CPX Control Breast Tissue Expander

K142998 · Mentor Worldwide, LLC · LCJ · Dec 19, 2014 · SU

Device Facts

• Record ID: K142998
• Device Name: CPX Control Breast Tissue Expander
• Applicant: Mentor Worldwide, LLC
• Product Code: LCJ · SU
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The CPX(TM) Control Breast 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

CPX Control Breast Tissue Expander is an inflatable silicone shell used for tissue expansion in breast reconstruction or defect correction. Device implanted subcutaneously or submuscularly by a surgeon. Expansion achieved via incremental filling with sterile Sodium Chloride U.S.P. solution through an integral, magnetically detectable injection port. Includes a BUFFERZONE self-sealing area to prevent leakage from accidental needle punctures. Injection port location identified using the provided CENTERSCOPE magnetic locator. Internal structural elements, including reinforced silicone sheeting and tethering, provide directional expansion in the lower pole. Suture tabs allow attachment to surrounding tissue for stability. Device is temporary, intended for use up to six months. Benefits include controlled tissue stretching to facilitate reconstructive procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility testing (ISO 10993-1) and mechanical bench testing, including elongation, tensile strength, break force, joint testing, overexpansion, and injection valve competency, performed per ASTM F1441-03 and FDA guidance.

Technological Characteristics

Silicone elastomer shell with integral magnetic injection port and BUFFERZONE self-sealing technology. Features internal reinforced silicone sheeting and tethering for directional expansion. Includes suture tabs. Provided sterile. Mechanical testing per ASTM F1441-03.

Indications for Use

Indicated for breast reconstruction post-mastectomy, correction of underdeveloped breast, scar revision, and tissue defect procedures. Intended for temporary subcutaneous or submuscular implantation; not for use beyond six months.

Predicate Devices

• Mentor CPX4 Breast Tissue Expanders and Mentor CPX 4 Breast Tissue Expanders with Suture Tabs (K130813)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2014

Mentor Worldwide LLC Ms. Manchi Cheung Regulatory Manager 201 Mentor Drive Santa Barbara, California 93111

Re: K142998

Trade/Device Name: CPX (TM) Control Breast Tissue Expanders Regulatory Class: Unclassified Product Code: LCJ Dated: October 16, 2014 Received: October 17, 2014

Dear Ms. Cheung:

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -S

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) K142998

Device Name CPX (TM) Control Breast Tissue Expanders

### Indications for Use (Describe)

The CPX(TM) Control Breast 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mentor CPX™ Control Breast Tissue Expanders is provided below.

### I. SUBMITTER Mentor Worldwide LLC 201 Mentor Drive Santa Barbara, CA 93111

Contact Person: Manchi Cheung Regulatory Manager Phone: [phone] Fax: [phone] [e-mail]

Date Prepared: October 16, 2014

#### II. DEVICE

| Name of Device: | Mentor CPX TM Control Breast Tissue Expanders |
|-------------------------------|-----------------------------------------------|
| Common Device Name: | Expander, Skin, Inflatable |
| Classification<br>Regulation: | Unclassified, Pre-Amendment |
| Panel: | General & Plastic Surgery |
| Product Code: | LCJ |

#### III. PREDICATE DEVICE

K130813, Mentor CPX4 Breast Tissue Expanders and Mentor CPX 4 Breast Tissue Expanders with Suture Tabs This predicate has not been subjected to a design-related recall.

No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The CPX™ Control Breast Tissue Expander consists of a silicone elastomer shell, with interior structural elements to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture.

Identification of the injection port site is accomplished by use of the CENTERSCOPE®

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Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. 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.

The MENTOR CPX™ Control Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The CPX Control devices are provided sterile in various styles and sizes.

The following accessories are packaged with the CPX Control Tissue Expander:

- . Centerscope Magnetic Injection Port Finder
- Winged Infusion Set ●

#### V. INDICATIONS FOR USE

The CPX™ Control Breast 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.

#### VI. COMPARISON OF TECHOLOGICAL CHARACTERISTICS WITH PREDICATE

The technological principle for both the proposed and predicate devices is the same. Both devices expansion are based on incremental filling of a silicone shell with saline fluid to stretch the surrounding tissue. Filling is achieved via an integral injection dome with needle guard, and a magnetic injection finder to locate the dome.

The proposed and predicate devices are based on the following same technological elements:

- Same intended use
- Same operating principle ●
- Same materials, same dimensional and volume ranges
- Same integral injection Dome with neodymium needle guard
- . Same BUFFERZONE® area with self-sealing technology around the injection dome to prevent accidental needle punctures
- . Same suture tabs to attach device to surrounding tissue
- Same use of reinforced silicone sheeting applied to areas of the device for directional expansion in the lower pole
- . Compliance with the same recognized standards and test requirements.

The following additional design features are included in the proposed device. These design features are made using materials featured in the predicate device.

- . An additional reinforced silicone sheeting is applied to the interior perimeter of the shell, adjacent to the base
- . Use of tethering elements inside the shell to further minimize expansion in the upper pole and the area around the base, providing additional directional expansion to the lower pole.

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#### VII. PERFORMANCE DATA

# Biocompatibility Testing:

The CPX Control Breast Tissue Expander is an implantable device, the contact category according to ISO10993-1 is: Implant, tissue contacting, permanent (> 30 days). All materials used in the CPX Control tissue expander are identical to the materials used in the predicate device.

## Mechanical Testing:

Mechanical testing was conducted in accordance with Draft Guidance for Industry and Staff -Class II Special Controls Guidance for Tissue Expanders, issued December 22, 2008 and ASTM F1441-03, Standard Specification for Soft-Tissue Expanders. The following mechanical testing was performed:

- Elongation ●
- . Tensile Strength
- Break Force .
- . Joint Testing
- Overexpansion .
- Injection Valve Competency ●

All mechanical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the proposed device is substantially equivalent to the predicate device.

#### VIII. CONCLUSION

The CPX Control Breast Tissue Expander is substantially equivalent to the legally marketed predicate device, CPX4 Breast Tissue Expander and CPX4 Breast Tissue Expander with Suturing Tabs (K130813). The CPX Control Breast Tissue Expander has the same indications for use, operating principle and technological characteristics as the predicate device. Performance evaluations demonstrate that the subject device is substantially equivalent to the predicate device.