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.

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.

AI/ML Overview

The provided text describes the RectalPro™75 Endorectal Balloon, a device intended for prostate immobilization during radiation therapy planning. It is a 510(k) submission, meaning the manufacturer is claiming substantial equivalence to a legally marketed predicate device, not necessarily proving novel safety and effectiveness through extensive clinical trials.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the performance of the predicate device and relevant international standards. The reported device performance is presented as meeting these criteria.

Acceptance Criteria Category	Specific Acceptance Criteria (Reference/Standard)	Reported RectalPro™75 Endorectal Balloon Performance
Biocompatibility	Device determined to be biocompatible (per ISO 10993-1)	Device determined to be biocompatible. (Materials PVC with Blue colorant; Silicone; Polypropylene were tested per ISO 10993 and found to be biocompatible).
Bioburden	Bioburden < 100 CFU (per ANSI/AAMI/ISO 11737-1) or comparable to predicate. Predicate: Bioburden < 100 CFU.	Device met acceptance criteria. (Specifically, Bioburden < 100CFU reported).
Leakage (Water)	No leaking with 100cc water after 10 min (Predicate performance for comparison). RectalPro™75 internal protocol criteria: No leaking with 110cc water after 60 min.	Device met acceptance criteria. (Specifically, no leaking with 110cc water after 60 min reported).
Tensile (Burst) (Air)	Did not burst with 100cc air under 7.1 lbs force (Predicate performance for comparison). RectalPro™75 internal protocol criteria: Did not burst with 140cc air under 7.7 lbs force for 12 min.	Device met acceptance criteria. (Specifically, did not burst with 140cc air under 7.7 lbs force for 12 min reported).
Stopper Resistance	Force required to move was 4.91 lbs average (Predicate performance for comparison). RectalPro™75 internal protocol criteria: Stopper did not move under 10 lbs of force.	Device met acceptance criteria. (Specifically, stopper did not move under 10 lbs of force reported).
Transportation	Met requirements (per ASTM D4169:2016)	Device met requirements.
Risk Assessment	Acceptable residual risks (per ISO 14971)	Device has acceptable residual risks.
Shelf Life	Similar to predicate (predicate has 2 years).	2.5 years. (This is similar and actually longer than the predicate, indicating comparable or better stability).

2. Sample Size Used for the Test Set and Data Provenance

The provided text discusses non-clinical bench testing. There is no mention of a "test set" in the context of clinical data or patient studies. The "test set" in this context refers to the samples of the device used for the various bench tests (e.g., individual balloons for leak, burst, and stopper resistance tests). The sample sizes for these specific bench tests are not explicitly stated in the document, only the results for a single device or a general statement of "device met acceptance criteria."

The data provenance is bench testing conducted by QLRAD International Ltd. (the manufacturer). There is no mention of country of origin for any clinical data, as no clinical studies are reported.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable. The "test set" here refers to the device and its components undergoing engineering and material performance tests, not clinical performance read by experts to establish a "ground truth" for a diagnostic or imaging device. The "ground truth" for these tests would be the measurement results against predefined engineering specifications.

4. Adjudication Method for the Test Set

This is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not the nature of the testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The submission is a 510(k) for a device that stabilizes the prostate, not a diagnostic or imaging AI tool requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study, as this term typically applies to AI algorithms, was mentioned or performed. The device is a physical medical device.

7. Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" is established by engineering specifications and measurements performed on the device samples. For example:

Biocompatibility: Results of standardized in vitro/in vivo tests against ISO 10993.
Bioburden: Microbial count below a specified threshold (100 CFU).
Leakage/Burst: Absence of leaks or rupture under specific pressure/volume/time conditions.
Stopper Resistance: Force required to move the stopper meeting a defined threshold.
Transportation: Device integrity after simulated transport according to ASTM D4169.

8. Sample Size for the Training Set

This is not applicable. There is no mention of any AI or machine learning algorithms, and therefore, no "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set for an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180478

Device Name RectalPro™75 Endorectal Balloon

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: (512) 327.9997 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

{4}------------------------------------------------

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 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.
1. 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.
1. 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.

