(90 days)
Tumark for Eviva and Tumark for Brevera are intended to attach a marker to soft tissue at the surgical site during a percutaneous procedure. The devices are indicated for use to radiologically mark the surgical location in breasts following a percutaneous procedure. They are not indicated to be used with magnetic resonance imaging (MRI) techniques.
Tumark for Eviva and Tumark for Brevera are sterile, single use, preloaded tissue site marking systems consisting of a non-absorbable nickel-titanium marker, an introducer cannula and a plastic handheld applier with deployment mechanism.
The introducer cannula has a blunt tip and can only be used together with an introducer. The handle is equipped with a slide-button which allows for a one handed placement of the marker by pressing it forward. A safety catch system prevents the slide-button to inadvertently move forward and therefore prevents a premature deployment of the marker.
The provided text is a 510(k) Summary for the "Tumark for Eviva" and "Tumark for Brevera" devices. This document summarizes the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, rather than a standalone study proving its performance against specific acceptance criteria for regulatory approval of a novel device. The primary goal of a 510(k) is to show substantial equivalence, not necessarily to prove efficacy/safety as an entirely new product.
Therefore, many of the requested details about a standalone study, multi-reader multi-case studies, expert adjudication methods, and explicit training set details are not present in this type of submission. The focus is on bench and in vitro testing relative to the predicate device.
Here's an analysis of the provided information, addressing what is available and noting what is not:
1. Table of Acceptance Criteria and the Reported Device Performance
| Aspect | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Testing per ISO-10993-1 | Device met required biocompatibility requirements. | Device met required biocompatibility requirements. All acceptance criteria met. |
| Sterility | Testing per ISO 11737-1 and ISO 11737-2 | Device can be sterilized by the sterilization process. | Device can be sterilized by the sterilization process. All acceptance criteria met. |
| Shelf life | Confirm the function of the device after accelerated and real-time aging | Device performance is maintained after simulated aging conditions. | Device performance is maintained after simulated aging conditions. All acceptance criteria met. |
| Blunt cannula tip | Confirm that cannula does not damage wall of introducer sheath | The introducer sheath was undamaged after placing the marker. The marker could be placed at the intended location. | The introducer sheath was undamaged after placing the marker. The marker could be placed at the intended location. All acceptance criteria met. |
| Cannula is compatible with introducers of respective vacuum biopsy systems | Confirm that marker can be deployed into the target region | The marker could be placed at the intended location. | The marker could be placed at the intended location. All acceptance criteria met. |
| Functionality of protection tube | Confirm that cannula lies within removable protection tube after being removed out of the blister | The protection tube does not fall off by itself during handling but can be removed manually from the cannula. | The protection tube does not fall off by itself during handling but can be removed manually from the cannula. All acceptance criteria met. |
| Device Performance | Confirm that marker can be placed in the target area | X-, Q-, and Vision markers could be deployed into the breast phantom. The device performs as intended. | X-, Q-, and Vision markers could be deployed into the breast phantom. The device performs as intended. All acceptance criteria met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test (e.g., number of devices tested for sterility, shelf life, or blunt tip evaluation). The "Device Performance" test mentions "X-, Q-, and Vision markers" and deployment into a "breast phantom," implying a physical test, but the number of deployments or phantoms is not given.
- Data Provenance: The document does not specify the country of origin of the data. The applicant is based in Germany.
- Retrospective or Prospective: Not applicable as the studies described are bench and in vitro tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the "studies" are bench and in vitro tests assessing physical and material properties, not diagnostic performance requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided as the "studies" are bench and in vitro tests, not diagnostic performance studies with a need for adjudication.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not applicable. The device is an implantable marker, not an AI-powered diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- A standalone performance study in the context of an algorithm was not done and is not applicable. The device is a physical medical device (implantable marker). The performance studies listed are bench tests of its physical and material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench and in vitro tests, the "ground truth" would be established physical measurements, material science standards (e.g., ISO for biocompatibility and sterility), and successful mechanical deployment into a phantom. There is no expert consensus, pathology, or outcomes data used for these types of tests.
8. The sample size for the training set
- This information is not applicable/not provided. The device is an implantable marker, not an AI or algorithm-based system that requires a "training set." The tests conducted are to confirm the physical and biological properties of the device.
9. How the ground truth for the training set was established
- This information is not applicable/not provided as there is no "training set" for this type of device.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.