(864 days)
Sientra Silicone Tissue Expander (K070303)
Not Found
No
The device description focuses on material properties, mechanical features, and an RFID system for port location and traceability. There is no mention of algorithms, data processing for decision making, or learning capabilities.
No.
The device is described as a "Tissue Expander" used for temporary implantation to prepare a site for reconstructive surgery (e.g., following mastectomy) by expanding tissue. Its primary function is mechanical, not directly therapeutic in the sense of treating a disease or medical condition. While it aids in a reconstructive process, the device itself doesn't provide treatment.
No
The device is a tissue expander used for reconstruction, not for diagnosis. While it has an RFID system for locating the injection port and traceability, this functionality is supportive of its primary therapeutic purpose (tissue expansion), not for diagnosing a medical condition.
No
The device description clearly outlines a physical implant (tissue expander) and a hardware accessory (Port Locator) that utilizes RFID technology. While the Port Locator has associated software, the core medical device is a physical implant, 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 temporary implantation to develop surgical flaps and additional tissue coverage. This is a surgical procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a tissue expander, a physical implant used to stretch tissue. It includes features for implantation, inflation with saline, and location within the body. These are all related to a surgical procedure, not a diagnostic test.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose a condition, monitor a disease, or determine compatibility. The RFID feature is for locating the injection port and traceability, not for diagnostic purposes.
- Performance Studies: The performance studies focus on biocompatibility, animal testing (tissue reaction), mechanical properties, sterilization, electrical safety, software validation, and MR compatibility. These are all relevant to the safety and performance of a surgical implant, not an IVD.
In summary, the Motiva Flora® SmoothSilk® Tissue Expander is a surgical device used for tissue expansion, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
Motiva Flora® SmoothSilk® Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.
Product codes (comma separated list FDA assigned to the subject device)
LCJ
Device Description
The Motiva Flora® SmoothSilk® Tissue Expander (MFSTE) is intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and is not intended for use beyond six (6) months. All MFSTEs require periodic, incremental inflation with sterile saline for injection until the desired tissue expansion is developed. Once the desired tissue expansion is achieved, the tissue expander is surgically removed and a breast implant is inserted within the breast pocket.
The MFSTE is constructed of successive cross- linked layers of silicone elastomer with an Integrated Injection Port system for incremental expander filling. The Tissue Expanders are available in a range of sizes to meet diverse patient needs and achieve individualized aesthetic results. The MFSTE has a controlled surface architecture produced by the mandrel imprinting technique with an average roughness of 4 microns. Each MFSTE is supplied sterile.
The injection port is dome-shaped with a radiofrequency identification (RFID) coil embedded in the needle stop. This needle stop prevents inadvertent puncture through the base of the injection port during the filling process.
The injection port is found with the Motiva Flora® Port Locator accessory through the air wound coil's RFID signal placed inside the needle stop. The RFID wireless system comprises two components: the tag and the reader. The Motiva Flora® Port Locator (the reader) has antennas that emit radio waves and receive the signal coming from the RFID coil tag in the needle stop to locate the center of the injection port. The user interface of the Motiva Flora® Port Locator includes LED lights to guide the user during the process. This is an innovative technology not available in other tissue expanders on the market.
In addition, the RFID transponder functions as a traceability feature, which provides a unique electronic serial number (ESN) for each expander. The ESN allows access to a database with the device information (serial and lot number, size, projection, model, manufacturing date, etc.).
Additional design features of the MFSTE include a non-ferromagnetic component design that allows the device to be used with Magnetic Resonance (MR) and Computerized Tomography (CT) under certain conditions.
The MFSTE includes six (6) fixation tabs (TrueFixation®) to provide the surgeon options to suture the tissue expander in the breast pocket. Another design feature is its reinforced base.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Biocompatibility Testing:
Biocompatibility testing was conducted for both the MFSTE and Port Locator in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA's guidance document titled, Use of International Standard ISO 10993-1:2020, "Biological Evaluation of medical devices – Part 1: Evaluation and Testing within a risk management process". The results of the comprehensive biological safety evaluation based on the biocompatibility testing performed demonstrate that the MFSTE and Port Locator meet the requirements of ISO 10993-1:2018 and FDA 's 2020 guidance.
Animal Testing:
GLP animal studies were conducted by NAMSA using the ovine model to compare the local tissue reaction of the MFSTE and the Sientra Silicone Tissue Expander (K070303). Histopathologic evaluation revealed that the tissue response to both the MFSTE and the Predicate Device was a typical and expected response to a foreign body (ie., formation of a capsule around the implant) and was not considered adverse. The MFSTE was considered to demonstrate equivalent biologic response as compared to the Predicate Device.
