The CPX 14 Breast Tissue Expanders with Smooth Surface 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 with Smooth Surface consist of a silicone elastomer shell, with superior and anterior reinforcement that allows 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® 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 CPX™4 Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The CPX™4 Tissue Expanders with Smooth Surface are provided sterile. The devices are provided in three styles (Low, Medium and Tall) and in various sizes. The following accessories are packaged with the CPX™4 Tissue Expanders with Smooth Surface: Centerscope Magnetic Injection Port Finder, Winged Infusion Set.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device (breast tissue expander). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI device meets specific acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment will not be found in this document.

However, I can extract information related to the device's
mechanical testing performance and the acceptance criteria for those tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Parameter)	Reported Device Performance (Result/Outcome)
Joint Strength (adherence of components to smooth shell)	Met pre-determined acceptance criteria.
Overexpansion	Met pre-determined acceptance criteria.

Note: The specific quantitative acceptance criteria values (e.g., specific force in N, volume thresholds) are not provided in this summary, only that they were "pre-determined" and met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "mechanical testing was conducted on the modified device." It does not specify the number of devices or test repetitions.
Data Provenance: Not applicable in the context of clinical data for AI. This is a report on mechanical bench testing for a physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not applicable. This relates to mechanical bench testing, not image analysis or clinical diagnosis where expert ground truth would be established. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication Method for the Test Set

Not applicable. This relates to mechanical bench testing. Adjudication methods are typically used for subjective human assessments, e.g., in clinical trials or image labeling.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No. This document is not about an AI device. It's about a physical medical implant (a breast tissue expander).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done

No. This is not an AI device.

7. The Type of Ground Truth Used

Engineering/Physical Measurements: The "ground truth" for this device's performance is derived from standardized mechanical testing (specifically, ASTM F1441-03 for soft-tissue expanders) and risk analysis procedures. The results are objective measurements of physical properties (joint strength, overexpansion).

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set as it's not an AI device.

Summary of what the document addresses regarding the device:

The document focuses on demonstrating that the modifications to the CPX™4 Breast Tissue Expander (specifically, a smooth surface instead of textured and increased suture tabs) do not negatively impact its safety and effectiveness compared to the predicate device. This is primarily done through:

Comparison of Technological Characteristics: Stating that the fundamental technology, principles of operation, intended use, and indications for use remain the same.
Mechanical Testing: Bench testing was performed to evaluate parameters related to "joint strength and overexpansion" according to ASTM F1441-03. The key finding is that "All mechanical performance testing results met their pre-determined acceptance criteria."
Biocompatibility Assessment: Confirming that all patient-contact materials are identical to the predicate device, thus new biocompatibility testing was not warranted.

The "acceptance criteria" are implied to be the thresholds or standards outlined in the ASTM F1441-03 standard and Mentor's internal design control procedures for mechanical performance, which the modified device successfully met.

Summary

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2018

Mentor Worldwide LLC c/o Mr. Martin Sprunck Associate Director, Regulatory Affairs 33 Technology Drive Irvine, California 92618

Re: K182335

Trade/Device Name: CPX 4 Breast Tissue Expander with Smooth Surface Regulatory Class: Unclassified Product Code: LCJ Dated: August 27, 2018 Received: August 28, 2018

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. Although this letter refers to your product as a device, please be avare 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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good

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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 mediation-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,

David Krause -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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Section 5: Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K182335

Device Name

Mantor® CPXTM4 Broast Tissue Expanders with Smooth Surface

Indications for Use (Describe)

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 PRAStam@rda.hhs.gov

fAn 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.8

FORM FDA 3881 (7/17)

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Section 6: 510(k) Summary

Image /page/3/Picture/4 description: The image shows the logo for Mentor Worldwide LLC. The logo features a blue compass-like symbol on the left, followed by the word "MENTOR" in bold, blue letters. Below "MENTOR" are the words "WORLDWIDE LLC" in smaller, lighter blue letters. The logo is clean and professional, conveying a sense of guidance and global reach.

