(274 days)
The Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area.
The Nucletron Intracavitary Mould Applicator Set as described in this submission is designed for Intracavitary Brachytherapy procedures. The device consists of a disposable silicone cylinder, with eight radial placed catheters to the surface of the cylinder, which is inserted Intracavitary into the target volume, i.e. the rectum. The cylinder is fixated, by using an applicator introduction tool and the filling wires are removed, which protected the catheters from kinking during transport. In the center of the cylinder a central catheter can be placed. X-ray catheters or CT markers are inserted into the application. Radiographic images, planal images or transverse images of the target volume are taken to determine the precise position of the applicator. This information is then used for Brachytherapy treatment planning purposes. The Intracavitary Mould Applicator Set is a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the radioactive source. The afterloader is the treatment unit, it strictly provides a treatment path for the treatment source. The physicist and the clinical staff verify that the applicator is properly attached prior to treatment. For the first treatment the Intracavitary Mould Applicator Set is attached to the afterloader (treatment head), doing transfer tube. After the applicator is properly attached, a check cable run is performed to ensure that there are no obstructions, which will interest the transfer of the cable run. In a province of cable run, the radioactive source will be transferred into the applicator and the prescribed dose of radiation will be delivered. After the treatment is completed the Intracavitary Mould Applicator Set is removed from the patient. The device uses similar (implantable) materials as in the legally marketed predicate device cited the Freiburger Flap. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set. The Intracavitary Mould Applicator Set is used as an accessory to the Nucletron microSelectron.
Here's an analysis based on the provided document, addressing your request for acceptance criteria and study information.
Important Note: The provided document is a 510(k) summary for a medical device (Intracavitary Mould Applicator Set) that demonstrates substantial equivalence to a predicate device. This type of submission generally does not include rigorous clinical studies with acceptance criteria, sample sizes, and expert ground truth establishment in the same way a de novo or PMA submission would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device. Therefore, many of your requested points will either be "Not Applicable" (N/A) or indicate that such detailed studies were not required for this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | The modified device must have the same intended use as the legally marketed predicate device (K953946, Miami Vaginal Applicator Set). | The "Intracavitary Mould Applicator Set is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment." This is stated to be the same intended use as the predicate device. |
| Technological Characteristics Equivalence | The device must be "substantially equivalent" in design, materials, and operating principles to the predicate device. | The device consists of a disposable silicone cylinder with eight radial catheters for brachytherapy. X-ray catheters/CT markers are used for planning. It's a closed system to prevent source contact with body fluids. It uses similar (implantable) materials and similar implant techniques as the predicate device (Freiburger Flap and Miami Vaginal Applicator Set). The manufacturer explicitly states the device is "substantially equivalent to the cleared predicate...K953946." |
| Safety and Effectiveness (Implied) | The device must be as safe and effective as the predicate device for its intended use. This is demonstrated through equivalence claims. | The device is designed to correctly position radiation sources for intracavitary brachytherapy. The closed system design prevents radioactive source contact with body fluids. A check cable run is performed to ensure proper applicator attachment and absence of obstructions. The materials are similar to legally marketed implantable devices. No specific quantitative safety/effectiveness metrics or studies are reported in this 510(k) summary beyond the substantial equivalence claim. |
| Applicator Functionality and Use with Afterloader | The applicator must function correctly with Nucletron remote afterloading equipment and facilitate the delivery of prescribed radiation doses. | The device is explicitly designed for use with "Nucletron remote afterloading equipment" and "strictly provides a treatment path for the treatment treatment unit." The "Adler the treatment" describes the process of checking the applicator position and ensuring the absence of obstructions before treatment, which implies functional verification. The "Indications for Use Statement" mentions "The applicator set provides a means of delivering the prescribed radiation dose to the treatment area." No quantitative performance data for dose delivery accuracy or applicator reliability are provided. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. This 510(k) summary does not describe a formal "test set" or a clinical study that would have such a sample size. The substantial equivalence argument is based on comparison of design, materials, and intended use against a predicate device.
- Data Provenance: Not applicable for a traditional test set. The information provided is descriptive of the device and its relation to a predicate device, not data from a specific clinical evaluation.
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. No formal ground truth establishment process for a test set is described in this 510(k) summary.
- Qualifications of Experts: N/A.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication Method: Not applicable. No test set requiring expert adjudication 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
- MRMC Study: No. This device is an accessory for brachytherapy and does not involve AI or human "readers" in the diagnostic sense.
- Effect Size: Not applicable.
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 applicator, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable for a formal study. The "ground truth" here is the prior FDA clearance of the predicate device (K953946), implying its safety and effectiveness have already been established. The new device is compared against this established benchmark.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable.
Summary of the K041715 Submission:
This 510(k) submission for the Nucletron Intracavitary Mould Applicator Set relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (Nucletron's Miami Vaginal Applicator Set, K953946). The key argument is that the new device has:
- The same intended use.
- Similar technological characteristics (design, materials, operating principle).
- Raises no new questions of safety or effectiveness.
Therefore, the submission does not contain or require the types of detailed clinical performance studies (with acceptance criteria, sample sizes, expert ground truth, etc.) that would typically be associated with AI/ML devices or novel high-risk devices undergoing a De Novo or PMA pathway. The "acceptance criteria" are effectively satisfied by a successful argument for substantial equivalence, which the FDA concurred with, allowing the device to be marketed.
§ 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.