(332 days)
Not Found
No
The summary describes a physical implant and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies focus on the physical properties and clinical outcomes related to the implant's function as a spacer.
Yes
The device is intended to reduce the radiation dose delivered to the anterior rectum during prostate cancer radiotherapy by creating space, which is a therapeutic effect aimed at improving patient outcomes.
No
Explanation: The BioProtect Balloon Implant System is used to create space between the prostate and rectum during radiotherapy to reduce radiation dose to the rectum. It is a therapeutic device, not a diagnostic one. While it uses ultrasound guidance for placement, the device itself does not diagnose a medical condition.
No
The device is a physical implant system consisting of a balloon, deployer, and delivery kit, not solely software.
Based on the provided information, the BioProtect Balloon Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to physically position the anterior rectal wall away from the prostate during radiotherapy to reduce radiation dose to the rectum. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (a balloon) and its delivery system. It does not involve reagents, calibrators, or other components typically associated with IVD tests.
- Mechanism of Action: The device works by creating a physical space, not by analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical effect of the balloon (rectal dose reduction, balloon stability, degradation) and safety outcomes related to the implantation and presence of the device. They do not involve metrics like sensitivity, specificity, or AUC which are common for IVD performance evaluation.
In summary, the BioProtect Balloon Implant System is a therapeutic device used to modify the anatomical relationship between organs during a medical procedure (radiotherapy), not a device used to diagnose a condition by examining samples outside the body.
N/A
Intended Use / 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.
Product codes
OVB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
transrectal ultrasound (TRUS)
Anatomical Site
anterior rectal wall away from the prostate
Indicated Patient Age Range
Adult human males
Intended User / Care Setting
licensed medical professionals
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
-
- In vitro degradation (physical, chemical, mechanical tests)
-
- Effect of radiation dose on the balloon
-
- Balloon spacing stability
-
- Resistance to internal pressure
-
- Usability testing
-
- Dimensions verification
Results indicated all acceptance criteria were met.
- Dimensions verification
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.
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 25% in rV70 postimplantation, with a relative mean dose reduction of 84.8% of the rectum receiving 70Gy.
Rectal radiation dose 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
§ 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.
0
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
1
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
2
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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3
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 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.
4
-
- 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
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.
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
5
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.
| Descriptive
Information | BioProtect Balloon Implant System
(Subject Device) | SpaceOAR System
(Predicate Device - DEN140030) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | SpaceOAR 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 SpaceOAR 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. | The SpaceOAR System is composed of
biodegradable material and maintains space
for the entire course of prostate radiotherapy
treatment and is completely absorbed by the
patient's body over time. |
| Prescription Use | For prescription use only. | For prescription use only. |
| Classification
and Product
Code | 21 CFR 892.5725
OVB - Absorbable perirectal spacer | 21 CFR 892.5725
OVB - Absorbable perirectal spacer |
| Mode of Action | System that facilitates implantation of
balloon between anterior rectal wall and
prostate prior to radiotherapy. This
temporarily creates space between the
anterior rectal wall and prostate during
radiotherapy for prostate cancer which is
eventually absorbed following the course of
radiotherapy treatment | Systems that facilitate implantation of 10cc
PEG biodegradable hydrogel between the
anterior rectal wall and prostate prior to
radiotherapy. This temporarily creates
space between the anterior rectal wall and
prostate during radiotherapy for prostate
cancer which is eventually absorbed
following the course of radiotherapy
treatment. |
| Operating
Principles | ● Spacer
● Implantable
● Biodegradable
● Biocompatible
● Transperineally approach
● TRUS guided | ● Spacer
● Implantable
● Biodegradable
● Biocompatible
● Transperineally approach
● TRUS guided |
| Descriptive
Information | BioProtect Balloon Implant System
(Subject Device) | SpaceOAR System
(Predicate Device - DEN140030) |
| Material | Poly (L-lactide-co-ε-caprolactone) which is a
bioresorbable copolymer | Polyethylene glycol (PEG) hydrogel that is
formed in-situ. |
| System basic
components | Biodegradable, injectable balloon (mounted
on a deployer)
Balloon Delivery Kit (18-gauge echogenic
needle, dilator and introducer sheath) | The SpaceOAR® System consists of
Components for the preparation of a
synthetic, absorbable hydrogel spacer and
Delivery mechanism.
Once assembled, the Y-connector allows for
hydrogel injection via an 18-gauge needle. |
| Technology | Pre folded Balloon inflated with Saline | When mixed the solutions are cross linked to
form a soft hydrogel. The spacer is formed
by mixing two solutions, the Precursor, and
the Accelerator. The Precursor solution is
formed through the mixing of the Diluent
solution (Trilysine buffer solution) with the
PEG powder. The mixing of the solutions is
accomplished as the material passes
through a static mixer in the Y-connector
prior to passing through an injection needle. |
| Surgical
Approach | Implanted transperineally in a minimally
invasive procedure in the space between the
prostate and the rectum under transrectal
ultrasound (TRUS) guidance using a
dedicated delivery system. | Implanted transperineally in a minimally
invasive procedure in the space between the
prostate and the rectum under transrectal
ultrasound (TRUS) guidance using a
dedicated delivery system. |
| Form | Balloon | In Situ formed hydrogel |
| Sizes | In its deployed inflated configuration, the
balloon has the following dimensions:
Length: 48mm
Width: 35mm
Height: 10-18mm
Height can be controlled depending on
desired spacing, by controlling the amount of
saline injected prior to balloon sealing. | 10 ml injectable gel |
| Resorption Time | Biodegradable material maintains space for
the entire course of prostate radiotherapy
treatment (approximately 3 months) and is
completely absorbed by the patient's body
over time (approximately 6 months). | Biodegradable material maintains space for
the entire course of prostate radiotherapy
treatment (approximately 3 months) and is
completely absorbed by the patient's body
over time (approximately 6 months). |
| Implantation
procedure 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 |
| Sterilization
Method | 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 in
a humidity bag in a carton box | Packed in sterile blister and Tyvek located in
a carton box |
Table 1. Substantial Equivalence of the Subject Device as Compared to Predicate Device
6
7
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:
-
- In vitro degradation (physical, chemical, mechanical tests)
-
- Effect of radiation dose on the balloon
-
- Balloon spacing stability
-
- Resistance to internal pressure
-
- Usability testing
-
- 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.
8
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