EndoGI S-Path Biliary Stent System

K222627 · Endo GI Medical · FGE · Sep 28, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K222627
• Device Name: EndoGI S-Path Biliary Stent System
• Applicant: Endo GI Medical
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Sep 28, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The EndoGI S-Path Biliary Stent System is a medical device used by physicians in clinical settings to manage biliary conditions. It consists of a 10 Fr delivery catheter and a preloaded, radiopaque plastic stent with a 65° duodenal bend. The system is compatible with guidewires up to 0.035". The physician uses the delivery catheter to place the stent into the biliary tract. Once deployed, the stent provides drainage, splinting, or patency for strictures or stones. The radiopaque material allows for visualization during and after deployment. The device is a modification of a previously cleared system, featuring additional stent lengths (80 mm and 140 mm) and minor delivery system improvements to accommodate these sizes.

Clinical Evidence

Bench testing only. Validation testing included mechanical, dimensional, kink resistance, and flow rate testing to confirm performance after system modifications. No clinical data was provided.

Technological Characteristics

System consists of a 10 Fr delivery catheter and a radiopaque plastic stent with a 65° duodenal bend. Compatible with 0.035" guidewires. Available in 80 mm, 110 mm, and 140 mm lengths. Mechanical, dimensional, kink resistance, and flow rate specifications verified via bench testing.

Indications for Use

Indicated for patients requiring biliary tract drainage, bile duct splinting during healing, or maintenance of bile duct patency in the presence of a stricture or stone.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EndoGI Biliary Stent System (K202477)

Submission Summary (Full Text)

{0}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

### 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

Page 1 of 1

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

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 [phone] [phone] omri(@EndoGI-Medical.com

### Primary Contact:

Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: [phone] 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<br>Product Code: FGE<br>Regulation No: 876.5010<br>Class: 2<br>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.