The Ultraflex™ Tracheobronchial Uncovered Stent System consists of a self-expanding nitinol stent preloaded onto a flexible delivery catheter. The stent is a permanent implant designed to provide intraluminal support to keep open the inner wall of the tracheobronchial tree. A suture is threaded through the stent loops at the proximal end of the stent, to aid in stent removal during the initial procedure in the event of incorrect placement. The stent is preloaded onto the delivery catheter via crocheting of the deployment suture around the stent onto the delivery catheter. The system is provided sterile.

The Ultraflex™ Tracheobronchial Stent is available with either a proximal or distal release system. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The proximal release system begins stent deployment from the upper (proximal) end of the delivery catheter.

The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire, and has two (2) radiopaque (RO) markers on the delivery system to facilitate fluoroscopic placement.

To deliver the stent, the stent delivery system is passed over the guidewire into the tracheobronchial lumen. The delivery catheter is advanced, so that the stent is in the appropriate implant position. This positioning step is conducted under fluoroscopy and/or by bronchoscopic visualization of the stent. The stent is deployed by holding the handle hub in the palm of one hand, and grasping the finger ring, that is attached to the deployment suture, with the other hand. By retracting the finger ring the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. This deployment technique is identical to the predicate Ultraflex stent. The deployed stent expands and creates a scaffold support to assist in maintaining lumen patency of the airway at the implant position.

The materials of the stent material, the delivery catheter and the deployment suture are identical to those of the predicate Ultraflex™ Tracheobronchial Stent System (K012883, K963241).

The retention suture material is identical to that of the predicate Ultraflex™ Esophageal NG Stent System (K091816). The wire knot adhesive and the retention suture knot adhesives have been changed to Ultraviolet (UV) cured adhesives with enhanced strength and shorter manufacturing curing times.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ultraflex™ Tracheobronchial Uncovered Stent System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute performance against specific acceptance criteria through a clinical study with human readers and ground truth.

Therefore, many of the requested categories for AI/ML device studies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training sets) are not applicable to this submission.

However, based on the provided text, I can extract information related to the performance data and the conclusion of the study to demonstrate the device meets acceptance criteria by showing substantial equivalence to predicate devices.

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

The acceptance criteria here are implicitly based on demonstrating that the new device is as safe, as effective, and performs as well as the predicate devices. The performance data presented demonstrates that the device met required specifications which are aligned with these criteria.

Acceptance Criteria (Implicit from 510(k) Equivalence)	Reported Device Performance
Material Equivalence & Performance: New device materials, design, and manufacturing processes are substantially equivalent to predicate devices, and perform comparably regarding physical characteristics.	"The materials of the stent material, the delivery catheter and the deployment suture are identical to those of the predicate Ultraflex™ Tracheobronchial Stent System (K012883, K963241).""The retention suture material is identical to that of the predicate Ultraflex™ Esophageal NG Stent System (K091816).""In-vitro and In-vivo testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.""Testing included but was not limited to: Dimensional, fatigue, compression, expansion, deployment accuracy, integrity.""Fatigue, compression, expansion, deployment accuracy and integrity testing were successfully conducted in simulated use bench models."
Sterility: Device meets established sterility standards.	"Sterility was performed using Ethylene Oxide according ANSVAAMI 11135-1: 2007 with an Sterility Assurance Level of 10-6. Sterilization residuals comply with ANSI/AAMI 10993-7: 2008."
Biocompatibility: Device materials are biocompatible.	"Biocompatibility was confirmed via AAMI/ANSI/ISO 10993-1: 2009. Testing included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, acute systemic toxicity, subacute toxicity - intravenous and intraperitoneal, genotoxicity - Ames assay and mouse lymphoma, and an intramuscular toxicity implant test."
Pyrogenicity: Device does not contain pyrogens.	"No detectable endotoxin was confirmed via Pyrogen testing conducted according to AAMI ST72 and USP 85 and USP 161."
Overall Safety & Effectiveness: Device is as safe, effective, and performs as well as predicate devices for its intended use.	"Boston Scientific Corporation has demonstrated that no significant differences exist between the proposed UltraflexTM Tracheobronchial Stent System and the predicate Ultraflex™ Tracheobronchial Stent System (K012883), the predicate UltraflexTM Esophageal NG Stent System (K091816), and the predicate Merit Medical Endotek Aero™ Tracheobronchial Stent System (K082284, K083625). Therefore, the Ultraflex™ Tracheobronchial Stent System is as safe, as effective and performs as well as the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "In-vitro and In-vivo testing" and "simulated use bench models." It also states, "Testing was conducted on both the proposed sterile Ultraflex™ Tracheobronchial Stent and the non-sterile Aero™ Tracheobronchial Stent System." However, specific sample sizes (e.g., number of stents tested for each parameter) are not provided. The data provenance is internal testing performed by Boston Scientific Corporation. The nature of the tests (bench models, in-vitro/in-vivo) suggests a prospective, controlled testing environment rather than retrospective data from a specific country of origin.

