(134 days)
The Kelowna GYN Templates are intenstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy.
The Crook Prostate Templates are interstitial brachytherapy treatments for prostate cancer using HDR or PDR brachytherapy.
The Kelowna GYN and Crook Prostate Templates are applicators for Brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source the correct dose for the treatment area. The applicators act to guide the radioactive source to the correct location or locations for treatment.
The key performance characteristics of Kelowna GYN and Crook Prostate Templates are as follows:
- Constructed of polyetheretherketone (PEEK), Titanium and stainless steel
- Used when performing HDR or PDR brachytherapy within a CT environment
- Accommodate the organization of interstitial implants; used with interstitial needles
- Provide for individual needle collet fixation
- Can be manually or machine cleaned; steam sterilizable
- Suitable for re-use
- Suitable for patient contact for a period of less than 30 days
- MR conditional and suitable for use during MR imaging for MRI systems of 1.5T or 3.0T if used with Varian interstitial plastic needles
The provided text describes the regulatory clearance of the "Kelowna GYN and Crook Prostate Templates" by Varian Medical Systems. The device is a brachytherapy applicator system. The submission (K232949) is a 510(k) premarket notification, indicating it's a submission for a device substantially equivalent to an already marketed device, not a novel device requiring extensive clinical trials for efficacy.
The core of this submission is a change in the device's MR compatibility from "MR unsafe" to "MR conditional" when used with specific Varian interstitial plastic needles, along with minor updates to compatible afterloaders and optional accessories.
Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical performance testing related to these changes, particularly MR compatibility and general device safety and functionality.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a brachytherapy applicator system, the "acceptance criteria" are generally related to the device's physical and functional performance, biocompatibility, sterilization, and MR compatibility, rather than specific diagnostic or therapeutic sensitivity/specificity metrics typically found in AI/imaging device clearances. The document reports that the device meets these criteria, implying successful completion of the tests.
| Acceptance Criteria (Test Category) | Reported Device Performance |
|---|---|
| Biocompatibility | "The biocompatibility evaluation for the subject device was conducted according to ISO 10993-1 'Biological Evaluation of a Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process.' This includes the following tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute Toxicity." |
| (Implies successful completion as the device was cleared.) | |
| Sterilization Effectiveness & Durability | "Sterilization testing for the subject device was conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect the safety or effectiveness." |
| (Implies successful completion as the device was cleared.) | |
| MR Compatibility (Primary Focus of Submission) | "MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The Kelowna GYN and Crook Prostate Templates are MR Conditional when used with Varian interstitial plastic needles and comply with the following MR standards: ASTM F2052-21 (Displacement Force), ASTM F2213-17 (Torque), ASTM F2182-19e2 (RF Induced Heating), ASTM F2119-07 (MR Artifacts)." |
| (Device successfully demonstrated MR Conditional status adhering to specific ASTM standards.) | |
| Mechanical & Design Performance | "The Kelowna GYN and Crook Prostate Templates have undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the Kelowna GYN and Crook Prostate Templates performs as intended. Design verification and design validation testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard." |
| (Implies successful performance in accordance with quality and risk management standards.) | |
| Electrical Safety & EMC | "This item is not applicable to the subject device. No electrical safety and electromagnetic compatibility tests have been included in this submission in support of the substantial equivalence determination." |
| (No performance reported as not applicable.) | |
| Software Verification & Validation | "This item is not applicable to the subject device. The devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination." |
| (No performance reported as not applicable.) | |
| Substantial Equivalence | "Varian believes the major technological characteristics are substantially equivalent to the predicate device and the differences do not raise new questions of safety and effectiveness. The results of verification and validation as well as conformance to relevant safety standards demonstrate that the device meets the safety and performance criteria. Varian considers the Kelowna GYN and Crook Prostate Templates to be as safe and effective as the predicate and to perform at least as well as the predicate device (K162533)." |
| (Overall conclusion based on all non-clinical tests.) |
2. Sample Size Used for the Test Set and the Data Provenance
The document pertains to a physical medical device (applicators for brachytherapy) and does not involve AI or imaging "test sets" in the conventional sense for diagnostic algorithms. The testing described (biocompatibility, sterilization, MR compatibility, mechanical/design) uses physical samples of the device and materials, not patient data sets. Therefore, the questions about "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the context of this device's non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is not an AI/imaging algorithm requiring ground truth annotation by experts. The "ground truth" for the non-clinical tests is established by objective measurements and standardized protocols (e.g., meeting specific force limits in MR environment, sterility assurance levels).
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable. No expert adjudication process is described or relevant for the non-clinical tests conducted.
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
Not applicable. This is not an AI-assisted diagnostic or therapeutic imaging device involving human readers or interpretation of medical cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not have an AI algorithm component.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described:
- Biocompatibility: Ground truth is defined by the toxicological response observed in standardized in vitro and in vivo assays as per ISO 10993.
- Sterilization: Ground truth is established by microbiological challenge tests demonstrating lethal effects on microorganisms and material integrity limits.
- MR Compatibility: Ground truth is defined by quantitative measurements (e.g., displacement force, temperature rise, artifact size) meeting the limits specified in the relevant ASTM standards for "MR Conditional" labeling.
- Mechanical & Design Performance: Ground truth is the device's adherence to engineering specifications and functional requirements under defined test conditions.
8. The Sample Size for the Training Set
Not applicable. This device does not use an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not use an AI algorithm that requires a training set with established ground truth.
§ 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.