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510(k) Data Aggregation
(166 days)
An implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora.
The device of this submission is identical to the predicate devices except that the MEDPOR® Porous Polyethylene is formed around the glass tube.
This 510(k) premarket notification for the MEDPOR® Coated Tear Drain (K012108) explicitly states that the device is substantially equivalent to predicate devices. This means that instead of presenting new performance data against specific acceptance criteria, the manufacturer is asserting that the new device is as safe and effective as existing legally marketed devices.
Therefore, the provided document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device.
For K012108, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices. The "study" proving this primarily involves a comparison of the new device's design, materials, and indications for use to those of the predicate devices.
Given this context, I will address the requested information based on what is available and explain why certain information is not present in a 510(k) submission focused on substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per 510(k) submission) |
|---|---|
| Design and Materials: Identical or very similar to predicate devices. | The device of this submission is identical to the predicate devices except that the MEDPOR® Porous Polyethylene is formed around the glass tube. This indicates a minor design modification around existing predicate components. |
| Intended Use/Indications: Same as predicate devices. | Indications for Use: "An implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora." This matches the intended use for similar lacrimal drain implants. |
| Functionality: Expected to perform comparably to predicate devices in bypassing an obstructed lacrimal drainage system. | Not explicitly stated as a quantified performance metric. Substantial equivalence relies on the assumption that the minor design change (coating the existing glass tube) does not negatively impact functionality compared to the predicate, and in fact, the coating is likely intended to improve integration. |
| Safety and Biocompatibility: Materials are well-established for use in medical implants (MEDPOR® Porous Polyethylene, borosilicate glass). | MEDPOR® Porous Polyethylene is a predicate device material (MEDPOR® Surgical Implant Material). Borosilicate glass Jones tube is also a predicate. This implies that the materials' safety and biocompatibility are already established. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a substantial equivalence claim based on design and material comparison. No separate "test set" of patient data or clinical outcomes is presented in this 510(k) summary for performance evaluation.
- Data Provenance: Not applicable. The "proof" is the comparison against the legally marketed predicate devices, not new clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for a test set is not established in this type of submission.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring expert adjudication is presented.
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
- MRMC Study: No. This device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable for new device performance in this submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This is not an AI/machine learning device.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" for this 510(k) submission is a comparison to predicate devices. The manufacturer demonstrates that the MEDPOR® Coated Tear Drain is substantially equivalent to:
- MEDPOR® Surgical Implant Material: This predicate provides the basis for the porous polyethylene material used.
- Pre-amendment borosilicate glass Jones tube: This predicate provides the basis for the glass tube component.
The key argument for substantial equivalence is that the new device's design is "identical to the predicate devices except that the MEDPOR® Porous Polyethylene is formed around the glass tube." This minor modification is presented as not raising new questions of safety or effectiveness and maintaining the same indications for use as the predicates. The FDA's decision to grant substantial equivalence implies agreement with this assessment.
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