(197 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical function of a physical balloon for prostate immobilization. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The device is intended for temporary positioning and stabilization of the prostate during imaging for radiation therapy planning. It does not actively treat a disease or condition, but rather assists in the imaging process.
No
The device is a positioning and immobilizing device, not intended for diagnosis but for stabilizing the prostate during imaging for radiation therapy planning. Its purpose is mechanical support and positioning, not to provide diagnostic information or interpret images.
No
The device is a physical, inflatable balloon made of polyurethane and other medical-grade materials, intended for physical positioning of anatomical structures. It is not software.
Based on the provided information, the RadiaDyne Prostate Immobilizer Rectal Balloon is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended for the physical positioning and stabilization of anatomical structures (rectal wall and prostate) during imaging procedures (CT and X-ray) for radiation therapy planning. It does not perform any tests on biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health or condition.
- Device Description: The device is a physical, inflatable balloon used for mechanical support and positioning. It does not contain reagents, assays, or other components typically associated with IVD testing.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of analytes, or generation of diagnostic results.
The device is a medical device used in conjunction with imaging for treatment planning, but its function is mechanical and positioning-based, not diagnostic.
N/A
Intended Use / Indications for Use
The 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.
The RadiaDyne Prostate Immobilizer Rectal Balloon 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. 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.
Product codes
PCT
Device Description
The RadiaDyne Prostate Immobilizer Rectal Balloon, as shown in figures 1 and 2 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 Prostate Immobilizer Rectal Balloon 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 Prostate Immobilizer Rectal Balloon is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. RadiaDyne's device is designed for single use, is provided non-sterile to the end user, is not intended to be sterilized by the end user, and is packaged in a kit configuration. Each kit contains the following items: Rectal Balloon (polyurethane); Syringe (accessory to the device); Lubricant (accessory to the device); Locking Stopper (accessory to the device); and Instructions Manual. The balloon consists of Formia Process The main section of the device consists of a balloon and tubing which are made of polyurethane. The remainder of the device is made from other medical grade materials consisting of the following components shown in Table 1.
The device can be inflated with either air or water, and this process is carried out with the single use disposable syringe that is supplied with the device in the accessory kit. The locking stopper supplied with the Prostate Immobilizer Rectal Balloon controls the depth at which the balloon is inserted into the rectum. The device can therefore be locked into place once inserted into place. RadiaDyne's Prostate Immobilizer Rectal Balloon is offered with a gas release valve (Models GRB) and without a gas release valve (Models: RB). Prior to insertion of the balloon, rectal gas can be removed from the rectum by methods not involving the balloon, such as inserting a pediatric catheter. The gas release model incorporates an open conduit through the balloon stem so that the rectal gas can be released once the balloon is inserted.
After inflation, the gas release conduit continues to provide an escape path for any additional gas arriving at the superior end of the balloon, thus preventing gas accumulation during the procedure. The gas release valve is always open and does not require any action to function. If the model without the gas release valve is used, some transient gas may accumulate during the procedure, as is customary when no balloon is inserted. Aside from this feature, the GRB and RB models are identical in materials, construction and function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) exam and X-ray
Anatomical Site
Rectum, Prostate, Rectal Wall, Seminal Vesicles (stabilization mentioned in device features)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or a Physician directed healthcare professional; Clinical setting where Radiation Therapy (RT) planning and delivery occur.
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)
Nonclinical/Bench Studies:
- Biocompatibility/Materials:
- Cytotoxicity: Toxicity grade of 0 (no reactivity).
- Skin Irritation: Primary irritation index of 0.0 (negligible response).
- Sensitization: Grade I reaction, classified as having weak allergenic potential.
- Acute Systemic Toxicity: No significant difference between test and control animals.
- Shelf Life/Sterility:
- Subject device functions properly after 2 years storage. Shelf-life declared as 2 years.
- Bioburden testing results were well below specified limits. Device is non-sterile.
- Performance Testing - Bench:
- Bioburden testing: Conducted based on Trade Secret Formula. Colony Forming Units (CFU) enumerated.
- Leakage Testing: All devices subject to leak testing as final quality control check.
- Tensile-strength and Burst-strength Testing (in air): Balloon capable of withstanding a test-fill volume of Trade Secret Formula & Process of H2O before rupturing. Tensile strength is Trade Secret Formula & Process using a standardProcess COUPO11 at Trade Secret Formula & Process of travel.
- Burst-strength testing (in vivo): Each product code designed to a Trade Secret Formula inflation volume. Test simulates in vivo use of rectal balloon inside the Trade Secret Formula & Process and inflating in a Formula & P rectum.
