RectalPro 75 Endorectal Balloon

K180478 · Qlrad International , Ltd. · PCT · Nov 13, 2018 · Radiology

Device Facts

• Record ID: K180478
• Device Name: RectalPro 75 Endorectal Balloon
• Applicant: Qlrad International , Ltd.
• Product Code: PCT · Radiology
• Decision Date: Nov 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5720
• Device Class: Class 2

Indications for Use

The RectalPro™75 Endorectal Balloon device is a 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 are used for Radiation Therapy (RT) planning.

Device Story

RectalPro™ 75 is a single-use, non-powered, inflatable rectal balloon; used to immobilize the prostate and displace normal tissue during radiation therapy planning (CT/X-Ray). Device consists of a curved shaft with an inflatable balloon, a locking stopper for depth control, and a syringe for inflation with air or water. Operated by clinicians in a clinical setting; inserted into the rectum and inflated to stabilize the prostate; deflated and removed post-procedure. Provides a predictable, reproducible prostate position; benefits patient by improving radiation targeting accuracy and sparing adjacent healthy tissue.

Clinical Evidence

Bench testing only. Assessments included biocompatibility (ISO 10993-1), bioburden (ISO 11737-1), leak/burst testing, transportation testing (ASTM D4169:2016), and risk assessment (ISO 14971). Results met all acceptance criteria and demonstrated performance comparable to the predicate device.

Technological Characteristics

Materials: PVC with blue colorant, silicone, polypropylene. Principle: Inflatable balloon for mechanical immobilization. Energy: Non-powered (manual syringe inflation). Form factor: Curved shaft with balloon, locking stopper, and luer-lock tubing. Connectivity: None. Sterilization: Non-sterile, not intended for user sterilization. Standards: ISO 10993-1 (biocompatibility), ISO 11737-1 (bioburden), ASTM D4169:2016 (transportation), ISO 14971 (risk).

Indications for Use

Indicated for male patients requiring prostate stabilization during CT or X-Ray imaging for radiation therapy planning.

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

• Myriad Prostate Caddy™ Immobilization Rectal Balloon (K150234)

Submission Summary (Full Text)

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November 13, 2018

QLRAD International Ltd. % Audrey Swearingen Regulatory Affairs Specialist Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 AUSTIN, TX 78746

Re: K180478

Trade/Device Name: RectalPro™ 75 Endorectal Balloon Regulation Number: 21 CFR 892.5720 Regulation Name: Prostate Immobilizer Rectal Balloon Regulatory Class: Class II Product Code: PCT Dated: October 11, 2018 Received: October 12, 2018

Dear Mr. Swearingen:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hse 2. Nils

for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180478

Device Name RectalPro™75 Endorectal Balloon

#### Indications for Use (Describe)

The RectalPro™15 Endorectal Balloon device is a single-use disposable, inflatable, non-powered positioning device intended for us 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 are used for Radiation Therapy (RT) planning.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

# RectalPro™75 Endorectal Balloon

## K180478

### 1. Submission Sponsor

QLRAD International Ltd. (QLRAD)

Wormerweg 6

1311 XB Almere

The Netherlands

Contact: Arjen Winkel

Title: President and CEO

## 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Contact: Audrey Swearingen Title: Regulatory Affairs Manager

## 3. Date Prepared

February 21, 2018

### 4. Device Identification

| | Trade/Proprietary Name: | RectalPro™ Endo Rectal Balloon (ERB) (“RectalPro 75”) |
|--|-------------------------|-------------------------------------------------------|
| | Common/Usual Name: | Rectal Balloon for Prostate Immobilization |
| | Classification Name: | Prostate immobilizer rectal balloon |
| | Regulation Number: | 21 CFR 892.5720 |
| | Product Code: | PCT |
| | Device Class: | Class II |
| | Classification Panel: | Radiology |

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### 5. Legally Marketed Predicate Device(s)

K150234, Myriad Prostate Caddy™ Immobilization Rectal Balloon Item, Myriad Medical, LLC

### 6. Indication for Use Statement

The RectalPro™75 Endorectal Balloon device is a 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 are used for Radiation Therapy (RT) planning.

