(234 days)
No
The summary describes a mechanical stent and delivery system with no mention of AI or ML capabilities.
Yes.
The device is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms, which is a therapeutic purpose.
No
Explanation: The device is a self-expanding tubular prosthesis designed to maintain patency of tracheobronchial strictures, which is a therapeutic function, not a diagnostic one. Its intended use is treatment, not diagnosis.
No
The device is a physical stent made of Nitinol wire and a silicon membrane, delivered via a physical delivery system. It is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "treatment of tracheobronchial strictures caused by malignant neoplasms." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a "self-expanding tubular prosthesis designed to maintain patency of tracheobronchial strictures." This is a physical implant used to treat a condition within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
The BONASTENT® Tracheal/Bronchial Stent System is a medical device used for treatment, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The BONASTENT® Tracheal/Bronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms.
Product codes
JCT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronchial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Deployment Testing: To validate the accuracy and repeatability of the delivery system.
- Expansion Force: To measure the force exerted by the metal self-expanding stent during expansion (compared to predicate).
- Compression Force Testing: To measure the force required to compress the metal self-expanding types of stents after expansion (compared to predicate).
- Dimensional Testing: To verify the reproducibility of the metal self-expanding types of stents length and diameter after deployment.
- Corrosion Testing: To establish the compatibility of the stent materials with the corrosive environment in the tracheobronchial tree.
- Tensile strength tests: Performed for any deployment system that includes components that are bonded or welded.
The in-vitro tests confirm that all components, subassemblies, and/or full devices met the required specifications.
The comparative tests (expansion and compression) support the claim of substantial equivalence to the AERO Tracheobronchial Stent System (K062511).
Biocompatibility:
Tests conducted on reference devices (due to similarities in materials and manufacturing techniques):
Stent Part:
- Cytotoxicity
- Maximization sensitization
- Acute systemic toxicity
- Rabbit Pyrogen Study
- Intracutaneous reactivity
- Bacterial reverse mutation assay
- Intramuscular implantation study (13 and 26 week).
Delivery Device:
- Cytotoxicity
- Maximization sensitization
- Rabbit Pyrogen Study
- Intracutaneous reactivity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Expansion Force: For BONASTENT® Tracheal/Bronchial Stent System: 10X20 0.367 lbs., 20X80 0.748 lbs. For AERO Tracheobronchial Stent System: 10X20 0.390 lbs., 20X80 0.763 lbs.
- Compression force: For BONASTENT® Tracheal/Bronchial Stent System: 10X20 0.517 lbs., 20X80 1.026 lbs. For AERO Tracheobronchial Stent System: 10X20 0.519 lbs., 20X80 1.026 lbs.
- Corrosion (in simulated gastric fluid): Resistant to corrosion for a duration equivalent to 3 years.
- Deployment time: Non-aged stents average 16.97 sec, Aged stents 16.4 sec.
Predicate Device(s)
AERO Tracheobronchial Stent System by Alveolus, Inc; K062511
Reference Device(s)
Bonastent™ Esophageal by EndoChoice Inc.; K092144, Bonastent™ Biliary by EndoChoice Inc .; K093003
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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.
1
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)
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
4
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
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.
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 | Deployment | |
| Testing | To validate the accuracy and repeatability of the delivery system | |
| 2 | Expansion Force | To measure the force exerted by the metal self-expanding stent during |
| expansion (compared to predicate) | ||
| 3 | Compression | |
| Force Testing | To measure the force required to compress the metal self-expanding | |
| types of stents after expansion (compared to predicate) | ||
| 4 | Dimensional | |
| Testing | To verify the reproducibility of the metal self-expanding types of | |
| stents length and diameter after deployment | ||
| 5 | Corrosion | |
| Testing | To establish the compatibility of the stent materials with the corrosive | |
| environment in the tracheobronchial tree | ||
| 6 | Tensile strength | |
| tests | Performed for any deployment system that includes components that | |
| are 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 Stent
System | AERO Tracheobronchial
Stent 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 sec
Aged 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 (in | ||
| simulated gastric | ||
| fluid) | Resistant to corrosion for | |
| a duration equivalent to 3 | ||
| years | 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.