StemPro® MSC SFM is a serum-free medium (SFM) specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). StemPro® MSC SFM enables human MSC growth and increased consistency compared to classical serum-supplemented medium. In addition, human MSCs can be expanded for multiple passages while maintaining their multipotential phenotype (i.e. ability to differentiate into osteogenic, chondrogenic, adipogenic lineages). StemPro® MSC SFM contains two components: StemPro® MSC SFM Basal Medium and StemPro® MSC SFM Supplement.

AI/ML Overview

This is a 510(k) premarket notification for a tissue culture medium, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's the relevant information based on the provided text:

Device Name: StemPro® MSC SFM Medium

Predicate Device: Knockout™ SR Medium (K100616)

Intended Use: StemPro® MSC SFM Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications. This device is a chemically defined tissue culture media used to support the growth or maintenance of human tissue or cells in culture.

Acceptance Criteria and Reported Device Performance

The device demonstrates substantial equivalence to its predicate by meeting performance standards outlined in a "Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications".

Acceptance Criteria (Special Control Objective)	Reported Device Performance (Life Technologies Corporation's Equivalent Tests)
Demonstrate lack of potential toxicity of materials in the media to cells or tissue and demonstrate support of tissue and cell growth	StemPro® MSC SFM Performance Assay
Demonstrate lack of endotoxin or pyrogen contamination	Limulus Ameobocyte (LAL) test (25 USP Monograph <85>)
Validation of Aseptic Processing and Sterility Assurance Level (SAL)	Determination of SAL to be ≥ 10-3 and compliance with GMP requirements
Demonstrate Chemical purity	Incoming Raw Material testing using USP, ACS, FCC, GIBCO, or Cell Culture requirements
Stability/Shelf-Life (pH, non-cytotoxicity, support of cell growth)	pH continues to meet specifications; media is not cytotoxic and supports mammalian cell growth over 12 months. Container/closure system protects from microbial contamination.

Study Details (Not applicable for AI/ML device)

This is a medical device submission for a tissue culture medium, not an AI/ML enabled device. Therefore, the following AI/ML-specific questions are not applicable:

Sample size used for the test set and the data provenance: Not applicable. Performance testing involved laboratory assays rather than clinical data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance studies of tissue culture media relies on established laboratory testing methodologies and specifications.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For performance tests like cytotoxicity, LAL, and chemical purity, the ground truth is established by the specified assay results conforming to pre-defined scientific and regulatory standards (e.g., USP monographs, internal specifications). For cell growth, it's the observed ex vivo cell proliferation and maintenance of phenotype.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Pay 113

K103302

510(k) Summary		FEB 18 2011
Life Technologies Corporation - StemPro® MSC SFM Medium
Device Name:	StemPro® MSC SFM Medium
Common/Usual Name:	StemPro® MSC SFM
Classification Name:	Tissue culture media for human ex vivo tissue and cellculture processing applications (per 21 CFR § 876.5885)
Product Code:	NDS
Submitter:	Life Technologies Corporation3175 Staley RoadGrand Island, New York 14072
Telephone:	(716) 774-3122
Facsimile:	(716) 774-0230
Email:	kelli.tanzella@lifetech.com
Contact:	Kelli Tanzella, Ph.D.
Date Prepared:	October 11, 2010
Predicate Device:
Trade Name	Manufacturer	510(k)
Knockout™ SR Medium	Life Technologies Corporation	K100616
Intended Use
StemPro® MSC SFM Medium is a liquid tissue culture media product intended forhuman ex vivo tissue and cell culture processing applications.

Substantial Equivalence

The tissue culture media presented in this 510(k) submission, StemPro® MSC SFM The tissue ontal views provalent to Knockout™ SR Medium S10(k) K100616
manufactured by Life Technologies Corporation. Knockout™ SR Medium received 510(k) clearance from the FDA on May 20, 2010 as a Class II Device, and is listed under Product Code 78 NDS (Tissue culture media for human ex vivo tissue and cell culture processing applications). The 510(k) for Knockout™ SR Medium was reviewed by the gastroenterology control panel.

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K103302

A. These tissue culture products (StemPro® MSC SFM and Knockout™ SR Medium) are used for human ex vivo tissue and cell culture processing applications and have the same principles of operation, technological characteristics, efficacy (generic cellular growth and maintenance) and safety (consistency in chemical content and formulation, biocompatibility with cells. and purity). :
. .

