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.

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 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.

AI/ML Overview

This document is an FDA 510(k) summary for the SpaceOAR Hydrogel System. It is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and study results for a new device's performance.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not present in this type of FDA submission. The submission relies on the established performance of the predicate device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "The subject SpaceOAR® Hydrogel System met all acceptance criteria for verification and validation." However, it does not list specific quantitative acceptance criteria or their corresponding performance results in a table format. It only lists categories of tests performed.

Acceptance Criteria Category	Reported Device Performance
Sterilization Validation	Met all acceptance criteria
Modulus Testing	Met all acceptance criteria
Gel Volume (Swell) Testing	Met all acceptance criteria
Gel Time Testing	Met all acceptance criteria
Pot Life Testing	Met all acceptance criteria
Endotoxin Testing	Met all acceptance criteria

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a "test set" or provide data provenance in the context of clinical performance for the subject device. The submission relies on equivalence to a predicate device. The performance data listed (sterilization, modulus, etc.) are engineering/laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the submission does not detail a clinical study with a "test set" requiring expert ground truth in the traditional sense of diagnostic AI or imaging device evaluation.

4. Adjudication method for the test set

This information is not provided for the reasons stated above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not mentioned or provided in this 510(k) summary. This type of study is typically for diagnostic imaging devices and AI systems, not for a physical implantable device like a hydrogel spacer.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not applicable to the SpaceOAR Hydrogel System, which is a physical medical device and not an algorithm.

7. The type of ground truth used

For the engineering/laboratory tests listed (Sterilization Validation, Modulus Testing, etc.), the "ground truth" would be established by pre-defined engineering specifications and validated test methods. The submission implies that the results of these tests (e.g., sterilization effectiveness, material properties like modulus, gel volume, gel time, pot life, endotoxin levels) adhered to these specifications.

8. The sample size for the training set

This information is not applicable/not provided as this is a physical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/not provided as this is a physical device.

Summary of Device Performance (based on this 510(k) summary):

The 510(k) application for the SpaceOAR Hydrogel System (K181465) demonstrates substantial equivalence to its predicate device (cleared under DEN140030). The core argument is that the subject device has identical design, materials, and sterilization cycle to the predicate device.

To support this claim, the manufacturer performed several verification and validation tests:

Sterilization Validation: Confirmed the device's sterility.
Modulus Testing: Evaluated the material's stiffness/elasticity.
Gel Volume (Swell) Testing: Assessed how much the hydrogel swells.
Gel Time Testing: Measured the time it takes for the components to form a gel.
Pot Life Testing: Determined how long the mixed components remain viable for use.
Endotoxin Testing: Ensured the absence of harmful bacterial endotoxins.

The document explicitly states: "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." This means that the clinical performance and safety of the device are inferred from the predicate device, and the current submission focuses on verifying the manufacturing and design equivalence of the new device to the existing one. The "acceptance criteria" here largely pertain to meeting the engineering specifications and demonstrating manufacturing consistency with the already-cleared device.

Summary

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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.

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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

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5 INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
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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.

510(k) Number (if known)

K181465

Device Name

SpaceOAR Hydrogel System

Indications for Use (Describe)

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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CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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

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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).

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.

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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.

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.