- Stopper resistance testing: Trade Secret Formula & Process placement of the balloon ensures Trade Secret Formula & Process the best product performance. Test involves Trade Secret Formula & Process in a controlled manner Trade Secret Formula & Process.
- Vent testing (for GRB models): Air flow must be greater than Trade Secret Formula & Process.
Clinical Information (Literature Review):
- Wachter et al [1]: Observed maximum prostate anterior-posterior (AP) displacements >5 mm in 2/10 patients with endorectal balloons vs. 8/10 without. Concluded endorectal balloon reduces prostate movements. 252 patients treated, no complications related to balloon.
- D'Amico et al [2]: Similar balloon shape/fill volume. Concluded endorectal balloon reduced intrafraction motion; maximum prostate AP displacement decreased from 4 mm to ≤1 mm. Placement well tolerated by all patients.
- Woel et al [3]: Acute toxicity in patients using intrarectal balloon during first 15 fractions. Toxicity resolved by end of treatment or 3 months after. Balloon well tolerated, none discontinued use. Balloon similar in fill volume, shape, and fills parallel to rectal wall.
- Patel et al [4]: Rectal balloon significantly reduces rectal wall volume in high dose region for radiation therapy. Balloon catheter well-tolerated without complications, some required topical lidocaine. None discontinued use. Balloon similar in fill volume to subject device.
- Bastasch et al [5]: 393/396 (99.2%) of patients tolerated 100 ml barium-enema type endorectal balloon for entire 35-day course (prostate IMRT). 0.8% required volume reduction, 4.3% lubricant jelly, 11.6% anal medication, 6.8% antidiarrhea medication. Clinically acceptable acute anorectal toxicity. No grade 3 or 4 toxicities. Differed in key parameters from subject balloon.
- Ronson et al [6]: 3,474/3561 (97.6%) patients tolerated rectal balloon throughout entire prostate irradiation. 87 patients declined for 85.5% of total treatment days (mean percent). Fill volumes = 120cc well tolerated. Subject balloon fill volume (60-100ml) is less.
- Both et al [7] (using subject balloon system): Reported on intrafraction prostate displacements with electromagnetic tracking. Daily endorectal balloon placement consistently stabilized prostate, preventing >5 mm displacement. 3-mm internal margin may suffice for 95% of intrafraction movement for up to 6 minutes.
- Wang et al [8] (using subject balloon system): Quantified intrafraction prostate motion. Percentage of time prostate displaced was less in subject endorectal balloon group. Reduced internal margins in almost all directions, especially anterior-posterior.
- Wootton et al [9] (using subject balloon system): Retrospectively examined effectiveness of endorectal balloon with passive gas release conduit. Found subject balloons with gas-release mechanism effectively release bowel gas, decrease probability of balloon displacement, and may improve workflow.
Key Results: The literature review consistently supports that endorectal balloons, including the subject device, are safe and well-tolerated, effectively reduce prostate motion, and can improve target localization and reduce radiation exposure to healthy tissues in prostate cancer radiotherapy. Risks such as anorectal toxicity, tissue damage, perforation, and patient intolerance, while noted, are considered manageable with appropriate controls and clinical practices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Wachter et al [1]: prostate anterior-posterior (AP) displacements >5 mm in 2/10 patients with endorectal balloons, compared to 8/10 patients without.
- D'Amico et al [2]: decrease in maximum prostate AP displacement from 4 mm to ≤1 mm.
- Bastasch et al [5]: 393/396 (99.2%) tolerated the balloon. 0.8% required volume reduction, 4.3% lubricant jelly, 11.6% requested anal medication and 6.8% requested antidiarrhea medication. No grade 3 or 4 toxicities.
- Ronson et al [6]: 3,474/3561 (97.6%) tolerated the rectal balloon. 87 patients (2.4%) declined for one or more treatments but still utilized the balloon for 85.5% of the total treatment days (mean percent).
- Both et al [7]: 3-mm internal margin may sufficiently account for 95% of intrafraction prostate movement for up to 6 minutes of treatment time. Lateral internal margin could be further reduced to 2 mm.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DE NOVO CLASSIFICATION REQUEST FOR PROSTATE IMMOBILIZER RECTAL BALLOON DECISION SUMMARY
1. Regulatory Information:
a. Identification:
FDA identifies this type of device as:
Rectal Balloon for Prostate Immobilization
The 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.
- New Regulation Number: 21 CFR 892.5720 b.
- Classification: II C.
