(21 days)
The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for maintaining esophageal lumen patency in patients with strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.
The Endoventions Esophageal Stent Technology System is comprised of two components: the stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is selfexpanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a larger diameter near the distal and proximal ends to minimize the possibility of the possible only near the distar and proximal strace to maintain a constant length over the entire overall stent geometry lo doclynbu to this unique design the stent has range of possible diamelers. The a facilitating the selection of the appropriate stent length.
The provided document is a 510(k) summary for the Endoventions ALIMAXX-E™ Esophageal Stent System. This document describes a medical device and its substantial equivalence to previously cleared devices. It does not contain information about studies proving the device meets acceptance criteria in the way typically expected for AI/ML device evaluations (i.e., performance metrics, sample sizes, expert ground truth, etc.).
Instead, the document focuses on:
- Device Description: The physical characteristics of the esophageal stent and its delivery system.
- Intended Use (Indications): Maintaining esophageal patency in malignant strictures and occlusion of esophageal fistulae.
- Substantial Equivalence: Comparing the device to existing predicate devices (Boston Scientific Ultraflex™ and Rusch International Polyflex Stents).
- Testing for Substantial Equivalence: Mentions "summaries of physical test results, and mechanical test results as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)." This refers to engineering/mechanical testing, not clinical performance studies with human readers or AI.
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving those criteria are met because such a study (as you've defined it for AI/ML devices) is not present in this 510(k) summary. The FDA's 510(k) pathway for traditional medical devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through bench testing, biocompatibility testing, and sometimes limited clinical data, rather than extensive performance studies with specified acceptance criteria for algorithm performance, reader improvement, or stand-alone accuracy against expert ground truth.
Disclaimer: This response is based solely on the provided text. If a detailed performance study with acceptance criteria, human reader comparisons, or AI performance metrics exists for this device, it is not included in the provided 510(k) summary.
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K051621
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JUL 1 1 2005
15 510(k) SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name:Contact: | EndoventionsDon CanalVice President RA/QA |
|---|---|
| Address: | 9013 Perimeter Woods, Suite |
te A Charlotte, NC 28216
| Telephone: | (704) 926 - 4837 |
|---|---|
| Fax: | (704) 926 - 4838 |
Date Prepared: June 17, 2005
General Device Information
| Product Name: | ALIMAXX-ETM Esophageal Stent System |
|---|---|
| Classification: | "Esophageal Prosthesis", Product code: ESW21 CFR 878.3610 - Class II |
Predicate Devices
Boston Scientific Corp. Inc. Ultraflex™ Esophageal NG Stent System [501(k) Number K032930]
Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559]
Description
The Endoventions Esophageal Stent Technology System is comprised of two components: the stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is selfexpanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a larger diameter
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K051621
Page 2 of 2
near the distal and proximal ends to minimize the possibility of the possible only near the distar and proximal strace to maintain a constant length over the entire overall stent geometry lo doclynbu to this unique design the stent has range of possible diamelers. The a facilitating the selection of the appropriate stent length.
Intended Use (Indications)
The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for The Endoventions ALMI 000 = = = == =========================================================================================================================================== haintaining CSOphagoal lamoir patt turnors. The stent is also indicated for occlusion of esophageal fistulae.
Substantial Equivalence
This Notice supports the position that the Endoventions Esophageal Stent is This Notice Supporte the position be of previously cleared devices, including the Substantially oqurvalorit to - Ultraflex™ Esophageal NG Stent System [501(k) Boston Scientifie Solph International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559].
The 510(k) Notice contains summaries of physical test results, and The STO(I) Notios ochaalite os specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998).
The data presented demonstrate that the device is biocompatible and is suitable for its indicated use.
The single-patient-use components of the ALIMAXX-E™ Esophageal Stent System are provided non-sterile.
Conclusions
Endoventions believes that the information provided establishes that similar Lindoventions believes have been used for the same clinical applications as the legally manced doness notent. The materials from which the Endoventions device is fabricated have an established history of use in clinical applications, device is labhoated have an octably in occordance have been tested in accordance with applicable FDA guidelines.
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Image /page/2/Picture/2 description: The image shows a black and white drawing of a bird in flight. The bird is facing left and has three lines that make up its body. There is some text in a circular pattern to the left of the bird. The text is not clear enough to read.
JUL 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville -MD 20050
Mr. Donald V. Canal Vice President RA/QA Endoventions 9013 Perimeter Woods, Suite A CHARLOTTE NC 28216
K051621 Re:
Trade/Device Name: Endoventions™ ALIMAXX-E™ Esophageal Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: June 17, 2005 Received: June 21, 2005
Dear Mr. Canal:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you'ls organism of substantial equivalence of your device to a legally prematice notification - results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire speoms acries for your of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, produse note the regulation on your responsibilities under the Act from the 007.77). Tournal ourers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
NITE RIDER
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K05/621
12 INTENDED USE STATEMENT
Device Name: Endoventions, ALIMAXX-E™ Esophageal Stent System
Indications For Use:
The Endoventions ALIMAXX-E™ Esophageal Stent System is intended for maintaining The Endovehilons ALIMAXA-E - Esophageal strictures caused by infrinsic and / or extinsic esophageal futher patchey in occlusion of esophageal fistulae.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancye Brogdon
(Division Sign-Off)
Division of Reproducive, Abdominal,
and Radiological Devices
310(k) Number K051621
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”