(164 days)
Not Found
No
The device description focuses on mechanical components and tissue manipulation, with no mention of AI/ML or related concepts.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI tract," which describes a medical intervention to treat or manage a condition.
No
The device is described as an endoluminal fastener and delivery system for tissue approximation and ligation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like a flexible fastener delivery device, sterile polypropylene fastener implants, a stylet, pusher, and internal lumens. It is a hardware device used for tissue approximation and ligation.
Based on the provided information, the EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- StomaphyX Function: The StomaphyX device is a surgical tool used within the body (endoluminal) to physically approximate and ligate tissue in the GI tract. It is a mechanical device that performs a procedure, not a test on a sample.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is purely mechanical tissue manipulation.
Therefore, the StomaphyX device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EndoGastric Solutions StomaphyXTMe endoluminal fastener and delivery system is indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI tract.
Product codes
OCW
Device Description
The EndoGastric Solutions StomaphyXTM endoluminal fastener and delivery system consist of The Lauvousi. 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 fasteners. The 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
GI 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
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
EndoGastric Solutions, Inc. Mr. Michael A. Daniel Vice President, Regulatory and Clinical Affairs 8210 154" Avenue, N.E. Redmond, WA 98052
Re: K062875 Trade/Device Name: EndoGastric StomaphyX Device and Accessories Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE Itr): February 21, 2007
Received (Date on orig SE ltr): February 22, 2007
Dear Mr. Daniel,
This letter corrects our substantially equivalent letter of March 9, 2007.
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.
JUL 2 7 2015
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
1
Page 2 -
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 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 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/ResourcesforYou/Industry/default.htm. 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/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
2
Indications for Use
510(k) Number (if known): K062875
EndoGastric StomaphyX Device and Accessories Device Name:
Indications For Use:
The EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system is indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI 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)
David be. hyan
(Division Signatur)
Division of Reproductive, Abdominal, and
Radiological Devices Radiological Davice 510(k) Namber
Page 1 of 1
EndoGastric Solutions, Inc. 510(k) Submission. September 18, 2006.
Page 16 of 39
3
3. 510(k) SUMMARY
HAR 0 3 2007
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: K062875
Applicant Information:
| Date Prepared: | February 21, 2007 |
|---|---|
| Date last revised: | March 9, 2007 |
| Name: | EndoGastric Solutions, Inc. |
| Address: | 8210 154th Avenue N.E. |
| Redmond, WA 98052 | |
| Phone: 425 307 9200 | |
| Fax: 425 307 9201 | |
| Contact Person: | Michael A. Daniel |
| Phone Number: | Office: 925-254-5228 / Cell 415-407-0223 |
| Facsimile Number: | (925) 254-5187 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system |
| Common Name: | Endoscopic Clip Applier, Implantable Fastener and Accessories |
| Classification Name: | Endoscope and Accessories 78 KOG / 21 CFR 876.1500 |
Predicate Devices:
The EndoGastric Solutions StomaphyXTM endoluminal fastener and delivery system is substantially equivalent in intended use and method of operation to a combination of the following predicate devices:
K011016 - LSI Solutions Flexible Suture Placement Device & Accessories K994290 - Bard Endoscope Suturing System / Bard EndoCinch (K003956)
4
Device Description:
The EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system consist of The Lauvousi. 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 fasteners. The 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 StomaphyX™ endoluminal fastener and delivery system is indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI tract.
Comparison to Predicate Device(s):
The design of the EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system 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™ endoluminal fastener and delivery system 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 StomaphyX Device has been shown to be substantially equivalent to currently marketed predicate devices.
EndoGastric Solutions, Inc. 510(k) Submission. February 21, 2007
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