Mechanical Testing:
Mechanical testing was conducted in accordance with ASTM F1441-03:2014, Standard Specification for Soft-Tissue Expander Devices. The following mechanical testing was performed:
- Elongation
- Tensile Strength
- Break Force
- Joint Testing
- Overexpansion
- Needle Stop Penetration
- Injection Port Competence
- Critical and Non-Critical Fused or Adhered Joints
All mechanical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the MFSTE is substantially equivalent to the Predicate Device.
Sterilization Testing
Sterilization Validation was conducted in compliance with BS EN ISO 20857:2010, Sterilization of health care products – Dry heat: Requirements for the development, validation, and routine control of a sterilization process for medical devices. All testing met the requirements of the Motiva Flora® SmoothSilk Tissue Expander.
Port Locator Electrical Safety (ES) and Electromagnetic Compatibility (EMC) Testing:
Testing was conducted to address the ES and EMC considerations for the Motiva Flora® Port Locator ("Port Locator") accessory, which reads the passive RFID tag within the MFSTE to accurately locate the implanted tissue expander injection port. All ES and EMC testing was conducted in accordance with the IEC 60601 series consensus standards, the AIM Standard 7351731, and the FCC 47 CFR Part 15 Subparts B and C. The following ES and EMC testing was conducted:
Electrical Safety
- ANSI/AAMI ES 60601-1:2005/(R)2012, Third Edition, Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1:2005 + AMD1:2012, Third Edition, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-6:2010 + AMD1:2013, Third Edition, Medical Electrical equipment Part . 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
Electromagnetic Compatibility
- IEC 60601-1-2:2015. Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- FCC 47 CFR Part 15 Subpart B, Unintentional Radiators
- FCC 47 CFR Part 15 Subpart C, Intentional Radiators
- AIM Standard 7351731 Medical Electrical Equipment and System Electromagnetic ● Immunity Test for Exposure to Radio Frequency Identification Readers Version 2
All Electrical Safety and Electromagnetic Compatibility testing results met the essential requirement specifications for the Motiva Flora® Port Locator, demonstrating the device will properly fulfill its intended function.
Port Locator Software Testing:
Software testing was conducted in accordance with the General Principles of Software Validation, Final Guidance for Industry and FDA Staff (2002), and the Software Requirement Specification for Motiva Flora® Port Locator. All software testing results met their pre-determined acceptance criteria, thus demonstrating that the proposed device complies with the required specifications.
MR Conditional:
Non-clinical testing demonstrated that the MFSTE is MR Conditional in accordance with ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment."; ASTM F2213-06, "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"; ASTM F2182-11a, "Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging"; and ASTM F2119-07, "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants". The following testing was performed:
- Magnetically Induced Displacement Force
- Magnetically Induced Torque
- Heating by RF Fields
- Image Artifact
- Exposure tests at 1.5-Tesla/64-MHz and 3-T/128-MHz
All testing results met the pre-determined acceptance criteria, demonstrating that the device poses no known hazards in specified MR environments with specified conditions of use.
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.
Sientra Silicone Tissue Expander (K070303)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 13, 2023
Motiva USA LLC Rosalyn d'Incelli VP Clinical and Medical Affairs 125 East De la Guerra St, Suite 203A Santa Barbara, California 93101
Re: K211676
Trade/Device Name: Motiva Flora SmoothSilk Tissue Expander Regulatory Class: Unclassified Product Code: LCJ Dated: December 27, 2022 Received: December 28, 2022
Dear Rosalyn d'Incelli:
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. 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 located 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 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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).
Sincerely,
David Krause -S
David Krause, Ph.D. Deputy Director Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211676
Device Name
Motiva Flora® SmoothSilk® Tissue Expander
Indications for Use (Describe)
Motiva Flora® SmoothSilk® Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.
