(344 days)
Not Found
No
The device description and performance studies focus on material properties and mechanical function, with no mention of AI/ML or related concepts like image processing or data analysis for decision making.
No.
The device is intended for physical expansion of tissue and does not directly treat or cure any disease or medical condition.
No
The device, LifeCell Tissue Expander, is intended for breast reconstruction and treatment of soft tissue deformities, which is a therapeutic function, not diagnostic.
No
The device description clearly states the device is composed primarily of silicone elastomers and includes physical components like an expansion shell, injection site, magnetic locating system, titanium needle guard, and suture tabs. This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The LifeCell Tissue Expander is a device intended for subdermal implantation to expand tissue within the body. It is a physical implant used for reconstructive and cosmetic purposes. It does not perform any tests on bodily samples.
The description clearly indicates it's a physical implant made of silicone elastomers, used for tissue expansion through saline injection. This is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The LifeCell Tissue Expanders are intended for use in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The LifeCell Tissue Expanders are intended for temporary subdermal implantation and are not intended for use beyond six months.
Product codes
LCJ
Device Description
The LifeCell Tissue Expander is composed primarily of silicone elastomers. The predicate device and the LifeCell Tissue Expander utilize the same fundamental technology:
- A silicone expansion shell with a smooth or textured surface which expands with sequential injections of sterile saline
- An injection site, a magnetic locating system, a titanium needle guard, and suture tabs
The LifeCell Tissue Expander is provided sterile and its packaging consists of an inner polycarbonate thermoform tray, containing a tissue expander, sealed with Tyvek® lidstock. The sealed inner tray is placed inside a sterile barrier system which is composed of an outer polycarbonate tray that is then sealed with a Tyvek® lid. The LifeCell Tissue Expander is available in multiple styles and sizes, and each product is labeled accordingly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast, soft tissue
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)
The LifeCell Tissue Expander has undergone biocompatibility and preclinical testing including tensile strength, percent elongation, tensile set, joint strength testing, overexpansion testing, injection port testing and tissue expander injection port competency over time testing. The data demonstrates the LifeCell Tissue Expander possesses sufficient material and functional properties for the intended use.
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
K112534
1/2
510(K) SUMMARY III.
AUG 1 0 2012
LifeCell Tissue Expander
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
LifeCell Corporation One Millennium Way Branchburg, NJ 08876 Phone: (908) 947-1116 or (908) 947-1114 Facsimile: (908) 947-1095 Email: kmeany@lifecell.com or skalinani@lifecell.com
Contact Person: Kristen Meany, CQA, RAC or Sadhana Kalinani
Date Prepared: August 31, 2011
Date Revised: August 10, 2012
Name of Device and Name/Address of Sponsor
LifeCell Tissue Expander
LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Common or Usual Name
Tissue Expander
Classification Regulation
LCJ (Unclassified)
Predicate Device
Allergan Medical NATRELLE® 133 Tissue Expander with Suture Tabs (K102806)
Intended Use / Indications for Use
The LifeCell Tissue Expanders are intended for use in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The LifeCell Tissue Expanders are intended for temporary subdermal implantation and are not intended for use beyond six months.
1
2/2
Technological Characteristics
The LifeCell Tissue Expander is composed primarily of silicone elastomers. The predicate device and the LifeCell Tissue Expander utilize the same fundamental technology:
- A silicone expansion shell with a smooth or textured surface which expands with t sequential injections of sterile saline
- An injection site, a magnetic locating system, a titanium needle guard, and suture tabs .
The LifeCell Tissue Expander is provided sterile and its packaging consists of an inner polycarbonate thermoform tray, containing a tissue expander, sealed with Tyvek® lidstock. The sealed inner tray is placed inside a sterile barrier system which is composed of an outer polycarbonate tray that is then sealed with a Tyvek® lid. The LifeCell Tissue Expander is available in multiple styles and sizes, and each product is labeled accordingly.
Performance Data
The LifeCell Tissue Expander has undergone biocompatibility and preclinical testing including tensile strength, percent elongation, tensile set, joint strength testing, overexpansion testing, injection port testing and tissue expander injection port competency over time testing. The data demonstrates the LifeCell Tissue Expander possesses sufficient material and functional properties for the intended use.
Substantial Equivalence
The LifeCell Tissue Expander is substantially equivalent to a legally marketed predicate device, NATRELLE® 133 Tissue Expander with Suture Tabs (K102806). The LifeCell Tissue Expander has the same intended uses and indications for use, and similar technological Shpander inas and principles of operation as the predicate device. Performance data demonstrate that the LifeCell Tissue Expander functions equivalently to the predicate device. Thus, the LifeCcll Tissue Expander is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 10 2012
Lifecell Corporation % Ms. Kristen Meany, CQA, RAC One Millenum Way Branchburg, New Jersey 08876
Re: K112534
Trade/Device Name: LifeCell Tissue Expander Regulatory Class: Unclassified Product Code: LCJ Dated: August 09, 2012 Received: August 10, 2012
Dear Ms. Meany:
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
3
Page 2 - Ms. Kristen Meany, CQA, RAC
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours,
Sincerely yours,
Mark A. Miller
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT II.
510(k) Number (if known):
Device Name: LifeCell Tissue Expander
Indications for Use:
The LifeCell Tissue Expanders are intended for use in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The LifeCell Tissue Expanders are intended for temporary subdermal implantation and are not intended for use beyond six months.
AND/OR
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (21 C.F.R. 807 Subpart C) K (1253)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for David Krause
Page of
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112534
510(k) Submission
LifeCell Corporation
Page 39 of 256