The BONASTENT® Tracheal/Bronchial (BTB) is a self-expanding tubular prosthesis designed to maintain patency of tracheobronchial strictures caused by malignant tumors. The stent is made of Nitinol wire and is weaved using a hook & cross wire construction; a silicon membrane covers the stent and is designed to prevent stent migration. Stent sizes range in diameter from 10mm to 20mm and in length from 50mm to 80mm.

The BONASTENT® Tracheal/Bronchial is available on two types of delivery devices. The Y-Shape Handle Delivery Device is used for stents with an outer diameter of 10Fr and less. The I-Shape Handle Delivery Device which is used for stents with an outer diameter larger than 10F.

AI/ML Overview

The provided text describes the 510(k) Summary for the BONASTENT® Tracheal/Bronchial device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with explicit acceptance criteria and device performance metrics in the typical sense of a clinical trial. However, it does outline performance characteristics compared to its predicate.

Here's an analysis based on the information provided, framed to address your request for acceptance criteria and supporting studies where possible, while noting limitations due to the nature of a 510(k) summary for a stent:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a tracheal/bronchial stent), the "acceptance criteria" are implicitly defined by demonstrating equivalence to a legally marketed predicate device (AERO Tracheobronchial Stent System). The performance data supplied are comparative benchmarks rather than direct acceptance criteria against a defined threshold.

Performance Metric	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (BONASTENT® Tracheal/Bronchial)	Predicate Device Performance (AERO Tracheobronchial)
Intended Use	Treatment of tracheobronchial strictures caused by malignant neoplasms.	Treatment of tracheobronchial strictures caused by malignant neoplasms.	Treatment of tracheobronchial strictures caused by malignant neoplasms.
Stent Material	Nitinol	Nitinol	Nitinol
Covering Material	(Compared for differences)	Silicone	Polyurethane membrane
Stent Diameter (mm)	10, 12, 14, 16, 18, 20	10, 12, 14, 16, 18, 20	10, 12, 14, 16, 18, 20
Stent Length (mm)	20-80	20-80	20-80
Delivery Diameter	(Compared for differences)	8F - 12F	16F and 22F
Deployment Time	(Reference, as predicate unknown)	Non-aged stents average 16.97 sec; Aged stents 16.4 sec	Unknown
Expansion Force (10x20 stent)	Comparable to 0.390 lbs. (AERO)	0.367 lbs.	0.390 lbs.
Expansion Force (20x80 stent)	Comparable to 0.763 lbs. (AERO)	0.748 lbs.	0.763 lbs.
Compression Force (10x20 stent)	Comparable to 0.519 lbs. (AERO)	0.517 lbs.	0.519 lbs.
Compression Force (20x80 stent)	Comparable to 1.026 lbs. (AERO)	1.026 lbs.	1.026 lbs.
Corrosion Resistance (in simulated gastric fluid)	Comparable to predicate (which is unknown, but "Resistant" is the claim)	Resistant to corrosion for a duration equivalent to 3 years	Unknown
Biocompatibility	Demonstrated	Passed various tests (Cytotoxicity, Maximization sensitization, Acute systemic toxicity, Rabbit Pyrogen Study, Intracutaneous reactivity, Bacterial reverse mutation assay, Intramuscular implantation study)	Passed (implied previous results for reference devices)
Deployment Testing	Accuracy and repeatability of the delivery system validated.	All components, subassemblies, and/or full devices met required specifications.	N/A (Internal test)
Dimensional Testing	Reproducibility of stent length and diameter after deployment verified.	All components, subassemblies, and/or full devices met required specifications.	N/A (Internal test)
Tensile Strength Tests	Performed for deployment system components with bonds/welds.	All components, subassemblies, and/or full devices met required specifications.	N/A (Internal test)

2. Sample Size Used for the Test Set and Data Provenance

The "test set" in this context refers to the samples used in bench testing.

Sample Size: Not explicitly stated for each test, but implied to be sufficient for the validation and comparative testing performed on the stent models (e.g., 10x20 and 20x80 stents) and deployment systems.
Data Provenance: The studies are described as "Bench Testing" and "in-vitro tests," meaning they were conducted in a laboratory environment. There is no information regarding country of origin for the data or whether it's retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. This document pertains to bench testing and substantial equivalence, not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical data review, typically by medical experts for diagnoses or outcomes, which is not part of this bench testing summary.

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 a medical device (stent) submission, not an AI diagnostic or assistive device.

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

Not applicable. This is a medical device (stent) submission, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" is defined by the physical properties measured against established engineering and material standards, or by direct comparison to the predicate device's measured performance. For instance, expansion force measurements are compared directly to the predicate's measurements. Biocompatibility relies on standardized tests.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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

October 17, 2014

EndoChoice, Incorporated C/O Ms. Bosmat Friedman Regulatory Consultant Push-Med LLC/MJ RAC 1208-12 Rockford Road Toronto, ON M2R3A2 CANADA

Re: K140472

Trade/Device Name: BONASTENT® Tracheal/Bronchial Regulation Number: 878.3720 Regulation Name: Prosthesis, Tracheal, Expandable Regulatory Class: Class II Product Code: JCT Dated: September 15, 2014 Received: September 17, 2014

Dear Ms. Friedman:

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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140472

Device Name

BONASTENT® Tracheal/Bronchial

Indications for Use (Describe)

The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

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Section 5

510(k) Summary

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510(K) SUMMARY [as required by section 807.92(c)] BONASTENT® Tracheal/Bronchial 510(k) Number K140472

SUBMITTER 1.

