(27 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 revised EndoGI S-Path System incorporates one preloaded stent which has a straight body and one end incorporating a 65° bend (duodenal bend). The stent is identical to the previously cleared EndoGI stent and is comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment. The EndoGI S-Path System is available 10 Fr and includes a single preloaded 110 mm stent. The system is compatible with a guidewire of up to 0.035".
The provided text is a 510(k) summary for the EndoGI S-Path Biliary Stent System, which is a medical device. This type of document is filed with the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. As such, it does not typically contain detailed information about acceptance criteria and clinical study results in the same way an approval for a novel device would.
Instead, the document focuses on demonstrating substantial equivalence primarily through technological comparison and performance testing (bench testing) rather than extensive clinical studies with human subjects.
Here's a breakdown based on the categories you requested, highlighting what is (and isn't) present in the document:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in terms of clinical outcomes (e.g., sensitivity, specificity for a diagnostic device). Instead, it mentions that "Repeat bench testing demonstrated that the system functions as intended and yielded substantially equivalent results to the results obtained with the predicate." and "Due to the modifications to the delivery system mechanical and kink resistance 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."
The "acceptance criteria" here are implicitly related to the performance specifications of the predicate device and the ability of the modified device to meet those same specifications in bench testing, particularly for mechanical and kink resistance. Specific numerical acceptance criteria or performance metrics are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench testing" and "validation testing" for mechanical and kink resistance. These types of tests typically involve a sample size of devices tested in a lab setting, not human subjects. The document does not specify the sample size of devices used for these bench tests, nor is there any mention of data provenance in terms of country of origin or retrospective/prospective nature, as these are not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the information provided. The study mentioned is bench testing of physical device properties, not a study requiring expert interpretation or establishment of ground truth in a diagnostic or clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in clinical studies for resolving discrepancies in expert opinions or clinical outcomes, which is not the type of study described here.
5. 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
This is not applicable. The device is a biliary stent system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (a stent delivery system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not explicitly stated in terms of a clinical ground truth. For the bench testing, the "ground truth" would be the engineering specifications and performance expectations derived from the predicate device and general medical device standards. The "results obtained with the predicate" serve as the benchmark for comparison.
8. The sample size for the training set
This is not applicable as this is not an AI/algorithm device that requires a training set. The "study" mentioned is bench testing of a physical device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
In summary:
The provided document describes a 510(k) submission for a modified biliary stent system. The "study" referenced is bench testing (mechanical and kink resistance testing) conducted to demonstrate that the delivery system functions as intended and is substantially equivalent to a previously cleared predicate device.
- Acceptance Criteria & Performance: The acceptance criteria are implicit, focusing on the new device performing as safely and effectively as the predicate during mechanical and kink resistance testing. Specific quantitative criteria and performance results are not detailed, beyond stating that it "functions as intended" and "yielded substantially equivalent results."
- Study Type: Bench testing.
- Sample Size: Not specified for bench tests.
- Data Provenance: Not applicable (lab-based testing).
- Experts/Ground Truth: Not applicable in the context of clinical experts or ground truth. The "ground truth" for compliance is based on engineering specifications and comparison to the predicate's established performance.
- No MRMC, Standalone, or AI-related studies were performed.
The core of this submission relies on demonstrating that the physical modification (changing from a double to a single stent system) did not negatively impact the device's safety and effectiveness compared to the predicate, as verified through standard engineering and performance tests.
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September 24, 2020
Endo GI Medical % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269
Re: K202477
Trade/Device Name: EndoGI S-Path Biliary Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 27, 2020 Received: August 28, 2020
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 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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
for
Glenn B. Bell, Ph.D. 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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Indications for Use
510(k) Number (if known) K202477
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY [SPECIAL 510(K)] EndoGI S-Path Biliary Stent System 510(k) Number K202477
I. SUBMITTER
Applicant's Name:
EndoGI Medical Omri Naveh, CEO 4625474-52-972+ 6098600-4-972+ 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
II. DEVICE
Trade Name: EndoGI S-Path Biliary Stent System
| Classification Code: | Name: Catheter, Biliary, Diagnostic |
|---|---|
| Product Code: FGE | |
| Regulation No: 876.5010 | |
| Class: 2 | |
| Review Panel: Gastroenterology/Urology |
III. PREDICATE DEVICES
Predicate device EndoGI Biliary Stent System, by EndoGI Medical, Ltd., Product code FGE, cleared Under: K193600.
IV. DEVICE DESCRIPTION
The revised EndoGI S-Path System incorporates one preloaded stent which has a straight body and one end incorporating a 65° bend (duodenal bend). The stent is identical to the previously cleared EndoGI stent and is comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.
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The EndoGI S-Path System is available 10 Fr and includes a single preloaded 110 mm stent. The system is compatible with a guidewire of up to 0.035".
V. 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.
VI. 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 a single stent rather than the two preloaded stents available on the predicted. As a result, the overall system length was shortened, and the handle design simplified. Repeat bench testing demonstrated that the system functions as intended and yielded substantially equivalent results to the results obtained with the predicate. Since the previously cleared system represents a "worst-case-scenario" with respect to shelf life, sterilization and biocompatibility testing, these tests were not repeated as they are fully applicable to the EndoGI S-Path System.
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 elimination of one stent from the original double stent system. This modification resulted in a shorter delivery system with a simplified handle. Repeat performance testing demonstrated that both system function in an equivalent manner. Consequently, it is clear that the EndoGI S-Path System is as safe and effective as its predicate without raising any new safety and/or effectiveness concerns.
VII. PERFORMANCE DATA
Validation Testing
Due to the modifications to the delivery system mechanical and kink resistance 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.
Since no modifications were made to the system materials, packaging or manufacturing processes, there was no need to repeat biocompatibility, sterilization or shelf-life testing.
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VIII. 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.