The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum.

The BioProtect Balloon Implant System is composed of a balloon made of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Device Description

The BioProtect Balloon Implant™ System is composed of a single use, biodegradable, inflatable balloon implant, designed to act as a spacer between the prostate and the rectum. The BioProtect Balloon Implant System is supplied sterile. The balloon is implanted transperineally using transrectal ultrasound (TRUS) guidance and remains stable throughout the radiation treatment and gradually degrades over time.

The BioProtect Balloon Implant System consists of single use components detailed below:

Balloon biodegradable, inflatable balloon acts as a spacer between the prostate and rectal wall.
Balloon Deployer delivery system, the balloon is mounted and folded on the deployer
Delivery Kit - an applicator system used to position and deploy the balloon in the intended location. It includes an 18-gauge echogenic needle, blunt-tipped tissue dilator, and balloon introducer sheath.

The BioProtect Balloon Implant System is for prescription use only.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device Name: BioProtect Balloon Implant™ System

Indications for Use: The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloon Implant System is composed of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from primary efficacy/safety endpoints)	Reported Device Performance
Efficacy Primary Endpoint: Reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy when compared to pre-implantation values, in 75% of the subjects assigned to the balloon group.	97.9% of subjects gained rectal dose reduction >25% in rV70 post-implantation. Relative mean dose reduction of 84.8% of the rectum receiving 70Gy. Rectal radiation dose consistently reduced in all radiation levels (40Gy to 80Gy). Sign test p-values were <0.001 for all levels.
Safety Primary Endpoint: Proportion of subjects with Grade 1 or greater rectal adverse events and implantation procedure-related adverse events with a duration of at least 2 days through the first six (6) months, demonstrating non-inferiority to the control group.	Proportion of 18% in the Balloon Group vs. 23.1% in the Control Group, achieving the one-sided non-inferiority test for the Balloon Group (p < 0.001). No Serious Adverse Device Event (SADE) or Unanticipated Adverse Device Effect (UADE) occurred.
Balloon Stability: Maintain stable distance between rectal wall and prostate throughout radiotherapy.	Stable distance between rectal wall and prostate measured at last radiation treatment day (1.8 cm) compared to post-implantation (1.9 cm).
Complete Degradation: Complete balloon degradation.	Complete balloon degradation at 6 months demonstrated in 98.5% of subjects.
Bladder Volume (Implicit, for context): Monitor bladder volume changes.	Pre-implantation mean of 194.3cc (±128.51cc) and post-implantation mean of 231.5cc (±134.56cc) show a modest increase.
Treatment Constraint Achievement (Implicit, for context): Ability to meet PTV and rectal/bladder constraints.	No plan in the balloon group failed to meet all constraints. Significantly higher likelihood in achieving PTV and all rectal constraints (83.5% vs 57.7%) favoring the balloon arm, as well as all PTV and bladder constraints (70.5% vs 60.3%).

Study Details

The study that proves the device meets the acceptance criteria is a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled clinical study (IDE G17020).

Sample size used for the test set and the data provenance:
- Sample Size: 222 subjects were enrolled and randomized.
- Data Provenance: The study was a multi-center clinical study. The document does not specify the country of origin but refers to "IDE G17020," which is an FDA Investigational Device Exemption number, implying the study was conducted under FDA oversight, likely with sites in the US (though not explicitly stated). It was a prospective study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that the primary safety endpoint was assessed by an independent Clinical Events Committee (CEC) blinded to subject assignment.
- Qualifications of experts: Not specified in the provided text.
Adjudication method for the test set:
- The primary safety endpoint was assessed by an independent Clinical Events Committee (CEC), implying an adjudication process, but the specific method (e.g., 2+1, 3+1) is not explicitly detailed. The CEC's role suggests independent review and consensus on adverse events.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This study was a clinical trial comparing the device (balloon + fiducial markers) to a control (fiducial markers only) in human patients for real-world clinical outcomes related to radiation dosage and adverse events, not an imaging-based assessment by multiple readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an AI algorithm. The performance described is the device's effectiveness in a human patient setting, not the performance of an algorithm.
The type of ground truth used:
- Clinical Outcomes Data: This includes actual measurements of rectal radiation dose reduction, recorded adverse events (evaluated by an independent CEC), and physical measurements of balloon stability and degradation within patients.
The sample size for the training set:
- Not applicable for a physical medical device. "Training set" typically refers to data used to train machine learning algorithms. This was a clinical trial for a physical implant.
How the ground truth for the training set was established:
- Not applicable. As above, this concept applies to AI/ML development, not a physical medical device clinical trial.

