(35 days)
The SAVI Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.
This submission for the SAVI Applicator Kit (K080565) from Cianna Medical, Inc. is a 510(k) premarket notification. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on comparability rather than extensive new clinical trial data with specific acceptance criteria and detailed performance metrics as one might find for a novel, high-risk device.
Based on the provided text, a detailed table of acceptance criteria and reported device performance, as well as an effect size from an MRMC study, sample size for training/test sets, or information about expert ground truth adjudication, are not explicitly stated or applicable in the context of this 510(k) submission.
Here's a breakdown of the available information according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided as a quantifiable table with specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity). The submission's "Performance Data Summary" states: "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."
The conclusion further states: "Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the SAVI Applicator is determined to be substantially equivalent to existing legally marketed devices."
This implies that the performance demonstration was to show that the SAVI Applicator performs at least as well (or equivalently) to its predicate devices for its intended use, rather than meeting specific numerical performance targets.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, often supported by bench testing and sometimes small clinical studies for specific aspects if there are significant technological differences. The document does not describe a traditional clinical study with a "test set" in the context of AI or diagnostic device performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided. As there's no described "test set" and ground truth establishment in the context of AI or diagnostic performance, this information is not present.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No information provided. This is unlikely for a device of this nature and type of submission (510(k) for substantial equivalence of an accessory device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable/Not provided. The SAVI Applicator is a physical medical device (an accessory to brachytherapy equipment), not an algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable/Not provided in the context of a "test set" evaluation. The "ground truth" for this device's approval is its substantial equivalence to predicate devices, meaning it meets the same functional and safety requirements that previous similar devices have already established.
8. The Sample Size for the Training Set
Not applicable/Not provided. This is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided.
Summary of Device and Approval Context:
The SAVI Applicator is an "accessory to commercially available remote afterloading equipment used during brachytherapy procedures." Its function is to "provide pathways from which a prescribed radiation dose is delivered to the treatment area."
The approval (K080565) is based on a 510(k) submission, which aims to demonstrate substantial equivalence to predicate devices (Biolucent Applicator K062830, K061241, K070659).
The "Performance Data Summary" indicates that "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." This typically involves bench testing, material compatibility, and engineering analyses to ensure the device performs as intended and is as safe and effective as the predicate devices.
Key FDA Limitation: The FDA, in its approval letter (K080565), imposed a specific warning: "The safety and effectiveness of the SAVI Applicator Kit for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This highlights that while the device was found substantially equivalent for its intended accessory use, its potential broader implication as a replacement therapy had not been proven and required a specific disclaimer.
§ 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.