(73 days)
The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.
The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.
The intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
The key performance characteristics of this applicator set are as follows:
- . The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
- 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
- The tandems and the pivot assembly are made from strong, lightweight titanium.
- Four different ovoid sizes to allow for varying anatomy.
- . Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
- . Ability to image the patient using CT imaging.
- Ability to image the patient using MR imaging.
- Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
- . Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
- Can be manually or machine cleaned, disinfected and steam sterilizable.
- Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
- Suitable for patient contact for a period of less than 30 days
This document is a 510(k) Premarket Notification for the Titanium Flexible Geometry FSD Applicator Set (GM11013400). It does not describe an AI/ML powered device. The information provided focuses on the substantial equivalence to a predicate device through non-clinical performance testing. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, etc.) are not applicable to this submission.
Here is the information that can be extracted relevant to the performance and acceptance criteria for this medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Conducted | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | ISO 10993-1 and applicable parts | Compatibility of skin-contact component material meets biocompatibility requirements. |
| Magnetic Resonance (MR) Compatibility | ASTM F2503-23 (Marking) | MR Conditional; complies with standards for marking, RF induced heating, magnetically induced displacement force, torque, and image artifacts. |
| ASTM F2182-19e2 (RF Heating) | ||
| ASTM F2052-21 (Displacement Force) | ||
| ASTM F2213-17 (Torque) | ||
| ASTM F2119-07 (2013) (Image Artifacts) | ||
| Cleaning, Disinfection, Sterilization | Demonstrated effectiveness for components and specified number of uses | Testing conducted to demonstrate effective sterilization and multi-use capability. |
| Human Factors/Usability | IEC 62366 (Human Factors Validation Study) | Device performs well as intended for intended users, uses, and use environments. |
| Mechanical & Acoustic Testing | Formal Design Verification & Validation Testing (21 CFR §820, ISO 13485, ISO 14971) | Device performs as intended; conformance to applicable requirements and hazard safeguards. |
| Safety & Efficacy | Conformance to FDA-recognized consensus standards (various ISO and EN ISO standards, e.g., ISO 13485, ISO 14971, ISO 10993, IEC 60601) | Demonstrated through verification and validation, meeting safety and performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This submission concerns a physical medical device (applicator set), not an AI/ML model for data-driven analysis. Performance testing likely involved physical prototypes or units, but specific "sample sizes" in the context of data analysis are not presented.
- Data Provenance: Not applicable in the context of clinical data used for AI/ML development. The testing described is non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, mechanical, human factors).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the type of device and testing described. The "ground truth" for this device's performance is established by objective engineering and safety standards.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication is typically for resolving discrepancies in expert labels for AI/ML ground truth.
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
- No. This is not an AI-powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-powered device.
7. The Type of Ground Truth Used
- The ground truth for this device's performance is based on objective engineering standards, regulatory requirements, and validated test methods. This includes:
- Compliance with ISO 10993 for biocompatibility.
- Compliance with ASTM standards for MR compatibility.
- Demonstrated effectiveness for cleaning, disinfection, and sterilization.
- Usability verification through human factors studies (IEC 62366).
- Verification and validation against design specifications and risk management (21 CFR §820, ISO 13485, ISO 14971).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not an AI/ML device.
§ 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.