- Product Code: PCT d.
-
- Background:
- Device Name: Prostate Immobilizer Rectal Balloon a.
- Submission number: K132194 b.
- Date of De Novo Request: July 15, 2013 C.
- Contact in USA: Mark A. Heller d. Goodwin Procter LLP 901 New York Avenue, NW Washington, DC 20001 USA Phone: (202) 346-4107 Fax: (202) 346-4444 E-mail: mheller@goodwinprocter.com
- Requester's Recommended Classification: Class II e.
1
3. Indications for Use:
The RadiaDyne Prostate Immobilizer Rectal Balloon 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. 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.
Device Description: 4.
- Device Description: The RadiaDyne Prostate Immobilizer Rectal Balloon, as a. shown in figures 1 and 2 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 Prostate Immobilizer Rectal Balloon 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 Prostate Immobilizer Rectal Balloon is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. RadiaDyne's device is designed for single use, is provided non-sterile to the end user, is not intended to be sterilized by the end user, and is packaged in a kit configuration. Each kit contains the following items: Rectal Balloon (polyurethane); Syringe (accessory to the device); Lubricant (accessory to the device); Locking Stopper (accessory to the device); and Instructions Manual. The balloon consists of Formia Process
The main section of the device consists of a balloon and tubing which are made of polyurethane. The remainder of the device is made from other medical grade materials consisting of the following components shown in Table 1.
Table 1
Bill of Material
(Key Materials/Components Only)
RadiaDyne Prostate Immobilizer Rectal Balloon
Main Device
2
| Component | Material |
|---|---|
| Balloon | Polyurethane |
| Catheter tubing | (b)(4) Trade Secret Formula & Process |
| Connector | |
| HUB | |
| Inner lumen | |
| 1-way Stopcock, 90° turn | |
| Handle | |
| Venting Tip | |
| 1.0 mm Fiducial Marker | |
| (only for “F” model | |
| designated devices) | Tantalum |
| Accessory Kit | |
| Syringe (100 ml) | Polypropylene/Rubber |
| Lubricant | Fougera Surgilube® |
| Locking Stopper | (b)(4) Trade Secret Formula & |
| Process |
The device can be inflated with either air or water, and this process is carried out with the single use disposable syringe that is supplied with the device in the accessory kit. The locking stopper supplied with the Prostate Immobilizer Rectal Balloon controls the depth at which the balloon is inserted into the rectum. The device can therefore be locked into place once inserted into place. RadiaDyne's Prostate Immobilizer Rectal Balloon is offered with a gas release valve (Models GRB) and without a gas release valve (Models: RB). Prior to insertion of the balloon, rectal gas can be removed from the rectum by methods not involving the balloon, such as inserting a pediatric catheter. The gas release model incorporates an open conduit through the balloon stem so that the rectal gas can be released once the balloon is inserted.
3
Image /page/3/Figure/0 description: This image is a diagram of the RadiaDyne Prostate Immobilizer Rectal Balloon GRB Series, which includes a gas release valve. The diagram labels 14 different parts of the device, including the soft/flexible tip, fiducial marker, gas release tip, tapered design, distal bulbous balloon section, mid-line groove, thin wall balloon, customizable fill content, locking depth stopper, depth markers, semi-flexible shaft, gas release vent, flexible syringe connector tubing, and rapid release valve. The diagram also includes a list of features of the device, such as its atraumatic design for comfortable insertion and its ability to stabilize seminal vesicles.
4
Image /page/4/Figure/1 description: The image is a figure of the RadiaDyne Prostate Immobilizer Rectal Balloon RB Classic Series. The figure shows the device with labels and descriptions of its features. Some of the features include a soft/flexible tip, fiducial marker, tapered design, distal bulbous balloon section, mid-line groove, thin wall balloon, customizable fill content, locking depth stopper, depth markers, semi-flexible shaft, flexible syringe connector tubing, and a rapid release valve. The figure is labeled as Figure 2.
5
After inflation, the gas release conduit continues to provide an escape path for any additional gas arriving at the superior end of the balloon, thus preventing gas accumulation during the procedure. The gas release valve is always open and does not require any action to function. If the model without the gas release valve is used, some transient gas may accumulate during the procedure, as is customary when no balloon is inserted. Aside from this feature, the GRB and RB models are identical in materials, construction and function. Some of the key design features of the RadiaDyne Prostate Immobilizer Rectal Balloon are shown in the product specific marketing literature in figures 1 and 2.
