The EndoGastric Solutions EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

Device Description

The EndoGastric Solutions EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories is a disposable, single use system consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. Two polypropylene fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed simultaneously 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 for deployment into the tissue. The operator, controlling the distal end of the device through the mechanical controls captures and positions a fold of tissue at the gastroesophageal junction. The delivery trigger mechanism deploys both fasteners simultaneously at the captured tissue position, creating a permanent surgical fundoplication. Additional fasteners are used as needed to complete the valve restoration.

AI/ML Overview

The provided text is a 510(k) summary for the EsophyX Z Fastener Delivery Device. This document is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device, and thus does not include a study design or acceptance criteria in the typical sense of a clinical trial for a novel device.

The "acceptance criteria" and "device performance" in this context refer to the device's ability to meet its design specifications and user needs, and perform as safely and effectively as its predicate device. This is primarily demonstrated through verification and validation testing, rather than a clinical study measuring diagnostic accuracy or treatment outcomes against a predefined numerical threshold.

Therefore, many of the requested elements for describing a study are not directly applicable or are not detailed in this type of regulatory document.

However, I can extract the relevant information regarding the performance data and how substantial equivalence was established:

Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) Summary)

| Acceptance Criteria (Implied) | Reported Device Performance Description of How Performance was Verified |
| :----------------------------------------------------------------- | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Meets Design Specifications and User Needs | The EsophyX Z modifications met design specifications and user needs. The device meets product specifications and user requirements. Verification and validation testing results were provided. |
| Functional Performance (Fastener Deployment, Endoscope Insertion/Withdrawal) | Functional performance was confirmed. Testing included: fastener deployment, endoscope insertion and withdrawal, shielded stylets, retractor performance, sharp edges, and rotational and translational performance. As part of design validation, animal labs were performed verifying fastener deployment in various tissue types. |
| Substantially Equivalent in Safety and Effectiveness to Predicate Device | The EsophyX Z is as safe and effective and performs as well as the predicate device (EsophyX2 HD System). This conclusion is based on the intended use, indications for use, product technical information, performance testing and biocompatibility information provided in the premarket notification. |
| Biocompatibility | The device components are biocompatible. Biocompatibility information was provided in the premarket notification (specific details of testing are not in this summary). |
| Maintenance of Technological Characteristics | The device shares key technological elements with the predicate device, including: a flexible shaft, fastener delivery device inserted transorally with a separate endoscope for visualization; polypropylene, H-shaped fasteners as permanent implants; use of tissue invagination to correct hiatal hernias up to 2cm; and mechanical user interface controls for fastener loading, tissue capture, positioning, and deployment. | Demonstrated through summary of technological characteristics compared to the predicate device. |

Detailed Study Information (Based on provided text):

Sample size used for the Test Set and Data Provenance:
- The document mentions "animal labs were performed verifying fastener deployment in various tissue types" for design validation. However, the specific sample size (number of animals or fasteners) for these animal labs is not specified in the provided 510(k) summary.
- The data provenance is animal (pre-clinical), rather than human clinical data. The summary states: "Clinical evaluation as part of design validation was not required for the modifications made to the EsophyX Z to establish safety and effectiveness equivalence."
Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided as the assessment was primarily engineering verification and animal model testing, not human expert interpretation of clinical data.
Adjudication method for the test set:
- Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human readers or assessments. This information is not applicable/provided for the engineering and animal testing described.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and its effect size:
- No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical evaluation as part of design validation was not required..."
If a standalone (algorithm only without human-in-the-loop performance) was done:
- This is a mechanical device, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable. The device's performance was evaluated inherently without a "human-in-the-loop" in the sense of an AI-assisted reading workflow; rather, it evaluates the device's mechanical and functional operation.
The type of ground truth used:
- For the animal labs, the "ground truth" was likely direct observation of fastener deployment and tissue approximation in animal tissues, evaluated against the expected mechanical and functional outcomes.
- For the other tests (dimensional, mechanical, performance specifications), the "ground truth" was the device's design specifications and user requirements.
Sample size for the training set:
- This is a mechanical device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of data for model training is not applicable.
How the ground truth for the training set was established:
- As this is not an AI/ML device, the concept of a "training set" and its ground truth is not applicable.

Summary

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

March 3, 2015

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

Re: K143645

Trade/Device Name: EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated: February 24, 2015 Received: February 25, 2015

Dear Steven 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 (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 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 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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Indications for Use

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

510(k) Number (if known) K143645

Device Name

EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories

Indications for Use (Describe)

The EndoGastric Solutions EsophyX Z Fastener Delivery 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 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: K143645

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

Date Prepared:	March 2, 2015
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:	425.307.9226
Facsimile Number:	425.307.9201

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

Device Trade Name:	EsophyX® Z Fastener Delivery Device with SerosaFuseFasteners and Accessories
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 HD System cleared via 510(k) # K142113.

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

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510(k) Summary (Continued):

two separate channels via lumens in a flexible shaft where they are then in position for deployment into the tissue. The operator, controlling the distal end of the device through the mechanical controls captures and positions a fold of tissue at the gastroesophageal junction. The delivery trigger mechanism deploys both fasteners simultaneously at the captured tissue position, creating a permanent surgical fundoplication. Additional fasteners are used as needed to complete the valve restoration.

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

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

Transoral incisionless fundoplication is the technological principle for both the subject and predicate devices and is based on transoral instrumentation for approximating, ligating and permanently joining esophageal/gastric tissue, restoring the valvular functionality at the gastroesophageal junction and reducing gastroesophageal reflux.

Both subject and predicate devices are based on the following technological elements:

A flexible shaft, fastener delivery device inserted transorally using a separate. . appropriately sized endoscope to provide visualization of the entire procedure
Polypropylene, H-shaped fasteners acting as permanent implants to secure tissue ●
Use of tissue invagination to correct hiatal hernias up to 2cm ●
Mechanical user interface controls on the delivery device which control fastener . loading, tissue capture, fastener positioning at the distal device end and fastener deployment through the captured tissue

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

Verification and validation testing results provided evidence the modifications met the design specifications and user needs. Testing included dimensional, mechanical, and performance specifications including fastener deployment, endoscope insertion and withdrawal, shielded stylets, retractor performance, sharp edges and rotational and translational performance.

As part of design validation, animal labs were performed verifying fastener deployment in various tissue types. Clinical evaluation as part of design validation was not required for the modifications made to the EsophyX Z to establish safety and effectiveness equivalence.

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510(k) Summary Continued:

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

The verification and validation testing demonstrate the EsophyX Z is as safe and effective and performs as well as the predicate device referenced in this submission. The 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 Z device has been shown to be substantially equivalent to the EsophyX2 HD device, when used as intended.

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.