Summary

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August 25, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

BioProtect, Ltd. % Janice Hogan Partner Hogan Lovells U.S. LLP 1735 Market Street, Floor 23 PHILADELPHIA, PA 19103

Re: K222972

Trade/Device Name: BioProtect Balloon Implant™ System Regulation Number: 21 CFR 892.5725 Regulation Name: Absorbable perirectal spacer Regulatory Class: Class II Product Code: OVB Dated: August 21, 2023 Received: August 21, 2023

Dear Janice Hogan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222972

Device Name BioProtect Balloon Implant™ System

Indications for Use (Describe)

The BioProtect Balloon Implant System is intended to temporarily position the antenor rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum.

The BioProtect Balloon Implant System is composed of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K222972

510(k) Summary BioProtect Ltd.'s BioProtect Balloon Implant™

System

l. Contact Information

Submitter:

Janice Hogan Hogan Lovells US LLP janice.hogan@hoganlovells.com

Ph: (267) 675-4611

Sponsor:

BioProtect, Ltd. 8 Tsor St., Tzur Yigal Israel, 4486200 Phone: +972 (9) 8667-891 Fax: +972 (9) 7731-932

II. Date of 510(k) Summary Preparation:

August 24, 2023

III. Subject Device

Trade name:	BioProtect Balloon Implant™ System
Common name:	Absorbable Perirectal Spacer
Classification name:	Absorbable Perirectal Spacer
Regulation Number:	21 CFR 892.5725
Product code:	OVB
Regulatory class:	II (Special Controls)
Review Panel:	Radiology

IV. Predicate Device

Identification of Predicate Device: SpaceOAR System (DEN140030) Common/Usual Name: Hydrogel Spacer

V. Device Description

The BioProtect Balloon Implant System consists of single use components detailed below:

1. Balloon biodegradable, inflatable balloon acts as a spacer between the prostate and rectal wall.

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1. Balloon Deployer delivery system, the balloon is mounted and folded on the deployer
ന Delivery Kit - an applicator system used to position and deplov the balloon in the intended location. It includes an 18-qauge echogenic needle, blunt-tipped tissue dilator, and balloon introducer sheath.

The BioProtect Balloon Implant System is for prescription use only.

VI. Indications for Use

VII. Summary of Technological Characteristics Compared to the Predicate Device

The intended use and principles of operation of the BioProtect Balloon Implant System and the SpaceOAR predicate device are identical. Both devices meet the regulatory definition for Absorbable Rectal Spacers outlined in 21 CFR 892.5725.

Both devices facilitate implantation of biodegradable materials in a minimally invasive procedure between the anterior rectal wall and the prostate under transrectal ultrasound (TRUS) guidance using a dedicated delivery system prior to radiotherapy for prostate cancer. Both devices mechanically create a space between the anterior rectal wall and the prostate to protect the anterior rectum from excessive radiation during radiation treatment for prostate cancer. The space created by both devices is performed by injecting fluid at the perirectal layer. Both devices are single-use and are provided sterile to licensed medical professionals only and are biodegradable and absorbed by the body over time. The target population of both devices is adult human males receiving radiation therapy for prostate cancer.

The principal differences between the subject and predicate devices are:

Material Composition The BioProtect Balloon Implant is composed of Poly (L-lactide-co-s-● caprolactone) (PLCL) which is a bioresorbable copolymer, whereas the SpaceOAR is comprised of a polyethylene glycol (PEG) hydrogel that is crosslinked in-situ.
. Formation of Perirectal Spacing – The BioProtect Balloon Implant is inflated with saline and can be deflated and repositioned if needed, whereas the predicate device is gel formed insitu by mixing two solutions and cannot be repositioned.
. Volume - The inflated balloon contains up to 17 ml of iniected saline providing 10-18 mm space height, whereas the predicate device places 10 ml of hydrogel.
Implantation Process The BioProtect balloon implant is pre-folded on an integral deployer . whereas the predicate is an injectable gel. The implantation procedure of the BioProtect balloon includes establishing a working channel along the plane from the prostate apex to base using a beveled tip dilator dissection with an option of hydro dissection, and then insertion of the balloon through the working channel and slowly filling it with saline. The

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inflated balloon is then sealed, using a pluq sealing made of the same material as the balloon itself, detached from the deployer and the inflated balloon is left in situ.

