(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.
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February 10, 2023
DxTx Medical, Inc. % Paul Lawson Director of Quality and Regulatory DxTx Medical Inc. 639 Alpha Dr PITTSBURGH PA 15238
Re: K223249
Trade/Device Name: Pro-Tx Endorectal Balloon (PROT-25) Regulation Number: 21 CFR 892.5720 Regulation Name: Rectal Balloon For Prostate Immobilization Regulatory Class: Class II Product Code: PCT Dated: September 7, 2022 Received: October 21, 2022
Dear Paul Lawson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner. The date of the signature is February 10, 2023. The time of the signature is 06:58:50 -05'00'.
Lora D. Weidner, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K223249
Device Name
Pro-Tx Endorectal Balloon (PROT-25)
Indications for Use (Describe)
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.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
Pro-Tx Endorectal Balloon
K223249
I. Sponsor Information
DxTx Medical, Inc. ATTN: Paul Lawson 639 Alpha Drive Pittsburgh, PA 15238
Phone: 412-596-3221 Email: paul.lawson@dxtxmedical.com https://dxtxmedical.com/
II. Date of 510(k) Preparation:
January 12, 2023
III. Subject Device:
| Trade name: | Pro-Tx Endorectal Balloon |
|---|---|
| Common Name: | Rectal balloon for prostate immobilization |
| Classification Name: | Prostate Immobilizer Rectal Balloon |
| Regulation number: | 21 CFR 892.5720 |
| Product Code: | PCT |
| Regulatory class: | II |
| Review Panel: | Radiology |
IV. Predicate Device
| De Novo Number: | DEN130036 |
|---|---|
| 510(k) Number: | K132194 |
| Trade name: | RadiaDyne Prostate Immobilizer Rectal Balloon |
| Common Name: | Rectal balloon for prostate immobilization |
| Classification Name: | Prostate Immobilizer Rectal Balloon |
| Regulation number: | 21 CFR 892.5720 |
| Product Code: | PCT |
| Regulatory class: | II |
| Review Panel: | Radiology |
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V. Device Description
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).
VI. Intended Use / Indications for Use
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.
VII. Summary of Technological Characteristics Compared to Predicate Device
The intended use and principles of operation of the DxTx Medical Pro-Tx Endorectal Balloon and the RadiaDyne RB Classic Prostate Immobilizer Rectal Balloon predicate device are substantially equivalent. Both devices meet the regulatory definition for Prostate Immobilizer Rectal Balloon outlined in 21 CFR 892.5720.
Both devices 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.
| Feature | Predicate DeviceDe Novo Number: DEN130036/510(k) Number: K132194 | DxTx Medical DevicePro-Tx Endorectal Balloon |
|---|---|---|
| Indications forUse | Single-use disposable, inflatable, non-poweredpositioning device intended for use in thetemporary positioning of the rectal wall andadjacent structure in the male human anatomies.The purpose of the device is to stabilize theprostate during Computed Tomography (CT)exam and X-ray, when these imaging techniques | The DxTx Medical Pro-Tx EndorectalBalloon is a disposable, single use non-powered inflatable positioning deviceintended to be used for temporarypositioning of the rectal wall and adjacentstructures in the male human anatomies and |
| Feature | Predicate DeviceDe Novo Number: DEN130036/510(k) Number: K132194 | DxTx Medical DevicePro-Tx Endorectal Balloon |
| are used for Radiation Therapy (RT) planning.The placement of the balloon requires aPhysician, or a Physician directed healthcareprofessional, and is performed as a separateprocedure apart from the standard CT exam andRT treatment. | to assist in positioning the prostate in amore predictable and reproducible location.The purpose of the DxTx Medical Pro-TxEndorectal Balloon is to stabilize the rectalwall and surrounding anatomy during allphases of radiation therapy, includingtreatment planning, image verification, andradiotherapy delivery. Only trainedhealthcare professionals are intended tooperate this device. | |
