(233 days)
The WALLSTENT™ RP Endoprosthesis and WALLSTENT™ Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial are comprised of two components: The implantable metallic stent and the UNISTEP Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (5mm-12mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in (0.89mm) guidewire.
This document describes the regulatory clearance for the WALLSTENT™ RP Endoprosthesis Tracheobronchial and WALLSTENT™ Endoprosthesis Tracheobronchial. This is a medical device, specifically a self-expanding stent used to treat tracheobronchial strictures caused by malignant neoplasms.
The submission is a 510(k) premarket notification, which means the manufacturer is demonstrating that the device is substantially equivalent to a legally marketed predicate device. Therefore, the "study" described is primarily focused on demonstrating this substantial equivalence, particularly regarding MRI compatibility, rather than a clinical study evaluating the device's efficacy against clinical acceptance criteria in a human population.
Given the nature of the document (a 510(k) summary), many of the requested details about acceptance criteria for device performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training set information are not directly applicable or available. The study in question is a non-clinical bench test study for MR compatibility.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria for clinical performance (e.g., success rates, complication rates) or an AI model's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device and safety, particularly regarding MR compatibility.
| Acceptance Criteria (General Principle for 510(k)) | Reported Device Performance (Summary of Non-Clinical Test) |
|---|---|
| Substantial Equivalence to Predicate Device (WALLSTENT™ Tracheobronchial Endoprosthesis K992510) | "The proposed WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial is substantially equivalent to the existing Wallstent Endoprosthesis Tracheobronchial cleared by FDA under premarket notification K992510 (November 18, 1999). WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial has the same intended use, scientific technology, design, sterilization method, and packaging as the applicable predicate device. The only difference is to the MR Safety labeling information within the Directions for Use." |
| Safety and Compatibility in the Magnetic Resonance (MR) Environment | "Bench testing in accordance with FDA guidance document Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, dated December 11, 2014) to support labeling as MR Conditional. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing. Therefore, the concept of a "test set" in the context of patient data or clinical images does not apply. The "sample size" would refer to the number of physical devices or components tested in the lab. This specific number is not explicitly stated in the provided text, but the testing was for MR compatibility. The data provenance is from bench testing conducted by Boston Scientific Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study is non-clinical bench testing for MR compatibility, not a study involving medical images needing expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench test, not a study involving human interpretation or adjudication of medical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document describes a 510(k) submission for a physical medical device, not an AI or imaging software. The study performed was non-clinical bench testing for MR compatibility.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The Type of Ground Truth Used
For the MR compatibility testing, the "ground truth" would be established by physical measurements and adherence to the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." This involves objective physical testing for parameters such as magnetically induced displacement force, torque, and heating, and assessment of image artifact.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or algorithm-based device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Boston Scientific Corporation Ms. Carah Kucharski Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311-1566
Re: K152842
Trade/Device Name: WALLSTENT™ RP Endoprosthesis Tracheobronchial, WALLSTENTTM Endoprosthesis Tracheobronchial Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal Prosthesis Regulatory Class: Class II Product Code: JCT Dated: April 18, 2016 Received: April 19, 2016
Dear Ms. Kucharski:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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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Indications for Use
510(k) Number (if known) K152842
Device Name
WALLSTENT™ RP Endoprosthesis Tracheobronchial/ WALLSTENT™ Endoprosthesis Tracheobronchial
Indications for Use (Describe)
The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced 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) |
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510k Summary
Per 21 CFR §807.92
May 18th, 2016
| Common or UsualName | Self-Expanding Stent | |
|---|---|---|
| Trade Name(s) | WALLSTENT™ RP Endoprosthesis Tracheobronchial andWALLSTENT™ Endoprosthesis Tracheobronchial | |
| Product Code | JCT – Prosthesis, Tracheal, Expandable | |
| Classification ofDevice | The WALLSTENT Endoprosthesis Tracheobronchial device has beenclassified as Class II devices according to 21 CFR 878.3610 –Esophageal Prosthesis. | |
| Submitter's Nameand Address | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311-1566 | |
| Contact Name andInformation | Carah KucharskiRegulatory Affairs SpecialistPhone: 763-494-1683Fax: 763-255-0738Email: carah.kucharski@bsci.com | |
| Section 514 of theAct PerformanceStandards | Currently no FDA mandated or voluntary performance standards existfor this device. | |
| EstablishmentRegistrationNumbers | Owner /Operator: Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 3005099803 | |
| ManufacturingFacility: Boston Scientific Ireland Ltd. (BSIL)Ballybrit Business ParkGalway, IrelandERN: 9681260 | ||
| Predicate Devices | WALLSTENT™ Tracheobronchial Endoprosthesis K992510 clearedNovember 18, 1999 | |
| Intended Use/Indications for Use | The WALLSTENT™ RP Endoprosthesis and WALLSTENT™Endoprosthesis Tracheobronchial are indicated for use in thetreatment of tracheobronchial strictures produced by malignantneoplasms. | |
| Description ofDevice | The WALLSTENT RP Endoprosthesis Tracheobronchial andWALLSTENT Endoprosthesis Tracheobronchial are comprised of twocomponents: The implantable metallic stent and the UNISTEP Plusdelivery system. The stent is composed of biomedical superalloy wire,braided in a tubular mesh configuration. This design configurationresults in a stent that is flexible, compliant, and self-expanding. Thedelivery system consists in part of coaxial tubes. The exterior tubeserves to constrain the stent until retracted during delivery.Radiopaque marker bands situated on the interior and exterior tubesaid in imaging during deployment. Small stent sizes (5mm-12mm) mayhave a radiopaque core to improve radiopacity. The interior tube of thecoaxial system contains a central lumen that accommodates a 0.035in (0.89mm) guidewire. | |
| Comparison ofRequiredTechnologicalCharacteristics | The proposed WALLSTENT RP Endoprosthesis Tracheobronchialand WALLSTENT Endoprosthesis Tracheobronchial is substantiallyequivalent to the existing Wallstent Endoprosthesis Tracheobronchialcleared by FDA under premarket notification K992510 (November 18,1999). WALLSTENT RP Endoprosthesis Tracheobronchial andWALLSTENT Endoprosthesis Tracheobronchial has the sameintended use, scientific technology, design, sterilization method, andpackaging as the applicable predicate device. The only difference is tothe MR Safety labeling information within the Directions for Use.Bench testing in accordance with current FDA guidance supports alabeling as MR Conditional. | |
| Summary of Non-Clinical TestSummary | Bench testing was performed in accordance with FDA guidancedocument Establishing Safety and Compatibility of Passive Implants inthe Magnetic Resonance (MR) Environment, dated December 11,2014) to support labeling as MR Conditional. The results of thesetests provide reasonable assurance that the proposed device hasbeen designed and tested to assure conformance to the requirementsfor its intended use. No new safety or performance issues wereraised during the device testing. | |
| Conclusion | Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed WALLSTENT RPEndoprosthesis Tracheobronchial and WALLSTENT EndoprosthesisTracheobronchial has been shown to be appropriate for its intendeduse and is considered to be substantially equivalent to theWALLSTENT Endoprosthesis Tracheobronchial (K992510). |
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§ 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.”