The SpaceOAR System implantation process consists of preparing the precursor syringe assembling the delivery components for injection, inserting the needle all the way posterior to the prostate base, hydro dissecting the space using saline and then injecting the hydrogel.

Insertion/Placement Insertion of the predicate requires hydrodissection that is ● accomplished by injecting saline via a needle and syringe into the perirectal space. The BioProtect balloon is placed in the desired area on a deployer, following blunt dissection, and is then injected with saline to form a larger pre-shaped balloon.
Shape - The geometrical shape of the balloon is predetermined whereas the predicate device is injected as a liquid gel, and as such the final shape of the gel is less predictable and can be less symmetrical.

A substantial equivalence table highlighting the similarities and minor differences between the subject and predicate devices is provided below.

DescriptiveInformation	BioProtect Balloon Implant System(Subject Device)	SpaceOAR System(Predicate Device - DEN140030)
Indications forUse	The BioProtect Balloon Implant System isintended to temporarily position the anteriorrectal wall away from the prostate duringradiotherapy for prostate cancer and increating this space it is the intent of theBioProtect Balloon Implant System to reducethe radiation dose delivered to the anteriorrectum.	SpaceOAR System is intended totemporarily position the anterior rectal wallaway from the prostate during radiotherapyfor prostate cancer and in creating this spaceit is the intent of SpaceOAR System toreduce the radiation dose delivered to theanterior rectum.
	The BioProtect Balloon Implant System iscomposed of a balloon made of abiodegradable material that maintains thespace for the entire course of prostateradiotherapy treatment and is completelyabsorbed by the patient's body over time.	The SpaceOAR System is composed ofbiodegradable material and maintains spacefor the entire course of prostate radiotherapytreatment and is completely absorbed by thepatient's body over time.
Prescription Use	For prescription use only.	For prescription use only.
Classificationand ProductCode	21 CFR 892.5725OVB - Absorbable perirectal spacer	21 CFR 892.5725OVB - Absorbable perirectal spacer
Mode of Action	System that facilitates implantation ofballoon between anterior rectal wall andprostate prior to radiotherapy. Thistemporarily creates space between theanterior rectal wall and prostate duringradiotherapy for prostate cancer which iseventually absorbed following the course ofradiotherapy treatment	Systems that facilitate implantation of 10ccPEG biodegradable hydrogel between theanterior rectal wall and prostate prior toradiotherapy. This temporarily createsspace between the anterior rectal wall andprostate during radiotherapy for prostatecancer which is eventually absorbedfollowing the course of radiotherapytreatment.
OperatingPrinciples	● Spacer● Implantable● Biodegradable● Biocompatible● Transperineally approach● TRUS guided	● Spacer● Implantable● Biodegradable● Biocompatible● Transperineally approach● TRUS guided
DescriptiveInformation	BioProtect Balloon Implant System(Subject Device)	SpaceOAR System(Predicate Device - DEN140030)
Material	Poly (L-lactide-co-ε-caprolactone) which is abioresorbable copolymer	Polyethylene glycol (PEG) hydrogel that isformed in-situ.
System basiccomponents	Biodegradable, injectable balloon (mountedon a deployer)Balloon Delivery Kit (18-gauge echogenicneedle, dilator and introducer sheath)	The SpaceOAR® System consists ofComponents for the preparation of asynthetic, absorbable hydrogel spacer andDelivery mechanism.Once assembled, the Y-connector allows forhydrogel injection via an 18-gauge needle.
Technology	Pre folded Balloon inflated with Saline	When mixed the solutions are cross linked toform a soft hydrogel. The spacer is formedby mixing two solutions, the Precursor, andthe Accelerator. The Precursor solution isformed through the mixing of the Diluentsolution (Trilysine buffer solution) with thePEG powder. The mixing of the solutions isaccomplished as the material passesthrough a static mixer in the Y-connectorprior to passing through an injection needle.
SurgicalApproach	Implanted transperineally in a minimallyinvasive procedure in the space between theprostate and the rectum under transrectalultrasound (TRUS) guidance using adedicated delivery system.	Implanted transperineally in a minimallyinvasive procedure in the space between theprostate and the rectum under transrectalultrasound (TRUS) guidance using adedicated delivery system.
Form	Balloon	In Situ formed hydrogel
Sizes	In its deployed inflated configuration, theballoon has the following dimensions:Length: 48mmWidth: 35mmHeight: 10-18mmHeight can be controlled depending ondesired spacing, by controlling the amount ofsaline injected prior to balloon sealing.	10 ml injectable gel
Resorption Time	Biodegradable material maintains space forthe entire course of prostate radiotherapytreatment (approximately 3 months) and iscompletely absorbed by the patient's bodyover time (approximately 6 months).	Biodegradable material maintains space forthe entire course of prostate radiotherapytreatment (approximately 3 months) and iscompletely absorbed by the patient's bodyover time (approximately 6 months).
Implantationprocedure steps	Establishing a working channel along the plane from prostate base using a beveled tip dilator dissection (Hydro dissection is optional) Insertion of the balloon through the working channel filling the Balloon with saline. Sealing the inflated balloon	Preparing the precursor syringe Hydro dissecting the space using saline Assembling the delivery components for injection, inserting the needle all the way posterior to the prostate base Injecting the SpaceOAR hydrogel
SterilizationMethod	ethylene oxide	ethylene oxide
Sterility	Sterile, SAL 10-6	Sterile, SAL 10-6
Singe Use/Reuse	Single use only	Single use only
Packaging	Packed in sterile blister and Tyvek located ina humidity bag in a carton box	Packed in sterile blister and Tyvek located ina carton box

