(50 days)
The Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.
The Alveolus/Endoventions ALIMAXX-E DV Esophageal Stent System provides an alternate method to deploy the Alveolus/Endoventions Esophageal stent. The implantable stent for the Alveolus/Endoventions ALIMAXX-E and the subject device are the same. The ALIMAXX-E DV delivery device provides a direct visualization (DV) of the stent deployment by providing a channel inside of the delivery device for a flexible endoscope. This channel allows the physician to directly visualize placement location, and deployment of the stent.
The provided text describes a medical device, the ALIMAXX-E DV Esophageal Stent System, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria through a performance study against a predefined standard.
Therefore, most of the requested information cannot be extracted from the given text.
Here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria or report performance metrics against such criteria. It states that "The 510(k) Notice contains summaries of physical test results for the delivery device as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998)" and "The data presented demonstrate that the device is suitable for its indicated use." However, the actual results or explicit acceptance criteria are not included in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided. The document mentions "physical test results" but does not detail the sample size or the nature of the data (e.g., in-vitro, in-vivo, clinical, retrospective/prospective).
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):
- Cannot be provided. This type of information is not relevant to a 510(k) submission focused on mechanical device testing and substantial equivalence, and therefore is not present. "Ground truth" in the context of expert review is typically associated with diagnostic or AI performance studies, which this is not.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. Not applicable or mentioned.
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:
- Cannot be provided. This is a medical device (stent system), not an AI diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. As noted above, "ground truth" as typically defined for diagnostic or AI studies is not relevant here. The "proof" for this device's suitability comes from physical testing and comparison to predicate devices, not from clinical ground truth establishment in the diagnostic sense.
8. The sample size for the training set:
- Cannot be provided. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set is mentioned.
{0}------------------------------------------------
MAR 2 2 /006
K060239
Pacze 1 of 2
15 510(k) SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Alveolus, Inc. |
|---|---|
| Contact: | Don Canal |
| Vice President RA/QA |
9013 Perimeter Woods, Suite A Address: Charlotte, NC 28216
| Telephone: | (704) 926 - 4837 |
|---|---|
| Fax: | (704) 926 - 4838 |
Date Prepared: January 16, 2006
General Device Information
| Product Name: | ALIMAXX-E DVTM Esophageal Stent System |
|---|---|
| Classification: | "Esophageal Prosthesis", Product code: ESW21 CFR 878.3610 - Class II |
Predicate Devices
Alveolus/Endoventions ALIMAXX-E Esophageal Stent System [510(k) Number K051621]
Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559]
Description
The Alveolus/Endoventions ALIMAXX-E DV Esophageal Stent System provides an alternate method to deploy the Alveolus/Endoventions Esophageal stent. The implantable stent for the Alveolus/Endoventions ALIMAXX-E and the subject device are the same. The ALIMAXX-E DV delivery device provides a direct visualization (DV) of the stent deployment by providing a channel inside of the
{1}------------------------------------------------
K060239
Page 2 of 2
delivery device for a flexible endoscope. This channel allows the physician to directly visualize placement location, and deployment of the stent.
Intended Use (Indications)
The Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.
Substantial Equivalence
This Notice supports the position that the Alveolus/Endoventions ALIMAXX-E DV Esophageal Stent is substantially equivalent to a number of previously cleared devices, including the Alveolus/Endoventions ALIMAXX-E Esophageal Stent System [510(k) Number K051621] and the Rusch International Polyflex Stent for the Esophagus with Introducer / Delivery System [510(k) Number K030559].
The 510(k) Notice contains summaries of physical test results for the delivery device as specified in the FDA Guidance Document for Testing Esophageal and Tracheal Prostheses (April 28, 1998).
The data presented demonstrate that the device is suitable for its indicated use.
The single-patient-use components of the ALIMAXX-E DV™ Esophageal Stent System are provided non-sterile.
Conclusions
Alveolus/Endoventions believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the subject device. The materials from which the Alveolus/Endoventions device is fabricated have an established history of use in clinical applications, and the devices produced by Alveolus/Endoventions have been tested in accordance with applicable FDA quidelines.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The image is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2006 .
Mr. Donald V. Canal Vice President RA/QA Alveolus, Inc. 9013 Perimeter Woods, Suite A CHARLOTTE NC 28216
Re: K060239
Trade/Device Name: Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: January 27, 2006 Received: January 31, 2006
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.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins leter with anon-you to organizatial equivalence of your device of your device to a legally prematics notification: "The PDF manings" proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire speatre 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 C) (1) Also, prease note the regulation on your responsibilities under the Act from the 801:37). Tournal Manufacturers, 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.litml.
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
{4}------------------------------------------------
12 INTENDED USE STATEMENT
Device Name: Alveolus/Endoventions, ALIMAXX-E DV™ Esophageal Stent System
Indications For Use:
The Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System is intended for The Aveous/Endoventions ALM/ OO L D + Loophageal strictures caused by intrinsic and / maintaining occamaged nors and for 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)
Nancy Bragdon
(Division Sign-Off)
Division of Reproductive, Abdominal. and Radiological Devi 510(k) Number
§ 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.”