- b. Principle of Operation: 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. The balloon is inserted in the patient's rectum and inflated with air or water using the syringe. Standard imaging and treatment protocols are to be used to verify the device placement and adjust the stopper depth until the desired device position is obtained. The balloon is intended to stabilize the prostate and displace normal tissue away from the radiation treatment area. Stabilization of the prostate is intended to allow more consistent treatment targeting and delivery of radiation to tumor only. The displacement of normal tissue is intended to reduce unnecessary radiation exposure and reduce side effects from radiation treatment.
- Modes of Operation: The device can be used to stabilize the prostate during C. Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning.
- Accessories: The device is packaged in a kit configuration with the following d. items: rectal balloon, syringe (optional), lubricant, stopper, and instruction manual.
5. Summary of Nonclinical/Bench Studies
Nonclinical performance data were provided to address the following areas:
a. Biocompatibility/Materials:
Biocompatibility testing was submitted for the subject device which is intended for direct skin and/or mucosal membrane contact with the patient for less than 24 hours. There is also the possibility for contact with breached or compromised skin/mucosal surface; as such the Formula & Process
6
- Cytotoxicity was evaluated (b)(4) Trade Secret Formul
The test articles had a toxicity grade of 0 which indicates no reactivity.
Skin Irritation was evaluated using (b)(4) Trade Secret Formu .
The results showed no significantly greater biological reaction than sites treated with the control article. The primary irritation index was 0.0. The response was categorized as negligible.
-
Sensitization: (b)(4) Trade Secret Formul .
All sites were observed for evidence of dermal (b)(4) Trade Secret Formula & Treactions & Treaction & Process after patch removal. Based on the Secret Formula score the test article has a Grade I reaction and is classified as having weak allergenic potential. -
Acute Systemic Toxicity was evaluated by (b)(4) Trade Secret Formula . The result showed no significant difference between test and control animals.
These tests adequately address the biocompatibility concerns for the subject device.
b. Shelf Life/Sterility:
The sponsor has provided shelf-life testing data. which ensures that the subject device is within acceptable bioburden limits and device will function properly after 2 years of storage. Therefore, the shelf-life of RadiaDyne's Prostate Immobilizer Rectal Balloon is declared on the product label and is set at two The sponsor has specified that the bioburden limit for the subject vears. device iS Formula & Process and the tested devices were all well below Formula Recess This specification derives from the medical and which is acceptable. scientific literature and the fact that the product is neither intended nor offered for sale as sterile, and is for use in the rectum, an anatomical cavity laden with bacteria and enormously high CFU counts. Please refer to Bench testing section for bioburden testing results.
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Electromagnetic Compatibility and Electrical Safety: C.
Not applicable
d. Software:
Not applicable
Performance Testing - Bench e.
The following performance tests were performed:
-
Bioburden testing: It was conducted based on (b)(4) Trade Secret Formul .
This process was repeated process times per article. Colony Forming Units (CFU) were enumerated for each volume. (b)(4) Trade Secret Form -
Leakage Testing: All devices are subject to leak testing as the final quality . control check. Each device is filled and held under pressure pressure process before they are released to inspection. Devices that pass the leak test are accepted for final processing to finished goods.
-
Tensile-strength and Burst-strength Testing (in air): A sampling of each . lot is subject to burst-strength testing. The purpose of the testing is to verify the elastic deformation and seal integrity. The balloon is capable of withstanding a test-fill volume of Formula & Process of H2O before rupturing. (b)(4) Trade Secret Fo The tensile strength is (b)(4) Trade Secret Formula & using a standardProcess COUPO11 at Formula & Process of travel.
Burst-strength testing (in vivo): Each product code is designed to a (b)(4) Trade Secret Formula inflation volume. This is a controlled test to ensure that the balloon is capable of inflating to its designed volume plus a reasonable safety factor. This test simulates in vivo use of rectal balloon inside the (b)(4) Trade Secret Formula & Process and inflating in a Formula & P rectum by
- Stopper resistance testing: Formula & Process placement of the balloon ensures . (b)(4) Trade Secret Formula & Process the best product performance.
8
| (b)(4) Trade Secret Formula & Process are essential to ensuring (b)(4) Trade Secret Formula & Process placement. The stopper |
|---|
| test involves (b)(4) Trade Secret Formula & Process in a controlled |
| manner (b)(4) Trade Secret Formula & Process The results take into account the |
| combination of both (b)(4) Trade Secret Formula & Process |
- Vent testing: To test the gas release portion (vent) of the device, (b)(4) Trade Secret Formula & Process
| The air flow must be greater |
|---|
| than (b)(4) Trade Secret Formula & Process (b)(4) Trade Secret Formula & Process |
All the above performance tests are adequate.
