(28 days)
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease, which is a medical condition, making it a therapeutic device.
No
The device description and intended use clearly state that it is used for transoral tissue approximation, full thickness plication, and the treatment of symptomatic chronic gastroesophageal reflux disease, functioning as a surgical tool to mimic suturing. There is no mention of diagnostic functions.
No
The device description clearly details a physical, mechanical device with fasteners and accessories used in a surgical procedure. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EsophyX Z+ Device is a surgical device used for a procedure (Transoral Incisionless Fundoplication - TIF) performed inside the patient's body to treat GERD. It physically manipulates tissue and deploys fasteners.
- Lack of Sample Analysis: The device does not analyze any samples taken from the patient's body. Its function is entirely mechanical and procedural.
Therefore, the EsophyX Z+ Device falls under the category of a surgical or interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
ODE
Device Description
The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single-use, sterile 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 by ethylene oxide (EO). The delivery 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 SerosaFuse tissue fasteners are constructed of injection molded polypropylene and are of a strength equivalent to 3-0 suture. The SerosaFuse Implantable Fastener Cartridge is dual-lever containing 20 fasteners in each lever, and is designed to be removable. Each fastener consists of a leading leg, interconnecting web and trailing leg. The fastener's unique design allows it to be loaded onto a stylet, passed into and down a small delivery lumen of the device and subsequently delivered through apposed tissue surfaces in the GI tract. When deployed in tissue, the fastener serves as a suture-like implantable.
The system is used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The EsophyX Z+ device deploys the SerosaFuse fastener during an endoscopic procedure. 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. The EsophyX Z+ device is capable of transoral tissue approximation, ligation, and full thickness plication in the GI tract. The process essentially mimics the standard surgical technique of grasping tissue and apposing/approximating the tissue, piercing, and suturing the tissue fold. Each of these steps is controlled at the device proximal end, though plication, ligation and gastroesophageal valve formation is accomplished at the distal end of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
User Population: Interventional Gastroenterologists and Surgeons.
Care Setting: operating room environment.
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
Non-clinical testing was conducted to demonstrate that the EsophyX Z+ device is as safe and effective as the predicate device:
- Labeling verification.
- Benchtop performance testing, including evaluation of device forces, fastener loading and deployment, and dimensional verification
In all instances, the EsophyX Z+ device functioned as intended and demonstrated passing results.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 26, 2024
EndoGastric Solutions, Inc. % John J. Smith Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Columbia Square Washington, District of Columbia 20004
Re: K240879
Trade/Device Name: EsophyX Z+ 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: March 29, 2024 Received: March 29, 2024
Dear John J. Smith:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Indications for Use (Describe)
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 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.
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)
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."
4
510(K) SUMMARY
EndoGastric Solutions, Inc. EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Submitter
EndoGastric Solutions, Inc. 18109 NE 76th Street Redmond, WA 98052 Phone: +1 408-705-5521 Facsimile: +1 425-650-7028 Contact Person: Shala Famil
Date Prepared: March 29, 2024
Name of Device: EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Classification Name: 21 CFR 876.1500, Endoscope and accessories - Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Regulatory Class: Il
Product Code: ODE
Predicate Device: EndoGastric Solutions, Inc., EsophyX Z Device with SerosaFuse Fasteners and Accessories (K172811)
Device Description
The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single-use, sterile 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 by ethylene oxide (EO). The delivery 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 SerosaFuse tissue fasteners are constructed of injection molded polypropylene and are of a strength equivalent to 3-0 suture. The SerosaFuse Implantable Fastener Cartridge is dual-lever containing 20 fasteners in each lever, and is designed to be removable. Each fastener consists of a leading leg, interconnecting web and trailing leg. The fastener's unique design allows it to be loaded onto a stylet, passed into and down a small delivery lumen of the device and subsequently delivered through apposed tissue surfaces in the GI tract. When deployed in tissue, the fastener serves as a suture-like implantable.
The system is used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The EsophyX Z+ device deploys the SerosaFuse fastener during an endoscopic procedure. A separate commercial endoscope operating independently
5
down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. The EsophyX Z+ device is capable of transoral tissue approximation, ligation, and full thickness plication in the GI tract. The process essentially mimics the standard surgical technique of grasping tissue and apposing/approximating the tissue, piercing, and suturing the tissue fold. Each of these steps is controlled at the device proximal end, though plication, ligation and gastroesophageal valve formation is accomplished at the distal end of the device.
