(32 days)
No
The description focuses on the physical properties, materials, and mechanical function of the tissue expander and its accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for breast reconstruction after mastectomy and other tissue procedures, which aims to restore or improve body function or appearance.
No
The device description indicates it is a breast tissue expander used for reconstruction, not for diagnosing medical conditions. Its function is to expand tissue, which is a therapeutic rather than a diagnostic procedure.
No
The device description clearly details a physical breast tissue expander made of silicone elastomer with an internal magnet and includes physical accessories like a magnetic injection port finder and a winged infusion set. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Breast Tissue Expander" intended for "temporary subcutaneous or submuscular implantation" for breast reconstruction and other tissue procedures. It is a physical implant used in the body, not a test performed on a sample from the body.
- Intended Use: The intended use is for surgical procedures involving tissue expansion, not for diagnostic testing of biological samples.
- Device Description: The description focuses on the physical components of the expander, its materials, and how it is used for expansion and filling. There is no mention of analyzing biological samples.
Therefore, the Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LCJ
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 .
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
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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).
2
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
3
Indications for Use
510(k) Number (if known) K241918
Device Name
MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
Indications for Use (Describe)
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.
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 LLC
31 Technology Drive
Irvine, 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 |
| | Classification
Regulation: | 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
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
5
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 .
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,
6
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).