Summary of Clinical Information 6.
The following is the summary of the literature provided by the sponsor that supports a reasonable assurance of safety and effectiveness for the subject device:
Wachter et al [1] observed maximum prostate anterior-posterior (AP) displacements >5 mm in 2/10 patients treated with endorectal balloons, compared to 8/10 patients treated without endorectal balloons. Using repeated CT-examinations, lead to the conclusion that an endorectal balloon reduces prostate movements during treatment. A total of 252 patients were treated for localized prostate cancer using fractionated radiation therapy to a total dose of 66 Gy (ICRU reference point) with the rectal balloon catheter used in daily radiation treatment. It was reported there were no complications related to the balloon application. These balloons were longer compared to the subject balloon and did not cause any perforations or other tissue damage. D'Amico et al [2] with a balloon similar shape and fill volume to the subject balloon concluded that an endorectal balloon reduced intrafraction motion, as repeated CT-imaging with 1 min time intervals showed a decrease in maximum prostate AP displacement from 4 mm to ≤1 mm. They also concluded that the placement and inflation of the endorectal balloons were well tolerated by all patients. Woel et al [3] described acute toxicity in patients treated with four-field three-dimensional (3D) conformal radiation therapy (CRT) using an intrarectal (endorectal) balloon during the first 15 fractions of radiation therapy. The finding of this study show that the expected increase in acute genitourinary, gastrointestinal, and dermatologic toxicity is resolved either by end of treatment or by 3 months after treatment. In this follow-up study, Woel et al [3] found that the intrarectal (endorectal) balloon was well tolerated by all of the patients; none of the patients had to discontinue use of the balloon device. The balloon used in this study is similar to the subject balloon in fill volume, shape and it fills parallel to the rectal wall. Patel et al [4] demonstrated that the use of a rectal balloon significantly reduces the rectal wall volume in the high dose region for radiation therapy and should produce corresponding reductions in rectal complication rates. They also
9
found that the balloon catheter has been well-tolerated without any complications, but some patients required the use of topical lidocaine ointment due to rectal irritation. None of the patients in this study had to discontinue use of the endorectal balloon. The balloon used in this study was similar in fill volume to the subject device balloon
It has been reported that the Baylor College of Medicine/Methodist Hospital group [5] has been using endorectal balloons in prostate IMRT since 1998. In their study, they report that three hundred ninety-three of the 396 patients (393/396=99.2%) tolerated the 100 ml barium-enema type endorectal balloon for the entire 35-day course of the Intensity modulated radiation therapy (IMRT) treatment. Only 0.8% (3/396) required volume reduction to 50 ml, 4.3% (17/396) required lubricant jelly, 11.6% (46/396) requested anal medication and 6.8% (27/396) requested antidiarrhea medication. The rate of acute anorectal toxicity was clinically acceptable. No patient had grade 3 or 4 toxicities. Duration of the toxicities typically was 1 to 2 weeks. Patients with pre-existing anorectal disease are at higher risk of developing acute anorectal toxicity with the use of an endorectal balloon. This finding is considered as a warning/contraindication. The endorectal balloon (barium enema) used in this study differs from the subject balloon in key parameters like balloon shape and shaft design. The subject balloon shape is more favorable from safety point of view because of more favorable fill volume and balloon shape. Ronson et al [6] also observed equally good results in a group of 3561 patients. Of all the patients evaluated, 3,474 patients (3474/3561=97.6%) tolerated the rectal balloon throughout the entire of prostate irradiation treatment. Only 87 patients (87/3561=2.4%) declined the balloon for one or more treatments. Importantly, these patients still utilized the balloon for 85.5% of the total treatment days (mean percent). Rectal balloons with fill volumes=120cc were well tolerated by the study patients. The subject balloon fill volume of 60-100ml is less than the fill volume used by Ronson et al [6] and thus favorable from safety and tolerance point of view.
The studies by Both et al [7], Wang et al [8], and Wootton et al [9] using the subject balloon system demonstrate that the application of endorecral balloons is safe and well-tolerated. Some patients with pre-existing anorectal disease require additional clinical care
Both et al [7] using the subject balloon system reported on intrafraction prostate displacements measured with electromagnetic tracking system. It was reported that the use of daily endorectal balloon placement consistently stabilized the prostate, preventing clinically significant displacement (>5 mm) during imaging and therapy. A 3-mm internal margin may sufficiently account for 95% of intrafraction prostate movement for up to 6 minutes of treatment time. Directional analysis suggests that the lateral internal margin could be further reduced to 2 mm. Wang et al [8] using the subject balloon system quantified interafraction prostate motion between patient groups treated with and without daily endorectal balloons employed during prostate radiotherapy and established the effectiveness of the subject endorectal balloon.
