(21 days)
Not Found
No
The summary describes a physical hydrogel spacer and delivery system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy, thereby reducing the radiation dose to the rectum, which is a therapeutic effect.
No
The device's purpose is to act as a physical spacer during radiotherapy to reduce radiation dose to the rectum, not to diagnose a condition or disease.
No
The device description clearly states it is a "Hydrogel System" composed of biodegradable material and a delivery mechanism, indicating it is a physical medical device, not software.
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 spacer and a delivery mechanism. It is implanted into the body to create space. This is a therapeutic or interventional device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on physical properties, sterilization, shelf life, and system functionality, which are typical for implanted medical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SpaceOAR System does not fit this description.
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 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
The SpaceOAR Hydrogel System consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. The SpaceOAR hydrogel is a synthetic, absorbable polyethylene glycol (PEG)based hydrogel that upon injection creates a space that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. SpaceOAR hydrogel is completely synthetic with no animal or human derived components. It is composed of biodegradable material and 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).
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
The modifications to the subject SpaceOAR System have been tested to ensure compliance to the initial specifications. Based on the change assessment including risk analysis, the design verification tests outlined below were repeated. The test methods used were the same as those submitted for the predicate device.
- Sterilization Validation
- Shelf Life Testing ●
- System Needle to Hub Tensile Strength
- Fluid Connection
- SpaceOAR Hydrogel System Prep and Assembly Time
- PEG Vial Puncture Force ●
- . Packaging Performance Testing
A risk-based biocompatibility assessment of these limited changes indicates that no new biocompatibility testing is required to assess the proposed device change. The proposed SpaceOAR System is biologically safe for its intended use.
The clinical workflow for device implantation is identical for both the predicate and proposed device. Therefore, clinical data were not required to support a determination of substantial equivalence.
Verification and validation of the proposed device were completed and confirmed that the proposed SpaceOAR System meets the same functional and performance specifications as the predicate SpaceOAR System.
The conclusion of the assessments demonstrates that the modified device continues to function as intended in a manner equivalent to the predicate device. The modified device raises no new issues of safety or effectiveness compared to the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
August 28, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
Boston Scientific Corporation % Ms. Jeanne O'Toole Principal Regulatory Affairs Specialist 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K202224
Trade/Device Name: SpaceOAR System Regulation Number: 21 CFR 892.5725 Regulation Name: Absorbable Perirectal Spacer Regulatory Class: Class II Product Code: OVB Dated: August 6, 2020 Received: August 7, 2020
Dear Ms. O'Toole:
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 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)
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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 mediation-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K202224
Device Name SpaceOAR System
Indications for Use (Describe)
SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this 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.
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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SECTION 5
510(k) Summary for SpaceOAR Hydrogel System
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752
B. Contact
Jeanne O'Toole Principal Regulatory Affairs Specialist 508-683-4271 jeanne.otoole@bsci.com
C. Proposed Device
Trade Name: SpaceOAR Hydrogel System, Model Number: SO-2101 Common / Usual Name: Hvdrogel Spacer Regulation Number: 892.5725 Classification Name: Absorbable Perirectal Spacer Classification: Class II Product Code: OVB Review Panel: Radiology
D. Predicate Device
Trade Name: SpaceOAR Hydrogel System, Model Number: SO-2101 Common / Usual Name: Hydrogel Spacer Regulation Number: 892.5725 Classification Name: Absorbable Perirectal Spacer Classification: Class II Product Code: OVB Identification of Predicate Device: SpaceOAR Hydrogel System, K181465
E. Device Description
The SpaceOAR Hydrogel System consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. The SpaceOAR hydrogel is a synthetic, absorbable polyethylene glycol (PEG)based hydrogel that upon injection creates a space that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. SpaceOAR hydrogel is completely synthetic with no animal or human derived components. It is composed of biodegradable material and maintains space for the
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SECTION 5
entire course of prostate radiotherapy treatment (approximately 3 months) and is completely absorbed by the patient's body over time (approximately 6 months).
F. 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.
The Indications for Use Statement for the proposed SpaceOAR System is identical to the predicate device.
G. Technological Characteristics Compared to Predicate
The principles of operation and underlying technological characteristics of the proposed SpaceOAR System and the predicate device are identical. Both devices are 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. The PEG hydrogel is broken down through hydrolysis and excreted from the body through renal filtration.
The differences between the subject device and the predicate are minor. Differences include:
- The Bioset component is being replaced by an aluminum cap vial stopper, and vented ● vial adapter (VVA), that includes a hollow spike and a flange that enables the spike to be centered over the cap, and stopper.
- The 18g X 15cm needle hub is being modified to add a white colorant and a blue ● stamped marking to indicate needle bevel direction. There are no changes to the design specifications of the hub or needle.
- The system packaging tray is being modified to account for the change in components from the Bioset to the VVA. The tray material is unchanged.
- The outer pouch which acts as the sterile barrier is being modified. The bottom web material of the outer pouch has been changed from 48ga (0.48mil) PET layer and 200 Ga (2 ml) LDPE layer to 100 Ga (1ml) Biaxially Oriented Nylon/PE/COEX layer, 10# LDPE and 200 Ga (2 ml) Peelable Sealant. The top web Tyvek material is identical to that of the predicate device.
- The device labeling, including the instructions for use (IFU), is being modified to ● reflect system component changes.
The technological characteristics remain equivalent to the predicate device because the modifications that are the subject of this submission are limited to replacing the Bioset component, which has been discontinued by the manufacturer, as well as improvements to the existing design.
H. Substantial Equivalence
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The modified SpaceOAR System is substantially equivalent to the predicate SpaceOAR System (K181465). It has the same intended use of creating a temporary space between the prostate and the rectum and the same indication for use. The system design and principles of operation remain the same.
I. Performance Data
The modifications to the subject SpaceOAR System have been tested to ensure compliance to the initial specifications. Based on the change assessment including risk analysis, the design verification tests outlined below were repeated. The test methods used were the same as those submitted for the predicate device.
- Sterilization Validation
- Shelf Life Testing ●
- System Needle to Hub Tensile Strength
- Fluid Connection
- SpaceOAR Hydrogel System Prep and Assembly Time
- PEG Vial Puncture Force ●
- . Packaging Performance Testing
The predicate and proposed device are predominantly identical in device design with limited changes to device components, packaging and labeling. A risk-based biocompatibility assessment of these limited changes indicates that no new biocompatibility testing is required to assess the proposed device change. The proposed SpaceOAR System is biologically safe for its intended use.
The principles of operation and underlying device technology are identical for both the predicate and proposed device. The clinical workflow for device implantation is identical for both the predicate and proposed device. Therefore, clinical data were not required to support a determination of substantial equivalence.
Verification and validation of the proposed device were completed and confirmed that the proposed SpaceOAR System meets the same functional and performance specifications as the predicate SpaceOAR System.
The conclusion of the assessments demonstrates that the modified device continues to function as intended in a manner equivalent to the predicate device. The modified device raises no new issues of safety or effectiveness compared to the predicate.
J. Conclusion
Based on the test data, the same intended use, and same indications for use, the modified SpaceOAR System is substantially equivalent to its predicate device, K181465.