SpaceOAR Vue Hydrogel 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 Vue Hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Vue Hydrogel is composed of biodegradable material and maintain space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Device Description

The SpaceOAR Vue Hydrogel 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 Vue 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 Vue 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 Vue Hydrogel 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.

AI/ML Overview

The provided document does not contain acceptance criteria for device performance or a study that specifically proves the device meets such criteria in terms of clinical outcomes or reader performance.

The document is a 510(k) summary for the SpaceOAR Vue Hydrogel. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (SpaceOAR® Hydrogel System) rather than presenting a de novo clinical study with specific performance metrics for the new device.

Here's what can be extracted based on the provided text, addressing your questions where possible:

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

No explicit table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for clinical effectiveness is provided in the document. The performance data section lists types of testing performed, but not the specific acceptance criteria or results for each beyond stating that "The subject device has met the same device specifications as the predicate device."

Acceptance Criteria Category	Reported Device Performance
Sterilization Validation	Met requirements
Modulus Testing	Met requirements
Gel Volume (Swell) Testing	Met requirements
Gel Time Testing	Met requirements
Pot Life Testing	Met requirements
Usability Testing	Met requirements
Biocompatibility Testing	Met requirements
Preclinical Testing	Met requirements
Overall Device Specification	Met the same finished device specifications as the predicate device

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

The document does not detail a "test set" in the context of clinical performance or image interpretation. The testing mentioned in Section VII ("PERFORMANCE DATA") appears to be primarily related to engineering, material science, and safety testing of the device itself (e.g., sterilization, gel properties, usability, biocompatibility, preclinical testing). Therefore, information on sample size for a test set (e.g., patient cases) or data provenance (country of origin, retrospective/prospective) is not available.

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 focuses on substantial equivalence based on technical characteristics and predicate device performance, not a new clinical study assessing image interpretation or a specific disease outcome requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication by experts is described.

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

No MRMC study is mentioned. This device is a hydrogel spacer, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not relevant to this submission.

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

This question is not applicable. The device is a physical hydrogel spacer used in conjunction with radiotherapy, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not describe a clinical study that would require "ground truth" in the sense of comparing device output to a definitive diagnosis. The device's primary function is to physically create space and reduce radiation dose, which would be evaluated through physical properties and radiation dosimetry, not diagnostic accuracy.

8. The sample size for the training set

The document does not describe a training set. This is not an AI/machine learning device.

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

Not applicable, as there is no training set for an AI/machine learning algorithm.

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). 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.

July 19, 2019

Augmenix, Inc. % Mr. Marcus Garcia Principal Regulatory Affairs Specialist 201 Burlington Road, North Building BEDFORD MA 01730

Re: K182971

Trade/Device Name: SpaceOAR Vue Hydrogel Regulation Number: 21 CFR 892.5725 Regulation Name: Absorbable Perirectal Spacer Regulatory Class: Class II Product Code: OVB Dated: June 13, 2019 Received: June 14, 2019

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. 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

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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 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.

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) K182971

Device Name Space OAR Vue Hydrogel

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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6 510(k) Summary

Date: October 25, 2018

l. 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

ll. DEVICE

Device Trade Name: SpaceOAR Vue™Hydrogel, Model Number: SV-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

lll. PREDICATE DEVICE

Predicate Device Trade Name: SpaceOAR® Hydrogel System Cleared for Marketing Under: DEN140030 and K181465.

Reference device: TracelT® Tissue Marker K151998 and K121964.

IV. DEVICE DESCRIPTION

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delivered to the anterior rectum. SpaceOAR Vue 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 Vue Hydrogel 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 Vue Hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Vue Hydrogel 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 Vue Hydrogel is identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The underlying technological characteristics of the subject SpaceOAR Vue Hydrogel and the predicate device are identical. Both devices are a system that facilitates the implantation of 10mL biodegradable PEG 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 key difference between the SpaceOAR Vue and the predicate device is the additional feature of radiopacity. SpaceOAR Vue introduces the added benefit of radiopacity for CT and CBCT visibility. All other features of the devices remain the same.

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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 Testing ●
Pot Life Testing
Usability Testing
Biocompatibility Testing ●
Preclinical Testing .

The subject device has met the same device specifications as the predicate device; therefore, clinical data were not required to support a determination of substantial equivalence.

Summary

Verification and/or validation of the subject device was completed and confirmed that the subject SpaceOAR Vue Hydrogel meets the same finished device specification as the predicate SpaceOAR® Hydrogel System.

VIII. CONCLUSION

The subject SpaceOAR Vue Hydrogel met all acceptance criteria for verification and/or 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.