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The percentage of time that the prostate was displaced in any direction was less in the subject endorectal balloon group for almost all magnitudes of motion considered. The directional analysis shows that the endorectal balloon reduced internal margins in almost all directions, especially the anterior-posterior direction.
Wootton et al [9] using the subject ballon system retrospectively examined the effectiveness of an endorectal balloon that has a passive gas release conduit for the removal of rectal gas during prostate proton radiotherapy. Bowel gas buildup can cause balloon displacement. They found that the subject balloons with gas-release mechanism can effectively release bowel gas, decrease the probability of balloon displacement and may be able to improve clinical workflow by reducing the need for separate medical procedures to reduce bowel gas.
The review of the available literature related to the use of endorectal balloons and the subject balloons shows that the subject balloon is safe and well tolerated by patients. However, as the literature suggests, there are a few risks involved which can be mitigated by applying general and special controls. The literature also reveals that the benefit of the Prostate Immobilizer Rectal Balloon is to improve target localization and reduce prostate motion, which may improve treatment outcomes in external beam radiotherapy. The review of the different clinical studies also raises a question about reproducibility of daily endorectal balloon insertion. This can be improved by applying position verification strategies to confirm the position of rectal balloon relative to prostate gland. In view of all the reviewed clinical studies, it can be concluded that the subject balloon is a reasonably safe and effective device.
References:
- S. Wachter et al., The Influence of a Rectal Balloon as Internal Mobilization [1] Device on Variations of Volumes and Dose-Volume Histograms During Treatment Course of Conformal Radiotherapy for Prostate Cancer. 52 INT. J. RADIAT. ONCOL. BIOL. PHYS. 91-100 (2002).
- A.V. D'Amico, et al., A Practical Method to Achieve Prostate Gland [2] Immobilization and Target Verification for Daily Treatment, 51 INT. J. RADIAT. ONCOL. BIOL. PHYS. 1431-36 (2001).
- Woel et al., Acute Gastrointestinal, Genitourinary, and Dermatological (31 Toxicity During Dose-escalated 3Dconformal radiation Therapy (3DCRT) Using an Intrarectal Balloon for Prostate Gland Localization and Immobilization, 62 INT. J. RADIAT. ONCOL. BIOL. PHYS. 392-396 (2005).
- R.R. Patel et al., Rectal Dose Sparing with a Balloon Catheter and Ultrasound [4] Localization in Conformal Radiation Therapy for Prostate Cancer, 67 RADIOTHER. & ONCOL. 285-94 (2003).
- M.D. Bastasch, M.D., et al., Tolerance of Endorectal Balloon in 396 Patients ારો Treated With Intensity-Modulated Radiation Therapy (IMRT) for Prostate Cancer, 29 AM. J. CLIN. ONCOL. 8-11 (2006).
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- B.B. Ronson, et al., Patient Tolerance of Rectal Balloons in Conformal [6] Radiation Treatment of Prostate Cancer, 64 INT. J. RADIAT. ONCOL. BIOL. PHYS. 1367-70 (2006).
- S. Both, et al., Real-Time Study of Prostate Intrafraction Motion During [7] External Beam Radiotherapy with Daily Endorectal Balloon, 81 INT. J. RADIAT. ONCOL. BIOL. PHYS. 1302-09 (2011).
- K.K. Wang et al., A Study to Quantify the Effectiveness of Daily Endorectal [8] Balloon for Prostate Intrafraction Motion Management, 83 INT. J. RADIAT. ONCOL. BIOL. PHYS. 1055-63 (2011).
- L.S. Wootton et al., Effectiveness of a Novel Gas-Release Endorectal Balloon ldl in the Removal of Rectal Gas for Prostate Proton Radiation Therapy, 13 J. APP. CLIN. MED. PHYS., 190-97 (2012).
7. Labeling
The labeling for the RadiaDyne Prostate Immobilizer Rectal Balloon is consistent with the clinical data and covers all the hazards and other clinically relevant information that may impact safe and effective use of the device. The labeling is sufficient and satisfies the requirements of 21 CFR Part 801.109 Prescription devices. The following summarizes how the RadiaDyne Prostate Immobilizer Rectal Balloon labeling addresses the special controls:
Labeling must include adequate instructions for use on the proper a. insertion procedure, positioning, and inflation of the rectal balloon.