Intended Uses

StemPro® MSC SFM Medium is a tissue culture product intended for human ex vivo tissue and cell culture processing applications. This device is a chemically defined tissue culture media used to support the growth or maintenance of human tissue or cells in culture.

B. Principles of Operation and Technological Characteristics

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C. Pre-Clinical Testing ..

Performance standards under Section 514 of the Federal Food, Drug, and Cosmetic Act have been established in Guidance Document "Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers," issued May 16, 2001. The specific assay tests and Life Technologies Corporation's equivalent tests are described below in greater detail.

Special Control Objective	Life Technologies CorporationKnockout™ SR Medium
Demonstrate lack of potentialtoxicity of materials in the media tocells or tissue and demonstratesupport of tissue and cell growth	StemPro® MSC SFM PerformanceAssay
Demonstrate lack of endotoxin orpyrogen contamination	Limulus Ameobocyte (LAL) test (25USP Monograph <85>)
Validation of Aseptic Processing andSterility Assurance Level (SAL)	Determination of SAL to be ≥ 10-3compliance with GMP requirements

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	regarding aseptic processing
Demonstrate Chemical purity	Incoming Raw Material testing usingUSP, ACS, FCC, GIBCO, or CellCulture requirements

Stability/Shelf-Life - -

Life Technologies Corporation performs shelf life testing for StemPro® MSC SFM Medium using retained product stored at 2° - 8° C. In addition, a minimum of one new production lot of StemPro® MSC SFM Medium is tested each year to verify that the product continues to meet the established shelf life. Based on analysis of product performance over time, Life Technologies Corporation has established a shelf life of twelve months for the StemPro® MSC SFM Medium formulation. Stability testing involves the assessment of these functional aspects of media, including demonstrating: (1) that the pH continues to meet specifications; and (2) the media is not cytotoxic and supports the growth of mammalian cells. The pH is tested to demonstrate that the media is not chemically altered during its storage. In assessing cytoxicity, Life Technologies Corporation demonstrates that the media functions in supporting the growth of mammalian cells and that the media does not become toxic to mammalian cells during storage.

In addition, results from the studies indicate the container/closure system provides protection from microbial.contamination.

D. Conclusion

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

StemPro® MSC SFM and Knockout™ SR Medium are used for human ex vivo
ticayo and coll culture processing and have the seme principles of tissue and cell culture processing applications and have the same principles of operation, technological characteristics, efficacy (generic cellular growth and maintenance) and safety (consistency in chemical content and formulation, biocompatibility with cells, and purity). Their efficacy in supporting the survival, growth, development, and maintenance of human cells or tissue culture systems has been well established in scientific publications included in this submission. StemPro® MSC SFM and Knockout™ SR Medium are manufacturer in accordance with QSR requirements and are labeled as aseptically processed. Thus, StemPro® MSC SFM is substantially equivalent to the legally marketed device intended for the human ex vivo tissue and cell culture processing applications.

K10 3302

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" encircles the eagle. The text is arranged in a circular fashion around the eagle, with the department's name at the bottom and "USA" at the top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Kelli L. Tanzella, Ph.D. Sr. Manager, Americas Regulatory Affairs Life Technologies" Inc. 3175 Staley Road GRAND ISLAND NY 14072

FEB 18 201

Re: K103302

Trade/Device Name: StemPro® MSC SFM Medium – StemPro® MSC SFM Basal Medium and StemPro® MSC SFM Supplement for ex-vivo Tissue and Cell Culture

Regulation Number: 21 CFR §876.5885

Regulation Name: Tissue culture media for human ex vivo tissue and cell culture processing applications.

Regulatory Class: II Product Code: NDS Dated: February 17, 2011 Received: February 18, 2011

Dear Dr. Tanzella:

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 of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 yours,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KIO3302 510(k) Number (if known): __

Device Name: StemPro® MSC SFM Medium

Indications for Use:

StemPro® MSC SFM Medium is a liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHRE PAGE IF NEEDED)

Concurrence of CDRH, Office of Evaluation (ODE) .

Prescription Use
(Per 21 CFR 801.109)

Roger M. Whang

stro-Renal, and

Over-The -Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.

(a)
Identification. Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.(b)
Classification. Class II (special controls): FDA guidance document, “Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Processing Applications; Final Guidance for Industry and FDA Reviewers.”