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510(k) Data Aggregation
(266 days)
The Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are intended for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The Universal Titanium Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The Universal Multi-Channel Cylinder Set is indicated for use for cancer treatment of the vaginal vaginal stump, cervix, uterus, endometrium and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Multi-Channel Cylinder Set are indicated for use for cancer treatment of the vagina, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The Universal Titanium Cervix Probe Sets in combination with the Universal Multi-Channel Cylinder Set are indicated for use for cancer treatment of the vagina, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The Universal Interstitial Cylinder Set is indicated for use for cancer treatment of the vaginal vaginal stump, cervix, uterus and endometrium using intracavitary and interstitial HDR or PDR brachytherapy. The Universal Cervix Probe Sets in combination with the Universal Interstitial Cylinder Set are indicated for use for cancer treatment of the vagina, cervix, uterus and endometrium using HDR or PDR brachytherapy. The Universal Titanium Cervix Probe Sets in combination with the Universal Interstitial Cylinder Set are indicated for use for cancer treatment of the vagina, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The Universal Cylinder Applicator Family (UCAF) is designed to be used with Varian afterloaders (GammaMedplus, VariSource, and Bravos) to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) intracavity and interstitial brachytherapy treatments for gynaecological and rectal applications.
The provided text describes the Universal Cylinder Applicator Family (UCAF), a medical device used for brachytherapy. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must do) | Reported Device Performance (How the device was shown to meet the criteria) |
|---|---|
| Functional Performance (with specified afterloaders) | Test results demonstrate conformance to applicable requirements and specifications, indicating the device functions correctly with compatible afterloaders (GammaMedplus, VariSource, Bravos). |
| Durability (number of use cycles) | Testing has been performed to demonstrate the device can withstand the number of use cycles it will experience in its specified lifetime. |
| Radioactive Source Positional Accuracy | Testing has been performed to demonstrate the device enables the radioactive source to be located to the required accuracy and that the positional accuracy of the source in the devices is adequate. |
| Material Resistance to Radiation | Testing has been performed to demonstrate the device is constructed of materials that are not significantly affected by the radiation to which it is exposed during its specified lifetime. |
| Sterilization Effectiveness | Testing has been performed to demonstrate the device may be sterilized effectively and that it can be used and sterilized for the specified cycle limits. Conforms to ISO 14161:2009, ANSI AAMI ST79:2017, ISO 17665-1:2006, ISO TS 17665-2:2009, ISO 17664:2017. |
| Biocompatibility | The biocompatibility evaluation was conducted in accordance with ISO 10993-1, including Chemical characterization, Cytotoxicity, Sensitization, Irritation (intracutaneous reactivity), and Material mediated pyrogenicity. Test results demonstrate conformance. The device is categorized as a surface device in contact with mucosal membrane and prolonged contact duration. Conforms to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2016, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2012, ISO 10993-17:2009, ISO 10993-18:2005, ANSI AAMI BE83:2006. |
| CT Compatibility and MRI Safety | CT compatibility was evaluated. MRI safety testing was conducted in accordance with FDA guidance and included Magnetically-induced displacement force, Magnetically-induced torque, RF-induced heating, and MRI image artifacts. Testing demonstrated the UMC and UIC sets are safe to use in MRI environments under specified conditions. Conforms to ASTM F2503-13, ASTM F2052-15, ASTM F2213-11, ASTM F2182-11a, ASTM F2119-07. |
| Conformance to Quality Management, Risk Management, and Usability Standards | Verification and validation testing were conducted in accordance with FDA Quality System Regulation 21 CFR 820, ISO 13485 – Quality Management System standard, ISO 14971 – Risk Management standard, and IEC 62366-1:2015 for usability. Conforms to EN ISO 13485:2016, EN ISO 14971:2012, IEC 62366-1:2015. |
| Electrical Safety (if applicable as part of the afterloader system interaction) | Conforms to IEC 60601-1:2005, MOD and IEC 60601-2-17:2013. (Implied for the system with which it interacts.) |
| Packaging Integrity | Conforms to EN ISO 11607-1:2017, ISTA 3A:2008, ASTM D4332-13, ASTM D4169-09, ASTM D4728-06, ASTM D5276-98. (Packaging tests are listed as part of standards conformance, implying the device meets these for safe delivery and preservation.) |
| No remaining critical discrepancy reports (DRs) classified as Safety or Customer Intolerable (Implied) | "There were no remaining discrepancy reports (DRs) which could be classified as Safety or Customer Intolerable." (This is a final conclusion based on the testing performed, suggesting that all identified issues were resolved or deemed non-critical). |
2. Sample Size Used for the Test Set and the Data Provenance
The submission explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." Therefore, there is no human test set sample size and no data provenance in terms of country of origin or retrospective/prospective human data for this device. All testing was non-clinical bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no human studies or clinical trials were conducted, there was no "ground truth" established by human experts for a test set in the context of clinical performance. The ground truth for the engineering and safety performance was established by adherence to recognized national and international standards and internal verification and validation protocols by the manufacturer's qualified personnel.
4. Adjudication Method for the Test Set
Not applicable, as no human test set or clinical adjudication processes were involved. Performance was assessed via engineering and bench testing against predefined specifications and recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." An MRMC study involves human readers, which was not performed. Therefore, there is no effect size given for human readers improving with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is not an AI algorithm. It is a physical medical device (applicators for brachytherapy). Therefore, the concept of a "standalone algorithm" performance is not applicable. The device's performance was evaluated as a physical entity through bench testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench testing, the "ground truth" was based on:
- Engineering specifications and design requirements: The device had to perform within specified tolerances (e.g., source positional accuracy, durability).
- Recognized national and international standards: Adherence to standards like ISO 10993 (biocompatibility), ASTM (MRI safety), ISO 13485 (quality management), etc., served as the benchmark or "ground truth" for demonstrating safety and effectiveness in specific aspects.
- Manufacturer's internal verification and validation protocols.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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