The EndoGastric Solutions EsophyX2 Device with SerosaFuse Fastener 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 junction and reduce hiatal hernia < 2cm in patients with symptomatic chronic gastroesophageal reflux disease.

Device Description

The EndoGastric Solutions, EsophyX2 device with SerosaFuse Fasteners consist of an all mechanical, flexible fastener delivery device with user controls outside the patient's body and sterile polypropylene fasters delivered transorally through a flexible shaft into the Oldy and sterile delivery mechanism comprised of three elements a flexible shaft into the OI tra delivery mechanism comprised of three elements: a style, a pusher rod, and a delivery tube. All three fastener delivery elements run the letinents. I sylet, a pusher rod, and a delivery tube. All three the luments run the delivery tube and the purpos nod ide. The Stylet runs 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 pusher fou nace over the length of the stylet is designed to pierce and hold the desired tissue plication in place and guide the fastener into. There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded automatically 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 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, guided by the stylet which precedes it into the tissue. The leading leg of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing 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 unit is provided sterile and is a single use device.

AI/ML Overview

The provided text describes a Special 510(k) submission for a device modification, the EndoGastric Solutions EsophyX2 System. This type of submission is for modifications to a legally marketed device and typically doesn't involve new clinical studies for effectiveness, but rather verification testing to confirm the modified device performs as intended and is as safe and effective as the predicate device.

Therefore, the input does not contain the kind of detailed information about acceptance criteria, efficacy studies (like MRMC, standalone), ground truth establishment, or sample sizes for clinical trials that would be present in an original 510(k) or PMA. The focus is on demonstrating substantial equivalence through design, performance, and biocompatibility testing against the predicate device.

Given these limitations, here is the information extracted and, where data is not available, a clear indication that it's not provided in the document:

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

The document states: "Verification testing provided proof the modifications met the design specifications". However, it does not detail specific acceptance criteria values or the quantitative results of these performance tests. It broadly asserts that the modifications were validated.

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 provided in the document. The submission focuses on device modifications and internal verification testing, not a clinical trial with a defined test set of patients.

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 and not provided. As this is a 510(k) for a device modification, there is no mention of a "test set" requiring ground truth established by experts in the context of clinical efficacy. The substantial equivalence is based on engineering and biocompatibility testing.

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

This information is not applicable and not provided.

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. The device is a surgical tool (endoscopic clip applier), not an AI-powered diagnostic system, so an MRMC study is irrelevant.

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

This information is not applicable. The device is a surgical tool that requires human operation; it does not operate in a "standalone" algorithmic fashion.

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

For this device modification, the "ground truth" for showing equivalence would have been validated engineering specifications and biocompatibility standards. The document states "biocompatibility testing provided evidence there were no changes to that safety aspect of the device." It does not refer to clinical outcomes, pathology, or expert consensus as ground truth for this modification.

8. The sample size for the training set

This information is not applicable and not provided. The development of this mechanical device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided.

Summary

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KOA2400 1 of 2 Special 510(k): Device Modification EsophyX

SECTION 12. 510(K) SUMMARY

NOV - 6 2009

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: _TBD

Applicant Information:

Date Prepared:

July 24, 2009

Name: Address:

EndoGastric Solutions, Inc. 8210 154th Avenue N.E. Redmond, WA 98052 Phone: 425 307 9200 Fax: 425 307 9201

Contact Person: Phone Number: Facsimile Number:

Steve Hoffman Office: 425-307-9226 (425) 307-9201

Device Information:

Classification:	Class II
Trade Name:	EndoGastric Solutions EsophyX2 System
Common Name:	Endoscopic Clip Applier, Implantable Fastener and Accessories
Classification Name:	Endoscope and Accessories (21 CFR 876.1500, Product Code ODE)

Predicate Device:

The EndoGastric Solutions EsophyX Device with SerosaFuse Fastener is substantially equivalent in intended use and method of operation to a combination of the following predicate device:

K071651 - EndoGastric Solutions EsophyX System with SerosaFuse Fastener and accessories

Device Description:

EndoGastric Solutions, Inc. Confidential

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There are two separate tubes or channels in the device, referred to as the posterior and anterior channels.

A fastener is loaded automatically 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 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, guided by the stylet which precedes it into the tissue. The leading leg of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing 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 unit is provided sterile and is a single use device.

Indications for Use:

The EndoGastric Solutions EsophyX2 System with SerosaFuse Fastener 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 gastroesophageal. reflux disease.

Comparison to Predicate Device:

The design of the EndoGastric Solutions EsophyX2 System with SerosaFuse Fastener is essentially the same device with moderate design modifications to make the device easier to use, reduce cost of goods and improve manufacturability. They are devices designed to reach the desired location under endoscopic visualization, grasp tissue in some fashion and place sutures/fasteners in a desired location. The product is re-loadable for repeat fastener placement. The products share common features such as a sterile, stainless steel needle called a stylet, housed a fastener delivery tube. Both devices use the same mechanism to deliver a fastener through soft tissue by manually actuating the needle with a handle/knob mechanism. The devices are packaged sterile and are for single patient use.

Further, the EndoGastric Solutions EsophyX2 System with SerosaFuse Fastener and the predicate device have the same intended use, which is to place fasteners/sutures/clips to approximate soft tissue under endoscopic visualization. Verification testing provided proof the modifications met the design specifications and biocompatibility testing provided evidence there were no changes to that safety aspect of the device.

Summary:

Based upon the intended use, product technical information, performance and biocompatibility information provided in this pre-market notification, the EndoGastric Solutions EsophyX2 system with SerosaFuse Fastener is substantially equivalent to the currently marketed predicate device in terms of design, performance and intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Steven J. Hoffman Director, Regulatory Affairs & Quality Assurance EndoGastric Solutions, Inc. 8210 154th Avenue, N.E. REDMOND WA 98052

NOV - 6 2009

Re: K092400

Trade/Device Name: EndoGastric Solutions EsophyX2 Device with SerosaFuse Fastener and Accessories Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated: October 6, 2009 Received: October 7, 2009

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 -

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012400

Special 510(k): Device Modification EsophyX

INDICATIONS FOR USE 7.1

510(k) Number (if known): TBD

Device Name: EndoGastric Solutions EsophyX2 Device with SerosaFuse Fastener and Accessories

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K092400

EndoGastric Solutions, Inc. Confidential

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.