(109 days)
The 3D Interstitial Ring Applicator Sets (60° and 90°) and the Ring Applicator Sets (45°, 60° and 90°) are intended for use for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy.
The 3D Interstitial Ring Applicator Sets (60° and 90°), are applicators for intracavitary or intracavitary/interstitial 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 to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
The Ring Applicator Sets (45°, 60° and 90°), are applicators for intracavitary 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 to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
This FDA 510(k) summary describes a new medical device, the Varian Medical Systems 3D Interstitial Ring Applicator Sets and Ring Applicator Sets, and claims substantial equivalence to a predicate device, the Mick Radio Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator With Rectal Ring Retractor.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Specification | Predicate Device Performance (K030110) | New Device Reported Performance | Acceptance Criteria Met (Yes/No) |
|---|---|---|---|
| Compatible Afterloader | GammaMed plus, GammaMed 12i(t), VariSource | GammaMedplus iX, GammaMedplus | Yes (compatible with listed afterloaders) |
| Intended Use | High dose rate Brachytherapy treatment of the uterus and cervix | Cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy | Yes (expanded but similar) |
| Indications for Use | High Dose Rate irradiation of the uterus and cervix | Cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy | Yes (expanded but similar) |
| Design | Ring applicators 30°, 45°, 60°; 32mm diameter. Intrauterine tandems 30°, 45°, 60°; 20mm, 40mm, 60mm, 80mm lengths | 3D interstitial ring applicators Sets (60° and 90°), 30mm diameter. Intrauterine tandems 60° and 90°; 30mm, 40mm, 50mm, 60mm, 70mm, 80mm lengths. Holes for needle application. Ring applicators Sets (45°, 60°, 90°); 26mm, 30mm diameter. Intrauterine tandems 45°, 60°, 90°; 30mm, 40mm, 50mm, 60mm, 70mm, 80mm lengths | Yes (design variations are for expanded utility) |
| Materials | Stainless Steel, PPSU, PEEK, Titanium | PEEK, Titanium | Yes (different materials but assessed for biocompatibility) |
| Packing | Individual | Individual | Yes |
| Sterility | Provided non sterile | Provided non sterile | Yes |
| Sterilization Method | Steam sterilization (15 min @ 121°C, 5 min @ 134°C, 18 min @ 134°C) | Steam sterilization (4 min @ 132°C, 3 min @ 134°C, 5 min @ 134°C) | Yes (different parameters but assessed for effectiveness) |
| Biocompatibility | Full biocompatibility | Full biocompatibility | Yes |
| Anatomical Sites | Uterus, cervix | Uterus, cervix, vagina | Yes (expanded but similar) |
| Compatibility with environment/other devices | CT compatible | CT compatible, MR conditional for 1.5 and 3 Tesla | Yes (adds MR compatibility) |
| Where Used | Brachytherapy treatment room | Brachytherapy treatment room | Yes |
| Device Functions Correctly | Implicit for predicate | Demonstrated through bench testing | Yes |
| Withstands Cycles of Use | Implicit for predicate | Demonstrated through bench testing | Yes |
| Radioactive Source Positional Accuracy | Implicit for predicate | Demonstrated through bench testing (accuracy required) | Yes |
| Material unaffected by radiation | Implicit for predicate | Demonstrated through bench testing | Yes |
| Sterilization Effectiveness | Implicit for predicate | Demonstrated through bench testing | Yes |
| Usability (IEC 62366:2007) | Implicit for predicate | Conformance to applicable requirements and specifications demonstrated through bench testing | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The submission form does not explicitly detail a "test set" in the context of clinical data for performance evaluation. Instead, it relies on bench testing for technical performance.
- Sample Size for Bench Testing: Not specified in terms of number of devices or iterations, but implies sufficient testing to demonstrate functionality, durability, accuracy, and material integrity.
- Data Provenance: The bench testing would inherently be prospective in nature, conducted by the manufacturer (Varian Medical Systems, Inc.) in Palo Alto, CA, USA, for the purpose of this submission. Since it's bench testing, country of origin is the manufacturing/testing location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on bench testing against engineering specifications and industry standards (like IEC 62366:2007) rather than clinical performance based on expert-determined ground truth. Therefore, no experts were used to establish a clinical ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. Since no clinical "test set" requiring expert judgment for ground truth establishment was conducted, there was no adjudication method. Bench testing results would typically be assessed against predefined pass/fail criteria by engineering and quality personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a physical medical instrument (an applicator for brachytherapy), not an AI/software-based diagnostic tool that would involve human readers or AI assistance. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Its function is to physically guide a radioactive source.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" used was engineering specifications, design requirements, and applicable international standards (e.g., for afterloader compatibility, material properties, sterilization effectiveness, positional accuracy, usability to IEC 62366:2007 requirements). There was no clinical ground truth (like pathology, expert consensus on disease, or outcomes data) established for the performance evaluation in this submission.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
§ 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.