Pro-Tx Endorectal Balloon (PROT-25)

K223249 · Dxtx Medical, Inc. · PCT · Feb 10, 2023 · Radiology

Device Facts

• Record ID: K223249
• Device Name: Pro-Tx Endorectal Balloon (PROT-25)
• Applicant: Dxtx Medical, Inc.
• Product Code: PCT · Radiology
• Decision Date: Feb 10, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.5720
• Device Class: Class 2

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.

Device Story

Disposable, non-powered inflatable balloon device; used for rectal wall and prostate immobilization during radiation therapy. Device consists of shaft, inflatable liquid silicone rubber balloon, and brass radiopaque marker. Operated by trained healthcare professionals in clinical settings. Device inserted rectally; inflated with air or fluid to stabilize anatomy; gas venting feature allows automatic release of rectal gas. Provides predictable, reproducible prostate positioning for treatment planning and delivery. Benefits include improved target localization and stabilization during radiation therapy. Output is physical stabilization of anatomy; healthcare provider uses device to ensure accurate radiation delivery.

Clinical Evidence

Bench testing only. No clinical data. Performance verification included biocompatibility evaluation, 2-year accelerated aging shelf-life testing, and mechanical bench testing (axial pull, inflation integrity, burst strength, vent occlusion, drop test, and flexure test) to confirm equivalence to predicate.

Technological Characteristics

Materials: PVC, Polycarbonate, Polyethylene, Polypropylene, Copolyester, Liquid Silicone Rubber (balloon), brass (radiopaque marker). Non-powered, inflatable balloon with gas venting. Dimensions: 17" length, 0.3" shaft OD. MR Conditional. Single-use, disposable. No software or electronic components.

Indications for Use

Indicated for male patients requiring temporary positioning of the rectal wall and adjacent structures to stabilize the prostate during radiation therapy (planning, image verification, and delivery).

Regulatory Classification

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.

Special Controls

In addition to the general controls of the FD&C Act, the Prostate Immobilization Rectal Balloon is subject to the following special controls: - 1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing: - Biocompatibility testing of the final finished device; i) - 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.

*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.

Predicate Devices

• RadiaDyne Prostate Immobilizer Rectal Balloon (DEN130036/K132194)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 ( <i>Select one or both, as applicable</i> ) |
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| <span></span> <div style="display:inline-block;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:inline-block;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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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: [phone] Email: [e-mail] 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<br>De Novo Number: DEN130036/<br>510(k) Number: K132194 | DxTx Medical Device<br>Pro-Tx Endorectal Balloon |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Single-use disposable, inflatable, non-powered<br>positioning device intended for use in the<br>temporary positioning of the rectal wall and<br>adjacent structure in the male human anatomies.<br>The purpose of the device is to stabilize the<br>prostate during Computed Tomography (CT)<br>exam and X-ray, when these imaging techniques | The DxTx Medical Pro-Tx Endorectal<br>Balloon is a disposable, single use non-<br>powered inflatable positioning device<br>intended to be used for temporary<br>positioning of the rectal wall and adjacent<br>structures in the male human anatomies and |
| Feature | Predicate Device<br>De Novo Number: DEN130036/<br>510(k) Number: K132194 | DxTx Medical Device<br>Pro-Tx Endorectal Balloon |
| | are used for Radiation Therapy (RT) planning.<br>The placement of the balloon requires a<br>Physician, or a Physician directed healthcare<br>professional, and is performed as a separate<br>procedure apart from the standard CT exam and<br>RT treatment. | to assist in positioning the prostate in a<br>more predictable and reproducible location.<br><br>The purpose of the DxTx Medical Pro-Tx<br>Endorectal Balloon is to stabilize the rectal<br>wall and surrounding anatomy during all<br>phases of radiation therapy, including<br>treatment planning, image verification, and<br>radiotherapy delivery. Only trained<br>healthcare professionals are intended to<br>operate this device. |
| Size | Similar to Pro-Tx | 17" long, shaft outer diameter 0.3" |
| Technology<br>Characteristics | Soft Tip<br>Thin Wall Balloon<br>Fiducial marker<br>Semi-flexible shaft<br>Depth markers on shaft<br>Depth stopper<br>Flexible syringe connector tubing<br>Rapid release valve (balloon fill and empty)<br>Gas release vent<br>Gas release valve (GRB Series only, not on RB<br>Classic Series: Allows controlled release of<br>rectal gas after balloon insertion | Soft Tip<br>Thin Wall Balloon<br>Fiducial marker<br>Semi-flexible shaft<br>Depth markers on shaft<br>Depth stopper<br>Flexible syringe connector tubing<br>Rapid release valve (balloon fill and empty)<br>Gas release vent<br>No gas release valve - Rectal gas<br>automatically vents out |
| Accessories | 100 ml Syringe<br>Lubricant | No accessories - customer provides their<br>own; Luer lock interfaces with off the shelf<br>syringes |
| Safety | No product related hazards were reported in the<br>FDA MAUDE database since the product was<br>approved in January 2014 to 31 July 2022<br><br>MR Conditional for tantalum fiducial marker | No product related hazards were reported in<br>the FDA MAUDE database for the Bayer<br>Pro-Tekt, which is the design for the Pro-Tx<br>transferred to DxTx Medical, since the<br>initial distribution agreement in August<br>2010 to 31 July 2022<br>MR Conditional for brass fiducial marker |
| Effectiveness | Performance Tests (from De Novo):<br>Bioburden<br>Leakage<br>Tensile strength<br>Burst strength<br>Depth stopper resistance<br>Vent | Performance Tests<br>Bioburden<br>Leakage (Inflation Integrity)<br>Tensile strength (Axial Pull)<br>Burst strength<br>Depth stopper resistance<br>Vent (Occlusion)<br>3' Drop<br>45° Shaft Flexure |
| Material | Thin Wall Balloon: Polyurethane<br><br>Fiducial marker: Tantalum | Thin Wall Balloon: Silicone (equivalent<br>function)<br><br>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.