(21 days)
No reference devices were used in this submission.
No
The summary describes a physical hydrogel system for creating space during radiotherapy and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device actively changes the body's structure to achieve a medical purpose (reducing radiation dose to the rectum during prostate cancer radiotherapy), which is the definition of a therapeutic device.
No
The device is described as a hydrogel system intended to create space between the rectal wall and prostate during radiotherapy to reduce radiation dose, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical hydrogel system with syringes, a Y-connector, and a needle for injection, indicating it is a hardware-based medical device.
Based on the provided information, the SpaceOAR Hydrogel 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. It's a physical implant/spacer, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Activity: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition, monitor a disease, or determine compatibility.
- Performance Studies: The performance studies focus on the physical properties of the hydrogel (modulus, gel volume, gel time, etc.) and sterilization, which are relevant to a physical implant, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment decisions. The SpaceOAR Hydrogel System does not fit this description.
N/A
Intended Use / Indications for Use
SpaceOAR Hydrogel 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 Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Hydrogel 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)-base 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 (about 6 months).
The SpaceOAR® Hydrogel System consists of two syringes containing the PEG Precursor solution and the Accelerator solution (a buffered salt solution). The Precursor solution is formed by the user through the reconstitution of PEG powder with a Diluent (Trilysine buffer) solution (that is provided in a third syringe. The Accelerator solution is provided ready for use. The Syringes filled with the Precursor solution and the Accelerator solution are assembled with other applicator components, including a Y-connector for mixing the Precursor and Accelerator, and a needle to facilitate delivery of the hydrogel by injection to the tissue located between the anterior rectal wall and the prostate.
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)
Applicable verification and validation testing was performed as required by the Augmenix design control process. The following performance data were provided in support of the substantial equivalence determination:
- Sterilization Validation
- . Modulus Testing
- . Gel Volume (Swell) Testing
- . Gel Time Testina
- Pot Life Testing
- Endotoxin Testing .
The subject device is identical to the predicate device in design, materials and sterilization cycle; therefore, biocompatibility testing, shelf life testing, and clinical data were not required to support a determination of substantial equivalence.
Summary
Verification and validation of the subject device was completed and confirmed that subject SpaceOAR® Hydrogel System meets the same functional and performance specification as the predicate SpaceOAR® Hydrogel System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 25, 2018
Augmenix, Inc. % Marcus Garcia, RAC Regulatory Affairs Manager 201 Burlington Road BEDFORD MA 01730
Re: K181465
Trade/Device Name: SpaceOAR Hydrogel System Regulation Number: 21 CFR 892.5725 Regulation Name: Absorbable perirectal spacer Regulatory Class: II Product Code: OVB Dated: June 1, 2018 Received: June 4, 2018
Dear Mr. Garcia:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
5 INDICATIONS FOR USE STATEMENT
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K181465 |
|---|---|
| Device Name | SpaceOAR Hydrogel System |
| Indications for Use (Describe) | SpaceOAR Hydrogel 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 Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Hydrogel 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) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
6 510(k) Summarv
Date: June 1, 2018
1. SUBMITTER
Augmenix, Inc. 201 Burlington Road Bedford, MA 01730
Establishment Registration Number: 3008550999
Contact Person: Marcus Garcia, RAC
Phone: 781-541-4360 email: mgarcia@augmenix.com
II. DEVICE
Device Trade Name: SpaceOAR® Hydrogel System, Model Number: SO-2101 Device Common or Usual Name: Absorbable Perirectal Spacer Device Classification Name: Hydrogel Spacer Device Classification: Class II Device Product Code: OVB Device Review Panel: Radiology
III. PREDICATE DEVICE
Predicate Device Trade Name: SpaceOAR® Hydrogel System Cleared for Marketing Under: DEN140030.
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. 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)-base hydrogel that upon injection creates a space that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate
4
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 (about 6 months).
The SpaceOAR® Hydrogel System consists of two syringes containing the PEG Precursor solution and the Accelerator solution (a buffered salt solution). The Precursor solution is formed by the user through the reconstitution of PEG powder with a Diluent (Trilysine buffer) solution (that is provided in a third syringe. The Accelerator solution is provided ready for use. The Syringes filled with the Precursor solution and the Accelerator solution are assembled with other applicator components, including a Yconnector for mixing the Precursor and Accelerator, and a needle to facilitate delivery of the hydrogel by injection to the tissue located between the anterior rectal wall and the prostate.
V. INDICATIONS FOR USE
SpaceOAR® Hydrogel 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® Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR® Hydrogel 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 subject SpaceOAR® Hydrogel System is identical to the predicate device.
vi. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The underlying technological characteristics of the subject SpaceOAR® Hydrogel System and the predicate device are identical. Both devices are a system that facilitates 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.
5
VII. PERFORMANCE DATA
Applicable verification and validation testing was performed as required by the Augmenix design control process. The following performance data were provided in support of the substantial equivalence determination:
- Sterilization Validation
- . Modulus Testing
- . Gel Volume (Swell) Testing
- . Gel Time Testina
- Pot Life Testing
- Endotoxin Testing .
The subject device is identical to the predicate device in design, materials and sterilization cycle; therefore, biocompatibility testing, shelf life testing, and clinical data were not required to support a determination of substantial equivalence.
Summary
Verification and validation of the subject device was completed and confirmed that subject SpaceOAR® Hydrogel System meets the same functional and performance specification as the predicate SpaceOAR® Hydrogel System.
VIII. CONCLUSION
The subject SpaceOAR® Hydrogel System met all acceptance criteria for verification and validation. This demonstrates that the subject device performance is equivalent to the predicate device and that the subject device performance supports the requirements of the device intended use.