diameter (60Fr versus 54Fr);

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510(k) Summary Continued:

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

Verification and validation testing provides proof that the modifications meet the design specifications and user needs, and biocompatibility testing provides evidence that the EsophyX®2 HD device meets the biocompatibility requirements. Testing included dimensional, mechanical, and performance testing.

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

The verification and validation testing demonstrate that the EsophyX® HD device meets product specifications and user requirements.

Additional Information [807.92(d)]

None.

Summary:

Based upon the intended use, indications for use, product technical information, performance testing and biocompatibility information provided in this premarket notification, the EsophyX 2 HD device has been shown to be substantially equivalent to the EsophyX®2 System, when used as intended. The EsophyX®2 HD device has been verified and validated to be compatible with high definition endoscopes that are used in these applications.

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.