The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size Sientra Breast Implant to be implanted. The Sientra Gel Sizers are designed to complement the portfolio of Sientra OPUS® Silicone Gel Breast Implants ("Breast Implants" or "Implants"), and are therefore available in the same range of styles, dimensions and fill volume as Sientra Implants. The Sientra OPUS® Silicone Gel Breast Implant Sizers are constructed with a smoothsurfaced, silicone elastomer shell and a filler made of clear, high-strength silicone gel. Sientra's Gel Sizers have been demonstrated to be biocompatible. The printing on the exterior of the Gel Sizer shell is clearly marked, "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT", to clearly differentiate the Gel Sizers from Sientra's OPUS Breast Implants. Each Sientra Gel Sizer is dry-heat-sterilized, for single patient use only, and is not intended for long-term implantation or re-sterilization.

AI/ML Overview

This document describes the Sientra OPUS® Silicone Gel Breast Implant Sizer, a medical device, and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Conducted	Acceptance Criteria	Reported Device Performance
Gel Cohesion	Not explicitly stated, but implied to demonstrate appropriate gel properties relative to the predicate device.	Met predetermined acceptance criteria.
Elongation	Not explicitly stated, but implied to demonstrate appropriate material flexibility and strength relative to the predicate device.	Met predetermined acceptance criteria.
Break Force	Not explicitly stated, but implied to demonstrate appropriate material strength and integrity relative to the predicate device.	Met predetermined acceptance criteria.
Tensile Set	Not explicitly stated, but implied to demonstrate appropriate material elasticity and recovery properties relative to the predicate device.	Met predetermined acceptance criteria.
Patch to Shell Joint Integrity	Not explicitly stated, but implied to demonstrate the secure attachment of any patches or markings to the sizer shell, ensuring no detachment during use.	Met predetermined acceptance criteria.
Implant Marking Verification and Rub Testing	Not explicitly stated, but implied to ensure that the markings "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT" are clearly present, legible, and resistant to degradation (e.g., rubbing off) during handling and use. Intended to prevent misuse.	Met predetermined acceptance criteria for marking clarity and durability.
Biocompatibility	Demonstrated to be biocompatible.	Demonstrated to be biocompatible.
Sterility	Dry-heat-sterilized for single patient use.	Dry-heat-sterilized.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each bench test conducted. It generally refers to "performance testing" being conducted. The data provenance is from non-clinical bench testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying the data was generated to meet U.S. regulatory standards. The testing is retrospective in the sense that the device was developed and then tested, but it pertains to the device itself and not to patient data.

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable as the evaluation of this device relies on non-clinical bench testing against engineering and material specifications, not on expert interpretation of clinical data. Therefore, there was no ground truth established by medical experts for the test set.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation of this device relies on non-clinical bench testing against predefined acceptance criteria, not on expert consensus or adjudication of clinical cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a physical breast implant sizer, not an AI or imaging-based device that would benefit from such a study. The document explicitly states: "No clinical testing was performed to support this 510(k) submission."

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not applicable / not done as this is a physical medical device (a breast implant sizer), not an algorithm or software. The performance testing was of the physical properties and characteristics of the sizer itself.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on predefined engineering specifications, material properties, and regulatory standards for biocompatibility, sterility, and physical integrity that the device must meet to be considered safe and effective and substantially equivalent to its predicate.

8. Sample Size for the Training Set

This information is not applicable as this device is not an AI/machine learning model that requires a training set. The device is a physical product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

Summary

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November 16, 2020

Sientra, Inc Joann Kuhne Vice President of Regulatory Affairs. Ouality Assurance and Clinical 420 South Fairview Avenue, Suite 200 Santa Barbara, California 93117

Re: K200706

Trade/Device Name: Sientra OPUS Silicone Gel Breast Implant Sizer Regulatory Class: Unclassified Product Code: MRD Dated: October 22, 2020 Received: October 23, 2020

Dear Joann Kuhne:

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

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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.

