(28 days)
None
No
The summary describes a mechanical device (stent and delivery catheter) and mentions only mechanical and dimensional testing, with no indication of software, image processing, or AI/ML components.
Yes
The device is intended for "drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone," which are therapeutic interventions.
No
This device is a biliary stent system, which is used for the physical drainage, splinting, or patency of bile ducts, not for diagnosing a condition.
No
The device description explicitly states that the system consists of a stent and a stent delivery catheter, which are physical hardware components.
Based on the provided information, the EndoGI S-Path Biliary Stent System 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.
- Device Function: The description clearly states that the EndoGI S-Path Biliary Stent System is a device intended for delivery of stents to the biliary tract for drainage, splinting, or providing patency. This is a therapeutic or interventional procedure performed directly on the patient's anatomy.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples or performing any diagnostic tests on samples taken from the patient.
Therefore, the EndoGI S-Path Biliary Stent System is a medical device used for a therapeutic purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoGI S-Path Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Product codes
FGE
Device Description
The EndoGI S-Path Biliary Stent System consists of a stent and stent delivery catheter. The EndoGI S-Path Biliary Stent System catheter is 10 Fr in diameter and includes a single preloaded stent available in three lengths (80, 110 and 140 mm). The delivery catheter is compatible with a guidewire of up to 0.035”. EndoGI S-Path Biliary System stents have a straight body and one end incorporating a 65° bend (duodenal bend). Stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract, bile ducts
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
Validation Testing: Due to the modifications to the EndoGI S-Path; mechanical, dimensional, kink resistance and flow rate testing were repeated to demonstrate the system functions as intended. The results of the validation testing demonstrated that the EndoGI S-Path system is as safe and effective as its predicate and that the modifications to the system did not raise new questions of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2022
EndoGI Medical % Bosmat Friedman Regulatory Consultant ProMedoss. Inc. 3521 Hatwynn Rd. Charlotte, NC 28269
Re: K222627
Trade/Device Name: EndoGI S-Path Biliary Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: August 31, 2022 Received: August 31, 2022
Dear Bosmat Friedman:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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).
Sincerely,
April Marrone, Ph.D., MBA Acting 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222627
Device Name
EndoGI S-Path Biliary Stent System
Indications for Use (Describe)
The EndoGI S-Path Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
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)
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K222627 Page 1 of 2
510(K) SUMMARY [SPECIAL 510(K)] EndoGI S-Path Biliary Stent System 510(k) Number K222627
SUBMITTER 1.
Applicant's Name:
EndoGI Medical Omri Naveh, CEO 13 Wadi El Haj P.O. Box 1252 Nazareth, Israel +972-52-462-5474 +972-4-609-8600 omri(@EndoGI-Medical.com
Primary Contact:
Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 647-975-3974 bosmat.f(@promedoss.com
Date Prepared: August 31, 2022
2. DEVICE
Trade Name: EndoGI S-Path Biliary Stent System
| Classification: | Name: Biliary catheter and accessories
Product Code: FGE
Regulation No: 876.5010
Class: 2
Review Panel: Gastroenterology/Urology |
| ----------------- | ---------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
3. PREDICATE DEVICES
Predicate device: EndoGI Biliary Stent System, by EndoGI Medical, Ltd., Product code FGE, cleared Under: K202477.
DEVICE DESCRIPTION 4.
The EndoGI S-Path Biliary Stent System consists of a stent and stent delivery catheter. The EndoGI S-Path Biliary Stent System catheter is 10 Fr in diameter and includes a single preloaded stent available in three lengths (80, 110 and 140 mm). The delivery catheter is compatible with a guidewire of up to 0.035". EndoGI S-Path Biliary System stents have a
4
EndoGI S-Path Biliary Stent System - 510(k) Summary
straight body and one end incorporating a 65° bend (duodenal bend). Stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.
5. INDICATIONS FOR USE
The EndoGI S-Path Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
6. SUBSTANTIAL EQUIVALENCE
The EndoGI S-Path System is substantially equivalent to the predicate device based on the following:
Intended Use
The intended use of the proposed device is identical to that of the cleared device.
Technology
The revised system incorporates two new stent sizes, 80 mm and 140 mm. As a result, the overall system length was extended, and minor improvements were also incorporated in the delivery system. Repeat bench testing demonstrated that the system functions as intended and yielded substantially equivalent results to the results obtained with the predicate.
Discussion
The EndoGI S-Path System has identical indications for use as the previously cleared EndoGI System. The main technological difference between the EndoGI S-Path delivery system and the predicates is due to the addition of two stent sizes. This modification resulted in a longer delivery system. Repeat performance testing demonstrated that both systems function in an equivalent manner.
7. PERFORMANCE DATA
Validation Testing
Due to the modifications to the EndoGI S-Path; mechanical, dimensional, kink resistance and flow rate testing were repeated to demonstrate the system functions as intended. The results of the validation testing demonstrated that the EndoGI S-Path system is as safe and effective as its predicate and that the modifications to the system did not raise new questions of safety and effectiveness.
8. CONCLUSION
EndoGI Medical has demonstrated that the EndoGI S-Path System is substantially equivalent to the predicate device. Differences between the proposed S-Path System and the predicate device do not raise new questions of safety or efficacy.