The Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

Device Description

The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with selfsealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet, This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.

Identification of the injection dome site can be accomplished by use of the CENTERSCOPE™ Magnetic Injection Port Locator provided with the Tissue Expander. Instructions for use of the CENTERSCOPE™ Magnetic Injection Port Locator are provided within this document. Injections must be made using sterile, pyrogen-free Sodium Chloride U.S.P. Solution and into the injection dome area. If injections are made on or outside the injection dome, leakage can occur.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander gives surgeons the option to attach the device to surrounding tissue to enhance device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander, Catalogue Number SCPX-15TH-E, provides fill volume options from 930 cc to 1445 cc.

The following accessories are packaged with the CPX™4 PLUS Enhance Breast Tissue Expander:

Centerscope Magnetic Injection Port Finder .
Winged Infusion Set .

AI/ML Overview

The provided text describes the 510(k) premarket notification for the MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's clinical performance. As such, information regarding acceptance criteria for AI/algorithm performance, sample sizes for test and training sets, expert qualifications, or multi-reader multi-case studies is not applicable to this document.

The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by biocompatibility and mechanical testing.

Here's a breakdown of the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related)

The document mentions acceptance criteria related to mechanical testing, but the specific numerical criteria are not detailed. It only states that the results met the pre-determined acceptance criteria.

Acceptance Criteria Category	Reported Device Performance	Comments
Biocompatibility	All materials are identical to the predicate device, which are implant, tissue contacting, permanent (> 30 days). No new testing warranted.	The materials themselves are considered acceptable based on prior predicate device clearance.
Mechanical Testing	All mechanical performance testing results met their pre-determined acceptance criteria.	Testing evaluated parameters related to overexpansion and bladder leak testing in accordance with ASTM F1441-03. Specific numerical acceptance criteria are not provided.

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

Not applicable. This is not a study involving a "test set" of data in the context of an AI/algorithm. The device underwent physical and material testing.

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

Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm.

4. Adjudication Method

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not an AI/algorithm.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable.

8. The Sample Size for the Training Set

Not applicable.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the Provided Text):

The device (MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander) demonstrates that it meets acceptance criteria through:

Biocompatibility Testing: The device utilizes materials identical to a previously cleared predicate device for permanent tissue contact. This indicates that the materials have already met biocompatibility standards and no new testing was required.
Mechanical Testing: Specific mechanical tests were conducted in accordance with ASTM F1441-03, "Standard Specification for Soft-Tissue Expanders." These tests evaluated parameters such as overexpansion and bladder leak. The document states that all results met pre-determined acceptance criteria, thus demonstrating substantial equivalence to the predicate device. The changes specifically addressed in this testing were the change to a smooth surface and the addition of three suture tabs, which impacted the connection of external components (Base and Injection Dome) to the shell surface.

The "study" described is primarily a series of engineering and materials tests demonstrating that the modified physical device (with a smooth surface and additional suture tabs) maintains the same safety and performance characteristics as its predicate devices, especially regarding its physical integrity and material compatibility.

Summary

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August 2, 2024

Mentor Worldwide LLC Catherine Carvalho Associate Director Regulatory Affairs 31 Technology Drive Irvine, California 92618

Re: K241918

Trade/Device Name: MENTORTM CPX™4 PLUS Enhance Breast Tissue Expander Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP Dated: June 28, 2024 Received: July 1, 2024

Dear Catherine Carvalho:

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 (the 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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Alicia Hemphill -S" in a simple, sans-serif font. The name is split into two lines, with "Alicia" on the first line and "Hemphill -S" on the second line. The text is black against a white background, and the overall composition is clean and straightforward.

Digitally signed by Alicia Hemphill -S Date: 2024.08.02 16:56:29 -05'00'

Alicia L. Hemphill, M.S. Assistant Director DHT4B1: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241918

Device Name

MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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™4 Large Smooth Breast Tissue Expanders, with fill volumes up to 1445 cc is provided below.

I.	SUBMITTER	Mentor Worldwide LLC31 Technology DriveIrvine, CA 92618
		Contact Person:
		Catherine Carvalho
		Associate Director, Regulatory Affairs
		Phone: 508-880-8412
		ckilshaw@its.jnj.com
		Date Prepared: May 24, 2024
II.	DEVICE
	Name of Device:	Mentor TM CPXTM4 PLUS Enhance Breast Tissue Expanders(with fill volumes up to 1445 cc)
	Common Device Name:	Expander, Skin, Inflatable
	ClassificationRegulation:	Unclassified, Pre-Amendment
	Panel:	General & Plastic Surgery
	Product Code:	LCJ

III. PREDICATE DEVICE

Primary Predicate

K152496, Mentor™ CPX™4 Breast Tissue Expander with fill volumes up to 1445cc This predicate has not been subjected to a design-related recall.

Additional Predicate

K182335, Mentor™ CPX™ 4 Breast Tissue Expander with Smooth Surface This predicate has not been subjected to a design-related recall.

IV. DEVICE DESCRIPTION

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allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with selfsealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet, This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander, Catalogue Number SCPX-15TH-E, provides fill volume options from 930 cc to 1445 cc.

The following accessories are packaged with the CPX™4 PLUS Enhance Breast Tissue Expander:

Centerscope Magnetic Injection Port Finder .
Winged Infusion Set .

V. INDICATIONS FOR USE

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

VI. COMPARISON OF TECHOLOGICAL 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 with fill volumes up to 1445cc (K152496) and MENTOR™ CPX™4 Tissue Expander with Smooth Surface (K182335).

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 device has the same scientific technology,

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principles of operation, Intended Use, and Indications for Use as the cleared predicate device, CPXTM4 Breast Tissue Expander with fill volumes to 1445cc (K152496).

This special 510(k) pre-market notification describe a change to the surface of the tissue expander (from textured to smooth) and the addition of three suture tabs for a total of six suture tabs like the CPX™4 Smooth Tissue Expander cleared via K182335. The MENTOR™ CPX ™ 4 PLUS Enhance Breast Tissue Expander is provided sterile and deflated. The predicate MENTOR™ CPX TM4 Textured Surface device (K152496) is provided in Tall Height Style with fill volume up to 1445cc like the proposed device. All other components, device features and specifications remain unchanged.

VII. PERFORMANCE DATA Biocompatibility Testing:

The MENTOR™ CPX ™4 PLUS Enhance Breast Tissue Expander with fill volume to 1445cc is an implantable device; the contact category according to ISO 10993-1:2018 is: Implant, tissue contacting, permanent (> 30 days). All materials used in the proposed CPX ™ 4 PLUS Enhance Breast Tissue Expander 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.

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. The testing performed evaluated parameters related to overexpansion and bladder leak testing in accordance ASTM F1441-03, Standard Specification for Soft-Tissue Expanders. Since the proposed CPX™4 PLUS Enhance Breast 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.

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 proposed CPX™4 PLUS Enhance Breast Tissue Expander with fill volumes from 930 cc to 1445 cc has the same indications for use, operating principle and technological characteristics as the predicate devices. Performance evaluations demonstrate that the subject device is substantially equivalent to the predicate device, CPX™4 Breast Tissue Expander with fill volume to 1445cc, (K152496).

Regulation Number and Section

N/A