LIFECELL TISSUE EXPANDER

K112534 · Lifecell Corp. · LCJ · Aug 10, 2012 · SU

Device Facts

• Record ID: K112534
• Device Name: LIFECELL TISSUE EXPANDER
• Applicant: Lifecell Corp.
• Product Code: LCJ · SU
• Decision Date: Aug 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

LifeCell Tissue Expander is a silicone elastomer shell used for temporary soft tissue expansion. Device implanted subdermally by a surgeon; expanded periodically via sequential injections of sterile saline into an integrated injection site. Features include magnetic locating system, titanium needle guard, and suture tabs. Used in clinical settings for breast reconstruction or soft tissue deformity correction. Output is physical expansion of overlying tissue to create space for subsequent reconstructive procedures. Benefits include gradual tissue stretching to facilitate surgical outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility, tensile strength, percent elongation, tensile set, joint strength, overexpansion, and injection port competency over time.

Technological Characteristics

Silicone elastomer shell (smooth or textured); injection site; magnetic locating system; titanium needle guard; suture tabs. Provided sterile in polycarbonate trays with Tyvek lidstock. No electronic components or software.

Indications for Use

Indicated for patients requiring breast reconstruction post-mastectomy, treatment of underdeveloped breasts, or treatment of soft tissue deformities. Intended for temporary subdermal implantation (max 6 months).

Predicate Devices

• Allergan Medical NATRELLE® 133 Tissue Expander with Suture Tabs (K102806)

Submission Summary (Full Text)

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K112534
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#### 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: [phone] or [phone] Facsimile: [phone] Email: [e-mail] or [e-mail]

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.

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# 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.

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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

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# 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 [phone] or [phone] 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

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#### 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

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112534

510(k) Submission
LifeCell Corporation
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