(92 days)
The applicators presented in this 510(k) notification have been developed to function as Remote After-Loader sealed sources in the intracavitary treatment of cancer of the vagina and cervix.
The Mick Radio-Nuclear Instruments, Inc. HDR compatible Tandem and Ovoid Applicators are intended for use in HDR Brachytherapy as described for the predicate device (Cervix Applicator, Varian Medical Systems, K033371). The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy to cervix via high dose rate Brachytherapy requires the ability to properly link the applicator to the HDR unit so that the radioactive source can be remotely positioned in the applicator along with the ability to properly localize the sealed sources at the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR compatible Tandem and Ovoid Applicators are designed to act as such a device and utilize the same design as previously cleared for other applicators manufactured by Mick Radio-Nuclear Instruments (Vaginal Applicator Set, Shielded, K001544, HDR Tandem/Ring Applicator with Rectal Retractor, K011657).
The provided document is a 510(k) premarket notification for a medical device (HDR Compatible Tandem and Ovoid Applicators), which primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a detailed study.
Therefore, many of the requested items related to a performance study will not be present in this type of document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or provide a study with reported device performance in the way a clinical trial or performance verification study would. The acceptance is based on the device being "substantially equivalent" to predicate devices.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| N/A | N/A | The document does not define specific performance acceptance criteria for this 510(k) submission. Instead, it relies on substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
No test set or associated data provenance is described in this 510(k) submission. The submission relies on design and material similarities to predicate devices, not on new clinical performance data for this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. No ground truth establishment activity is described for a test set.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done or reported in this 510(k) submission.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical medical instrument, not an algorithm, so a standalone algorithm performance study is not relevant here.
7. Type of Ground Truth Used:
Not applicable. The document assesses the device's technical and safety characteristics in comparison to established predicate devices, not against a new ground truth established for a separate performance study.
8. Sample Size for the Training Set:
Not applicable. As this is a physical medical device, not an AI/ML algorithm, the concept of a "training set" is not relevant.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reasons as #8.
Summary of Device and Approval Basis:
The document describes the Mick Radio-Nuclear Instruments, Inc. HDR Compatible Tandem and Ovoid Applicators. This device is intended for use in High Dose Rate (HDR) Brachytherapy for the intracavitary treatment of cancer of the vagina and cervix.
The study that proves the device meets (or rather, is acceptable for marketing) is the 510(k) substantial equivalence submission (K040704).
- Basis for Acceptance: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This means that, based on the information provided, the new device has similar intended use, design, construction, materials, and performance characteristics to previously cleared devices.
- Predicate Devices:
- Henschke Applicator; Mick Radio-Nuclear Instruments, Inc. (K871217)
- Hilaris/Nori Applicator; Mick Radio-Nuclear Instruments, Inc. (K891377)
- Cervix Applicator; Varian Medical Systems, Inc. (K033371)
- Vaginal Applicator Set, Shielded, Mick Radio-Nuclear Instruments (K001544)
- HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments (K011657)
- Key Argument for Equivalence: "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."
In essence, this 510(k) does not present a new clinical study with specific performance metrics and acceptance criteria for this device. Instead, it argues that because the device is sufficiently similar to already approved and marketed devices, it can be presumed to be safe and effective.
§ 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.