(30 days)
Not Found
No
The description focuses on the mechanical and material properties of the tissue expander and a magnetic locator. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
This device is used for breast reconstruction, scar revision, and tissue defect procedures, which are therapeutic interventions.
No
Explanation: The device is described as a breast tissue expander used for reconstruction, not for diagnosis. Its function is to facilitate the expansion of tissue using saline injections.
No
The device description clearly details a physical implantable device made of silicone elastomer with an injection port and accessories like a magnetic locator and infusion set. This is a hardware medical 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 clearly states that the device is for breast reconstruction, correction of underdeveloped breasts, scar revision, and tissue defect procedures. These are all surgical procedures involving the body directly.
- Device Description: The description details a physical implantable device (silicone expander) and accessories for its use in a surgical setting (injection port, locator, infusion set).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is a medical device used for surgical and reconstructive purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Artoura (TM) Breast Tissue Expanders 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.
Product codes
LCJ
Device Description
The Mentor® Artoura™ Breat Tissue Expander consists 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 center of 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 Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.
The Mentor® Artoura™ devices are provided sterile in various styles and sizes.
The following accessories are packaged with the Artoura™ 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® Artoura™ 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 Artoura™ 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 joint strength, leak performance and other performance characteristics 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2015
Mentor Worldwide LLC Manchi Cheung Regulatory Manager 201 Mentor Drive Santa Barbara, California 93111
Re: K150777
Trade/Device Name: Artoura™ Breast Tissue Expanders Regulatory Class: Unclassified Product Code: LCJ Dated: March 25, 2015 Received: March 26, 2015
Dear 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
2
Indications for Use
510(k) Number (if known) K150777
Device Name Artoura (TM) Breast Tissue Expanders
Indications for Use (Describe)
The Artoura (TM) Breast Tissue Expanders 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.
Type of Use (Select one or both, as applicable)
2 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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3
510(k) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mentor® ArtouraTM Breast Tissue Expanders is provided below.
I. SUBMITTER
Mentor Worldwide LLC 201 Mentor Drive Santa Barbara, CA 93111
Contact Person: Manchi Cheung Regulatory Manager Phone: 805 -879-6790 Fax: 805-879-6167 mcheung3@its.jnj.com
Date Prepared: March 24, 2015
II. DEVICE
| 510 (k) Number: | K150777 |
|---|---|
| Name of Device: | Mentor Artoura® Breast Tissue Expanders |
| Common Device Name: | Expander, Skin, Inflatable |
| Classification | |
| Regulation: | Unclassified, Pre-Amendment |
| Panel: | General & Plastic Surgery |
| Product Code: | LCJ |
III. PREDICATE DEVICE
K142998, Mentor® CPX™ Control Breast Tissue Expanders This predicate has not been subjected to a design-related recall.
IV. DEVICE DESCRIPTION
The Mentor® Artoura™ Breat Tissue Expander consists 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 center of the
4
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 Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.
The Mentor® Artoura™ devices are provided sterile in various styles and sizes.
The following accessories are packaged with the Artoura™ Tissue Expander:
- . Centerscope Magnetic Injection Port Finder
- . Winged Infusion Set
V. INDICATIONS FOR USE
The Mentor® Artoura™ 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 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, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, CPX™ Control Breast Tissue Expander (K142998)
This 510 (k) pre-market notification describe changes to the predicate's device size and dimensions. All other components, device features and specifications remain unchanged. In addition, the brand name of the device is being updated to Artoura™ Breast Tissue Expander.
VII. PERFORMANCE DATA
Biocompatibility Testing:
The Mentor® Artoura™ 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 Artoura™ 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 joint strength, leak performance and other performance characteristics
5
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 Mentor® Artoura™ Breast Tissue Expander is substantially equivalent to the predicate device, Mentor®CPX™ Control Breast Tissue Expander (K142998). The Artoura® Breast Tissue Expander 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.