{5}------------------------------------------------

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 EndorectalBalloon	Myriad Prostate Caddy™Immobilization RectalBalloon
510(k) Number	To be determined	K150234	Not applicable
Product Code	PCT	PCT	Same
RegulationNumber	21 CFR 892.5720	21 CFR 892.5720	Same
Regulation Name	Rectal balloon forprostate immobilization	Rectal balloon for prostateimmobilization	Same
Indications for Use	The RectalPro™75Endorectal Balloon deviceis a single-use disposable,inflatable, non-poweredpositioning deviceintended for use in thetemporary positioning ofthe rectal wall andadjacent structure in themale human anatomies.The purpose of the deviceis to stabilize the prostateduring ComputedTomography (CT) exam,and X-Ray when theseimaging techniques areused for RadiationTherapy (RT) planning.	The Myriad ProstateCaddy™ ImmobilizationRectal Balloon is a single-use disposable, inflatable,non-powered positioningdevice intended for use inthe temporary positioningof the rectal wall andadjacent structure in themale human anatomies.The purpose of the deviceis to stabilize the prostateduring ComputedTomography (CT- exam,and X-Ray when theseimaging techniques areused for RadiationTherapy (RT) planning.The placement of theballoon requires aPhysician, or a Physiciandirected healthcareprofessional and isperformed as a separateprocedure apart from the	Similar Indicationsstatements. The intendeduse to immobilize /stabilize the prostateduring radiation therapy isthe same for both.
Manufacturer	QLRAD International Ltd.	Myriad Medical, LLC	Device Comparison
Trade Name	RectalPro™75 EndorectalBalloon	Myriad Prostate Caddy™Immobilization RectalBalloonstandard CT exam and RT treatment.
Mechanism ofAction	The balloon is inserted inthe patient's rectum andinflated with air or waterusing the syringe. Thestopper is used to lock thedevice at the desireddepth. The balloon isintended to stabilize theprostate and displacenormal tissue away fromthe radiation treatmentarea.	The balloon is inserted inthe patient's rectum andinflated with air or waterusing the syringe. Thestopper is used to lock thedevice at the desireddepth. The balloon isintended to stabilize theprostate and displacenormal tissue away fromthe radiation treatmentarea.	Same
DeviceComponents	Rectal balloon attached toCurved Shaft, withprotective sleeve;Locking Stopper;Tubing,Syringe	Rectal balloon attached toShaft, no protectivesleeve;Locking Stopper;Tubing;Syringe	Same basic componentsand configuration.RectalPro 75 has aprotective sleeve on theballoon to protect itduring handling andtransportation;RectalPro shaft is curvedon the end to assistinsertion into the rectum.These minor designchanges do not raise newquestions of safety andeffectiveness.
Inflated Diameter	4.5 cm with 60cc air4.6 cm with 80cc air5.0 cm with 100cc air	4.6 cm with 80cc air5.0 cm with 100cc air	Same
Gas Venting Valve	No	None verified	Not known. The RectalProERB is open-ended toallow release of gas.
Manufacturer	QLRAD International Ltd.	Myriad Medical, LLC	Device Comparison
Trade Name	RectalPro™75 EndorectalBalloon	Myriad Prostate Caddy™Immobilization RectalBalloon	Device Comparison
VisualizationMethod	CT / MRI	CT / MRI	Same
Sterilization	Not provided sterile norintended to be sterilized	Not provided sterile norintended to be sterilized	Same
Single Use	Yes	Yes	Same
Shelf Life	2.5 years	2 years	Similar
Patient ContactingMaterials	PVC with Blue colorant;Silicone;Polypropylene	PVC;'polymer';Other materials unknown	All materials used in themanufacture of theRectalPro75™ EndorectalBalloon are suitable forthis use and have beenused in numerouspreviously clearedproducts. The materialswere tested per ISO 10993and found to bebiocompatible.
Non-Clinical BenchTesting	Bioburden - < 100CFULeakage (water) – noleaking with 110cc waterafter 60 min;Tensile (Burst) (air) - didnot burst with 140cc airunder 7.7 lbs force for 12min.;Stopper Resistance -stopper did not moveunder 10 lbs of force	Bioburden - < 100CFULeakage (water) – noleaking with 100cc waterafter 10 min;Tensile (Burst) (air) - didnot burst with 100cc airunder 7.1 lbs force;Stopper Resistance - forcerequired to move was4.91 lbs average	The performance testingwas consistent with thepredicate device. Theresults showed that theRectalPro™75™ EndorectalBalloon performed asintended and is at least assafe and effective as thepredicate.

Table 5A – Comparison of Characteristics

{6}------------------------------------------------

{7}------------------------------------------------

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

{8}------------------------------------------------

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.

Regulation Number and Section

§ 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.