The instructions for the Prostate Immobilizer Rectal Balloon include the following: insert the device, position and lock the device; use gas release catheter or transient gas-release vent; fill the balloon component of the device; and remove the device. Statements in the Instructions for Use relate to the use of lubricant, using clinical imaging verification technique and treatment protocols, monitoring the patient's tolerance of the device, and the necessary procedures when a patient does not tolerate the device. The Instructions for Use also include photographs of the Prostate Immobilizer Rectal Balloon, diagrams related to inserting and removing the device, the complete Intended Use and Indications for Use statements, and information about transportation and storage of the device. The labeling also provides the information about used lubricant, Fougera Surgilube® and MR conditional for 3 T or less for tantalum fiducial marker.
device labeling must include appropriate contraindications, b. The warnings, and an expiration date that is supported by performance data as well as supporting the sterility if presented as sterile.
The labeling includes following warning statements: "Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport."; "Failure to perform the standard imaging position verification
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protocol may cause the device to not perform as intended."; "Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation." and "Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon." The labeling includes following contraindications: Hemorrhoids; Peri-rectal/Peri-anal abscess; Anal fissure; Prior low anterior resection; Rectal fistula; Rectal fissure; Rectal ulcer; Anal canal stricture; Diverticulitis; Surgery of the prostate, rectum or surrounding area within the last eight weeks; Radiation of the rectum or surrounding area within the last eight weeks; and Any standard exclusionary criteria recognized for endo-rectal / intra-rectal devices.
The labeling also includes an expiration date which has been specified as 2 years and states that the device is not sterile since this is not required for this application. The device labeling also states that it is for single use.
8. Risks to Health and Required Mitigation Measures
FDA has indentified following risks generally associated with the use of Prostate Immobilization Rectal Balloons:
- Anorectal Toxicity: Insertion of rectal balloon can cause adverse rectal i. tissue reaction on patients as a result of direct contact to the rectal mucosa. This reaction may also result due to toxic, irritating, or sensitizing agents present in the rectal balloon formulation (allergic reaction).
- ii. Tissue Damage: Healthy tissue damage can result due to lack of physical integrity of the rectal balloon. A lack of physical integrity of rectal balloon is a failure to perform the prostate immobilization due to low quality of the material and substandard structural feature of the device. It can lead to adverse consequences to the patients such as leakage which can cause tissue toxicity from contamination and balloon burst which can cause local injury. Lack of physical integrity of the rectal balloon can also cause other mechanical and functional disorders.
- iii. Perforation of the Rectum: Perforation of the rectum may occur due to traumatic insertion of the rectal balloon. The improper direction of the rectal balloon tip and excessive force are likely the main causes of traumatic insertion of the rectal balloon. Over distending the rectal balloon can also lead to perforation. The bowel gas buildup can also contribute to perforation.
- iv. Irradiation of Healthy Tissue: Irradiation to healthy tissue can occur due to incorrect balloon placement. Incorrect balloon placement may be due to bowel gas build up, incorrect balloon insertion, or incorrect inflation of the balloon and may cause irradiation of healthy tissue and/or an inadequate (higher or lower) radiation dose delivered to the treatment target.
13
- Patient intolerance: Insertion of the rectal balloon can be intolerable to the v. patient. This intolerance can be due to any one or combination of the following factors: pain, irritation, anxiety, and any type of discomfort. This intolerance is further exacerbated by every repeated physical insertion of the rectal balloon and daily irradiation assault as the rectum and anus will become more sensitive after a series of radiation treatments and repeated insertion of rectal balloon. If the patient is unable to tolerate the balloon during any of the treatment sessions throughout the entire radiation treatment course, this may result in a need to re-plan the radiation treatment and /or delay the delivery of the radiotherapy.
