(212 days)
No
The summary describes a physical device (silicone sizers) used for manual size determination during surgery and contains no mention of AI or ML.
No
The device, NATRELLE INSPIRA® Single Use Sizers, is used to assist surgeons in determining the appropriate size breast implant during augmentation or reconstruction procedures. It does not treat or cure a disease or condition, which is the primary function of a therapeutic device.
No
Explanation: The device is a sizer used to determine the appropriate breast implant size during surgery, not to diagnose a medical condition or disease.
No
The device description clearly states the sizers are constructed of a silicone elastomer shell filled with gel, indicating a physical, hardware-based device.
Based on the provided information, the NATRELLE INSPIRA® Single Use Sizers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to assist a surgeon in determining the appropriate size breast implant during a surgical procedure. This is a direct interaction with the patient's body for a surgical planning purpose.
- Device Description: The device is a physical object (silicone sizer) placed temporarily within the body.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any such testing.
- Anatomical Site: The device is used directly on the breast, which is an anatomical site within the body.
In summary, the NATRELLE INSPIRA® Single Use Sizers are a surgical tool used in vivo (within the living body) to aid in a surgical procedure, not an in vitro diagnostic test performed on specimens outside the body.
N/A
Intended Use / Indications for Use
NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.
Product codes (comma separated list FDA assigned to the subject device)
MRD
Device Description
NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures.
NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants.
NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.
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 placement
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 performance data including mechanical testing and biocompatibility data were submitted to support clearance of NATRELLE INSPIRA® Single Use Sizers. Where appropriate, testing was conducted according to methods prescribed by relevant standards. The testing was performed as required by the conducted risk analysis to verify and validate that the design outputs of the modified device met design input requirements. All pre- established acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image contains the words "Convert to PDF" in a simple, sans-serif font. The text is horizontally aligned and appears to be the main focus of the image. The background is a light, neutral color, providing contrast to the dark text.
Image /page/0/Picture/2 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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and arranged in two lines.
June 2, 2021
Allergan Aesthetics Kelly Carty Executive Director, Regulatory Affairs 2525 Dupont Dr. Irvine, California 92612
Re: K203229
Trade/Device Name: NATRELLE INSPIRA Single Use Sizers for Gel Implants Regulatory Class: Unclassified Product Code: MRD Dated: April 30, 2021 Received: Mav 3, 2021
Dear Kelly Carty:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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
Indications for Use
510(k) Number (if known) K203229
Device Name NATRELLE INSPIRA® Single Use Sizers
Indications for Use (Describe)
NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation procedures to assist the surgeon in determining the appropriate size breast implant.
Type of Use (Select one or both, as applicable)
|--|--|
|X 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."
3
5. 510(K) SUMMARY
Date Prepared:
April 27, 2020
510(k) Owner's Name and Contact Information:
Allergan Contact Person: Kelly Carty 2525 Dupont Drive Irvine, CA 92612 Email: Carty Kelly@allergan.com Phone: (714) 246-6180
Device Information:
Proprietary Name: NATRELLE INSPIRA® Single Use Sizers
Common Name: Sizer, Mammary, Breast Implant Volume
Classification Regulation: Unclassified, Pre-Amendment
Product Code: MRD
Predicate Device:
Natrelle® Re-Sterilizable Breast Implant Sizers (K831566)
Reference Device:
Natrelle® 133S Tissue Expander (K182054)
Device Description:
NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures.
NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer
4
shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants.
NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.
Intended Use/Indications for Use:
NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.
Technological Characteristics:
NATRELLE INSPIRA® Single Use Sizers have the same fundamental technological characteristics as the predicate device. Like the predicate, the NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel.
These devices will maintain all functionalities and performance from the current RSS (Resterilizable sizers) product line with the following differences:
- A new silicone gel will be used. The new gel to be used in the Single Use Sizers . differs from the gel in the predicate in the following aspects:
- 0 New supplier
- o Sizer gel is qualified for short-term implant whereas the gel in the predicate is qualified for long-term implant.
- o Colorant (cobalt aluminate blue spinel at a concentration of 0.1%) added
- The stamp on the shell is updated to reflect the new sizer name ●
- The labeling has been updated to reflect the product name as well as to ● remove instructions related to cleaning and resterilization
Performance Data:
Non-clinical performance data including mechanical testing and biocompatibility data were submitted to support clearance of NATRELLE INSPIRA® Single Use Sizers. Where appropriate, testing was conducted according to methods prescribed by relevant standards. The testing was performed as required by the conducted risk analysis to verify
5
and validate that the design outputs of the modified device met design input requirements. All pre- established acceptance criteria were met.
Conclusions:
The NATRELLE INSPIRA® Single Use Sizers have the same intended use, indications for use and fundamental scientific technology as the predicate device, Natrelle® Re-Sterilizable Breast Implant Sizers (K831566). The results of the risk evaluations and non-clinical testing demonstrate that the design features of the NATRELLE INSPIRA® Single Use Sizers do not raise different questions of safety and effectiveness or negatively affect safety and effectiveness (relative to the predicate device). Therefore, the NATRELLE INSPIRA® Single Use Sizers are substantially equivalent to the Natrelle® Re-Sterilizable Breast Implant Sizers (predicate device) cleared under K831566.