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 with Smooth Surface device is provided below.

I. SUBMITTER

Mentor Worldwide LLC 33 Technology Drive Irvine. CA 92618

Contact Person:

Martin Sprunck Associate Director, Regulatory Affairs Phone: 949-789-8589 Fax: 949-450-6886 msprunc9@its.jnj.com

Date Prepared: August 27, 2018

II. DEVICE

Name of Device:	MENTOR® CPX™4 Breast Tissue Expander with SmoothSurface
Common Device Name:	Expander, Skin, Inflatable
Classification	Unclassified, Pre-Amendment
Review Panel:	General & Plastic Surgery
Product Code:	LCJ

III. PREDICATE DEVICE

K130813, Mentor® CPX™4 Breast Tissue Expanders and Mentor® CPX™4 with Suture Tabs Breast Tissue Expanders

IV. DEVICE DESCRIPTION:

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

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are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

The CPX™4 Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The CPX™4 Tissue Expanders with Smooth Surface are provided sterile. The devices are provided in three styles (Low, Medium and Tall) and in various sizes.

The following accessories are packaged with the CPX™4 Tissue Expanders with Smooth Surface:

. Centerscope Magnetic Injection Port Finder
Winged Infusion Set o

V. INDICATIONS FOR USE:

The CPX™4 Tissue Expanders with Smooth Surface 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 TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE

The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device. Mentor® CPX™4 Breast Tissue Expanders and Mentor® CPX™4 with Suture Tabs Breast Tissue Expanders (K130813).

The technological principle for both the proposed and predicate devices is the same. Expansion of both the proposed and predicate devices is 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.

This 510(k) pre-market notification describes changes to the predicate's device shell surface. The predicate and proposed devices will be manufactured with identical components, however the CPX™4 Tissue Expanders with Smooth Surface will have a smooth exterior surface while the predicate device has a textured exterior surface. In addition, the proposed CPXTM4 Tissue Expanders with Smooth Surface will incorporate a total of six suture tabs while the predicate device configuration with suture tabs includes a total of three suture tabs. All other device features and specifications remain unchanged. The brand name of the proposed device is CPX™4 Tissue Expanders with Smooth Surface.

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PERFORMANCE DATA:

Mechanical Testing:

Mechanical testing was conducted on the modified device 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. Since the proposed CPX™4 Tissue Expanders with Smooth Surface will have a smooth outer surface, the connection of the external components relative to the shell surface will change. Specifically, the Base and Injection Dome components will be attached to the smooth surface (not the textured surface) of the shell.

Testing evaluated parameters related to joint strength and overexpansion in accordance with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders.

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

Biocompatibility Assessment:

The Mentor® CPX™4 Tissue Expanders with Smooth Surface are implantable devices. The contact category according to ISO 10993-1 is: Implant, tissue contacting, permanent (> 30 days). All materials used in the Mentor® CPX™4 Tissue Expanders with Smooth Surface are identical to the materials used in the predicate device. All patient contact materials are identical to the predicate device. No changes associated with the proposed device warrant new biocompatibility testing.

VII. CONCLUSION:

Mentor® CPX™4 Tissue Expanders with Smooth Surface are substantially equivalent to the predicate device, Mentor® CPX™4 Breast Tissue Expander (K130813). Mentor® CPX™4 Breast Tissue Expanders with Smooth Surface have the same indications for use, same intended use, same fundamental technology, operating principle and technological characteristics as the Mentor® CPX™4 Expanders (predicate device). Performance evaluations demonstrate that the subject device is as safe and effective as the predicate device. Mentor® CPX™4 Breast Tissue Expanders with Smooth Surface are therefore substantially equivalent to the predicate Mentor® CPXTM4 Breast Tissue Expanders (K130813).

Regulation Number and Section

N/A