(243 days)
Not Found
No
The description focuses on the physical properties and intended use of a silicone gel sizer, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a sizer used to determine the appropriate size of an implant, not to treat a condition or disease itself.
No
Explanation: The device is used to assist the surgeon in determining the appropriate size of a long-term implant, not to diagnose a medical condition or disease. It is a sizer for surgical planning.
No
The device description explicitly states it is a physical, intraoperative device constructed with a silicone elastomer shell and silicone gel filler. It is a tangible object used during surgery, not a software program.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The Sientra OPUS® Silicone Gel Breast Implant Sizer is an intraoperative device used temporarily during surgery to help the surgeon determine the correct size of a breast implant. It is placed inside the body during the procedure, not used to test specimens taken from the body.
- Intended Use: The intended use clearly states it's for "temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term Sientra OPUS® Breast Implant." This is a surgical aid, not a diagnostic test.
The device description and intended use clearly indicate it's a surgical tool for sizing, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
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 of the long-term Sientra OPUS® Breast Implant to be implanted.
Product codes
MRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperative
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)
Non-clinical testing was conducted, including: Gel Cohesion, Elongation, Break Force, Tensile Set, Patch to Shell Joint Integrity, and Implant Marking Verification and Rub Testing. Results demonstrated that the device met predetermined acceptance criteria and is substantially equivalent to the predicate device, raising no new questions of safety or effectiveness. No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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.
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
1
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
2
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)
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 of the long-term Sientra OPUS® Breast Implant to be implanted.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Traditional 510(k) Premarket Notification
5.0 510(k) Summary [807.92(a)(1)]
| Sponsor: | Sientra, Inc.
420 S. Fairview Avenue, Suite 200
Santa Barbara, CA 93117 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | JoAnn Kuhne, MSN, RAC
Vice President, Regulatory Affairs,
Quality Assurance and Clinical
Telephone: (805) 562-3500
Fax: (805) 562-8401
Email: 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 Sizer |
| Motiva 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.
4
Traditional 510(k) Premarket Notification
Device Description [807.92(a)(4)]
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.
Indications for Use [807.92(a)(5)]
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 of the long-term Sientra OPUS® Breast Implant to be implanted.
5
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
6
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.