(28 days)
The Proguide Needle Set is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.
The Proguide Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures. The Proguide Needle is inserted into the treatment area, using standard interstitional techniques. CT markers are inserted into the Proguide Needles for visualisation. Radiographic images are obtained to determine the precise location of the applicator within the body. This information is then used for Brachytherapy treatment planning purposes. The Proguide treatment needle is attached to the afterloader (treatment head), using transfer tubes. The Proguide treatment needles are a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The afterloader and the clinical staff verify that the applicator is properly attached prior to treatment. When the applicator is attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions, which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver the prescribed dose of radiation. After the treatment the Proquide treatment needles are disconnected from the attached transfer tubes, and removed from the implant. The device is the same as the legally marketed predicate device cited. The only change is that the device is EtO sterilized by the manufacturer, instead of being sterilized by the hospital. The Proguide Needle Set is used as an accessory to the Nucletron microSelectron.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Nucletron Proguide Needle Set. This type of submission is for medical devices demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or performance through extensive clinical trials with acceptance criteria.
Therefore, many of the requested categories related to acceptance criteria, detailed study design, and performance metrics for a novel medical device are not applicable to this document. The focus of a 510(k) is primarily on demonstrating equivalence, not on establishing independent performance or clinical efficacy against specific acceptance criteria.
Here's an breakdown based on the information available in the document and indicating what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This document does not describe specific performance acceptance criteria for the device itself, nor does it report performance against such criteria. The document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device. The "performance" described is that the modified device functions the same way as the predicate device, with the only change being the sterilization method.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. This document does not detail a test set, sample size, or data provenance in the context of a clinical study to establish new performance metrics. The 510(k) process typically relies on non-clinical testing (e.g., sterilization validation, biocompatibility) and comparison to a predicate device, rather than large-scale clinical test sets to assess performance as would be described in a clinical study for a novel device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. As no clinical test set for performance validation is described, there's no mention of experts establishing ground truth for such a test set.
4. Adjudication Method for the Test Set
Not Applicable. No test set requiring expert adjudication is described in this document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
Not Applicable. This device is a physical medical instrument (needle set) for brachytherapy, not an AI or imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant and not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. No ground truth in the context of a clinical performance study is discussed. The "truth" for this 510(k) largely revolves around the manufacturing and sterilization process being equivalent and safe, validated through non-clinical methods.
8. The Sample Size for the Training Set
Not Applicable. This device is a physical medical instrument, not an algorithm or AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this question is irrelevant.
Summary of Relevant Information from the Document:
The entire document focuses on demonstrating substantial equivalence to a predicate device (Proguide Needle Set, 510(k)#: K953946).
- Key "Study" or "Testing" Relevant to the Change: The only change to the device from its predicate is the sterilization method. The predicate device was sterilized by the hospital, while the modified device is EtO sterilized by the manufacturer. This change would have required validation of the EtO sterilization process to ensure sterility and material compatibility, but the details of that specific validation study are not provided in this 510(k) summary. The summary simply states that this is the change.
- Intended Use: The modified device has the same intended use as the predicate: "Proguide Needle Set is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR."
- Technological Considerations: "The Proguide Needle Set is substantially equivalent to the cleared predicate device, Proguide Needle Set, 510(k)#: K953946." This statement is the core of the 510(k) submission, confirming that the device meets the regulatory requirements for market approval based on equivalence, not novel performance criteria.
§ 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.