← Product Code LCJ · K130813 # MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS (K130813) _Mentor Corp. · LCJ · Apr 11, 2013 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K130813 ## Device Facts - **Applicant:** Mentor Corp. - **Product Code:** LCJ - **Decision Date:** Apr 11, 2013 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The Contour Profile Tissue Expanders 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. ## Device Story Inflatable silicone elastomer tissue expander used for breast reconstruction; temporary subcutaneous or submuscular implantation. Device features textured shell for collagen interface; integral magnetically detected injection port; BUFFERZONE self-sealing technology to prevent leakage from accidental needle puncture. Some models include suture tabs for tissue fixation. Operated by surgeons in clinical settings. Injection port location identified via external CENTERSCOPE Magnetic Injection Port Locator; sterile Sodium Chloride U.S.P. solution injected via infusion needle set to expand device. Gradual expansion facilitates tissue growth; device removed after target expansion achieved (not intended for use >6 months). ## Clinical Evidence Bench testing only. Evaluated joint strength, leak performance, and other performance parameters. All results met pre-determined acceptance criteria. ## Technological Characteristics Silicone elastomer shell with cross-linked layers; textured surface. Integral magnetically detected injection port with self-sealing BUFFERZONE technology. Suture tabs on select models. Dimensions and configuration modified for increased pliability. Non-powered, mechanical device. ## Predicate Devices - Mentor Contour Profile Tissue Expander ([K011500](/device/K011500.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Mentor CPX™4 Tissue Expander #### 5.0 510(k) Summary Image /page/0/Picture/5 description: The image shows the logo for MENTOR Worldwide LLC. The word "MENTOR" is written in large, bold, black letters. To the left of the word "MENTOR" is a symbol that looks like a compass rose. Below the word "MENTOR" are the words "WORLDWIDE LLC" in smaller, black letters. In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mentor® CPX™4 Breast Tissue Expanders and Mentor® CPX™4 With Suture Tabs Breast Tissue Expanders device is provided below. | Device Common Name: | Expander, Skin, Inflatable | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Proprietary Name: | Mentor® CPXTM4 Breast Tissue Expanders and Mentor®
CPXTM4 with Suture Tabs Breast Tissue Expanders | | Submitter: | MENTOR Worldwide LLC
201 Mentor Drive
Santa Barbara, CA 93111
Phone: 908-218-2651 | | Contact: | Martin Sprunck
Manager, Regulatory Affairs
MENTOR Worldwide LLC
201 Mentor Drive
Santa Barbara, CA 93111
Phone: 908-218-2651
Fax: 908-218-2595
msprunc9@its.jnj.com | | Date Prepared: | March 21, 2013 | | Classification | Unclassified, Pre-Amendment | | Regulation: | General & Plastic Surgery | | Panel: | LCJ | | Product Code: | K011500, Mentor Contour Profile Tissue Expander | | Predicate Device: | | ### Indication for Use: The Contour Profile Tissue Expanders 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. ### Device Description: The CPX™4 Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. In order to provide these tissue expanders with elasticity and integrity, the shells are made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the devices have integral, silicone elastomer, magnetically detected, injection ports and incorporate a BUFFERZONE® area with self-sealing technology that is attached to the inside of the anterior surface of the {1}------------------------------------------------ device to minimize and/or prevent leakage in the event of an accidental needle puncture. The textured shell provides a disruptive surface for collagen interface. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. Suture fixation tabs are incorporated into some models of the MENTOR® CPX™4 Tissue Expanders to give surgeons the option to attach the device to surrounding tissue for enhanced device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience. #### Technological Characteristics: The proposed modifications to the already cleared Contour Profile Tissue Expander include minor configuration changes to make the device more pliable, minor dimensional changes, and a modified magnet component. No new technological characteristics were introduced as a result of the proposed modifications. #### Performance Data: Non-clinical performance testing was conducted in order to demonstrate substantial equivalence with the predicate device. This testing was performed as required by the risk analysis and in accordance with design control procedures. The testing that was performed evaluated parameters related to joint strength, leak performance and other device performance parameters. All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device performs as well as or better than the predicate device. #### Substantial Equivalence: This 510(k) describes minor changes to the design of the Mentor Contour Profile Tissue Expander. There have been no changes to the indications for use or the intended use. The changes do not raise different questions of safety or effectiveness and results of non-clinical performance evaluations demonstrate that the proposed device is substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, curved shapes that resemble human figures or flowing lines. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 April 11. 2013 MENTOR Worldwide LLC % Mr. Martin Sprunck Manager, Regulatory Affairs 201 Mentor Drive Santa Barbara, California 93111 Re: K130813 ・ Trade/Device Name: Mentor® CPXTM4 Breast Tissue Expanders and Mentor®CPXTM4 with Suture Tabs Breast Tissue Expanders Regulatory Class: Unclassified Product Code: LCJ Dated: March 21, 2013 Received: March 25, 2013 · Dear Mr. Sprunck: 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. 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 (reporting of medical {3}------------------------------------------------ Page 2 - Mr. Martin Sprunck device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Sincerely yours, FOR # Peter DERumm -S - Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use Statement 4.0 K130813 510(k) Number (if known): Device Name: - - - -- Mentor® CPXTM4 Breast Tissue Expanders and Mentor® CPX™4 with Suture Tabs Breast Tissue Expanders ______________________________________________________________________________________________________________________________________________________________________________ #### Indications For Use: The Contour Profile Tissue Expanders 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. r Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 80l'Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # David Krause (Division Sign-Off) Division of Surgical Devices 510(k) Number: K130813 --- **Source:** [https://fda.innolitics.com/device/K130813](https://fda.innolitics.com/device/K130813) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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