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200706

Device Name

Sientra OPUS® Silicone Gel Breast Implant Sizer

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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Traditional 510(k) Premarket Notification

5.0 510(k) Summary [807.92(a)(1)]

Sponsor:	Sientra, Inc.420 S. Fairview Avenue, Suite 200Santa Barbara, CA 93117
Contact:	JoAnn Kuhne, MSN, RACVice President, Regulatory Affairs,Quality Assurance and ClinicalTelephone: (805) 562-3500Fax: (805) 562-8401Email: joann.kuhne@sientra.com
Date Prepared:	March 16, 2020

Device Information [807.92(a)(2)]

Proprietary Name:	Sientra OPUS® Silicone Gel Breast Implant Sizer
Classification Name:	Sizer, Mammary, Breast Implant
Classification:	Unclassified
Review Panel:	General and Plastic Surgery Devices Panel
Product Code:	MRD
Predicate Device:	Intraoperative, Single-Use, Sterile, Silicone Breast SizerMotiva Implant Matrix® (K183163)

Predicate Device [807.92(a)(3)]

The Sientra OPUS® Silicone Gel Breast Implant Sizer ("Sientra Gel Sizer") is substantially equivalent to the Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix®, cleared under K183163. The Sientra OPUS® Silicone Gel Breast Implant Sizer is comparable to the predicate device with respect to intended use, technological characteristics, performance testing, safety characteristics, and product labeling. The predicate device holds the same device classification name of Sizer, Mammary, Breast Implant, Volume, and the regulation is unclassified.

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Traditional 510(k) Premarket Notification

Device Description [807.92(a)(4)]

The Sientra OPUS® Silicone Gel Breast Implant Sizers are constructed with a smoothsurfaced, silicone elastomer shell and a filler made of clear, high-strength silicone gel. Sientra's Gel Sizers have been demonstrated to be biocompatible. The printing on the exterior of the Gel Sizer shell is clearly marked, "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT", to clearly differentiate the Gel Sizers from Sientra's OPUS Breast Implants. Each Sientra Gel Sizer is dry-heat-sterilized, for single patient use only, and is not intended for long-term implantation or re-sterilization.

Indications for Use [807.92(a)(5)]

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Comparison of the Technological Characteristics with the Predicate Device [807.92(a)(6)]

The proposed device, Sientra OPUS® Silicone Gel Breast Implant Sizer, and the predicate device, Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix®, are both single-use silicone gel sizers and share the same Indications for Use. In addition, they are both constructed of an outer silicone elastomer shell material, filled with silicone gel and are biocompatible. They are each provided sterile and are packaged in sterile barrier packaging with a shelf-life of five years. Furthermore, both the proposed and predicate devices were subjected to similar performance testing.

Performance Data [807.92(b)]

All necessary bench testing was conducted to support a determination of substantial equivalence of the Sientra OPUS® Silicone Gel Breast Implant Sizer to the predicate device.

Non-clinical Testing Summary [807.92(b)(1)]

The following performance testing was conducted on Sientra's Gel Sizer:

Gel Cohesion
Elongation
Break Force ●
Tensile Set
Patch to Shell Joint Integrity ●
Implant Marking Verification and Rub Testing

Results of the performance testing demonstrate that the Sientra OPUS® Silicone Gel Breast Implant Sizer met the predetermined acceptance criteria and thus is substantially equivalent to the predicate device. In addition, the collective non-clinical testing demonstrates that the Sientra OPUS® Silicone Gel Breast Implant Sizer does not raise

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Traditional 510(k) Premarket Notification

new questions of safety or effectiveness for its intended use when compared to the predicate device.

Clinical Testing Summary [807.92(b)(2)]

This section is not applicable. No clinical testing was performed to support this 510(k) submission.

Premarket Notification Conclusions [807.92(b)(3)]

The proposed and predicate devices are similar in terms of intended use, technological characteristics, safety characteristics, and performance testing. Any differences in the technological characteristics between the proposed and predicate devices to not raise any new issues of safety or effectiveness. Thus, the proposed Sientra OPUS® Silicone Gel Breast Implant Sizer is substantially equivalent to the predicate device.

Regulation Number and Section

N/A