(108 days)
The HDR MRI Lumen Marker is indicated as an accessory for use with FDA Market Cleared remote controlled radionuclide applicator systems that are used to treat tumors that are indicated for treatment with high dose rate (HDR) brachytherapy. The HDR MRI Lumen Marker is indicated for temporary placement in HDR applicator lumens.
The HDR MRI Lumen Marker is intended to facilitate the identification of HDR applicator treatment lumens. It is intended to be non-patient contacting and only placed in applicators that are designed to prevent patient tissue or bodily fluids accessing the inner lumen.
Once placed in an HDR applicator lumen the HDR MRI Lumen Marker is intended to be imaged with MRI. It is removed after MR imaging and prior to the placement of a radioactive source. The HDR MRI Lumen Marker is intended for use in a single patient and can be used more than once if required for a single course of treatment in a single patient.
The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length.
The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators. Each HDR MRI Lumen Marker is supplied with a silicone stopper designed to hold the device in place once fully inserted into an applicator.
Here's a breakdown of the acceptance criteria and study information for the HDR MRI Lumen Marker, based on the provided FDA 510(k) summary:
The provided document does NOT contain a study with acceptance criteria in the format typically seen for AI/CAD devices, nor does it discuss human reader performance, AI assistance, or standalone algorithm performance.
This device, the HDR MRI Lumen Marker, is a physical accessory used with existing medical equipment. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, meaning it performs similarly and is as safe and effective. It does not involve AI, computer-aided detection (CAD), or complex diagnostic performance metrics that would require the kind of clinical study details you've requested.
The "study" in this context refers to the comparison made for substantial equivalence, which is primarily a comparative analysis of the device's design, materials, and intended use against a legally marketed predicate device.
However, I can extract the information that is present and explain why some of your requested points are not applicable to this type of device submission.
Acceptance Criteria and Reported Device Performance
Since this is a physical accessory and not a diagnostic algorithm, the "acceptance criteria" are related to its physical properties, MRI visibility, and compatibility with existing systems, rather than diagnostic accuracy metrics. The "reported device performance" demonstrates it meets these functional expectations.
| Acceptance Criterion (Inferred from device description and comparison) | Reported Device Performance |
|---|---|
| Material Composition: HDPE tube and cobalt chloride N-Acetylcysteine saline solution. | Device is comprised of a polymer tube (HDPE) filled with a fluid (cobalt chloride N-Acetylcysteine saline solution). |
| Dimensions: Up to 350.0 mm in length, 1.0 mm in diameter, 19.0 mm distal sealing plug, 3.0 mm end-cap. | Meets specified dimensions. (Implicitly accepted by FDA clearance based on provided description). |
| MRI Visibility: Fluid clearly visible on MRI to facilitate identification of lumens. | "Filled with a fluid that is clearly visible on MRI." |
| Compatibility: Accessory for FDA Market Cleared remote controlled radionuclide applicator systems. | Indicated for use with FDA Market Cleared remote controlled radionuclide applicator systems. |
| Non-Patient Contacting: Device does not come into direct contact with the patient. | "Intended to be non-patient contacting and only placed in applicators that are designed to prevent patient tissue or bodily fluids accessing the inner lumen." |
| Temporary Placement: Removed after MR imaging and prior to radioactive source placement. | "Removed after MR imaging and prior to the placement of a radioactive source." |
| Single Patient Use: Can be used once or more for a single course of treatment in a single patient. | "Intended for use in a single patient and can be used more than once if required for a single course of treatment in a single patient." |
Details Not Applicable / Not Provided in the Document:
The following points are typically relevant for AI/Diagnostic imaging devices and are not applicable or not provided in this 510(k) summary for a physical medical device accessory:
- Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of patient data in the sense of a diagnostic classification study. The "testing" would involve physical and imaging compatibility tests, which are not detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is established for this device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done because this is not a diagnostic device that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for this device relates to its physical performance and MRI visibility, confirmed through engineering tests, not clinical diagnostic truth.
- The sample size for the training set: Not applicable. There is no concept of a "training set" for this kind of physical device.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (Substantial Equivalence Analysis)
The "study" proving the device meets its (implicit) acceptance criteria is the substantial equivalence analysis detailed in Section 02 of the 510(k) summary.
- Comparison to Predicate Device: The HDR MRI Lumen Marker is compared to the Interstitial Ring CT/MR Applicator Set (K091154 Nucletron).
- Key Similarities highlighted:
- Same intended uses (facilitate identification of lumens in HDR brachytherapy applicators).
- Same technological characteristics (polymer tube filled with MRI-visible fluid).
- Both are placed in pre-inserted HDR applicators and imaged with MRI.
- Neither comes into direct patient contact.
- Both are removed after MR imaging and before treatment.
- Conclusion: The HDR MRI Lumen Marker is found substantially equivalent to the predicate device, with "no differences that would affect the safety or effectiveness of the proposed device."
In essence, for a device like the HDR MRI Lumen Marker, the "acceptance criteria" are its functional and safety requirements, and the "study" is the demonstration through comparison to a similar, already-cleared device that it meets these requirements and is as safe and effective.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.