(26 days)
The EndoGastric Solutions EsophyX Z Device with SerosaFuse 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.
The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is a prescription use only, 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.
This document is a 510(k) Premarket Notification for the EsophyX® Z Device with SerosaFuse Fasteners and Accessories. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study design with specific numbers (sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria with quantitative performance metrics for the device. Instead, it relies on demonstrating that the modified device "met the design specifications and user needs" and performed "as well as the predicate device."
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Design Specifications | Met design specifications. |
| User Needs | Met user needs. |
| Mechanical Performance | Verified and validated. |
| Dimensional Performance | Verified and validated. |
| Biocompatibility | Meets all relevant requirements. |
| Safety and Effectiveness | As safe and effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "cadaver and animal labs" for "design validation" and "fastener deployment in various tissue types," but it does not provide specific sample sizes for these tests. The data provenance is experimental (cadaver and animal labs), not derived from human patient data in a test set. It does not mention country of origin or whether it was retrospective or prospective in detail, but given the nature of cadaver and animal labs, it would be prospective in an experimental setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to "design specifications and user needs" and "biocompatibility testing," which are typically evaluated against established technical standards and test protocols, not directly against ground truth established by medical experts in a clinical study context for performance metrics.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-read test set requiring adjudication in the context of device performance metrics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not mentioned or performed as the purpose of this submission is to demonstrate substantial equivalence of a medical device (EsophyX® Z Device with SerosaFuse Fasteners and Accessories) to a predicate device (EsophyX Z System), not to assess human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a medical instrument (Endoscopic Clip Applier, Implantable Fastener and Accessories) and not an algorithm or AI software. Therefore, an "algorithm only" performance study was not conducted.
7. Type of Ground Truth Used
For the mechanical, dimensional, and performance specifications, the ground truth would be based on engineering standards, design specifications, and successful operation within experimental settings (cadaver and animal tissue). For biocompatibility, the ground truth is established by validated laboratory tests (cytotoxicity, sensitization, and irritation or intracutaneous reactivity) against regulatory standards. There is no mention of pathology or outcomes data as a ground truth for the verification and validation reported.
8. Sample Size for the Training Set
This is not applicable as the device is a medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2016
EndoGastric Solutions, Inc. Steven J. Hoffman Corporate Compliance Officer 18109 NE 76th Street. Suite 100 Redmond, WA 98052
Re: K160960
Trade/Device Name: EsophyX® Z Device with SerosaFuse Fasteners and Accessories Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODE Dated: April 1, 2016 Received: April 5, 2016
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
510(k) Number (if known) K160960
Device Name
EsophyX® Z Device with SerosaFuse Fasteners and Accessories
Indications for Use (Describe)
The EndoGastric Solutions EsophyX Z Device with SerosaFuse 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.
| 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 1. 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: K160960
Applicant Information [807.92(a)(1)]:
| Date Prepared: | April 27, 2016 |
|---|---|
| Name: | EndoGastric Solutions, Inc. |
| Address: | 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 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)]:
The predicate device is the EndoGastric Solutions EsophyX Z System cleared via 510(k) # K143645.
Device Description: [807.92(a)(4)]:
The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is a prescription use only, 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
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510(k) Summary (Continued):
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)]:
The EndoGastric Solutions EsophyX Z 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 qastroesophageal 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.
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
The differences between the modified and predicate device include minor control changes:
- . A minor housing change adds more positive helical retractor lock stops
- A retractor lock mechanism modification allows the retractor to be pulled back while the lock is engaged.
- . An open-side tissue mold control mechanism modification to automatically open the mold when tension is removed on the closed-side.
Several non-operator control changes were made: to reduce device part count, reduce cost, increase manufacturability, or as an iterative design refinement.
Two patient contacting material changes were made by adding colorant to the same material cleared in the predicate device. Three other non-patient contacting materials were also changed. All were included in system biocompatibility testing.
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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 results provided evidence the device modifications met the design specifications and user needs. Testing included dimensional, mechanical and performance specifications. As part of design validation, cadaver and 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.
As a result of two different patient contacting materials being incorporated at the distal end of the modified EsophyX Z device, a biocompatibility evaluation was performed. Indicated testing included cytotoxicity, sensitization, and irritation or intracutaneous reactivity testing. Test results demonstrated the modified EsophyX Z meets all relevant biocompatibility testing requirements.
Conclusions Drawn from Performance Data [807.92(b)(3)]
The verification, validation and biocompatibility testing demonstrate the modified EsophyXZ 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.
Summarv:
Based upon the intended use, indications for use, product technical information, performance testing and biocompatibility information provided in this premarket notification, the modified EsophyX Z device has been shown to be substantially equivalent to the predicate EsophyX Z device, when used as intended.
§ 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.