Table 1. Substantial Equivalence of the Subject Device as Compared to Predicate Device

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The minor technological differences between the BioProtect Balloon Implant System and SpaceOAR System predicate device, raise no new issues of safety or effectiveness. Performance data demonstrate that the BioProtect Balloon Implant System is as safe and effective as the SpaceOAR System. Thus, the BioProtect Balloon Implant System is substantially equivalent to the predicate device.

VIII. Summary of Data to Support Substantial Equivalence

The determination of substantial equivalence was based on an assessment of non-clinical performance data obtained from in vitro characterization studies, an in vivo animal study, biocompatibility testing of the subject device, and pivotal clinical study.

a. Biocompatibility

Biocompatibility testing of the BioProtect Balloon Implant System was performed per applicable standards on sterilized samples, addressing the following evaluation endpoints:

· Cytotoxicity
Sensitization
· Irritation/Intracutaneous Reactivity
· Acute Systemic Toxicity
Material Mediated Pyrogenicity
Subacute/Sub-chronic Toxicity
Genotoxicity
Implantation
Chronic Toxicity
· Carcinogenicity
· Particulate Analysis

Tests for reproductive and developmental toxicity, toxicokinetics, immunotoxicity and carcinogenicity were determined not applicable to the BioProtect Balloon Implant system since it does not contain any levels of materials considered hazardous, does not contain materials of toxicological significance, and is nonimmunogenic.

Biological risk assessment concluded that all components of the subject device's system, which include the Balloon Implant, Deployer, and Balloon Delivery Kit, are considered safe for their intended use.

b. Bench Testing

Extensive in vitro testing was performed to confirm that the device meets its specifications to address degradation, mechanics, and usability and included:

1. In vitro degradation (physical, chemical, mechanical tests)
1. Effect of radiation dose on the balloon
1. Balloon spacing stability
1. Resistance to internal pressure
1. Usability testing
1. Dimensions verification

Results indicated all acceptance criteria were met.

c. Performance Testing - Animal

In vivo animal studies were performed at various time points (up to 12 months) and included small (rabbit) and large (swine and canine) animal models.

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In total, three animal studies were performed. The first (rabbit model) was aimed to assess the safety of the implant, and the other two studies aimed to assess both the safety and performance of the system and implant, including interaction with radiation. Histopathology at one-year post procedure revealed healthy tissue and proper biodegradability of the balloon.

The studies supported the safety, performance, and biodegradability of the BioProtect Balloon Implant System for its intended purpose.

d. Performance Testing - Clinical

A prospective, multi-center, randomized, double-arm, single blind, concurrently controlled study (IDE G17020) was conducted to demonstrate that the subject device's balloon would temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and in creating this space, reduce the radiation dose delivered to the anterior rectum. Two hundred twenty-two (222) subjects were enrolled in this clinical study and randomized in a 2:1 ratio to the treatment group (Fiducial markers and Balloon) or Control group (Fiducial markers only). All subjects were diagnosed with T1-T3 prostate cancer, with a planned treatment regime of radiotherapy by means of IMRT.

