(27 days)
Not Found
No
The description focuses on the mechanical and material properties of the tissue expander and a magnetic locator, with no mention of AI or ML.
Yes
The device is used for breast reconstruction, correction of an underdeveloped breast, scar revision, and tissue defect procedures, which are all therapeutic interventions aimed at improving a patient's physical condition or appearance.
No
This device, the MENTOR® ARTOURA™ Breast Tissue Expander, is used for breast reconstruction and tissue defect procedures. It is a temporary implantable device designed to expand tissue by injecting saline, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components such as a silicone elastomer shell, injection port, and a magnetic injection port locator, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for breast reconstruction, correction of underdeveloped breasts, scar revision, and tissue defect procedures. This involves surgical implantation and physical manipulation of tissue.
- Device Description: The device is a physical implant (silicone expander) with accessories for its use (locator, needle set). It is used to physically expand tissue.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis on biological samples.
The device is a medical device intended for surgical implantation and tissue manipulation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Mentor® ArtouralM Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectony, 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.
Product codes (comma separated list FDA assigned to the subject device)
LCJ
Device Description
MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface consist 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® 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® ARTOURA™ Breast 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 MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface are provided sterile in two styles (High and Ultra High) and various sizes.
The following accessories are packaged with the MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface:
- . 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 (reconstruction after mastectomy), subcutaneous or submuscular (implantation)
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)
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 ARTOURA™ Tissue Expanders with Smooth Surface will have a smooth outer surface and a textured inner surface (reverse shell configuration as compared to the predicate device), the connection of the internal and external components relative to the shell surface will change. Testing performed evaluated parameters related to joint strength of affected joints 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: MENTOR® ARTOURA™ Breast Tissue Expander with Smooth Surface is an implantable device, the contact category according to ISO 10993-1 is: Implant, tissue contacting, permanent (> 30 days). All materials used in the ARTOURA™ Breast Tissue Expander 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.
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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
Mentor Worldwide LLC Ms. Laura Vellucci Regulatory Affairs Fellow 33 Technology Drive Irvine, California 92618
Re: K161176
Trade/Device Name: ARTOURA™ Breast Tissue Expanders With Smooth Surface Regulatory Class: Unclassified Product Code: LCJ Dated: April 25, 2016 Received: April 26, 2016
Dear Ms. Vellucci:
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 of medical devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. 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 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,
Jennifer R. Stevenson -A
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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Mentor Worldwide LLC 33 Technology Drive Irvine, CA 92618
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K161176 | |
| Device Name | |
MENTOR Artoura Breast Tissue Expander with Smooth Surface
Indications for Use (Describe)
The Mentor® ArtouralM Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectony, 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) | 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
"An 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."
| FORM FDA 3881 (8/14) | Page 1 of 1 | ISC Publishing Services (301)-443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
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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® ARTOURA™ Breast Tissue Expanders with Smooth Surface is provided below.
I. SUBMITTER
Mentor Worldwide LLC 33 Technology Drive Irvine, CA 92618
Contact Person:
Laura C. Vellucci Regulatory Affairs Phone: 908-218-3002 Fax: 908-218-2595 lvellucc@its.jnj.com
Date Prepared: April 25, 2016
II. DEVICE
| Name of Device: | MENTOR® ARTOURA™ Breast Tissue Expanders with
Smooth Surface |
|-------------------------------|-----------------------------------------------------------------|
| Common Device Name: | Expander, Skin, Inflatable |
| Classification
Regulation: | Unclassified, Pre-Amendment |
| Panel: | General & Plastic Surgery |
| Product Code: | LCJ |
III. PREDICATE DEVICE
K150777, MENTOR® ARTOURA™ Breast Tissue Expanders
This predicate has not been subjected to a design-related recall or any type of any recall.
IV. DEVICE DESCRIPTION
MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface consist 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.
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® ARTOURA™ Breast 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 MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface are provided sterile in two styles (High and Ultra High) and various sizes.
The following accessories are packaged with the MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface:
- . Centerscope Magnetic Injection Port Finder
- . Winged Infusion Set
INDICATIONS FOR USE V.
MENTOR® ARTOURA™ 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.
COMPARISON OF TECHOLOGICAL CHARACTERISTICS WITH PREDICATE VI.
The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, MENTOR® ARTOURA™ Breast Tissue Expanders (K150777).
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. ARTOURA™ Breast Tissue Expanders and ARTOURA™ Breast Tissue Expanders with Smooth Surface devices will be manufactured with identical components, however the ARTOURA™ Tissue Expanders with Smooth Surface will have a smooth exterior surface while the predicate device has a textured exterior surface. All other device features and specifications remain unchanged. The brand name of the proposed device is MENTOR® ARTOURA™ Breast 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 ARTOURA™ Tissue Expanders with Smooth Surface will have a smooth outer surface and a textured inner surface (reverse shell configuration as compared to the predicate device), the connection of the internal and external components relative to the shell surface will change. .
Testing performed evaluated parameters related to joint strength of affected joints 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:
MENTOR® ARTOURA™ Breast Tissue Expander with Smooth Surface is an implantable device, the contact category according to ISO 10993-1 is: Implant, tissue contacting, permanent (> 30 days). All materials used in the ARTOURA™ Breast Tissue Expander 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.
CONCLUSION VII.
MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface are substantially equivalent to the predicate device, MENTOR® ARTOURA™ Breast Tissue Expander (K150777). MENTOR® ARTOURA™ 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 ARTOURA™ Breast Tissue Expanders (predicate device). Performance evaluations demonstrate that the subject device is as safe and effective as the predicate device. MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface are therefore substantially equivalent to the ARTOURA™ Breast Tissue Expanders (predicate device).