(392 days)
The Tracheal Stent System (OTW) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.
The Tracheal Stent System (OTW) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is partially or fully covered with silicone membrane and a polymer coating to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. To aid in visibility under fluoroscopy, there are Tantalum radiopaque markers at the body of the stent. The stent has flanges at the ends to aid in minimizing migration after
The provided text outlines the acceptance criteria and a study that demonstrates the Micro-Tech (Nanjing) Co., Ltd. Tracheal Stent System (OTW) meets these criteria for substantial equivalence to a predicate device. However, this is not a study that proves the device meets an acceptance criterion, but rather that it meets the acceptance criteria set by the predicate device.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of explicit acceptance criteria with numerical targets alongside performance results for each criterion. Instead, it states that "The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device AERO™ Tracheobronchial Stent Technology System." The "acceptance criteria" are implied by the successful completion of the listed tests in accordance with relevant standards and guidelines, demonstrating functional equivalence to the predicate.
| Test Category | Specific Tests Mentioned | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Vitro Cytotoxicity |
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogen
- Muscle Implant
- Chemical Characterization and Biological Risk Assessment (Stent)
- Vitro Cytotoxicity
- Skin Sensitization
- Irritation (Delivery System) | Conducted in accordance with ISO 10993-1: 2009 and FDA's biocompatibility guidance. Results indicate compliance and support substantial equivalence. |
| Device Performance | - Visual Inspection - Dimension Testing
- Deployment Force and Deployment Accuracy Testing
- Expansion Force Testing
- Compression Force Testing
- Tensile Strength Testing
- Corrosion Testing
- Fatigue testing
- Sterility Testing | Conducted and evaluated for the subject device in consultation with "Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998". Results met acceptance criteria and support substantial equivalence. |
| Shelf-life & Packaging | - Shelf-life testing (accelerated aging) - Packaging integrity testing | Conducted based on ASTM F1980-16, ISO 11607-1:2019, and ISO 11607-2:2019. Two-year aging test will be performed. Results meet requirements. |
| Sterilization Validation | - Validation of Ethylene Oxide Sterilization | Carried out in accordance with ISO 11135:2014+A1:2018. Results meet requirements. |
| MR Compatibility | - ASTM F 2052-15 (Magnetically Induced Displacement Force) - ASTM F2182-19e2 (Radio Frequency Induced Heating)
- ASTM F2119-07(2013) (MR Image Artifacts)
- ASTM F2213-17 (Magnetically Induced Torque)
- ASTM F2503 - 13 (Marking Medical Devices)
- FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021 | Evaluated in accordance with listed ASTM standards and FDA guidance. Results demonstrate compliance and support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for the various bench tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in the full test reports, which are not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for a device, not an AI/software product that relies on expert interpretation for ground truth. The "ground truth" for the performance tests would be established by the defined parameters and methodologies of the referenced international standards and FDA guidance documents.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human reader performance.
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 submission, not an AI/software submission. No MRMC study was conducted or mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device submission, not an AI/software submission. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
For the various performance tests (biocompatibility, mechanical performance, sterility, shelf-life, MR compatibility), the "ground truth" is defined by the acceptance limits and methodologies specified in the cited international standards (e.g., ISO 10993-1, ASTM F1980-16, ISO 11607, ISO 11135, ASTM F2052, etc.) and FDA guidance documents. These standards provide objective, measurable criteria for evaluating device properties.
8. The Sample Size for the Training Set
Not applicable. This is a medical device submission, not an AI/software submission. There is no mention of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for an AI algorithm.
§ 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.”