(151 days)
The DxTx Medical Pro-Tx Endorectal Balloon is a disposable, single use non-powered inflatable positioning device intended to be used for temporary positioning of the rectal wall and adjacent structures in the male human anatomies and to assist in positioning the prostate in a more predictable and reproducible location.
The purpose of the DxTx Medical Pro-Tx Endorectal Balloon is to stabilize the rectal wall and surrounding anatomy during all phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. Only trained healthcare professionals are intended to operate this device.
The DxTx Medical Pro-Tx Endorectal Balloon is a disposable, single use device for immobilization and localization of the rectal wall and surrounding anatomy on a daily basis for radiation therapy treatment. The Pro-Tx Endorectal Balloon includes the shaft and inflatable balloon with a gas venting feature. The Pro-Tx Endorectal Balloon is capable of being filled with air or fluid. The intended contact duration of the device is less than 60 minutes.
No components of this device contain medicinal substances, tissues or blood products.
The device component materials are PVC, Polycarbonate, Polyethylene, Polypropylene, Copolyester, Liquid Silicone Rubber (balloon), and brass (the radiopaque marker).
This FDA 510(k) summary describes the Pro-Tx Endorectal Balloon (PROT-25) and its equivalence to a predicate device, the RadiaDyne Prostate Immobilizer Rectal Balloon.
Here's an analysis of the provided information relating to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" for each performance test in a quantitative manner. Instead, it states that the performance tests were completed "to demonstrate performance equivalent to the predicate device and in compliance with 21 CFR 892.5720." This implies that the acceptance criteria are met if the new device performs at least as well as the predicate device across these specific tests, or adheres to regulatory standards where applicable.
Based on the "Effectiveness" section in the comparison table and the "Performance Verification (Bench Testing)" section, here's a reconstructed table reflecting the tests performed:
| Feature/Test | Predicate Device Performance Criteria (Implied) | DxTx Medical Device Performance (Reported) |
|---|---|---|
| Bioburden | Performance achieved (from De Novo study) | Performance achieved |
| Leakage/Inflation Integrity | Performance achieved (from De Novo study) | Performance achieved (Inflation Integrity) |
| Tensile Strength/Axial Pull | Performance achieved (from De Novo study) | Performance achieved (Axial Pull) |
| Burst Strength | Performance achieved (from De Novo study) | Performance achieved |
| Depth Stopper Resistance | Performance achieved (from De Novo study) | Performance achieved |
| Vent/Occlusion | Performance achieved (from De Novo study) | Performance achieved (Occlusion) |
| 3' Drop Test | Not explicitly listed for predicate (implied suitable performance) | Performance achieved |
| 45° Shaft Flexure | Not explicitly listed for predicate (implied suitable performance) | Performance achieved |
| Biocompatibility | No issues identified/documented safety issues (for predicate's design lineage) | No issues identified; no biocompatibility risks with the Pro-Tx device; post-market performance of legacy Pro-Tekt device had no documented safety issues. |
| Shelf-life | Demonstrated 2-year shelf life | Demonstrated 2-year shelf life after accelerated aging |
2. Sample size used for the test set and the data provenance
- Sample Size for Shelf-life: A box of 25 Pro-Tx devices was subjected to accelerated aging for the shelf-life study.
- Sample Size for other Bench Tests: Not explicitly stated for individual bench tests (Axial pull, inflation integrity, burst strength, occlusion, drop test, flexure test). Typically, such tests would involve a representative sample size from a production lot.
- Data Provenance: The accelerated aging study was conducted by an "independent ISO 17025-certified lab." Other bench test data are implied to be from internal testing by DxTx Medical, Inc. or associated labs. The predicate device's performance data likely came from its original De Novo study and post-market surveillance. The biocompatibility assessment references the design lineage from MEDRAD/Bayer Healthcare and its post-market performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the studies presented are primarily non-clinical bench and biocompatibility tests, not clinical performance studies requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests relates to engineering specifications and material properties.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving multiple expert readers.
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
An MRMC comparative effectiveness study was not done. This device is a physical medical device (an endorectal balloon) for positioning and stabilization during radiation therapy, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical, non-powered positioning device and does not involve any algorithm or AI for standalone performance evaluation.
7. The type of ground truth used
The "ground truth" for the performance tests is based on engineering specifications, material properties, and regulatory standards (21 CFR 892.5720). For biocompatibility, the ground truth refers to established biocompatibility guidelines and the absence of adverse events from the legacy device over a long period. For shelf-life, the ground truth is the maintenance of performance specifications after accelerated aging.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design was based on a previously marketed device (MEDRAD/Bayer Healthcare Pro-Tekt Endorectal Balloon).
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 892.5720 Rectal balloon for prostate immobilization.
(a)
Identification. A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing:
(i) Biocompatibility testing of the final finished device;
(ii) If provided sterile, sterilization validation;
(iii) If not provided sterile, bioburden testing of the final finished device;
(iv) Shelf life and expiration date validation; and
(v) Performance testing including but not limited to:
(A) Venting mechanism (if device has a vent mechanism);
(B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and
(C) Structural integrity testing (
e.g., tensile strength, balloon leakage and burst strength).(2) Labeling that includes:
(i) Appropriate warnings and contraindications, including, but not limited to the following statements:
(A) “Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.”;
(B) “Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.”;
(C) “Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.”; and
(D) “Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.”
(ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon;
(iii) Whether the device is sterile or non-sterile; and
(iv) An expiration date.