Applicant's Name:

EndoChoice, Inc. 18110 Wills Road, Suite 100 Alpharetta, GA 30009 Phone: 678-534-6021 Fax: 770-410-9008

Contact Person:

Bosmat Friedman Regulatory Affairs Consultant 647-975-3974 bosmat@pushmed.com

Date Prepared (revised):

October 15, 2014

2. DEVICE

Trade Name: BONASTENT® Tracheal/Bronchial

Common or Usual Name:

Tracheal Prosthesis

Classification:

Name: Prosthesis, Tracheal, Expandable Product Code: JCT Regulation No: 878.3720 Class: 2 Classification Panel: General & Plastic Surgery

PREDICATE DEVICES 3.

Main Predicate:

· AERO Tracheobronchial Stent System by Alveolus, Inc; K062511. Reference devices:

· Bonastent™ Esophageal by EndoChoice Inc.; K092144.
· Bonastent™ Biliary by EndoChoice Inc .; K093003.

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4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6. PREDICATE DEVICE

The stent weaving and construction is identical to the weaving and construction of both Bonastent predicates. The Y-shape Handle delivery device is identical to the delivery device of the BONASTENT Biliary cleared under K093003. The I-Shape Handle delivery device is identical to the delivery device of the Bonastent Esophageal cleared under K092144.

The stent part was tested for compression and expansion and compared to the AERO stent. The results of the tests support the company's claim of substantial equivalence.

7. PERFORMANCE DATA

Bench Testing

The following performance tests were conducted in accordance with FDA Guidance for Industry - Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses:

#	Name of Test	Purpose
1	DeploymentTesting	To validate the accuracy and repeatability of the delivery system
2	Expansion Force	To measure the force exerted by the metal self-expanding stent duringexpansion (compared to predicate)
3	CompressionForce Testing	To measure the force required to compress the metal self-expandingtypes of stents after expansion (compared to predicate)
4	DimensionalTesting	To verify the reproducibility of the metal self-expanding types ofstents length and diameter after deployment
5	CorrosionTesting	To establish the compatibility of the stent materials with the corrosiveenvironment in the tracheobronchial tree
6	Tensile strengthtests	Performed for any deployment system that includes components thatare bonded or welded

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The in-vitro tests that were performed confirm that all components, subassemblies, and/or full devices met the required specifications.

The comparative tests that were performed (expansion and compression) support our substantial equivalence claim to the AERO Tracheobronchial Stent System (K062511).

Biocompatibility

Due to the similarities in materials and manufacturing techniques between the Bonastent Tracheal/Bronchial stent and its reference predicate devices the company relied on the previous results that were obtained. The following tests were conducted on the reference devices:

Stent Part

Cytotoxicity i
Maximization sensitization ।
-Acute systemic toxicity
Rabbit Pyrogen Study ।
-Intracutaneous reactivity
Bacterial reverse mutation assay -
Intramuscular implantation study (13 and 26 week). -

Deliverv Device

Cytotoxicity ।
Maximization sensitization -
Rabbit Pyrogen Study ।
Intracutaneous reactivity ।

SUBSTANTIAL EQUIVALENCY TABLE 8.

The following table illustartes the similarties and differences bewteen the subject device and the main predicate, the AERO stent:

Product name	BONASTENT®Tracheal/Bronchial StentSystem	AERO TracheobronchialStent System
510(k) No.	K140472	K062511
Intended Use	The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.	The Alveolus AERO™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Stent material	Nitinol	Nitinol
Covering material	Silicone	polyurethane membrane
Stent diameter (mm)	10, 12, 14, 16, 18 and 20	10, 12, 14, 16, 18 and 20
Stent length (mm)	20-80	20-80
Delivery diameter	8F - 12F	16F and 22F
Deployment time	Non-aged stents average 16.97 secAged stents 16.4 sec	Unknown

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Expansion Force
	10X20 0.367 lbs.20X80 0.748 lbs.	10X20 0.390 lbs.20X80 0.763 lbs.
Compression force
	10X20 0.517 lbs.20X80 1.026 lbs.	10X20 0.519 lbs.20X80 1.026 lbs.
Corrosion (insimulated gastricfluid)	Resistant to corrosion fora duration equivalent to 3years	Unknown

Conclusion:

The Bonastent Tracheal/Bronchial has the same intended use and indication as the AERO stent. The two main differences between the Bonastent Tracheal/Bronchial and the AERO are: 1) different covering material and 2) different delivery device diameter. The results of the comparative testing (expansion and compression testing) as well as the biocompatibility results support our claim that the Bonastent Tracheal/Bronchial stent is substantially equivalent to the AERO stent.

Furthermore, the Bonastent Tracheal/Bronchial is substantially equivalent in technological characteristics to the two reference devices, Bonastent™ Esophageal and Bonastent™ Biliary.

Consequently, it is clear that the Bonastent Tracheal/Bronchial is substantially equivalent to its predicate and reference devices.

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.”