#### 7. Device Description

The RectalPro™ 75 Endorectal Balloon (ERB) is single use, disposable, inflatable, non-powered rectal 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. The RectalPro75 is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The ERB is inserted into the rectum and inflated prior to the start of a CT scan or RT therapy procedure. The device stabilizes the prostate once the device is inflated. The ERB is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session.

The RectalPro ERB is designed with a slim curved, extended shaft and balloon. The device is provided non-sterile to the end user, is not intended to be sterilized by the end user. It is packaged in a kit configuration, consisting of three primary components:

- 1. ERB shaft This is the shaft with attached balloon and attached clear plastic tubing for filling the balloon with air / water. The end of the tubing has a female luer lock. There are white markings on the side of the ERB shaft as insertion depth markings.
- 2. Stopper This is the circular plastic piece with one flat side, and one side containing four prongs. There is a hole in the middle of the stopper for placement onto the ERB shaft.
- 3. Air / water valve This is the small plastic valve on the air tube connected to the ERB shaft. The clamp on the air / water tube stops the air / water flow by squeezing the tube closed. This component stops air / water from releasing out of the balloon after it has been filled.

The kit also includes a standard 100 cc syringe with male luer lock connector, for connecting to the female luer connection of the ERB tubing, and is used to deliver the water or air to the ERB.

#### 8. Substantial Equivalence Discussion

The following table compares the RectalPro™75 Endorectal Balloon to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance.

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The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.

