(92 days)
Not Found
No
The device description details a purely mechanical system for tissue approximation and fastener delivery. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease and is used to approximate and plicate tissue in the gastrointestinal tract, which are therapeutic actions.
No
Explanation: The device description and intended use clearly state that the EsophyX2 device is used for "transoral tissue approximation, full thickness plication in the GI tract" and for "treatment of symptomatic chronic gastroesophageal reflux disease." It is a mechanical device designed to physically modify tissue, not to diagnose a condition.
No
The device description clearly details a mechanical, flexible fastener delivery device with user controls, a flexible shaft, and sterile fasteners, indicating it is a hardware-based medical device.
Based on the provided information, the EndoGastric Solutions EsophyX2 Device with SerosaFuse Fastener and Accessories is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for tissue approximation and plication within the GI tract to treat GERD. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a mechanical device with fasteners used for surgical manipulation of tissue. There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents or assays.
- Calibration or quality control procedures related to sample analysis.
The device is a surgical tool used for a therapeutic intervention, not for diagnosing a condition by analyzing samples.
N/A
Intended Use / 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
§ 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.
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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:
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
EndoGastric Solutions, Inc. Confidential
31
1
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 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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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
4
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:
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