| Size | Similar to Pro-Tx | 17" long, shaft outer diameter 0.3" |
| TechnologyCharacteristics | Soft TipThin Wall BalloonFiducial markerSemi-flexible shaftDepth markers on shaftDepth stopperFlexible syringe connector tubingRapid release valve (balloon fill and empty)Gas release ventGas release valve (GRB Series only, not on RBClassic Series: Allows controlled release ofrectal gas after balloon insertion | Soft TipThin Wall BalloonFiducial markerSemi-flexible shaftDepth markers on shaftDepth stopperFlexible syringe connector tubingRapid release valve (balloon fill and empty)Gas release ventNo gas release valve - Rectal gasautomatically vents out |
| Accessories | 100 ml SyringeLubricant | No accessories - customer provides theirown; Luer lock interfaces with off the shelfsyringes |
| Safety | No product related hazards were reported in theFDA MAUDE database since the product wasapproved in January 2014 to 31 July 2022MR Conditional for tantalum fiducial marker | No product related hazards were reported inthe FDA MAUDE database for the BayerPro-Tekt, which is the design for the Pro-Txtransferred to DxTx Medical, since theinitial distribution agreement in August2010 to 31 July 2022MR Conditional for brass fiducial marker |
| Effectiveness | Performance Tests (from De Novo):BioburdenLeakageTensile strengthBurst strengthDepth stopper resistanceVent | Performance TestsBioburdenLeakage (Inflation Integrity)Tensile strength (Axial Pull)Burst strengthDepth stopper resistanceVent (Occlusion)3' Drop45° Shaft Flexure |
| Material | Thin Wall Balloon: PolyurethaneFiducial marker: Tantalum | Thin Wall Balloon: Silicone (equivalentfunction)Fiducial marker: Brass (equivalent function) |
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The minor technological differences between DxTx Medical Pro-Tx Endorectal Balloon and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that DxTx Medical Pro-Tx Endorectal Balloon is as safe and effective as RadiaDyne Prostate Immobilizer Rectal Balloon predicate device. Thus, DxTx Medical Pro-Tx Endorectal Balloon is substantially equivalent.
VIII. Summary of Data to Support Substantial Equivalence
The determination of substantial equivalence was based on an assessment of non-clinical performance data obtained from biocompatibility and bench testing of the subject device to demonstrate the ability to meet the Special Controls in 21 CFR 892.5720.
Biocompatibility
The DxTx Medical Pro-Tx Endorectal Balloon was based on the MEDRAD/Bayer HealthCaredesigned Pro-Tekt Endorectal Balloon, which was on the market since 2010; the design for the latter was transferred to DxTx Medical. The biocompatibility characteristics for all Pro-Tx product components, manufacturing materials and methods were evaluated with no issues identified. The post-market performance of the legacy Pro-Tekt device had no documented safety issues. Therefore, there are no biocompatibility risks with the Pro-Tx device.
Shelf-life
A box of 25 Pro-Tx devices was subjected to 2 year accelerated aging by an independent ISO 17025-certified lab, after which the devices were inspected, and bench tested to demonstrate 2 year shelf life equivalent to the predicate device.
Performance Verification (Bench Testing)
The following tests were completed to demonstrate performance equivalent to the predicate device and in compliance with 21 CFR 892.5720: Axial pull tests, inflation integrity, burst strength, occlusion (vent function) test, drop test and flexure test.
IX. Conclusion
The DxTx Medical Pro-Tx Endorectal Balloon has a safety and effectiveness profile that is similar to the predicate device. In particular, the subject device has the same or similar indications, technological characteristics, and principles of operation as the predicate device. The minor differences between the two devices do not raise any new issues of safety and effectiveness when the device is used as labeled. Therefore, it can be concluded that the DxTx Medical Pro-Tx Endorectal Balloon is substantially equivalent to the predicate device.
§ 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.