Intended Use / Indications for Use
The subject and predicate EsophyX devices are both intended for transoral tissue approximation, plication and fastening of tissue in the GI tract, for the endoluminal treatment of gastroesophageal reflux disease. The subject device's indications for use are as follows:
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 gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic qastroesophageal 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 Technological Characteristics
The technological characteristics of the EsophyX Z+ device are largely unchanged from the EsophyX Z predicate device, which was cleared in K172811. This 510(k) submission primarily proposes changes to the instructions for use and other device labeling. A table comparing the key features of the subject and predicate devices is provided below.
| | EsophyX Z+
(Subject Device) | EsophyX Z
(Predicate Device, K172811) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 876.1500, Endoscope and
accessories (Class II) | 21 CFR 876.1500, Endoscope and
accessories (Class II) |
| Product Code | ODE (Endoscopic Suture/Plication
System, Gastroesophageal Reflux
Disease (Gerd)) | ODE (Endoscopic Suture/Plication
System, Gastroesophageal Reflux
Disease (Gerd)) |
| Intended Use | The EsophyX Z+ device is intended
for transoral tissue approximation,
plication and fastening of tissue in
the GI tract, for the endoluminal
treatment of gastroesophageal
reflux disease. | The EsophyX Z device is intended
for transoral tissue approximation,
plication and fastening of tissue in
the GI tract, for the endoluminal
treatment of gastroesophageal
reflux disease. |
| | EsophyX Z+ | EsophyX Z |
| | (Subject Device) | (Predicate Device, K172811) |
| Indications for Use | 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
gastroesophageal reflux disease in
patients who require and respond to
pharmacological therapy. It is also
indicated to narrow the 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 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 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. |
| User Population | Interventional Gastroenterologists
and Surgeons | Interventional Gastroenterologists
and Surgeons |
| Technological
Characteristics | The system is a prescription use
only, disposable, single-use, sterile
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).
The tissue fasteners are equivalent
to 3.0 suture and are permanent
implants. | The system is a prescription use
only, disposable, single-use, sterile
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).
The tissue fasteners are equivalent
to 3.0 suture and are permanent
implants. |
| Major Components | EsophyX Z+ Fastener Delivery
Device
SerosaFuse Fastener Cartridge and
Fasteners | EsophyX Z Fastener Delivery
Device
SerosaFuse Fastener Cartridge and
Fasteners |
| Accessories | Endoscope Compatibility Tool | Endoscope Compatibility Tool |
| Safety Features | Safety features include safe sharps
storage, fastener delivery lockout,
and prevention of tissue over-
plication | Safety features include safe sharps
storage, fastener delivery lockout,
and prevention of tissue over-
plication |
| Biocompatibility | Meets the requirements of ISO
10993-1 | Meets the requirements of ISO
10993-1 |
| Sterilization | Ethylene Oxide; meets
requirements of ISO 10993-7 | Ethylene Oxide; meets
requirements of ISO 10993-7 |
| | EsophyX Z+
(Subject Device) | EsophyX Z
(Predicate Device, K172811) |
| Standards with
which the Device
Complies | ISO 11135 | ISO 11135 |
| | ISO 11607-1 | ISO 11607-1 |
| | ISO 11737-1 | ISO 11737-1 |
SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
6
7
Performance Data
Non-clinical testing was conducted to demonstrate that the EsophyX Z+ device is as safe and effective as the predicate device:
- Labeling verification .
· Benchtop performance testing, including evaluation of device forces, fastener loading and deployment, and dimensional verification
In all instances, the EsophyX Z+ device functioned as intended and demonstrated passing results.
Conclusions
The EsophyX Z+ device is as safe and effective as the predicate EsophyX Z device (K172811). The EsophyX Z+ device has the same intended uses and indications, and similar technological characteristics and principles of operation as its predicate device. In addition, the minor differences between the EsophyX Z+ device and its predicate devices raise no new issues of safety or effectiveness. Thus, the EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is substantially equivalent.