(525 days)
Not Found
No
The document describes a physical medical device (tissue expander) and its accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Software Verification and Validation Testing" section explicitly states "Not applicable".
Yes
The device is intended for temporary implantation to develop surgical flaps and additional tissue coverage, particularly to aid in reconstructions following mastectomy, treatment of underdeveloped breasts, and soft tissue deformities, which are therapeutic applications.
No
The device is a tissue expander used for reconstruction and treatment of deformities, not for diagnosing medical conditions.
No
The device is a physical tissue expander made of silicone elastomer with integrated ports and a drainage system. The summary explicitly describes hardware components and bench testing related to these physical properties. Software verification and validation testing is listed as "Not applicable."
Based on the provided information, the Sientra AlloX2 Pro Tissue Expanders are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Sientra AlloX2 Pro Tissue Expanders are implantable devices used to physically expand tissue in the body. They are a surgical tool and implant, not a device that analyzes biological samples.
- Intended Use: The intended use clearly describes a surgical procedure involving implantation for tissue expansion, not the analysis of in vitro samples.
- Device Description: The description focuses on the physical construction, materials, and features related to implantation and expansion, not on analytical capabilities.
Therefore, the Sientra AlloX2 Pro Tissue Expanders fall under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Sientra AlloX2 Pro 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 reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.
Additionally, the Sientra AlloX2 Pro Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not replace short-term, immediate, intraoperatively placed drains.
Product codes
LCJ
Device Description
The Sientra AlloX2 Pro Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a smooth surface and an integrated magnetically locatable port system for incremental expander filling. The Sientra AlloX2 Pro Tissue Expanders have an incorporated drainage system accessed by a drain port. The incorporated drain system allows for aspiration of fluids from the periprosthetic space that may present during the expansion process. Both the integrated fill and drain ports can be accessed with an 18- gauge needle or smaller. The AlloX2 Pro Tissue Expanders have suture tabs providing an option for surgeons to suture the expander within the breast pocket. The AlloX2 Pro Tissue Expanders are labeled Magnetic Resonance (MR) Conditional. Patients implanted with the AlloX2 Pro Tissue Expanders may undergo Magnetic Resonance Imaging under specific MR conditions. The potential resulting risks associated with using the device in the MRI environment include the inability to fill the device, loss of port location functionality and potential reoperation should the patient require continued function of the tissue expander device after MRI exposure.
The Sientra AlloX2 Pro Tissue Expanders are manufactured in both mid-height and fullheight base options from 11 cm to 16 cm to meet diverse patient needs and to achieve individualized aesthetic results. The Sientra AlloX2 Pro Tissue Expanders are supplied sterile. The Sientra AlloX2 Pro Tissue Expander accessories include a magnetic port locating device (PRO Locator) that allows for simultaneous identification of the fill and drain ports for ease of identification, and a 21-gauge winged needle infusion set. Both are supplied sterile and individually packaged inside the product box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
subcutaneous or submuscular, breasts
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
Non-clinical Testing Summary:
Sterilization and Shelf Life: The Sientra AlloX2 Pro Tissue Expander is provided sterile with a Sterility Assurance Level (SAL) of 30 days). Testing was conducted according to methods prescribed by relevant ISO standards. All pre-established acceptance criteria were met.
Software Verification and Validation Testing: Not applicable. The subject device contains no software.
Electrical safety and electromagnetic compatibility (EMC): Not applicable. The subject device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Bench Testing: Mechanical testing was conducted on the proposed AlloX2 Pro Tissue Expanders 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. All Testing was conducted 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.
Magnetic Resonance Testing was performed per ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment as well as per FDA Guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 2021), for a passive device. The Magnetic Resonance Testing results demonstrated that patients implanted with the AlloX2 Pro Tissue Expanders may safely undergo Magnetic Resonance Imaging under specific MR conditions per device labeling.
Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Testing Summary: Not applicable. Clinical data is not necessary to establish the substantial equivalence of this device.
Key Metrics
Not Found
Predicate Device(s)
Sientra AlloX2 Tissue Expander (K140383)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 8, 2023
Sientra, Inc. Denise Daljes VP, R&D, Regulatory, and Quality 420 South Fairview Avenue Suite 200 Santa Barbara, California 93117
Re: K214124
Trade/Device Name: AlloX2 Pro Tissue Expanders Regulatory Class: Unclassified Product Code: LCJ Dated: January 12, 2023 Received: January 17, 2023
Dear Denise Daljes:
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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K214124
Device Name Sientra AlloX2 Pro Tissue Expanders
Indications for Use (Describe)
The Sientra AlloX2 Pro 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 reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.
Additionally, the Sientra AlloX2 Pro Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not teplace short-term, immediate, intraoperatively placed drains.
| 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 PRAStaff@fda.hhs.gov
"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."
3
Traditional 510(k) Premarket Notification
6.0 510(k) Summary [807.92(a)(1)]
| Sponsor: | Sientra, Inc.
420 S. Fairview Avenue, Suite 200
Santa Barbara, CA 93117 |
|----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Denise, Dajles
Chief Technical Officer
3333 Michelson Dr. Suite 650
Irvine, CA 92612
Telephone: (805) 562-3500
Email: denise.dajles@sientra.com |
May 31, 2023
Device Information [807.92(a)(2)]
Date Prepared:
| Regulatory Classification: | Unclassified (pre-amendment) |
|---|---|
| Product Code: | LCJ |
| Proprietary Name: | Sientra AlloX2 Pro™ Tissue Expander |
| Device Classification Name: | Expander, Skin, Inflatable |
| Review Panel: | General and Plastic Surgery Devices Panel |
| Predicate Device: | Sientra AlloX2 Tissue Expander (K140383) |
Indications for Use [807.92(a)(5)]
The Sientra AlloX2 Pro 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 reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.
