(182 days)
Not Found
DuraSeal P040034, Matrix VSG PMA P040044, DuraSeal Xact Sealant P080013, ReSure Sealant P130004, Bio-Seal DEN090007
No
The device description and performance studies focus on the physical properties and clinical outcomes of a hydrogel spacer, with no mention of AI/ML algorithms for image analysis, treatment planning, or any other function.
Yes
The device is intended to reduce the radiation dose delivered to the anterior rectum during radiotherapy for prostate cancer, which is a therapeutic purpose aimed at mitigating harm from a medical treatment.
No.
The device is a polyethylene glycol (PEG) hydrogel intended to create space between the anterior rectal wall and the prostate during radiotherapy for prostate cancer, thereby reducing radiation dose to the rectum. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the SpaceOAR System is a physical hydrogel material and a delivery mechanism, which are hardware components.
Based on the provided information, the SpaceOAR 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. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a hydrogel material injected into the body to create space. This is a therapeutic/interventional device, not a diagnostic one.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing samples (blood, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Input Imaging Modality: While ultrasound is used for guidance during the procedure, it is not the primary function of the device itself. The device is the hydrogel spacer.
- Performance Studies: The performance studies focus on the physical effect of the spacer (reducing radiation dose to the rectum) and safety outcomes related to the procedure and material. They do not involve diagnostic accuracy metrics like sensitivity, specificity, AUC, etc., which are typical for IVDs.
In summary, the SpaceOAR System is a medical device used for therapeutic/interventional purposes during radiation therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 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.
Product codes
OVB
Device Description
SpaceOAR System is a polyethylene glycol (PEG) hydrogel that upon injection creates a space 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 SpaceOAR System consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. Once assembled as shown in the figure above, the Y-connector allows for hydrogel injection via an 18 gauge needle. 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 Accelerator solution is a salt buffer solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior rectal wall, prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A prospective, randomized, parallel arm. multicenter study was conducted. Men with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for IG-IMRT (Image Guided Intensity Modulated Radiation Therapy) were included in the study. Following successful fiducial marker placement, two hundred twenty-two (222) subjects were randomized (2:1) to the Treatment group (149) or Control group (73) at 20 investigational sites in the United States. Subjects randomized to the treatment group underwent of 10mL SpaceOAR hydrogel. Subjects randomized to the Control group did not receive injection of the SpaceOAR hydrogel. Subjects began IMRT within 21 days following fiducial marker placement. The treatment planning studies, target volume definitions, and rectal contouring for each subject with or without hydrogel injection were performed using the identical technique and similar set-up.
The effectiveness goal of this study was to demonstrate that the proportion of subjects achieving a 25% reduction in rV70 for SpaceOAR treated subjects is greater than a minimally clinically acceptable success rate considered to be 70%. The primary safety objective was to demonstrate that SpaceOAR treated subjects who experienced a Grade 1 or greater safety endpoint event through the 6 Month Follow-Up assessment was lower than (i.e., superior to) that for the Control group.
Based on independent Core Lab measurements, 97.3% [95% CI: 93.2, 99.3] of SpaceOAR treated subjects achieved a >25% reduction in rV70. Based on investigator measurements, 91.8% [95% CI: 86.2, 95.7] of SpaceOAR treated subjects in the MITT (modified intent to Treat) Population achieving a reduction of ≥25% in rV70. Both results from independent Core Lab and investigator show statistically significant results (p25% reduction in rV70.
91.8% [95% CI: 86.2, 95.7] of SpaceOAR treated subjects in the MITT (modified intent to Treat) Population achieving a reduction of ≥25% in rV70.
The event rates for the two groups were comparable with 34.0% for the SpaceOAR treatment group vs. 31.9% for the Control group (p=0.6862).
Predicate Device(s)
Not Found
Reference Device(s)
DuraSeal P040034, Matrix VSG PMA P040044, DuraSeal Xact Sealant P080013, ReSure Sealant P130004, Bio-Seal DEN090007
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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DE NOVO CLASSIFICATION REQUEST FOR SPACEOAR SYSTEM
DECISION SUMMARY
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Absorbable perirectal spacer. 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.
