(186 days)
No
The summary describes a mechanical device for stent delivery and does not mention any AI/ML components or functionalities.
Yes.
The device is intended to treat conditions of the biliary tract, such as drainage, splinting, or maintaining patency in strictures or past stones, which are therapeutic functions.
No
This device is intended for the delivery of stents to the biliary tract for drainage, splinting, or providing patency, which are therapeutic actions, not diagnostic ones.
No
The device description clearly details physical components like stents made of radiopaque plastic and a delivery system with a handle and safety lock mechanisms. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for drainage and support of the biliary tract. This is an in vivo application.
- Device Description: The description details a physical stent and delivery system designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, or tissue) to provide diagnostic information. IVDs are used to examine these samples outside the body.
The device is a therapeutic medical device used for intervention within the patient's body.
N/A
Intended Use / Indications for Use
The EndoGI 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 (comma separated list FDA assigned to the subject device)
FGE
Device Description
The EndoGI System incorporates two preloaded stents. Both stents are identical in design with a straight body and one end incorporating a 65° bend (duodenal bend). The stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stents post deployment. Both stents are pre-mounted on the delivery system and are delivered via near-the-wire and over-the-wire methods. The EndoGI System is available 10 Fr and includes two 110 mm stents. The system is compatible with a guidewire of up to 0.035". The safety lock mechanisms are incorporated within the delivery device handle.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility:
The following biocompatibility tests were performed on the stent and delivery system:
Stent:
- Systemic Toxicity (Implant Method) and Implant Evaluation Test in Rabbits
- Systemic Toxicity (Dual Route Repeated Exposure Method) Test
- Material Mediated Pyrogenicity Test (ISO/USP)
- Acute Systemic Toxicity Test
- Guinea Pig Maximization Test
- Intracutaneous Reactivity Test
- Mouse Lymphoma Assay
- Ames Bacterial Reverse Mutation Assay
- MEM Elution Cytotoxicity Assay
Delivery System: - MEM Elution Cytotoxicity Assay
- Material Mediated Pyrogenicity Test
- Acute Systemic Toxicity Test
- Guinea Pig Maximization Test
- Intracutaneous Reactivity Test
Non-Clinical Performance Testing:
The EndoGI Biliary Stent System device has undergone and successfully passed the following tests:
- Mechanical Evaluation
- Kink Resistance
- Flow Rate
- Bond Strength
- Dimensional Verification
- EndoGI Biliary Stent Compression Force (Bile)
- EndoGI Biliary Stent Tensile Test (Bile)
Animal Performance Testing:
A GLP-like animal study on porcine model was conducted to evaluate the performance of the system and to validate its ability to successfully deploy two stents. A total of 6 repeats including 2 deployments and 6 stent retrievals were performed. The duration of the complete procedure (from delivery system insertion to the beginning of monitoring following retrieval) was 17 minutes - 29 minutes with an average of 20 minutes per repeat. The second stent deployment following the first stent was performed within 1-2 minutes with an average of 1 minute for second stent deployment. The goals of the study were met: namely, the system was able to successfully deliver 2 stents utilizing a one-step procedure, no local tissue reaction was visualized, and successful stent removal was achieved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EndoGI Medical, Ltd. % Bosmat Friedman Regulatory Consultant ProMedoss, Inc 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K193600
Trade/Device Name: EndoGI Biliary Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: FGE Dated: May 27, 2020 Received: May 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
1
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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 mediation-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,
Daniel G. Walter, Jr. 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
Indications for Use
510(k) Number (if known) K193600
Device Name EndoGI Biliary Stent System
Indications for Use (Describe)
The EndoGI 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
1 SUBMITTER
Applicant's Name:
EndoGI Medical Omri Naveh, CEO +972-52-4625474 +972-4-6098600 omri@EndoGI-Medical.com
Contact Person:
Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 647-975-3974 bosmat.f@promedoss.com
Date Prepared:
December 20, 2019
2 DEVICE
Trade Name: EndoGI Biliary Stent System
| Classification Code: | Name: Catheter, Biliary, Diagnostic |
|---|---|
| Product Code: FGE | |
| Regulation No: 876.5010 | |
| Class: 2 | |
| Review Panel: Gastroenterology/Urology |
3 PREDICATE DEVICE
Primary predicate device:
-
. AdvaniX™ Biliary Stent with NaviFleX™ RX Delivery System, manufactured by Boston Scientific, cleared under K101314; Product Code: FGE.
Reference device: -
Marathon Stent with Fusion Technology, manufactured by Cook Ireland, cleared under K060624; Product code: FGE.
4 DEVICE DESCRIPTION
The EndoGI System incorporates two preloaded stents. Both stents are identical in design with a straight body and one end incorporating a 65° bend (duodenal bend). The stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stents post deployment. Both stents are pre-mounted on the delivery system and are delivered via near-the-wire and over-the-wire methods.
4
The EndoGI System is available 10 Fr and includes two 110 mm stents. The system is compatible with a guidewire of up to 0.035". The safety lock mechanisms are incorporated within the delivery device handle.
