(151 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a non-powered inflatable balloon for positioning. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a "positioning device" intended for "temporary positioning of the rectal wall and adjacent structures" and to "assist in positioning the prostate in a more predictable and reproducible location" during radiation therapy. Its primary purpose is stabilization and immobilization, not to treat a disease or condition itself.
No
Explanation: The device is described as a "positioning device" intended to stabilize the rectal wall and surrounding anatomy during radiation therapy. Its purpose is to assist in "positioning the prostate in a more predictable and reproducible location" and to stabilize anatomy during "treatment planning, image verification, and radiotherapy delivery." These functions relate to therapy delivery and patient positioning, not the diagnosis of a disease or condition.
No
The device description clearly states it is a physical, disposable device made of various materials (PVC, Polycarbonate, etc.) with an inflatable balloon and shaft, intended for physical positioning. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for positioning and stabilization of anatomical structures during radiation therapy. This is a therapeutic/positioning function, not a diagnostic one.
- Device Description: The device is a physical, inflatable balloon used for mechanical positioning. It does not perform any tests on biological samples (blood, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device analyzing samples, detecting biomarkers, or providing any information about a patient's health status or disease.
- Input Imaging Modality: While imaging (CT and X-ray) is used in conjunction with the device, the device itself is not performing the imaging or providing a diagnosis based on the images. It's a tool used during the imaging and treatment process.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
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.
Product codes
PCT
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectal wall and adjacent structures in the male human anatomies
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Only trained healthcare professionals are intended to operate this device.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data demonstrate that DxTx Medical Pro-Tx Endorectal Balloon is as safe and effective as RadiaDyne Prostate Immobilizer Rectal Balloon predicate device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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
1
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
2
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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3
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 Device
De Novo Number: DEN130036/
510(k) Number: K132194 | DxTx Medical Device
Pro-Tx Endorectal Balloon |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Single-use disposable, inflatable, non-powered
positioning device intended for use in the
temporary positioning of the rectal wall and
adjacent structure in the male human anatomies.
The purpose of the device is to stabilize the
prostate during Computed Tomography (CT)
exam and X-ray, when these imaging techniques | 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 |
| Feature | Predicate Device
De Novo Number: DEN130036/
510(k) Number: K132194 | DxTx Medical Device
Pro-Tx Endorectal Balloon |
| | are used for Radiation Therapy (RT) planning.
The placement of the balloon requires a
Physician, or a Physician directed healthcare
professional, and is performed as a separate
procedure apart from the standard CT exam and
RT treatment. | 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. |
| Size | Similar to Pro-Tx | 17" long, shaft outer diameter 0.3" |
| Technology
Characteristics | Soft Tip
Thin Wall Balloon
Fiducial marker
Semi-flexible shaft
Depth markers on shaft
Depth stopper
Flexible syringe connector tubing
Rapid release valve (balloon fill and empty)
Gas release vent
Gas release valve (GRB Series only, not on RB
Classic Series: Allows controlled release of
rectal gas after balloon insertion | Soft Tip
Thin Wall Balloon
Fiducial marker
Semi-flexible shaft
Depth markers on shaft
Depth stopper
Flexible syringe connector tubing
Rapid release valve (balloon fill and empty)
Gas release vent
No gas release valve - Rectal gas
automatically vents out |
| Accessories | 100 ml Syringe
Lubricant | No accessories - customer provides their
own; Luer lock interfaces with off the shelf
syringes |
| Safety | No product related hazards were reported in the
FDA MAUDE database since the product was
approved in January 2014 to 31 July 2022
MR Conditional for tantalum fiducial marker | No product related hazards were reported in
the FDA MAUDE database for the Bayer
Pro-Tekt, which is the design for the Pro-Tx
transferred to DxTx Medical, since the
initial distribution agreement in August
2010 to 31 July 2022
MR Conditional for brass fiducial marker |
| Effectiveness | Performance Tests (from De Novo):
Bioburden
Leakage
Tensile strength
Burst strength
Depth stopper resistance
Vent | Performance Tests
Bioburden
Leakage (Inflation Integrity)
Tensile strength (Axial Pull)
Burst strength
Depth stopper resistance
Vent (Occlusion)
3' Drop
45° Shaft Flexure |
| Material | Thin Wall Balloon: Polyurethane
Fiducial marker: Tantalum | Thin Wall Balloon: Silicone (equivalent
function)
Fiducial marker: Brass (equivalent function) |
5
6
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.