(27 days)
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.
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
The provided text describes the 510(k) summary for the MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface. It details the device, its intended use, and a comparison to a predicate device, focusing on mechanical testing and biocompatibility.
Here's the information broken down as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Joint Strength | Not explicitly stated (implied "pre-determined acceptance criteria") | All mechanical performance testing results met their pre-determined acceptance criteria. |
| Overexpansion | Not explicitly stated (implied "pre-determined acceptance criteria") | All mechanical performance testing results met their pre-determined acceptance criteria. | |
| ASTM F1441-03 Compliance | Compliance with ASTM F1441-03 | Testing was performed in accordance with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders. | |
| Biocompatibility | Material Safety | Materials are identical to the predicate device, which has established biocompatibility. | All patient contact materials are identical to the predicate device. No changes warranted new biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical testing (test set) in terms of number of devices tested. It mentions that testing was conducted on "the modified device."
- Sample Size: Not explicitly stated.
- Data Provenance: Not specified, but generally, such testing would be conducted in-house by the manufacturer (Mentor Worldwide LLC). The document does not indicate country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is for a medical device (breast tissue expander) and involves mechanical and biocompatibility testing, not diagnostic performance where expert ground truth would be established.
4. Adjudication Method for the Test Set
This information is not applicable for mechanical and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results by multiple experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device is a breast tissue expander, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For mechanical testing, the "ground truth" is typically defined by pre-determined acceptance criteria based on established engineering standards (like ASTM F1441-03) and risk analysis. For biocompatibility, the "ground truth" is that the materials are safe for human implantation, established by prior testing and regulatory clearance of the predicate device's materials.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of mechanical and biocompatibility testing for a medical device like a breast tissue expander.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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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.
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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 SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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.
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| 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 withSmooth Surface |
|---|---|
| Common Device Name: | Expander, Skin, Inflatable |
| ClassificationRegulation: | 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.
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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).
N/A