| 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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510(k) SUMMARY
| Device Trade Name: | Motiva Flora® SmoothSilk® Tissue Expander K211676/S001 |
|---|---|
| Device Common Name | Expander, Skin, Inflatable |
| Device Class: | Unclassified, Pre-Amendment |
| Panel | General & Plastic Surgery |
| Product Code: | LCJ |
| Predicate Device: | Sientra Silicone Tissue Expander (K070303) |
| Owner/Submitter: | Motiva USA LLC |
| Address/Number: | 125 East De la Guerra St, Suite 203A, Santa Barbara, CA 93101 |
| Tel: +1 (805) 452-5421 | |
| Regulatory Contact: | Rosalyn d'Incelli |
| Date Prepared: | July 25, 2023 |
DEVICE DESCRIPTION
The Motiva Flora® SmoothSilk® Tissue Expander (MFSTE) is intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and is not intended for use beyond six (6) months. All MFSTEs require periodic, incremental inflation with sterile saline for injection until the desired tissue expansion is developed. Once the desired tissue expansion is achieved, the tissue expander is surgically removed and a breast implant is inserted within the breast pocket.
The MFSTE is constructed of successive cross- linked layers of silicone elastomer with an Integrated Injection Port system for incremental expander filling. The Tissue Expanders are available in a range of sizes to meet diverse patient needs and achieve individualized aesthetic results. The MFSTE has a controlled surface architecture produced by the mandrel imprinting technique with an average roughness of 4 microns. Each MFSTE is supplied sterile.
The injection port is dome-shaped with a radiofrequency identification (RFID) coil embedded in the needle stop. This needle stop prevents inadvertent puncture through the base of the injection port during the filling process.
The injection port is found with the Motiva Flora® Port Locator accessory through the air wound coil's RFID signal placed inside the needle stop. The RFID wireless system comprises two components: the tag and the reader. The Motiva Flora® Port Locator (the reader) has antennas that emit radio waves and receive the signal coming from the RFID coil tag in the needle stop to locate the center of the injection port. The user interface of the Motiva Flora® Port Locator includes LED lights to guide the user during the process. This is an innovative technology not available in other tissue expanders on the market.
4
In addition, the RFID transponder functions as a traceability feature, which provides a unique electronic serial number (ESN) for each expander. The ESN allows access to a database with the device information (serial and lot number, size, projection, model, manufacturing date, etc.).
Additional design features of the MFSTE include a non-ferromagnetic component design that allows the device to be used with Magnetic Resonance (MR) and Computerized Tomography (CT) under certain conditions.
The MFSTE includes six (6) fixation tabs (TrueFixation®) to provide the surgeon options to suture the tissue expander in the breast pocket. Another design feature is its reinforced base.
INTENDED USE/INDICATIONS FOR USE
For temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.
SUMMARY/COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The MFSTE and the Predicate Device have the same indications for use, design principles, and materials. As shown below, the MFSTE and Predicate Device have similar technological characteristics and ranges of volumes, sizes and projections.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Average Shell Surface | ||
| Roughness | ≤ 10 microns | ≤ 10 microns |
| Volume | 260cc - 995cc | 250cc - 900cc |
| Size, Width | 11.0 cm - 16.0 cm | 11.0 cm - 16.0 cm |
| Size, Height | 9.0 cm - 16.5 cm | 9.0 cm - 14.7 cm |
| Projection | 6.7 cm - 8.8 cm | 5.0 cm - 8.5 cm |
Both devices' tissue expansion mode of action is based on incremental filling of a silicone shell with sterile saline fluid to stretch the surrounding tissue. The Subject and Predicate Device both use a port location device to identify the integral injection port.
Substantial equivalence was demonstrated primarily by physical and mechanical testing including comparative testing and evaluation of material properties, biological, chemical, and physical properties.
5
The following includes a list of the Technological Characteristics of the MFSTE and Predicate Device, which have been determined to be the same or substantially equivalent.
- Indications for Use ●
- Shell Surface ●
- Dimension Range. ●
- Mechanical Performance ●
- Injection Port
- Port Location Methodology ●
- . Materials of Construction
The differences between the MFSTE and the Predicate Device are described below.
The MFSTE device uses a novel RFID tag and reader system for location of the injection port that is different from the magnetically detectable injection system used by the Predicate Device. Both products require a port location tool, but the MFSTE uses the Port Locator Accessory, which functions as an RFID reader, while the Predicate Device uses a Magnet Accessory.
Additionally, the MFSTE is labeled as "MR Conditional". Therefore, the patients may undergo MR imaging under specific MR conditions, while the Predicate Device is labeled "MR Unsafe".
The MFSTE includes six (6) fixation tabs (as compared to the two (2) fixation tabs for the Predicate Device) that are located on the perimeter of the tissue expander, providing the surgeon more options to secure the tissue expander within the breast pocket.
