(80 days)
This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diameter sleeves and interuterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.
The Mick Radio-Nuclear Instruments, Inc. HDR Miami Applicator is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR Miami Applicator meets these requirements.
This document describes a 510(k) premarket notification for the "HDR Miami Applicator." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process primarily relies on comparing the new device's design, materials, intended use, and performance characteristics to those of the predicate device, rather than requiring extensive clinical studies to prove effectiveness from scratch.
Therefore, the provided document does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria. It focuses on asserting substantial equivalence.
Here's an analysis based on the provided text, highlighting what is not available and what can be inferred:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are not detailed in terms of quantitative performance metrics, but rather the device's characteristics being "substantially equivalent" to the predicate. The "reported device performance" is essentially that it functions similarly to the predicate.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance (as stated in the document) |
|---|---|
| Design and Construction Similarity to Predicate Device | "This device is similar in design and construction... to the predicate devices." |
| Identical Materials to Predicate Device | "...utilizes the identical materials... to the predicate devices." |
| Same Intended Use as Predicate Device | "...and has the same intended use... to the predicate devices." Intended use: "Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system." More specifically, "placed in the vicinity of the cervix via the vagina just as described for the predicate device." |
| Same Performance Characteristics as Predicate Device | "...and has the same... performance characteristics to the predicate devices." |
| No New Issues of Safety or Effectiveness compared to Predicate | "No new issues of safety or effectiveness are introduced by using this device." |
| Biocompatibility (no new issues) | "No new issues of biocompataibility are raised with regard to this device." |
| Compatibility with existing HDR systems | "Designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A)." |
Study Details (Information Not Provided in this Document for Performance Testing)
The document is a 510(k) premarket notification, which is a regulatory submission focused on demonstrating substantial equivalence to a predicate device. It does not present a study with detailed performance data against specific acceptance criteria in the manner one might expect for a novel device requiring a PMA, or a device with new technological characteristics.
Here's why the requested study details are largely absent:
- Sample sizes used for the test set and the data provenance: Not applicable for a substantial equivalence claim based on design/material similarity. No clinical test set data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.
- Adjudication method: Not applicable.
- 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. This device is a physical applicator for radiotherapy, not an AI-assisted diagnostic or therapeutic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. As above, this is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" for the 510(k) is the established safety and effectiveness of the predicate device.
- The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of What the Document Conveys:
- Device Name: HDR Miami Applicator
- Intended Use: Used in brachytherapy to deliver intra-cavitary radiation therapy, specifically placed in the vicinity of the cervix via the vagina, similar to the predicate device. It is an accessory to the Varisource and Gammamed systems.
- Predicate Device: Nucletron Miami Vaginal Applicator (K953946)
- Demonstration of Acceptance/Compliance: The manufacturer asserts that the device is "substantially equivalent" to the predicate device because it is "similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics." They also state, "No new issues of safety or effectiveness are introduced by using this device." The FDA agreed with this assessment, hence the 510(k) clearance.
- Regulatory Context: This is a Class II device (21 CFR 892.5700 - Remote controlled radio-nuclide applicator system). No specific performance standards have been established by the FDA for this type of device under Section 514 of the Food, Drug, and Cosmetic Act.
In essence, the "study" for this device's acceptance criterion is the comparison to the predicate device, and the "proof" is the detailed submission to the FDA outlining these similarities, which the FDA then reviewed and cleared. Performance is inferred to be equal to the predicate without independent, novel clinical studies.
§ 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.