5 INDICATIONS FOR USE
The EndoGI 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.
SUBSTANTIAL EQUIVALENCE 6
The EndoGI Biliary Stent System is substantially equivalent to the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System. Both devices have similar indications for use; the main difference is that the EndoGI System allows the insertion of two stents on one delivery device while the predicate requires two separate delivery device insertions in order to achieve the same results.
Bothe devices incorporate a combination of rapid exchange and over-the-wire techniques to deliver the stent(s). Comparative bench testing demonstrated that the stent components of both systems are substantially equivalent. Additional bench and animal testing on the EndoGI delivery device demonstrated that the device performs as intended and that no new safety and effectiveness concerns have been introduced due to the ability of the system to deliver two stents.
| Feature | EndoGI System | Advanix™ (K101314) | Comparison to Primary
Predicate |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reg. Number | 876.5010 | 876.5010 | Same |
| Product Code | FGE | FGE | Same |
| Indication for
Use | The EndoGI 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. | Advanix™ Biliary Stent with
NaviFlex™ RX Delivery
System is intended for
delivery of the stent 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. | Similar-with the addition
of the ability to place two
stents with one passage
over the guide wire |
| Principle of
Operation | Combination of rapid
exchange and over-the-
wire techniques to
deliver and place two
stents | Combination of rapid
exchange and over-the-wire
techniques to deliver a single
stent | Similar; The performance
of the EndoGI System was
evaluated via bench and
animal testing, the results
of which support our
substantial equivalency
claim |
5
| Feature | EndoGI System | Advanix™
(K101314) | Comparison to Primary
Predicate |
|-----------------------|---------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------|
| Material | Various polymers and
stainless steel | Various polymers and
stainless steel | Similar; delivery system
and stent successfully
passed all biocompatibility
testing |
| Single use | Yes | Yes | Same |
| Sterility | EtO | EtO | Same |
| Mechanical Properties | | | |
| Tensile test | Obtained results supports substantial equivalency claim | | Similar |
| Compression test | Obtained results supports substantial equivalency claim | | Similar |
| Flow Rate | Obtained results supports substantial equivalency claim | | Similar |
7 PERFORMANCE DATA
Biocompatibility:
The following biocompatibility tests were performed on the stent and delivery system: Stent:
- Systemic Toxicity (Implant Method) and Implant Evaluation Test in Rabbits -
- -Systemic Toxicity (Dual Route Repeated Exposure Method) Test
- Material Mediated Pyrogenicity Test (ISO/USP) -
- Acute Systemic Toxicity Test -
- -Guinea Pig Maximization Test
- -Intracutaneous Reactivity Test
- -Mouse Lymphoma Assay
- Ames Bacterial Reverse Mutation Assay -
- MEM Elution Cytotoxicity Assay -
Delivery System:
For the delivery device:
- MEM Elution Cytotoxicity Assay -
- -Material Mediated Pyrogenicity Test
- -Acute Systemic Toxicity Test
- -Guinea Pig Maximization Test
- Intracutaneous Reactivity Test -
Non-Clinical Performance Testing:
The EndoGI Biliary Stent System device has undergone and successfully passed the following tests:
- Mechanical Evaluation -
- -Kink Resistance
- -Flow Rate
- -Bond Strength
- -Dimensional Verification
6
- EndoGI Biliary Stent Compression Force (Bile) -
- -EndoGI Biliary Stent Tensile Test (Bile)
Animal Performance Testing:
A GLP-like animal study on porcine model was conducted to evaluate the performance of the system and to validate its ability to successfully deploy two stents. A total of 6 repeats including 2 deployments and 6 stent retrievals were performed. The duration of the complete procedure (from delivery system insertion to the beginning of monitoring following retrieval) was 17 minutes - 29 minutes with an average of 20 minutes per repeat. The second stent deployment following the first stent was performed within 1-2 minutes with an average of 1 minute for second stent deployment.
The goals of the study were met: namely, the system was able to successfully deliver 2 stents utilizing a one-step procedure, no local tissue reaction was visualized, and successful stent removal was achieved.
8 CONCLUSION
The EndoGI System has similar indications for use as the main predicate, the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System. Although the indications for use statement of the Advanix addresses the placement of only one stent, the product labeling clearly demonstrates that multiple stent placement with the Advanix is actively promoted. Furthermore, multiple stent placement is common practice and therefore the ability of the EndoGI System to allow for the placement of two stents does not raise new safety or effectiveness concerns. The main technological difference between the EndoGI delivery system and the predicates is due to the systems' ability to incorporate two preloaded stents in one system. We believe that no new safety and effectiveness concerns are raised due to this technological difference. With respect to mode of operation, the EndoGI System utilizes a combination of rapid exchange and over-the-wire techniques to deliver the stents to the desired location, this is identical to the mode of operation of the identified predicates. The company has provided sufficient comparative testing between the EndoGI System and Advanix predicate as well as additional pre-clinical bench and animal data to demonstrate our substantial equivalency claim. Consequently, it is clear that the EndoGI System is as safe and effective as its primary predicate without raising any new safety and/or effectiveness concerns.