The proposed Esophageal, Biliary and Tracheobronchial Ultraflex stents are comprised of two components, a metallic expandable stent and a flexible delivery catheter. The stents are mounted on a delivery catheter. The delivery catheter is placed over a guidewire and through the working channel of an endoscope to deliver the stents are available in a variety of diameters and lengths.

AI/ML Overview

This document is a 510(k) summary for the Boston Scientific Ultraflex™ Stent Systems, seeking a labeling claim for MRI safety and compatibility. It is a Special 510(k), which implies modifications to an already cleared device, primarily regarding labeling for performance characteristics rather than changes to the fundamental design or indications for use. As such, the information provided focuses on the MRI safety claim rather than a comprehensive assessment of the stent system's primary clinical performance.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the primary functions of the stents (e.g., esophageal, biliary, or tracheobronchial stricture treatment). The focus of this 510(k) is specifically on MRI safety and compatibility.

For the MRI safety and compatibility claim, the document states:

Acceptance Criteria (Implied): The stent system must be demonstrated as "MRI safe and MRI compatible." While specific numerical thresholds for aspects like magnetic field interaction, heating, or image artifact are not quantified in this summary, the general acceptance criterion is that the device does not pose an unacceptable risk or degrade image quality significantly in an MRI environment.
Reported Device Performance: "Bench testing was conducted to support the MRI safety and compatibility claim." No specific quantified results of this bench testing (e.g., deflection angles, temperature rises, artifact sizes) are provided 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):

Sample Size: Not specified for the bench testing. For MRI compatibility testing of medical devices, the "sample size" typically refers to the number of device units tested.
Data Provenance: The bench testing would have been conducted in a laboratory setting, likely within Boston Scientific or a contract research organization. The document doesn't specify country of origin or whether it was retrospective/prospective, but bench testing is generally considered prospective in its execution for a regulatory submission.

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):

This question is not applicable to the type of study described. Bench testing for MRI safety and compatibility typically involves engineers and physicists conducting standardized tests according to recognized standards (e.g., ASTM F2052, F2182, F2119). Expert clinical interpretation (like from a radiologist) would not be directly involved in establishing "ground truth" for the physical properties measured during MRI bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 refer to a process for resolving discrepancies in expert opinions, typically in clinical studies or image interpretation. Bench testing results are usually objective measurements that do not require such adjudication.

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:

Not applicable. This submission concerns a physical medical device (stent) and its MRI compatibility, not an AI or imaging diagnostic product. Therefore, MRMC studies or AI assistance are not relevant to this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For MRI safety and compatibility bench testing, the "ground truth" is established by the physical measurements and properties of the device under specific, controlled MRI conditions, following recognized industry standards (e.g., ASTM standards for MRI compatibility). The "truth" is the measured magnetic field interaction, temperature rise, or image artifact extent.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would have a "training set."

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three profiles, representing the department's focus on health, human services, and well-being. The seal is simple and monochromatic.

AUG 15 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, Minnesota 55311

Re: K012883

Trade/Device Name: Ultraflex Stent Systems (i.e., Ultraflex Esophageal Stent System, Ultraflex Diamond Biliary Stent System, and Ultraflex Tracheobronchial Stent System) Regulation Number: 21 CFR 878.3610, 21 CFR 876.5010. and 21 CFR 878.3720

Regulation Name: Prosthesis, tracheal, expandable Regulatory Class: II Product Code: ESW, FGE, and JCT Dated: October 1, 2001 Received: October 2, 2001

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of October 12, 2001.

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 (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 (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

{1}------------------------------------------------

Page 2 - Ms. Angela Byland

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 continue 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Hubert Lermus

Mark N. Melkerson Director

Division of General, Restorative and Neurological Devices Office of Device Evaluatin Center for Devices and Radiological Devices

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

Indications for Use

K012883 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ultraflex Diamond Biliary Stent

Indications For Use:

The Ultraflex Diamond Biliary Stent is indicated for palliative treatment of patients with malignant biliary strictures.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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 of General, Restorative, and Neurological Devices Page 1 of _

6012883 510(k) Number_

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

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Ultraflex Esophageal Stent System Device Name:

Indications For Use:

The Ultraflex Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalyation (ODE)

Hule Leun

(Division Sign-Division of General, I Restor and Neurological Devices

1012883 510(k) Number_

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K012883

Ultraflex™ Tracheobronchial Stent System Device Name:

Indications for Use:

The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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 of General, Restorative, Page 1 of 1
and Neurological Devices

510(k) Number K012883

{5}------------------------------------------------

D12883 p. 1 of 2

Image /page/5/Picture/1 description: The image shows the logo for Boston Scientific. The text "Boston" is stacked on top of the text "Scientific". The font is a serif font and the text is black.

510(K) SUMMARY K012883

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4942 Fax: 508-683-5939

Contact: Kathleen Morahan Director Regulatory Affairs Original Date Prepared: August 6, 2001 Revision Date: July 14, 2006

. 2. Device:

Trade Name: Ultraflex™ Esophageal Stent System Common Name: Esophageal Prosthesis Classification Name: Esophageal Prosthesis Regulation Number: 878.3610 Product Code: ESW Classification: Class II

Trade Name: Ultraflex™ Diamond Biliary Stent System Common Name: Biliary Stent Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II

Trade Name: Ultraflex™ Tracheobronchial Stent System Common Name: Tracheal Prosthesis Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT Classification: Class II

3. Predicate Device:

Boston Scientific Corporation's Ultraflex™ Esophageal Stent System, K940838 Boston Scientific Corporation's Ultraflex™ Diamond Biliary Stent System, K962899 Boston Scientific Corporation's Ultraflex™ Tracheobronchial Stent System, K963241

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Boston Scientific. The logo is black and white. The words "Boston Scientific" are written in a serif font, with "Boston" on the top line and "Scientific" on the bottom line. There is a black triangle in the upper left corner of the image.

012883 p. 2 of 2

4. Device Description:

5. Intended Use:

The proposed Ultraflex Esophageal Stent System is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The proposed Ultraflex Diamond Biliary Stent System is indicated for palliative treament of patients with malignant biliary strictures.

The proposed Ultraflex Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

6. Technological Characteristics:

There are no differences in the technological characteristics between the proposed and predicate devices. The purpose of this Special 510(k) is to request a labeling claim that the Ultraflex stents are MRI safe and MRI compatible.

7. Performance Data:

Bench testing was conducted to support the MRI safety and compatibility claim.

8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Esophageal, Biliary and Tracheobronchial Ultraflex stents are substantially equivalent to Boston Scientific Corporation's currently marketed Esophageal, Biliary and Tracheobronchial Ultraflex stents.

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.”