| Identified Risks | Required Mitigation Measures |
|---|---|
| Anorectal Toxicity | |
| Insertion of rectal balloon can cause | |
| adverse rectal tissue reaction on patients as | |
| a result of direct contact to the rectal | |
| mucosa. This reaction may also result due | |
| to toxic, irritating, or sensitizing agents | |
| present in the rectal balloon formulation | |
| (allergic reaction). | Special controls (1)(i), (1)(ii), (1)(iii), |
| (1)(iv), (2)(i)(D), (2)(ii), (2)(iii), and | |
| (2)(iv) | |
| Tissue Damage | Special controls (1)(iv), (1)(v), (2)(i)(A), |
| (2)(i)(D), (2)(ii), (2)(iii), and (2)(iv) | |
| Healthy tissue damage can result due to | |
| lack of physical integrity of the rectal | |
| balloon. A lack of physical integrity of | |
| rectal balloon is a failure to perform the | |
| prostate immobilization due to low quality | |
| of the material and substandard structural | |
| feature of the device. It can lead to adverse | |
| consequences to the patients such as | |
| leakage which can cause tissue toxicity | |
| from contamination and balloon burst | |
| which can cause local injury. Lack of | |
| physical integrity of the rectal balloon can | |
| also cause other mechanical and functional |
Table: Identified Risks to Health and Required Mitigation Measures
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| disorders. | |
|---|---|
| Perforation of the Rectum | Special controls (1)(v)(A), (1)(v)(B), (2)(i)(A), (2)(i)(D), (2)(ii), (2)(iii), and (2)(iv) |
| Perforation of the rectum may occur due to traumatic insertion of the rectal balloon. The improper direction of the rectal balloon tip and excessive force are likely the main causes of traumatic insertion of the rectal balloon. Over distending the rectal balloon can also lead to perforation. The bowel gas buildup can also contribute to perforation. | |
| Irradiation of Healthy Tissue | Special controls (1)(v)(A), (1)(v)(B), (2)(i)(B), (2)(ii), (2)(iii), and (2)(iv) |
| Irradiation to healthy tissue can occur due to incorrect balloon placement. Incorrect balloon placement may be due to bowel gas build up, incorrect balloon insertion, or incorrect inflation of the balloon and may cause irradiation of healthy tissue and/or an inadequate (higher or lower) radiation dose delivered to the treatment target. | |
| Patient Intolerance | Special controls (1)(v)(A), (2)(i)(A), (2)(i)(C), (2)(ii), (2)(iii), and (2)(iv) |
| Insertion of the rectal balloon can be intolerable to the patient. This intolerance can be due to any one or combination of the following factors: pain, irritation, anxiety, and any type of discomfort. This intolerance is further exacerbated by every repeated physical insertion of the rectal balloon and daily irradiation as the rectum and anus will become more sensitive after a series of radiation treatments and repeated insertion of rectal balloon. If the patient is unable to tolerate the balloon during any of the treatment sessions throughout the entire radiation treatment course, this may result |
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| in a need to re-plan the radiation treatment | |
|---|---|
| and | |
| radiotherapy. | |
9. 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:
-
- 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).
-
- 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.
Benefit/Risk Determination 10.
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| Summary of the Benefits | The benefit of Prostate Immobilizer Rectal
Balloon is to improve target localization by
reducing prostate motion, which may
improve treatment outcomes in external
beam radiotherapy. These benefits include
improved treatment delivery with smaller
margins and improved positional
reproducibility. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of the Risks | The potential risks associated are anorectal
toxicity, tissue damage, perforation of the
rectum, irradiation of healthy tissue, and
patient intolerance. However, these risks
can be significantly reduced by applying
identified special controls. |
| Summary of Other Factors | For the successful use of this device,
during each imaging and subsequent
radiation treatment, the position of rectal
balloon relative to prostate gland should be
reproduced. This solely depends upon the
experience and expertise of the physician.
However, this risk can be effectively
minimized, if image verification techniques
are used. |
| Conclusion | The benefit of Prostate Immobilizer Rectal
Balloon is to improve target localization by
reducing prostate motion, which may
improve treatment outcomes in external
beam radiotherapy. These benefits include
improved treatment delivery with smaller
margins and improved positional
reproducibility. The motion of the prostate
has been a significant issue affecting the
treatment of the prostate cancer patients
receiving external beam radiation therapy.
There are risks involved, including the
misplacement of the prostate immobilizer
rectal balloon. These risks however can be
mitigated by applying general and the
identified special controls. Therefore, in
conclusion due to the benefit of improved
stability of the prostate during treatment,
this device certainly has potential to benefit |
| | patients undergoing external beam radiotherapy. |
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Other comments 11.
None
12. Conclusion:
The request for de novo review of the Prostate Immobilizer Rectal Balloon is granted. FDA believes that special controls, along with the applicable general controls, provide reasonable assurance of the safety and effectiveness of the device type. This device is classified under the following:
Product Code: PCT Device Type: Rectal Balloon for Prostate Immobilization Class: Class II (special controls) Regulation: 21 CFR 892.5720
(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). A rectal balloon for prostate immobilization must comply with the following special controls:
-
- 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:
18
- 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).
-
- 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.