Additionally, the Sientra AlloX2 Pro Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not replace short-term, immediate, intraoperatively placed drains.
4
Traditional 510(k) Premarket Notification Predicate Device [807.92(a)(3)]
The Sientra AlloX2 Pro Tissue Expander is substantially equivalent in respect to intended use, indications for use, device materials, performance, sterilization, and biocompatibility to the predicate device the Sientra AlloX2 Tissue Expander, cleared under K140383.
Device Description [807.92(a)(4)]
The Sientra AlloX2 Pro Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a smooth surface and an integrated magnetically locatable port system for incremental expander filling. The Sientra AlloX2 Pro Tissue Expanders have an incorporated drainage system accessed by a drain port. The incorporated drain system allows for aspiration of fluids from the periprosthetic space that may present during the expansion process. Both the integrated fill and drain ports can be accessed with an 18- gauge needle or smaller. The AlloX2 Pro Tissue Expanders have suture tabs providing an option for surgeons to suture the expander within the breast pocket. The AlloX2 Pro Tissue Expanders are labeled Magnetic Resonance (MR) Conditional. Patients implanted with the AlloX2 Pro Tissue Expanders may undergo Magnetic Resonance Imaging under specific MR conditions. The potential resulting risks associated with using the device in the MRI environment include the inability to fill the device, loss of port location functionality and potential reoperation should the patient require continued function of the tissue expander device after MRI exposure.
The Sientra AlloX2 Pro Tissue Expanders are manufactured in both mid-height and fullheight base options from 11 cm to 16 cm to meet diverse patient needs and to achieve individualized aesthetic results. The Sientra AlloX2 Pro Tissue Expanders are supplied sterile. The Sientra AlloX2 Pro Tissue Expander accessories include a magnetic port locating device (PRO Locator) that allows for simultaneous identification of the fill and drain ports for ease of identification, and a 21-gauge winged needle infusion set. Both are supplied sterile and individually packaged inside the product box.
5
Traditional 510(k) Premarket Notification
Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)]
The proposed device, the Sientra AlloX2 Pro Tissue Expanders are substantially equivalent to the predicate device, as they share the same function, intended use and indications for use. Any difference in technological characteristics do not raise any new issues of safety or efficacy.
The Sientra AlloX2 Pro Tissue Expander shell is constructed of the same materials of construction, the proposed Sientra AlloX2 Pro Tissue has a smooth surface only. Both the proposed and predicate devices include an expansion envelope with an integrated magnetically locatable port system for incremental expander filling in order to develop a surgical flap and an incorporated drainage system accessed by a drain port providing access to the periprosthetic space. While both devices have integral fill and drain ports and both use magnets for port location, the proposed device fill and drain ports are made of an implant grade polymer instead of titanium. The proposed device design allows for the use of an 18-gauge needle or smaller with the fill and drain ports as compared to the predicate device which is labeled for use with a 21-gauge needle or smaller. The proposed device includes suture tabs providing an option for surgeons to suture the expander within the breast pocket.
Both the predicate device and proposed device utilize a magnetically accessible port system and use a port location accessory (provided with the product) to enable identification of the integrated fill and drain ports. The predicate product magnetic port location accessory identifies the device ports individually, while the subject device PRO Locator, simultaneously identifies both the fill and drain ports which are clearly marked, "fill" and "drain". As with the predicate, the proposed device is packaged with a sterile 21-gauge winged needle infusion set that is individually packaged and may be used for injection into or aspiration from the respective fill and drain ports. There have been no changes to the winged needle since the predicate clearance (K140383).
Both accessory products, including the PRO Locator and 21-gauge needle winged needle set are provided sterile and are packaged in a sterile barrier packaging.
The proposed AlloX2 Pro Tissue Expanders have Magnetic Resonance (MR) Conditional labeling and patients implanted with the AlloX2 Pro Tissue Expanders may undergo Magnetic Resonance Imaging under specific MR conditions, as indicated in the labeling.
6
Traditional 510(k) Premarket Notification Performance Data [807.92(b)]
All necessary performance testing was conducted to support a determination of substantial equivalence of the Sientra AlloX2 Pro Tissue Expanders to the predicate device.
Non-clinical Testing Summary [807.92(b)(1)]
Sterilization and Shelf Life
The Sientra AlloX2 Pro Tissue Expander is provided sterile with a Sterility Assurance Level (SAL) of 30 days). Where appropriate, testing was conducted according to methods prescribed by relevant ISO standards. All pre-established acceptance criteria were met.
Software Verification and Validation Testing
Not applicable. The subject device contains no software.
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. The subject device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Bench Testing
Mechanical testing was conducted on the proposed AlloX2 Pro Tissue Expanders 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. All Testing was conducted 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.
7
Magnetic Resonance Testing was performed per ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment as well as per FDA Guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 2021), for a passive device. The Magnetic Resonance Testing results demonstrated that patients implanted with the AlloX2 Pro Tissue Expanders may safely undergo Magnetic Resonance Imaging under specific MR conditions per device labeling.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Testing Summary [807.92(b)(2)]
Not applicable. Clinical data is not necessary to establish the substantial equivalence of this device.
Conclusions [807.92(b)(3)]
The collective performance testing demonstrates that the Sientra AlloX2 Pro Tissue Expander does not raise new questions of safety or effectiveness for its intended use when compared to the predicate device.
Results of the performance testing demonstrate that the Sientra AlloX2 Pro Tissue Expander met the predetermined acceptance criteria and is substantially equivalent to the predicate device.