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)

Not applicable. This is a medical device submission, not an AI/ML algorithm study requiring human experts to establish ground truth for image or data interpretation. The "ground truth" for this device's performance is established by meeting engineering specifications and scientific standards in a lab setting, rather than expert consensus on clinical cases.

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

Not applicable. This is not an AI/ML algorithm study that would involve adjudication of expert interpretations.

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 is not an AI/ML algorithm that assists human readers. No MRMC study was conducted.

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

Not applicable. As this device is a physical medical implant, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently its function when implanted or used.

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

The "ground truth" for this device's performance is based on documented engineering specifications, international standards (e.g., ANSVAAMI, AAMI/ANSI/ISO, USP), and established scientific testing methodologies (e.g., cytotoxicity tests, fatigue tests, pyrogen testing). Performance is measured against these objective criteria rather than subjective expert consensus, pathology, or clinical outcome data in the context of an AI/ML study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set for an AI/ML algorithm was used.

Summary

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REVISED SECTION 6

510(k) Summary

3 2012 AUG

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752 Telephone: 508-683-4454 Fax: 508-683-5939

Contact: Thomas Hirte Senior Manager Regulatory Affairs Date Prepared: May 18, 2012

2. Proposed Device

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

3. Predicate Device:

Ultraflex™ Tracheobronchial Stent System Trade Name: Manufacturer and Clearance No .: Boston Scientific Corporation, K963241; K012883 Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product code: JCT Classification: Class II

Ultraflex™ Esophageal NG Stent System Trade Name: Manufacturer and Clearance Number: Boston Scientific Corporation, K091816 Classification Name: Esophageal Prosthesis Regulation Number: 878.3610 Product code: ESW Class II Classification:

Trade Name:	Aero DV TM Tracheobronchial Stent System
Manufacturer and Clearance Number:	Alveolus Inc. (Merit Medical Endotek), K083625, K082284
Classification Name:	Tracheal Prosthesis
Regulation Number:	878.3720.
Product code:	JCT
Classification:	Class II

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4. Proposed Device Description

The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire, and has two (2) radiopaque (RO) markers on the delivery system to facilitate fluoroscopic placement.

The materials of the stent material, the delivery catheter and the deployment suture are identical to those of the predicate Ultraflex™ Tracheobronchial Stent System (K012883, K963241).

Boston Scientific believes that these changes are minor improvements and do not significantly impact the overall performance of the device for its intended use.

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

The uncovered product offerings are as follows:

StentDiameter(mm)	Stent length (mm)
	20	30	40	60
8	✓	N/A	✓	N/A
10	✓	✓	✓	N/A
12	✓	✓	✓	N/A
14	✓	✓	✓	✓
16	N/A	N/A	✓	✓
18	N/A	N/A	✓	✓
20	N/A	N/A	✓	✓

N/A - Not Offered

5. Intended Use:

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

6. Technological Characteristics:

The material changes discussed in this premarket notification are identical to the materials changes cleared for the Ultraflex™ Esophageal NG Stent System (K091816). The proposed Ultraflex™ Tracheobronchial Stent System is nearly identical in design, materials, and manufacturing processes to the Ultraflex™ Esophageal NG Stent System (K091816) and the Ultraflex™ Tracheobronchial Stent System (K012883). The proposed Ultraflex Tracheobronchial Stent System is similar in design, and mode of action and intended use of the Merit Medical Endotek Aero DV™ Tracheobronchial Stent System (K082284. K083625).

