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 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 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.

AI/ML Overview

The provided text describes the 510(k) summary for the LifeCell Tissue Expander, and states a substantial equivalence claim to a predicate device, rather than providing specific acceptance criteria and detailed performance data from a clinical study for this device. Therefore, a direct answer to all points of your request based solely on the provided input is not possible.

However, I can extract the information that is present and explain based on the common practices for 510(k) submissions focusing on substantial equivalence.

Here's a breakdown of what the document does provide:

A table of acceptance criteria and the reported device performance:
- The document does not provide a table of acceptance criteria for clinical performance. Instead, it states: "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."
- It also states in the substantial equivalence section: "Performance data demonstrate that the LifeCell Tissue Expander functions equivalently to the predicate device."
- Therefore, the primary "acceptance criterion" demonstrated is that its material and functional properties are sufficient for intent and are equivalent to the predicate device. Specific numerical acceptance criteria were likely part of the internal testing protocols, but are not disclosed in this summary.
Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a clinical test set. The testing described is preclinical (biocompatibility, mechanical properties) and not human clinical data. Therefore, provenance in terms of country of origin or retrospective/prospective is not applicable for this type of submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on preclinical testing and substantial equivalence, not a study requiring expert readers to establish ground truth on clinical images or patient outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a preclinical submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical tissue expander, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the preclinical tests, the "ground truth" would be established by the specifications and standards for each material and functional test (e.g., a specific tensile strength value that must be met, or a specific range for percent elongation). For biocompatibility, it would be validated according to ISO standards.
The sample size for the training set:
- Not applicable. This refers to a physical device submitted under the 510(k) pathway for substantial equivalence, not a machine learning model requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

In summary, for the LifeCell Tissue Expander 510(k) submission, the "study that proves the device meets the acceptance criteria" is outlined as preclinical (biocompatibility, tensile strength, elongation, joint strength, overexpansion, injection port competency) testing. The acceptance criteria themselves are not explicitly detailed in the provided summary beyond the general statement that "The data demonstrates the LifeCell Tissue Expander possesses sufficient material and functional properties for the intended use" and that its "Performance data demonstrate that the LifeCell Tissue Expander functions equivalently to the predicate device."

This is typical for a 510(k) submission asserting substantial equivalence, especially for a device like a tissue expander. The FDA determined that based on this preclinical data and the comparison to the predicate, the device is substantially equivalent and thus safe and effective for its intended use. Clinical studies with human subjects are often not required for this type of device if substantial equivalence to a well-understood predicate can be demonstrated through material and functional testing.

Summary

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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: (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

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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 (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

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INDICATIONS FOR USE STATEMENT II.

510(k) Number (if known):

Device Name: LifeCell Tissue Expander

Indications for Use:

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

Regulation Number and Section

N/A