SUMMARY OF PERFORMANCE TESTING
Biocompatibility Testing:
Biocompatibility testing was conducted for both the MFSTE and Port Locator in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA's guidance document titled, Use of International Standard ISO 10993-1:2020, "Biological Evaluation of medical devices – Part 1: Evaluation and Testing within a risk management process". The results of the comprehensive biological safety evaluation based on the biocompatibility testing performed demonstrate that the MFSTE and Port Locator meet the requirements of ISO 10993-1:2018 and FDA 's 2020 guidance.
Animal Testing:
GLP animal studies were conducted by NAMSA using the ovine model to compare the local tissue reaction of the MFSTE and the Sientra Silicone Tissue Expander (K070303). Histopathologic evaluation revealed that the tissue response to both the MFSTE and the Predicate
6
Device was a typical and expected response to a foreign body (ie., formation of a capsule around the implant) and was not considered adverse.
The MFSTE was considered to demonstrate equivalent biologic response as compared to the Predicate Device.
Mechanical Testing:
Mechanical testing was conducted in accordance with ASTM F1441-03:2014, Standard Specification for Soft-Tissue Expander Devices. The following mechanical testing was performed:
- Elongation ●
- Tensile Strength ●
- Break Force ●
- Joint Testing ●
- Overexpansion ●
- Needle Stop Penetration ●
- Injection Port Competence
- Critical and Non-Critical Fused or Adhered Joints ●
Sterilization Testing
Sterilization Validation was conducted in compliance with BS EN ISO 20857:2010, Sterilization of health care products – Dry heat: Requirements for the development, validation, and routine control of a sterilization process for medical devices. All testing met the requirements of the Motiva Flora® SmoothSilk Tissue Expander.
All mechanical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the MFSTE is substantially equivalent to the Predicate Device.
Port Locator Electrical Safety (ES) and Electromagnetic Compatibility (EMC) Testing:
Testing was conducted to address the ES and EMC considerations for the Motiva Flora® Port Locator ("Port Locator") accessory, which reads the passive RFID tag within the MFSTE to accurately locate the implanted tissue expander injection port. All ES and EMC testing was conducted in accordance with the IEC 60601 series consensus standards, the AIM Standard 7351731, and the FCC 47 CFR Part 15 Subparts B and C. The following ES and EMC testing was conducted:
Electrical Safety
- . ANSI/AAMI ES 60601-1:2005/(R)2012, Third Edition, Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance
7
- . IEC 60601-1:2005 + AMD1:2012, Third Edition, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-6:2010 + AMD1:2013, Third Edition, Medical Electrical equipment Part . 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
Electromagnetic Compatibility
- IEC 60601-1-2:2015. Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- FCC 47 CFR Part 15 Subpart B, Unintentional Radiators
- FCC 47 CFR Part 15 Subpart C, Intentional Radiators
- AIM Standard 7351731 Medical Electrical Equipment and System Electromagnetic ● Immunity Test for Exposure to Radio Frequency Identification Readers Version 2
All Electrical Safety and Electromagnetic Compatibility testing results met the essential requirement specifications for the Motiva Flora® Port Locator, demonstrating the device will properly fulfill its intended function.
Port Locator Software Testing:
Software testing was conducted in accordance with the General Principles of Software Validation, Final Guidance for Industry and FDA Staff (2002), and the Software Requirement Specification for Motiva Flora® Port Locator.
All software testing results met their pre-determined acceptance criteria, thus demonstrating that the proposed device complies with the required specifications.
MR Conditional:
Non-clinical testing demonstrated that the MFSTE is MR Conditional in accordance with ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment."; ASTM F2213-06, "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"; ASTM F2182-11a, "Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging"; and ASTM F2119-07, "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants". The following testing was performed:
- Magnetically Induced Displacement Force
- Magnetically Induced Torque
- Heating by RF Fields
- Image Artifact
- Exposure tests at 1.5-Tesla/64-MHz and 3-T/128-MHz ●
8
All testing results met the pre-determined acceptance criteria, demonstrating that the device poses no known hazards in specified MR environments with specified conditions of use.
CONCLUSION
The MFSTE is substantially equivalent to the legally marketed Predicate Device, the Sientra Silicone Tissue Expander (K070303). The MFSTE has the same intended use/indications for use, operating principle, and similar technological characteristics as the Predicate Device. Performance evaluations and comparative physical/mechanical testing demonstrated that the MFSTE
and the Predicate Device are substantially equivalent and that there are no new issues of safety and effectiveness.