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7. Performance Data:

In-vitro and In-vivo testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. This 510(k) Notification contains physical test results for the Ultraflex™ Tracheobronchial Stent System as specified in the FDA "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prosthesis" document (April 28, 1998) as requested by the FDA. Testing included but was not limited to: Dimensional, fatigue, compression, expansion, deployment accuracy, integrity, sterility and biocompatibility.

Fatigue, compression, expansion, deployment accuracy and integrity testing were successfully conducted in simulated use bench models. Testing was conducted on both the proposed sterile Ultraflex™ Tracheobronchial Stent and the non-sterile Aero™ Tracheobronchial Stent System.

Sterility was performed using Ethylene Oxide according ANSVAAMI 11135-1: 2007 with an Sterility Assurance Level of 106. Sterilization residuals comply with ANSI/AAMI 10993-7: 2008.

Biocompatibility was confirmed via AAMI/ANSI/ISO 10993-1: 2009. Testing included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, acute systemic toxicity, subacute toxicity - intravenous and intraperitoneal, genotoxicity - Ames assay and mouse lymphoma, and an intramuscular toxicity implant test.

No detectable endotoxin was confirmed via Pyrogen testing conducted according to AAMI ST72 and USP 85 and USP 161.

8. Conclusion:

Boston Scientific Corporation has demonstrated that no significant differences exist between the proposed UltraflexTM Tracheobronchial Stent System and the predicate Ultraflex™ Tracheobronchial Stent System (K012883), the predicate UltraflexTM Esophageal NG Stent System (K091816), and the predicate Merit Medical Endotek Aero™ Tracheobronchial Stent System (K082284, K083625). Therefore, the Ultraflex™ Tracheobronchial Stent System is as safe, as effective and performs as well as the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 3 2012

Boston Scientific Corporation Ms. Janis F. Taranto Endoscopy Division 100 Boston Scientific Way Marlborough, Massachusetts 01752

Re: K121048

Trade/Device Name: UltraFlex™ Tracheobronchial Stent System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: II Product Code: JCT Dated: June 15, 2012 Received: June 18, 2012

Dear Ms. Taranto:

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. 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.

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Page 2- Ms. Taranto

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hh foc

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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SECTION 4

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	TBD
Device Name:	Ultraflex™ Tracheobronchial Stent System
Indications for Use:	The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasins.

X 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)

K121048

Rul J. P. 21

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

510(k) Premarket Notification, Ultraflex™ Tracheobronchlal Stent System

Regulation Number and Section

§ 878.3720 Tracheal prosthesis.

(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal 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.”

StentDiameter(mm)	Stent length (mm)
	20	30	40	60
8	✓	N/A	✓	N/A
10	✓	✓	✓	N/A
12	✓	✓	✓	N/A
14	✓	✓	✓	✓
16	N/A	N/A	✓	✓
18	N/A	N/A	✓	✓
20	N/A	N/A	✓	✓

StentDiameter(mm)	Stent length (mm)
	20	30	40	60
8	✓	N/A	✓	N/A
10	✓	✓	✓	N/A
12	✓	✓	✓	N/A
14	✓	✓	✓	✓
16	N/A	N/A	✓	✓
18	N/A	N/A	✓	✓
20	N/A	N/A	✓	✓

StentDiameter(mm)	Stent length (mm)
	20	30	40	60
8	✓	N/A	✓	N/A
10	✓	✓	✓	N/A
12	✓	✓	✓	N/A
14	✓	✓	✓	✓
16	N/A	N/A	✓	✓
18	N/A	N/A	✓	✓
20	N/A	N/A	✓	✓