| Manufacturer | QLRAD International Ltd. | Myriad Medical, LLC | Device Comparison |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | RectalPro™75 Endorectal<br>Balloon | Myriad Prostate Caddy™<br>Immobilization Rectal<br>Balloon | |
| 510(k) Number | To be determined | K150234 | Not applicable |
| Product Code | PCT | PCT | Same |
| Regulation<br>Number | 21 CFR 892.5720 | 21 CFR 892.5720 | Same |
| Regulation Name | Rectal balloon for<br>prostate immobilization | Rectal balloon for prostate<br>immobilization | Same |
| Indications for Use | The RectalPro™75<br>Endorectal Balloon device<br>is a single-use disposable,<br>inflatable, non-powered<br>positioning device<br>intended for use in the<br>temporary positioning of<br>the rectal wall and<br>adjacent structure in the<br>male human anatomies.<br>The purpose of the device<br>is to stabilize the prostate<br>during Computed<br>Tomography (CT) exam,<br>and X-Ray when these<br>imaging techniques are<br>used for Radiation<br>Therapy (RT) planning. | The Myriad Prostate<br>Caddy™ Immobilization<br>Rectal Balloon is a single-<br>use disposable, inflatable,<br>non-powered positioning<br>device intended for use in<br>the temporary positioning<br>of the rectal wall and<br>adjacent structure in the<br>male human anatomies.<br>The purpose of the device<br>is to stabilize the prostate<br>during Computed<br>Tomography (CT- exam,<br>and X-Ray when these<br>imaging techniques are<br>used for Radiation<br>Therapy (RT) planning.<br>The placement of the<br>balloon requires a<br>Physician, or a Physician<br>directed healthcare<br>professional and is<br>performed as a separate<br>procedure apart from the | Similar Indications<br>statements. The intended<br>use to immobilize /<br>stabilize the prostate<br>during radiation therapy is<br>the same for both. |
| Manufacturer | QLRAD International Ltd. | Myriad Medical, LLC | Device Comparison |
| Trade Name | RectalPro™75 Endorectal<br>Balloon | Myriad Prostate Caddy™<br>Immobilization Rectal<br>Balloon<br>standard CT exam and RT treatment. | |
| Mechanism of<br>Action | The balloon is inserted in<br>the patient's rectum and<br>inflated with air or water<br>using the syringe. The<br>stopper is used to lock the<br>device at the desired<br>depth. The balloon is<br>intended to stabilize the<br>prostate and displace<br>normal tissue away from<br>the radiation treatment<br>area. | The balloon is inserted in<br>the patient's rectum and<br>inflated with air or water<br>using the syringe. The<br>stopper is used to lock the<br>device at the desired<br>depth. The balloon is<br>intended to stabilize the<br>prostate and displace<br>normal tissue away from<br>the radiation treatment<br>area. | Same |
| Device<br>Components | Rectal balloon attached to<br>Curved Shaft, with<br>protective sleeve;<br>Locking Stopper;<br>Tubing,<br>Syringe | Rectal balloon attached to<br>Shaft, no protective<br>sleeve;<br>Locking Stopper;<br>Tubing;<br>Syringe | Same basic components<br>and configuration.<br>RectalPro 75 has a<br>protective sleeve on the<br>balloon to protect it<br>during handling and<br>transportation;<br>RectalPro shaft is curved<br>on the end to assist<br>insertion into the rectum.<br>These minor design<br>changes do not raise new<br>questions of safety and<br>effectiveness. |
| Inflated Diameter | 4.5 cm with 60cc air<br>4.6 cm with 80cc air<br>5.0 cm with 100cc air | 4.6 cm with 80cc air<br>5.0 cm with 100cc air | Same |
| Gas Venting Valve | No | None verified | Not known. The RectalPro<br>ERB is open-ended to<br>allow release of gas. |
| Manufacturer | QLRAD International Ltd. | Myriad Medical, LLC | Device Comparison |
| Trade Name | RectalPro™75 Endorectal<br>Balloon | Myriad Prostate Caddy™<br>Immobilization Rectal<br>Balloon | Device Comparison |
| Visualization<br>Method | CT / MRI | CT / MRI | Same |
| Sterilization | Not provided sterile nor<br>intended to be sterilized | Not provided sterile nor<br>intended to be sterilized | Same |
| Single Use | Yes | Yes | Same |
| Shelf Life | 2.5 years | 2 years | Similar |
| Patient Contacting<br>Materials | PVC with Blue colorant;<br>Silicone;<br>Polypropylene | PVC;<br>'polymer';<br>Other materials unknown | All materials used in the<br>manufacture of the<br>RectalPro75™ Endorectal<br>Balloon are suitable for<br>this use and have been<br>used in numerous<br>previously cleared<br>products. The materials<br>were tested per ISO 10993<br>and found to be<br>biocompatible. |
| Non-Clinical Bench<br>Testing | Bioburden - < 100CFU<br>Leakage (water) – no<br>leaking with 110cc water<br>after 60 min;<br>Tensile (Burst) (air) - did<br>not burst with 140cc air<br>under 7.7 lbs force for 12<br>min.;<br>Stopper Resistance -<br>stopper did not move<br>under 10 lbs of force | Bioburden - < 100CFU<br>Leakage (water) – no<br>leaking with 100cc water<br>after 10 min;<br>Tensile (Burst) (air) - did<br>not burst with 100cc air<br>under 7.1 lbs force;<br>Stopper Resistance - force<br>required to move was<br>4.91 lbs average | The performance testing<br>was consistent with the<br>predicate device. The<br>results showed that the<br>RectalPro™75™ Endorectal<br>Balloon performed as<br>intended and is at least as<br>safe and effective as the<br>predicate. |

## Table 5A – Comparison of Characteristics

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#### 9. Non-Clinical Performance Data

In demonstrating safety and effectiveness of RectalPro™75 Endorectal Balloon, and in showing substantial equivalence to the predicate device, QLRAD International Ltd. performed various assessments. The RectalPro™75 Endorectal Balloon meets the requirements for design and

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functionality, with test results confirming that the design input meets the design inputs and specifications for the device, and performs comparably to the predicate device.

The RectalPro™75 Endorectal Balloon was assessed for the following in accordance with internal requirements and international standards, and met all requirements:

- Biocompatibility per ISO 10993-1. Device determined to be biocompatible.
- . Bioburden testing per ANSI/AAMI/ISO 11737-1. Device met acceptance criteria.
- Leak and Burst testing per internal protocol. Device met acceptance criteria.
- Transportation testing per ASTM D4169:2016. Device met requirements.
- Risk assessment per ISO 14971. Device has acceptable residual risks.

#### 10. Statement of Substantial Equivalence

The device has the same intended use and the same or similar technological characteristics to the Prostate Caddy Balloon predicate device. The differences do not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

Therefore, the RectalPro™75 Endorectal Balloon is determined to be substantially equivalent to the predicate device.