(266 days)
Not Found
No
The description focuses on the mechanical and material properties of the tissue expander and its magnetic locating system. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device, a tissue expander, is used for reconstruction and correction of tissue, not for treating a disease or disorder.
No
The device is a tissue expander used for breast reconstruction and other tissue defect procedures. It is an implantable device designed to develop tissue flaps, not to diagnose a medical condition.
No
The device description clearly states it is constructed from silicone elastomer and includes physical components like an expansion envelope, injection site, and magnets. It also mentions mechanical testing, indicating a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Natrelle® 133 Plus MICROCELL™ Tissue Expander is a surgically implanted device used to physically expand tissue for reconstructive purposes. It is a medical device, but it does not analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for tissue expansion, not the analysis of biological specimens.
Therefore, based on the provided information, the Natrelle® 133 Plus MICROCELL™ Tissue Expander is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Natrelle® 133 Plus MICROCELL™ Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
Product codes
LCJ
Device Description
Natrelle® 133 Plus MICROCELL™ Tissue Expanders are designed to develop tissue flaps as part of 2-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a MICROCELL™ textured surface, an orientation line, three suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.
The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expander, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.
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
Not Found
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
Non-clinical performance data, including mechanical testing data and biocompatibility data, were submitted to support clearance of Natrelle® 133 Plus MICROCELL™ Tissue Expanders. Where appropriate, testing was conducted according to methods prescribed by relevant ASTM and/or ISO standards. All pre-established acceptance criteria were met.
Key Metrics
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 contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2018
Allergan Melissa Pathmajeyan Senior Manager 2525 Dupont Drive Irvine, California 92612
Re: K180826
Trade/Device Name: Natrelle 133 Plus MICROCELL Tissue Expander Regulatory Class: Unclassified Product Code: LCJ Dated: November 20, 2018 Received: November 23, 2018
Dear Melissa Pathmajeyan:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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,
Cynthia Chang -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180826
Device Name Natrelle® 133 Plus MICROCELL™ Tissue Expander
Indications for Use (Describe)
The Natrelle® 133 Plus MICROCELL™ Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
| 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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3
510(K) SUMMARY
Date Prepared:
December 14, 2018
510(k) Owner's Name and Contact Information:
Allergan Contact Person: Melissa Pathmajeyan 2525 Dupont Drive Irvine, CA 92612 Email: pathmajeyan melissa@allergan.com Phone: (714) 246-5919 Fax: (714) 796-9724
Device Information:
Proprietary Name: Natrelle® 133 Plus MICROCELL™ Tissue Expander Common Name: Expander, Skin, Inflatable Classification Regulation: Unclassified, Pre-Amendment Product Code: LCJ
Predicate Device:
Natrelle® 133 Plus Tissue Expander (K143354)
Device Description:
Natrelle® 133 Plus MICROCELL™ Tissue Expanders are designed to develop tissue flaps as part of 2-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a MICROCELL™ textured surface, an orientation line, three suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.
The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expander, its rare-earth, permanent magnet indicates the location of the MAGNA-
4
SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.
Intended Use/Indications for Use:
The Natrelle® 133 Plus MICROCELL™ Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
Technological Characteristics:
The Natrelle® 133 Plus MICROCELL™ Tissue Expander has the same fundamental technological characteristics as the predicate device. Like the predicate, the Natrelle® 133 Plus MICROCELL™ Tissue Expander is composed of a silicone expansion envelope with a textured surface, which expands with sequential injections of sterile saline. Both the predicate and the Natrelle® 133 Plus MICROCELL™ Tissue Expander utilize an integrated, self-sealing magnetic injection site that can be located using a magnetic locating device. Compared to the BIOCELL textured shell on the predicate device, the Natrelle® 133 Plus MICROCELL™ Tissue Expander has a MICROCELL textured shell. Allergan's MICROCELL surface texture has a lower surface area than Allergan's BIOCELL surface texture. All materials of construction, dimensions, and other device features remain the same.
Performance Data:
Non-clinical performance data, including mechanical testing data and biocompatibility data, were submitted to support clearance of Natrelle® 133 Plus MICROCELL™ Tissue Expanders. Where appropriate, testing was conducted according to methods prescribed by relevant ASTM and/or ISO standards. All pre-established acceptance criteria were met.
Conclusions:
The Natrelle® 133 Plus MICROCELL™ Tissue Expander has the same intended use, indications for use and fundamental scientific technology as the predicate device, the Natrelle® 133 Plus Tissue Expander. The results of non-clinical testing demonstrate that the design features of the Natrelle® 133 Plus MICROCELL™ Tissue Expander do not raise different questions of safety and effectiveness or negatively impact safety and effectiveness (relative to the predicate device). Therefore, the Natrelle® 133 Plus MICROCELL™ Tissue
5
Expander is substantially equivalent to the Natrelle® 133 Plus Tissue Expander (predicate device) cleared under K143354.