(184 days)
Not Found
No
The device description focuses on mechanical components and tissue manipulation, with no mention of AI/ML terms or functions.
Yes
The device is intended for tissue approximation, ligation, and full-thickness plication in the G.I. tract, which are procedures performed to treat or manage medical conditions within the gastrointestinal system.
No
The intended use of the device is for tissue approximation, ligation, and full-thickness plication, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines a physical delivery device and implantable fasteners made of polypropylene, indicating it is 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 "tissue approximation, ligation and full-thickness plication in the G.I. tract." This describes a surgical or procedural intervention on the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a mechanical device used to manipulate and fasten tissue within the G.I. tract. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue biopsies, etc.).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as reagents, calibrators, controls, or methods for analyzing biological markers.
In summary, the StomaphyX system is a surgical/procedural device used for tissue manipulation within the body, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The EndoGastric Solutions StomaphyXT system with SerosaFuse Fastener is intended for tissue approximation, ligation and full-thickness plication in the G.I. tract.
Product codes
OCW
Device Description
The EndoGastric Solutions StomaphyX™ Delivery Device and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. 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 fasten it using H shaped polypropylene fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
3. 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.
K073644 510(k) Number: _TBD
Applicant Information:
Date Prepared: June 23, 2008
EndoGastric Solutions, Inc. Name: 8210 154th Avenue N.E. Address: Redmond, WA 98052 Phone: 425 307 9200 Fax: 425 307 9201
| Contact Person: | Ken Perino |
|---|---|
| Phone Number: | Office: 425-307-9233 / Cell 206-963-8334 |
| 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 |
| Classification Name: | Endoscope and Accessories 78 OCW / 21 CFR 876.1500 |
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 devices:
K071651 - EndoGastric Solutions EsophyX System with SerosaFuse Fastener and accessories K062875 - EndoGastric Solutions StomaphyX Device and accessories
1
Device Description:
The EndoGastric Solutions StomaphyX™ Delivery Device and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. 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 fasten it using H shaped polypropylene fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries 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.
Intended Use:
The EndoGastric Solutions StomaphyX1M system with SerosaFuse™ Fastener is intended for tissue approximation, ligation and full-thickness plication in the G.I. tract.
Comparison to Predicate Device(s):
The design of the EndoGastric Solutions StomaphyX™ system with SerosaFuse™ Fastener is similar to the predicates listed in that they are all devices designed to reach the desired suture location under endoscopic visualization, grasp tissue in some fashion and place sutures/clips in a desired location. All products are re-loadable for repeat fastener/suture/clip placement. The products all share common features such as a sterile, stainless steel needle (called a stylet in the StomaphyX device) housed in a suture loading unit. 'They all deliver fastener/suture/clips through soft tissue by manually actuating the needle with a handle mechanism. All devices are packaged sterile and are for single patient use. Further, the EndoGastric Solutions Stomaphyx TM system with SerosaFusc ™ Fastener and the predicate devices have the same or similar intended use, which is to place sutures/clips (fasteners) to approximate soft tissue under endoscopic visualization.
Summary:
Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, the EndoGastric Solutions StomaphyX™ system with SerosaFuse™ Fastener has been shown to be substantially equivalent to currently marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 27 2008
Mr. Ken Perino Director Regulatory Affairs EndoGastric Solutions, Inc. 8210 154th Avenue N.E. REDMOND WA 98052
Re: K073644
Trade/Device Name: EndoGastric Solutions StomaphyX Delivery Device, Fasteners and Accessories Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated: June 17, 2008
Received: June 24, 2008
Dear Mr. Perino:
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 such 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.
3
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K073644 |
|---|---|
| --------------------------- | --------- |
Device Name: EndoGastric Solutions StomaphyX Device and Accessories
Indications For Use:
The EndoGastric Solutions StomaphyXTM system with SerosaFuse™ Fastener is intended for tissue approximation, ligation and full-thickness plication in the G.I. tract.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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 Device 510(k) Number
Page 1 of 1