This study had co-primary endpoints for safety and efficacy. The primary efficacy endpoint was defined as a reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy when compared to pre-implantation values, in 75% of the subjects assigned to the balloon group. The primary safety endpoint was based on the proportion of subjects with Grade 1 or greater rectal adverse events and implantation procedure related adverse events with a duration of at least 2 days through the first six (6) months.

The balloon placement was successful in all balloon group subjects. The primary efficacy endpoint was successfully met with 97.9% of subjects gaining rectal dose reduction >25% in rV70 postimplantation, with a relative mean dose reduction of 84.8% of the rectum receiving 70Gy. Moreover, the rectal radiation dose was consistently reduced in all radiation levels (from 40Gy to 80Gy), compared to pre-implantation values, with increasing relative reductions at higher doses. For all, the Sign test p-values were <0.001.

With respect to bladder volume, the pre-implantation mean of 194.3cc (±128.51cc) and postimplantation mean of 231.5cc (±134.56cc) show a modest increase.

Regarding treatment constraint combinations from the study, no plan in the balloon group failed to meet all constraints. There was a significantly higher likelihood in achieving PTV and all rectal constraints (83.5% vs 57.7%) favoring the balloon arm, as well as all PTV and bladder constraints (70.5% vs 60.3%).

The primary safety endpoint was assessed by an independent Clinical Events Committee (CEC) blinded to subject assignment. In this study, the primary safety outcome was successful, and demonstrated that the proportion of subjects with Grade 1 or greater rectal or procedure related adverse events through 6 months was lower in the balloon group compared to the control group. The results revealed a proportion of 18% in the Balloon Group compared to 23.1% in the Control Group, achieving the one-sided non-inferiority test for the Balloon Group (p < 0.001). No Serious Adverse Device Event (SADE) or Unanticipated Adverse Device Effect (UADE) occurred during the study.

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Balloon stability throughout the radiation treatment course was demonstrated by the stable distance between the rectal wall and the prostate, as measured at last radiation treatment day (1.8 cm) compared to the distance at post implantation (1.9 cm).

Complete balloon degradation at 6 months was demonstrated in 98.5% of the subjects, suggesting that the degradation process over time is safe, and with no potential late complications or side effects due to a partially resorbed balloon.

This study demonstrated the ease of balloon implantation, patient tolerance, and consistent rectal dose reduction. Throughout the entire follow-up period, the balloon group had a lower event rate, suggesting a benefit over time of the balloon compared to the Control. The balloon stability and lack of migration for the entire course of radiotherapy, when combined with the balloon visibility data at 6 months, supports the balloon degradation profile that is maintained throughout IMRT and typically resorbs by 6 months post-implantation.

IX. Conclusion

Based on the clinical performance of the BioProtect Balloon Implant System as documented in the IDE study, the BioProtect Balloon Implant has a safety and effectiveness profile that is similar to the predicate device. In particular, the subject device has the same or similar indications, technological characteristics, and principles of operation as the predicate device. The minor differences between the two devices do not raise any new issues of safety and effectiveness when the device is used as labeled. Therefore, it can be concluded that the BioProtect Balloon Implant System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.5725 Absorbable perirectal spacer.

(a)
Identification. An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.(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. For all clinical investigations used to support premarket notification submissions for this type of device, line listings of the study data must be provided.
(i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy.
(ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device.
(iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment.
(iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity.
(v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer.
(vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling.
(vii) The device must be demonstrated to be biocompatible.
(2) The risk management activities performed as part of the manufacturer's § 820.30 design controls must document an appropriate end user initial training program which will be offered as part of efforts to mitigate the risk of failure to correctly operate the device, including, but not limited to, documentation of an appropriate end user initial training program on the proper spacer deployment technique.
(3) The device labeling must include the following:
(i) A detailed summary of reported or observed complications related to the use of the device;
(ii) Appropriate warnings;
(iii) Detailed instructions for system preparations and detailed implant procedure instructions; and
(iv) An expiration date that is supported by performance data as specified in paragraph (b)(1)(vi) of this section.