(14 days)
Comfort Catheter System is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.
The Nucletron Comfort Catheter System 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 device consists of a Leader insertion needle with an opturator which is inserted through the skin surface into the target volume. I.e. breast. The opturator is ther removed and the flexible implant tube is inserted into hollow needle, the hollow needle is retracted when the flexible implant tube is in place. Optional a template can be used for positioning the insertion needles. Once the catheter is in place the insertion needle is removed and a button is placed over the plastic catheter and slid into contact with the skin surface. .The Flexible implant tube is pulled in position until the distal button is in contact with the skin surface. The proximal button is pulled over the flexible implant tube, until the button is in contact with the skin surface. The flexible implant tubes are cut off. at a predetermined length with the cutter. A flange is molded on the flexible implant tube with the flange molding tool, to fixate the proximal button. X-ray catheters or CT markers are inserted into the Proguide treatment needles for visualisation. Radiographic images, planar films or transverse slices, i.e. CT, MR is 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 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. For the first treatment a closed end Proguide treatment needle is inserted up to the distal end of the flexible implant tube. The Proguide treatment needle is immobilised with a stoptag. The Proquide treatment needle is attached to the afterloader (treatment head), using transfer tubes. 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 Proguide treatment needles are disconnected from the attached transfer tubes and from the implant (flexible implant tubes) by using the stop tags. In between treatment fractions the Proquide treatment needle are stored in a patient treatment box. The Stop tags must remain fixed on the Proguide treatment needles for the next fraction. When the course of treatment is completed the flexible implant tubes and buttons are removed from the patient. The device uses similar (implantable) materials as the legally marketed predicate device cited (Implant Guidance System). With respect to the legally marketed predicate device cited (MicroSelectron HDR V2: Breast Template), the implant technique has been optimised for interstitial techniques such as breast implants, no longer the catheters are protruding from the patients body in between fractions. This increases the patient comfort and flexibility. It is also easier for the hospital staff to apply and remove the catheters. The Comfort Catheter System is used as an accessory to the Nucletron microSelectron.
This appears to be a 510(k) premarket notification summary for a medical device called the "Comfort Catheter System." It establishes the substantial equivalence of the new device to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested points regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not present in this type of regulatory document.
Here's an analysis based on the provided text, indicating what information is present and what is not:
1. Table of acceptance criteria and the reported device performance:
- Not present. This document doesn't define specific quantitative performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) for the device. Instead, it focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
- Not applicable/Not present. As this is a 510(k) summary focused on substantial equivalence, there is no "test set" in the context of evaluating algorithm performance or clinical outcomes. The regulatory filing implicitly relies on the safety and effectiveness of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not present. No ground truth establishment (in the sense of expert review for data labeling) is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not present. No adjudication method is described.
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/Not present. This is not an AI/algorithm-focused device. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. This is not an AI/algorithm-focused device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not present. No specific ground truth methodology is described in the context of performance evaluation. The "ground truth" for this submission is adherence to regulatory requirements and demonstration of substantial equivalence to a safe and effective predicate device.
8. The sample size for the training set:
- Not applicable/Not present. There is no "training set" described as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/Not present.
Summary of available information related to "acceptance criteria" and "study":
The "study" in this context is the 510(k) premarket notification process, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device.
Acceptance Criteria (Implied for 510(k) substantial equivalence):
The primary "acceptance criterion" for this submission is that the Comfort Catheter System is substantially equivalent to the predicate device, the I Implant Guidance System (K020015), with respect to safety and effectiveness for its intended use. This is achieved by demonstrating:
- Same Intended Use: The modified device has the same intended use as the legally marketed predicate device: "Comfort Catheter System is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR."
- Similar Technological Considerations: The document states, "The Comfort Catheter System is substantially equivalent to the cleared predicate device, Comfort Catheter System, 510(k)#: K020015." It also highlights:
- It's designed as an accessory to Nucletron remote afterloading equipment (mHDR) for interstitial Brachytherapy.
- It uses similar (implantable) materials as the predicate device.
- It has optimized implant technique for interstitial procedures (e.g., breast implants) leading to increased patient comfort and flexibility, and easier application/removal for hospital staff (compared to MicroSelectron HDR V2: Breast Template, which is mentioned in the context of technique optimization, but K020015 is the primary predicate for substantial equivalence).
- The device is a closed system to prevent radioactive source contact with body fluids.
- The treatment catheter provides a treatment path but does not control the treatment unit; verification by afterloader and clinical staff is required.
Study Proving Device Meets Criteria:
The "study" is the 510(k) submission itself, where Nucletron B.V. presents a comparison of their device to the predicate device. The FDA's review of this submission culminated in the issuance of a substantial equivalence determination letter (AUG 15 2003, K032372).
The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement serves as the "proof" that the device met the implicit acceptance criteria for substantial equivalence under the 510(k) pathway.
§ 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.