(171 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a breast tissue expander and its accessories, with no mention of AI or ML technologies.
Yes.
The device is used for breast reconstruction after mastectomy, which is a therapeutic purpose.
No
The device description clearly states its purpose is for breast reconstruction and tissue expansion, which are therapeutic procedures. There is no mention of it being used to diagnose a medical condition.
No
The device description clearly details a physical implantable device made of silicone elastomer with an injection port and magnetic locator, indicating it is a hardware medical device.
Based on the provided information, the Mentor® CPX™4 Breast Tissue Expander is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for breast reconstruction, scar revision, and tissue defect procedures through temporary implantation. This is a surgical/implantable device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a silicone elastomer shell, injection port, and other components for physical expansion of tissue. This aligns with a medical device for implantation, not a diagnostic assay or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility and mechanical testing, which are relevant for implantable devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Mentor® CPX™4 Breast Tissue Expander does not fit this description.
N/A
Intended Use / Indications for Use
The CPX4 (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastection 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.
Product codes (comma separated list FDA assigned to the subject device)
LCJ
Device Description
The Mentor® CPX™4 Breast Tissue Expander consists of a silicone elastomer shell, with superior and anterior reinforcement 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®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 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™4 Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.
The Mentor® CPX™4 Breast Tissue Expander are provided sterile and deflated. The proposed Mentor® CPX™4 Breast Tissue Expander is provided in Tall Height Style with fill volume range from 850 cc to 1445 cc.
The following accessories are packaged with the CPX™4 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
The Mentor® CPX™4 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 modified CPX™4 tissue expander are identical to the materials used in the predicate device.
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 with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders.
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2016
Mentor Worldwide LLC Ms. Manchi Cheung Regulatory Manager 201 Mentor Drive Santa Barbara, California 93111
Re: K152496
Trade/Device Name: CPX 4 Breast Tissue Expander Regulatory Class: Unclassified Product Code: LCJ Dated: January 11, 2016 Received: January 12, 2016
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K152496
Device Name
CPX4(TM) Breast Tissue Expanders (with fill volumes up to 1445 cc)
Indications for Use (Describe)
The CPX4 (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastection 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)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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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™4 Breast Tissue Expanders, with fill volumes up to 1445 cc is provided below.
I. SUBMITTER
Mentor Worldwide LLC 33 Technology Drive Irvine, CA 92618
Contact Person: Manchi Cheung Associate Director, Regulatory Affairs Phone: 949 -450-6813 Fax: 949-450-6876 mcheung3@its.jnj.com
Date Prepared: February 16, 2016
II. DEVICE
| Name of Device: | Mentor ® CPX™4 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
K130813, Mentor® CPX™4 Breast Tissue Expanders The predicate Mentor® CPX™4 devices are provided in various styles with labeled fill volume range from 250 cc to 850 cc. This predicate has not been subjected to a design-related recall.
IV. DEVICE DESCRIPTION
The Mentor® CPX™4 Breast Tissue Expander consists of a silicone elastomer shell, with superior and anterior reinforcement 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.
4
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 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™4 Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.
The Mentor® CPX™4 Breast Tissue Expander are provided sterile and deflated. The proposed Mentor® CPX™4 Breast Tissue Expander is provided in Tall Height Style with fill volume range from 850 cc to 1445 cc.
The following accessories are packaged with the CPX™4 Breast Tissue Expander:
- CENTERSCOPE® Magnetic Injection Port Finder ●
- . Winged Infusion Set
V. INDICATIONS FOR USE
The Mentor® CPX™4 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.
COMPARISON OF TECHOLOGICAL CHARACTERISTICS WITH PREDICATE VI.
The technological principle for both the proposed and predicate devices is the same. Both devices' expansion 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. The proposed device has the same scientific technology, principles of operation. Intended Use, and Indications for Use as the cleared predicate device, CPXTM4 Breast Tissue Expander (K130813).
This 510(k) pre-market notification describes a changes to the volume (fill volume) and dimensions specified on the product labeling. The Mentor CPX™4 Breast Tissue Expander are provided sterile and deflated. The predicate Mentor® CPX™4 devices are provided in various styles with labeled fill volume range from 250 cc to 850 cc. The proposed Mentor® CPX™4 Breast Tissue Expander with suture tabs is provided in Tall Height Style with fill volume range from 850 cc to 1445 cc. All components, device features and specifications remain unchanged.
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PERFORMANCE DATA VII.
Biocompatibility Testing:
The Mentor® CPX™4 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 modified CPX™4 tissue expander are identical to the materials used in the predicate device.
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 with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders.
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 Breast Tissue Expander with fill volumes from 850 cc to 1445 cc 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, CPX™4 Breast Tissue Expander, (K130813).