(109 days)
The Medtronic InStent EsophaCoil Esophageal Stent System is intended for use in the treatment of esophageal obstructions produced by malignant neoplasms.
The Medtronic InStent EsophaCoil Proximal and Distal Extensions are intended for extending previously placed esophageal stents exhibiting tumor overgrowth or tumor ingrowth on the upper or lower portion of the existing stent respectively.
The Medtronic InStent EsophaCoil Distal Extension System is intended for use in extending previously implanted esophageal stents exhibiting tumor overgrowth on the distal side of the stent.
The Medtronic InStent EsophaCoil Proximal Extension System is intended for use in extending previously implanted esophageal stents exhibiting turnor overgrowth on the proximal side of the stent.
The Medtronic InStent EsophaCoil Esophageal Stent is a self-expanding, tightly wound spiral Nitinol wire coil which is flared at both ends to enhance fixation. The EsophaCoil Extension is identical to the EsophaCoil Esophageal Stent except that only one end is flared. The non-flared end of the EsophaCoil Extension is inserted into an implanted esophageal stent to extend the length of the stent. The delivery catheter is identical to the currently marketed device. The variable release handle utilizes three independently sliding levers located on the catheter 's proximal end that can release the stent in any sequence order; distal release, center release, or proximal release depending upon which of the sliding levers is pulled first, second, or third.
The provided document is a 510(k) premarket notification summary for a medical device, the Medtronic InStent EsophaCoil Esophageal Stent System and Extension Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic accuracy through extensive studies with acceptance criteria as one might expect for AI/ML devices or diagnostic tests.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this document as it describes a traditional medical device modification and extension, not an AI/ML diagnostic system or a comparative effectiveness study in the sense implied by the questions.
Here's a breakdown based on the provided text, while acknowledging the limitations for this type of device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for substantial equivalence) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Safety: | |
| - Corrosion resistance | - Corrosion testing performed; no safety concerns identified. |
| Effectiveness/Functionality: | |
| - Identical construction/materials to predicate | - Modified EsophaCoil Stent: identical to marketed, except for surface preparation. |
| - Similar design principles | - EsophaCoil Extension Systems: identical to marketed stent, but with only one flared end to extend existing stents. |
| - Similar intended use | - Intended use for esophageal obstructions from malignant neoplasms (stent) and extending existing stents (extensions). |
| Packaging and Sterilization: | |
| - Consistent with predicate | - Packaging and sterilization methods are consistent, contributing to substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission states "Corrosion testing was performed to evaluate the safety of the device. No other testing was deemed necessary for the new or modified devices." This indicates bench testing for material properties, not a clinical study with a "test set" of patients in the context of diagnostic performance or clinical outcomes. No details on sample size for corrosion testing or data provenance are provided.
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 submission does not involve subjective diagnostic assessment or a "ground truth" established by experts in the context of algorithm performance. The evaluation is based on material properties and design changes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There was no "test set" requiring adjudication in the context of diagnostic interpretation or clinical outcomes.
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 device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the corrosion testing: The "ground truth" would be established by validated scientific methods and standards for evaluating material corrosion (e.g., electrochemical measurements, visual inspection for degradation), generally accepted as objective measures rather than expert consensus on a clinical diagnosis.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, and there was no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, and there was no "training set."
Study That Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "Corrosion testing."
- Type of Study: Benchtop material testing.
- Purpose: To evaluate the safety of the device, specifically its resistance to corrosion.
- Findings (implicit): The document concludes, "Based on the testing performed and the nature of the changes, it was concluded that the modified devices are substantially equivalent to the currently marketed device. The construction, materials packaging and sterilization methods were found to be equivalent." This implies that the corrosion testing results were acceptable and did not raise new safety concerns compared to the predicate device.
- Rationale for Limited Testing: The submission states, "No other testing was deemed necessary for the new or modified devices." This is a common aspect of 510(k) submissions, where minor modifications to an already cleared device, or the introduction of a new model within an existing device family, may not require extensive new clinical or performance studies if the safety and effectiveness are established through substantial equivalence to the predicate. The changes (surface preparation, single vs. double flared end for extensions) were considered minor enough that only corrosion testing was required to affirm safety.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal 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.”