(30 days)
Not Found
No
The device description focuses on mechanical components and vacuum-assisted tissue manipulation, with no mention of AI or ML terms or functionalities. The "Not Found" entries for AI/ML mentions, training/test sets, and performance studies further support this conclusion.
No.
The "Intended Use / Indications for Use" states that the device is intended for "transoral tissue approximation, ligation and full-thickness plication in the G.I. tract," which describes a surgical or procedural function rather than a therapeutic one (i.e., treating a disease or condition).
No
The device is described as being for "transoral tissue approximation, ligation and full-thickness plication," which are surgical procedures, not diagnostic ones. It performs a physical alteration (fastening tissue) rather than detecting a condition or disease.
No
The device description clearly details a physical delivery system with mechanical components (stylet, pusher, lumens, fasteners) and is intended for transoral tissue approximation, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transoral tissue approximation, ligation and full-thickness plication in the G.I. tract." This describes a surgical or procedural intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for delivering fasteners to tissue within the G.I. tract. This is a mechanical device used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EndoGastric Solutions StomaphyX® system with SerosaFuse® Fastener is intended for transoral tissue approximation, ligation and full-thickness plications within the G.I. tract.
Product codes
OCW
Device Description
The EndoGastric Solutions StomaphyX Delivery System and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants delivered through a fastener cartridge. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device, The device uses vacuum to invaginate tissue through a port into a chamber and fastens it using Hshaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. The three elements run the length of the device, inside the outer shaft. The pusher is a hollow tube that rides over the length of the stylet provides a "pilot" hole for the fastener to pass through the tissue and both ride inside the lumen. The stylet is a wire three-faceted, sharpened tip at the distal end to pierce tissue. A fastener is loaded for deployment by depressing the lever on the removable, fastener cartridge located at the proximal end of the device. This action automatically snaps the fastener onto the stylet. When the pusher tube is pushed by the operator, the stylet carnes the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
G.I. tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
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.
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SECTION 12. 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: _K091832
JUL 2 2 2009
Applicant Information:
Date Prepared: June 5, 2009
Name: EndoGastric Solutions, Inc. Address: 8210 154" Avenue N.E. Redmond, WA 98052 Phone: 425 307 9200 Fax: 425 307 9201
| Contact Person: | Steve Hoffman |
|---|---|
| Phone Number: | Office: 425-307-9226 |
| Facsimile Number: | (425) 307-9201 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | EndoGastric Solutions StomaphyX® Delivery Device, Fasteners and |
| Accessories | |
| Common Name: | Endoscopic Tissue Approximation Device, Implantable Fastener and |
| Accessories | |
| Classification Name: | Endoscope and Accessories (21 CFR 876.1500, Product Code OCW) |
Predicate Devices:
The EndoGastric Solutions StomaphyX Device and Implantable Fasteners is substantially equivalent in intended use and method of operation to a combination of the following predicate device:
K062875 - EndoGastric Solutions StomaphyX Device and Accessories K073644 - EndoGastric Solutions StomaphyX Device and Accessories
Device Description:
The EndoGastric Solutions StomaphyX Delivery System and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants delivered through a fastener cartridge. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device,
EndoGastric Solutions, Inc. Confidential
1
The device uses vacuum to invaginate tissue through a port into a chamber and fastens it using Hshaped polypropylene fasteners.
The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. The three elements run the length of the device, inside the outer shaft. The pusher is a hollow tube that rides over the length of the stylet provides a "pilot" hole for the fastener to pass through the tissue and both ride inside the lumen. The stylet is a wire three-faceted, sharpened tip at the distal end to pierce tissue.
A fastener is loaded for deployment by depressing the lever on the removable, fastener cartridge located at the proximal end of the device. This action automatically snaps the fastener onto the stylet. When the pusher tube is pushed by the operator, the stylet carnes the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.
Indications for Use:
The EndoGastric Solutions StomaphyX® system with SerosaFuse® Fastener is intended for transoral tissue approximation, ligation and full-thickness plications within the G.I. tract.
Comparison to Predicate Device:
The design of the EndoGastric Solutions StomaphyX System with SerosaFuse® Fastener is identical to the predicate listed in that they are devices designed to reach the desired suture location under endoscopic visualization, grasp tissue in some fashion and place sutures/fasteners in a desired location. The products are re-loadable for repeat fastener/suture placement. The products share common features such as a sterile, stainless steel needle called a stylet, housed in a fastener loading unit. They deliver a fastener/suture 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 StomaphyX 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.
Summary:
Based upon the intended use, product technical information, performance and biocompatibility information provided in this pre-market notification, the EndoGastric Solutions StomaphyX 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 Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus in the logo is a modern, abstract design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven J. Hoffman Director, Ouality & Regulatory Affairs EndoGastric Solutions, Inc. 8210 154th Avenue, N.E. REDMOND WA 98052
JUL 222009
Re: K091832
Trade/Device Name: EndoGastric Solutions StomaphyX Device with SerosaFuse Fastener Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated: June 18, 2009 Received: June 22, 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 vour 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 of medical
3
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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
adde
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Ericlosure
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7.1 Indications for Use
510(k) Number (if known): K091832
Device Name: EndoGastric Solutions StomaphyX Device with SerosaFuse Fastener
Indications For Use:
The EndoGastric Solutions, StomaphyX System with SerosaFuse Fastener is intended for transoral tissue approximation, ligation and full-thickness plication in the G.I. tract.
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 _
EndoGastric Solutions, Inc. Confidential
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