Esophageal stenoses (strictures), such as stenting refractory benign . strictures and/or malignant strictures (resectable and non-resectable)
. Stenting esophago-respiratory fistulas
Maintaining esophagus lumen patency in esophageal strictures caused by . intrinsic or extrinsic tumors

Device Description

The Polyflex Esophageal Stent System consists of a stent and delivery system. The stent is composed of a polyester braided material encapsulated with silicone. The stent has blue (endoscopic control) and black (fluoroscopic control) markers at both ends and in the center to aid with stent positioning. The delivery system is provided unassembled and consists of the following components:

Delivery tube. Used to deliver the stent into the esophagus ●
Stent Loader. With basket for loading the stent into the Delivery tube ●
Wire Guide with Dilator and stent clamp. For atraumatic introduction of . the Delivery tube into the esophagus using a guidewire
Graduated Soft Positioner. Flexible aid with inner channel to deploy the . stent from the Delivery tube
. Stopper. Aid for the temporary fixation of the Polyflex stent during the loading procedure into the Delivery tube.

AI/ML Overview

The provided document (K080332) describes a 510(k) premarket notification for the Polyflex Esophageal Single-Use Stent System. This submission is a request to clarify the existing indication for use of an already marketed device (K030559), specifically by adding "resectable or non-resectable" to the stricture types.

Therefore, this submission does not contain information about new performance testing or studies conducted for this specific 510(k). It explicitly states: "No new materials or design changes were introduced. Therefore, the performance testing presented in 510(k) K030559 was not repeated."

As a result, I cannot provide details on the acceptance criteria and a study that proves the device meets those criteria from this document (K080332). The requested information typically comes from the original submission (K030559) or a new submission involving design changes or new performance claims.

Here's a breakdown of why I cannot answer each point based on the provided text:

A table of acceptance criteria and the reported device performance: Not available in this document. This 510(k) references the performance testing from K030559, but doesn't reproduce it.
Sample sized used for the test set and the data provenance: Not available. This would have been part of the K030559 submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission, as no new performance testing was conducted.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this submission, as no new performance testing was conducted.
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: Not applicable. This document describes a medical device (stent), not an AI-powered diagnostic or decision support system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document describes a medical device (stent), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available. This would have been part of the K030559 submission.
The sample size for the training set: Not applicable. This document describes a medical device (stent), not a machine learning model.
How the ground truth for the training set was established: Not applicable. This document describes a medical device (stent), not a machine learning model.

In summary, the provided 510(k) (K080332) is a "Special 510(k)" or similar submission to modify an existing indication of a substantially equivalent device, not a de novo submission with new performance data. To find the requested performance data and acceptance criteria, one would need to access the K030559 submission.

Summary

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K080332
Page 1 of 2

Section 5 510(k) Summary

1. Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4359 Fax: 508-683-5939

Contact: Ashley Pyle Regulatory Affairs Specialist Date Prepared: February 6, 2008

2. Device

Trade Name: Polyflex Esophageal Single-Use Stent System Common Name: Prosthesis, Esophageal Classification Name: Prosthesis, Esophageal Regulation Number: 878.3610 Product Code: ESW Classification: Class II

3. Predicate Devices

Polyflex Esophageal Single-Use Stent System, K030559

4. Device Description

Delivery tube. Used to deliver the stent into the esophagus ●
Stent Loader. With basket for loading the stent into the Delivery tube ●
Wire Guide with Dilator and stent clamp. For atraumatic introduction of . the Delivery tube into the esophagus using a guidewire
Graduated Soft Positioner. Flexible aid with inner channel to deploy the . stent from the Delivery tube
. Stopper. Aid for the temporary fixation of the Polyflex stent during the loading procedure into the Delivery tube.

SEP - 5 2008

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K080332
Page 2 of 2

5. Intended Use:

The Polyflex Esophageal Stent System is indicated for stenting:

Esophageal stenoses, such as stenting refractory benign strictures . and malignant strictures (resectable or nonresectable)
� Stenting esophago-respiratory fistulas
Maintaining esophageal lumen patency in esophageal strictures . caused by intrinsic or extrinsic tumors

6. Technological Characteristics:

The proposed Polyflex Esophageal Stent System has identical technological characteristics (materials, construction, manufacturing processes) as the currently marketed Polyflex Esophageal Stent System.

7. Performance Data:

This is a request to clarify the indication for stenting of esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures, by including resectable or non-resectable strictures. No new materials or design changes were introduced. Therefore, the performance testing presented in 510(k) K030559 was not repeated.

8. Conclusion:

The proposed Polyflex Esophageal Stent System is substantially equivalent to the currently marketed Polyflex Esophageal Stent System. BSC is requesting to clarify the indication for, stenting of esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures, by adding resectable and non-resectable strictures, in order define the stricture types, which are within the currently cleared indication, but not explicitly stated,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines emanating from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 200

Ms. Ashley Pyle Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752-1234

K080332 Re:

Trade/Device Name: Polyflex™ Single-Use Esophageal Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: August 28, 2008 Received: August 29, 2008

Dear Ms. Pyle:

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. Iisting 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 (PMA), 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.

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

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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Indications for Use;

510(k) Number (if known): K080332

Device Name: Polyflex Single-Use Esophageal Stent System

Indications for Use:

Stenting:

Esophageal stenoses (strictures), such as stenting refractory benign . strictures and/or malignant strictures (resectable and non-resectable)
. Stenting esophago-respiratory fistulas
Maintaining esophagus lumen patency in esophageal strictures caused by . intrinsic or extrinsic tumors

Prescription Use X (Part 21 CFR 801 Part 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)

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.”