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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.

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:

1. 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.
2. 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.
3. Adjudication method: Not applicable.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

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The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading (Brachytherapy). One common application of Brachytherapy is in the treatment of cancer of the cervix. 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 HDR Tandem/Ring Applicator with Rectal Retractor is placed in the vicinity of the vagina just as described for the predicate device (Nucletron Ring Applicator, K953946) and with a rectal retractor and varying intrauterine tube length diameters, clinical needs can be best optimized along with minimization of dose to the rectum.

The Mick Radio-Nuclear Instruments, Inc.. HDR Tandem/Ring Applicator with Rectal Retractor 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 Tandem/Ring Applicator with Rectal Retractor meets these requirements.

This document is a 510(k) premarket notification for a medical device, the "HDR Tandem/Ring Applicator with Rectal Retractor," from Mick Radio-Nuclear Instruments, Inc. It addresses the device's substantial equivalence to predicate devices, not an AI/ML device or a study proving acceptance criteria in the typical sense of diagnostic accuracy or performance metrics.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this submission.

This 510(k) summary focuses on demonstrating that the new device is as safe and effective as previously cleared (predicate) devices, primarily through comparison of design, materials, intended use, and performance characteristics. It does not involve a clinical study with performance metrics as one would find for an AI/ML diagnostic or predictive device. The "performance characteristics" mentioned are in the context of the device's physical and functional attributes for brachytherapy application, not in terms of AI model performance.

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The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are intended for use in Brachytherapy. The delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR) requires not only proper visualization and localization of the treatment volume. but precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear "HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.

The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.

The provided document is a 510(k) premarket notification for a medical device: the "HDR Contour TP Template and Implant Accessories." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through detailed performance studies.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

Here's why and what information is available:

• 510(k) Submissions and Performance Studies: For Class II devices like this one, a 510(k) typically demonstrates substantial equivalence by showing the new device is as safe and effective as a predicate device. This is often achieved by comparing design, materials, intended use, and performance characteristics to existing, cleared devices. Full-scale clinical trials or extensive performance studies with detailed acceptance criteria and statistical analysis are generally not required for a 510(k) unless the device introduces new technology, new indications for use, or raises new safety/effectiveness concerns.
• "Performance Standards": The document explicitly states: "Performance standards for applicators for remote controlled afterloading brachytherapy have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." This confirms that formal, regulator-defined performance standards with specific acceptance criteria are not applicable here.
• "Summary of Substantial Equivalence": The document states: "This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device." This is the core argument for clearance, not a report of specific test results against defined acceptance criteria.

Information that is present in the document but does not address your specific questions:

• Device Name: HDR Contour TP Template and Implant Accessories
• Intended Use: For use in Brachytherapy, specifically for "delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR)." It acts as an accessory to commercially available HDR Systems, holding multiple HDR needles in a pre-defined array for treatment delivery.
• Predicate Devices: A list of predicate templates, needles, and applicators (e.g., Syed/Neblett Prostate Template, Mick 200-TP and Mick TP Needle, H.A.M. Applicator).
• Classification: Class II device (21 CFR 892.5700).

In summary, none of the requested information regarding acceptance criteria, device performance results, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details) can be extracted from the provided 510(k) document because such detailed studies are not typically part of a substantial equivalence demonstration for this type of device.

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