NEW REGULATION NUMBER: 21 CFR 892.5725
CLASSIFICATION: II
PRODUCT CODE: OVB
BACKGROUND
DEVICE NAME: SPACEOAR SYSTEM
SUBMISSION NUMBER: DEN140030
DATE OF DE NOVO: OCTOBER 1, 2014
CONTACT:
AUGMENIX, INC. 204 SECOND AVE, LOWER LEVEL WALTHAM, MA 02451 PHONE: 908-625-7734 FAX: 781-895-3236
REQUESTER'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
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 SpaceOAR System is composed of biodegradable material and maintains space for the entire
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course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
LIMITATIONS
The SpaceOAR System is restricted as a prescription device regulated under 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
SpaceOAR System is a polyethylene glycol (PEG) hydrogel that upon injection creates a space 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 SpaceOAR System consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. Once assembled as shown in the figure above, the Y-connector allows for hydrogel injection via an 18 gauge needle. 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 Accelerator solution is a salt buffer solution.
Image /page/1/Picture/6 description: The image shows a dual syringe with a needle. The syringes are labeled as "Precursor Syringe" and "Accelerator Syringe". The needle is labeled as "18 G Needle" and the syringes are connected by a "Y-Connector".
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PRINCIPLE OF OPERATION
When mixed together, the solutions cross link to form a soft hydrogel. The mixing of the solutions is accomplished as the materials pass through a static mixer in the Y-comector prior to passing through the 18g injection needle. The in situ formed hydrogel spacer creates a temporary space between the prostate and rectum during radiation therapy. The hydrogel spacer maintains space for approximately 3 months and is and then gradually liquefies via hydrolysis: it is absorbed and cleared via renal filtration in approximately 6 months of implantation, a sufficient time to support the intended use.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The chemical composition of SpaceOAR System is similar to DuraSeal Xact Sealant, a Polyethylene Glycol (PEG) based hydrogel which was FDA approved (PMA P080013) in 2009 as a spinal dural sealant. The SpaceOAR hydrogel (b)(4) and degradation are both a function of temperature and pH. At (b)(4) the (b)(4)
As the hydrogel is not enzymatically degraded. a uniform hydrolysis rate is expected due to physiologically controlled temperature and pH which does not vary substantially from patient to patient. The chemical characteristics were validated in the bench testing mentioned below.
SpaceOAR hydrogel is an implant device contacting tissue/bone with permanent contact (>30 days). The SpaceOAR delivery system is classified as a short-term tissue external communicating device (25% reduction in rV70. Based on investigator measurements, 91.8% [95% CI: 86.2, 95.7] of SpaceOAR treated subjects in the MITT (modified intent to Treat) Population achieving a reduction of ≥25% in rV70. Both results from independent Core Lab and investigator show statistically significant results (p 25% of the rectal volume receiving at least
70Gy (i.e., rV70) (p 70% with statistical significance. Overall, the study results support that SpaceOAR increased the space between prostate and resulted in less radiation in the rectal area. The rate of Grade 1 or greater rectal adverse events or procedure adverse events through 6 months for the SpaceOAR group is similar to the Control group.
Risk of a harmful event is low as there were no device-related serious adverse events. The injection of the SpaceOAR hydrogel uses well established techniques. The SpaceOAR System is comprised of the same PEG hydrogel technology as other previously approved devices used on other body sites (DuraSeal P040034, Matrix VSG PMA P040044. DuraSeal Xact Sealant P080013. ReSure Sealant P130004 and Bio-Seal DEN090007). Additionally. long term follow up from the European and US clinical trials and post market AE data on over 2600 SpaceOAR System since CE Mark approval in 2010 and Australian TGA approval in 2011 did not record any AE's or complications related to persistent hydrogel or to long-term safety issues associated with SpaceOAR hydrogel use. Moreover, for this low to moderate risk device, risks can be mitigated through the identified special controls, and this device is not life-supporting or life-sustaining.
It is reasonable to conclude that the benefits of using the potential risk of injury when used as indicated in accordance with the instructions for use.
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CONCLUSION
The request for de novo for the SPACEOAR SYSTEM 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: OVB Device Type: Absorbable perirectal spacer Class: Class II (special controls) Regulation: 21 CFR 892.5725
(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). An absorbable perirectal spacer must comply with the following special controls:
- (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.
- Performance bench testing must demonstrate appropriate perirectal space (i) creation and maintenance for the duration of prostate radiotherapy;
- Performance bench testing must demonstrate that therapeutic radiation levels (ii) 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:
- Sterility testing must demonstrate the sterility of the device and the effects of (v) 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: and.
- (vii) The device must be demonstrated to be biocompatible.
- (2) The risk management activities performed as part of the manufacturer's 21 CFR 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
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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:
- A detailed summary of reported or observed complications related to the use (i) of the device;
- (ii) Appropriate warnings;
- Detailed instructions for system preparations and detailed implant procedure (iii) instructions; and,
- (iv) An expiration date that is supported by performance data as specified in subparagraph (b)(i)(vi).