(28 days)
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.
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.
This document is a 510(k) Summary for the EndoGI S-Path Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement is not available in the provided text.
Based on the information provided, here's what can be extracted:
Acceptance Criteria and Reported Device Performance (as inferred from the context of a 510(k) for device modification):
The document primarily states that "repeat bench testing demonstrated that the system functions as intended and yielded substantially equivalent results to the results obtained with the predicate." It also notes that "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."
While specific numerical acceptance criteria are not presented, the implicit acceptance criterion is that the modified device's performance is substantially equivalent to the predicate device for a set of defined performance tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent to predicate device | Repeat bench testing demonstrated the system functions as intended and yielded substantially equivalent results to the predicate. Validation testing confirmed the system is as safe and effective as its predicate. |
| Dimensional Performance: Equivalent to predicate device | Repeat bench testing demonstrated the system functions as intended and yielded substantially equivalent results to the predicate. Validation testing confirmed the system is as safe and effective as its predicate. |
| Kink Resistance: Equivalent to predicate device | Repeat bench testing demonstrated the system functions as intended and yielded substantially equivalent results to the predicate. Validation testing confirmed the system is as safe and effective as its predicate. |
| Flow Rate: Equivalent to predicate device | Repeat bench testing demonstrated the system functions as intended and yielded substantially equivalent results to the predicate. Validation testing confirmed the system is as safe and effective as its predicate. |
| Safety and Effectiveness: No new questions raised by modifications | The modifications to the system did not raise new questions of safety and effectiveness. The system is as safe and effective as its predicate. |
Missing Information (Not provided in the document):
- Sample size used for the test set and the data provenance: Not mentioned. The document only refers to "bench testing" and "validation testing" without detailing the number of units tested or if any clinical data was used (which is unlikely for a 510(k) for minor modifications).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not mentioned. The testing described appears to be bench testing of physical properties, not a clinical trial requiring expert ground truth establishment.
- Adjudication method for the test set: Not applicable/Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a physical medical device (biliary stent system), not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: For physical performance tests, the "ground truth" would be established by validated measurement standards and physical testing methodologies. No human-expert derived ground truth is applicable here.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Study Description (as inferred from the 510(k) Summary):
The "study" or rather, the performance evaluation, was a bench testing validation study. It was conducted to demonstrate that the modified EndoGI S-Path Biliary Stent System (which includes new stent sizes and minor delivery system improvements) performs as intended and is substantially equivalent to its predicate device (EndoGI Biliary Stent System, K202477).
The modifications included two new stent sizes (80mm and 140mm) and an extended overall system length.
The specific tests performed were:
- Mechanical testing
- Dimensional testing
- Kink resistance testing
- Flow rate testing
The conclusion was that these repeat performance tests demonstrated that the modified system functions in an equivalent manner to the predicate and that the modifications did not raise new questions of safety or efficacy. The data provenance is implied to be from the manufacturer's internal testing.
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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
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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 accessoriesProduct Code: FGERegulation No: 876.5010Class: 2Review 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
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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.
§ 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.