(202 days)
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No
The summary describes a tissue culture media product and its performance testing, with no mention of AI or ML technologies.
No
This device is a tissue culture media product intended for human ex vivo tissue and cell culture processing applications, specifically for the growth and expansion of human T lymphocytes outside the body. It does not treat or diagnose a disease in a living patient.
No
Justification: The device is a liquid tissue culture medium intended for human ex vivo tissue and cell culture processing applications, specifically for the growth and expansion of human T lymphocytes. It is not used to diagnose a disease or condition.
No
The device is a liquid tissue culture media product, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "intended for human ex vivo tissue and cell culture processing applications." This means the media is used outside the body to grow and expand cells, not to diagnose a condition in a patient.
- Device Description: The description focuses on the composition and function of the media for cell growth and expansion.
- Lack of Diagnostic Claims: There are no mentions of using this media to test patient samples for diagnostic purposes, detect diseases, or provide information for diagnosis.
- Predicate Device: The predicate device (AIM-V® Medium) is also a tissue culture medium, not an IVD.
- Performance Studies: The performance studies focus on the quality and functionality of the media for cell culture (sterility, LAL, stability, cell growth support), not on diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's purpose is to facilitate the growth and expansion of cells outside the body for other applications (likely therapeutic or research).
N/A
Intended Use / Indications for Use
OpTmizer™ CTS™ T-Cell Expansion SFM is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.
OpTmizer™ CTS™ T-Cell Expansion Serum Free Medium is a liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.
Product codes (comma separated list FDA assigned to the subject device)
NDS
Device Description
OpTmizer™ CTS™ T-Cell Expansion SFM has been developed for the growth and expansion of human T lymphocytes. OpTmizer™ CTS™ T-Cell Expansion SFM is a complete serum-free and xeno-free 1X medium consisting of the OpTmizer™ T-Cell Expansion Basal Medium with the addition of the OpTmizer™ T-Cell Expansion Supplement. OpTmizer™ CTS™ T-Cell Expansion Medium is designed for the expansion of CD3+ densities of > 3 x 10 cells/mL in static conditions and > 2 x 10 cells/ML in Wave bags.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance standards under Section 514 of the Federal Food, Drug, and Cosmetic Act have been established in "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 noted in the following table.
| Special Control Objective | Life Technologies Corporation OpTmizer™ CTS™ T-Cell Expansion SFM |
|---|---|
| Demonstrate lack of potential toxicity of materials in the media to cells or tissue and demonstrate support of tissue and cell growth | OpTmizer QC Performance Assay |
| Demonstrate lack of endotoxin or pyrogen contamination | Limulus Ameobocyte (LAL) test (25 USP Monograph ) |
| Validation of Aseptic Processing and Sterility Assurance Level (SAL) | Determination of SAL to be ≥ 10-3 compliance with GMP requirements regarding aseptic processing |
| Demonstrate Chemical purity | Incoming Raw Material testing using USP, ACS, FCC, GIBCO, or Cell Culture requirements |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.”
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K113566 page 1 of 3
JUN 2 1 2012
510(k) Summary
Life Technologies Corporation - OpTmizer™ CTS™ T-Cell Expansion SFM
| Device Name: | OpTmizer™ CTS™ T-Cell Expansion SFM |
|---|---|
| Common/Usual Name: | OpTmizer |
| Classification Name: | Tissue culture media for human ex vivo tissue and cell culture processing applications (per 21 CFR § 876.5885) |
| Product Code: | NDS |
| Submitter: | Life Technologies Corporation |
| 3175 Staley Road | |
| Grand Island, New York 14072 | |
| Telephone: | (716) 774-3122 |
| Facsimile: | (716) 774-0230 |
| Email: | kelli.tanzella@lifetech.com |
| Contact: | Kelli Tanzella, Ph.D. |
| Date Prepared: | November 30, 2011 |
| Predicate Device: | |
| Trade Name | Manufacturer 510(k) |
AIM-V® Medium
Life Technologies Corporation
Intended Use
OpTmizer™ CTS™ T-Cell Expansion SFM is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.
Substantial Equivalence
AIM-V® Medium is the predicate device for tissue culture media intended for human ex vivo tissue and cell culture processing applications. It is composed of chemically defined nutrient materials in solution (with or without supplements) that are essential for the survival and development of tissue or cells of human or other animal origin. These nutrients are provided in liquid form for use in supporting the growth or maintenance of human tissue and cells.
A. Intended Uses
OpTmizer™ CTS™ T-Cell Expansion SFM tissue culture product is intended for human ex vivo tissue and cell culture processing applications. These devices are 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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Page 2
510(k) Summary – Life Technologies OpTmizer™ CTS™ T-Cell Expansion SFM
OpTmizer™ CTS™ T-Cell Expansion SFM has been developed for the growth and expansion of human T lymphocytes. OpTmizer™ CTS™ T-Cell Expansion SFM is a complete serum-free and xeno-free 1X medium consisting of the OpTmizer™ T-Cell Expansion Basal Medium with the addition of the OpTmizer™ T-Cell Expansion Supplement. OpTmizer™ CTS™ T-Cell Expansion Medium is designed for the expansion of CD3+ densities of > 3 x 10° cells/mL in static conditions and > 2 x 10′ cells/ML in Wave bags.
C. Pre- Clinical Testing
Performance standards under Section 514 of the Federal Food, Drug, and Cosmetic Act have been established in "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 noted in the following table.
| Special Control Objective | Life Technologies Corporation
OpTmizerTM CTSTM T-Cell
Expansion SFM |
|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Demonstrate lack of potential toxicity
of materials in the media to cells or
tissue and demonstrate support of
tissue and cell growth | OpTmizer QC Performance Assay |
| Demonstrate lack of endotoxin or
pyrogen contamination | Limulus Ameobocyte (LAL) test (25
USP Monograph ) |
| Validation of Aseptic Processing and
Sterility Assurance Level (SAL) | Determination of SAL to be ≥ 10-3
compliance with GMP requirements
regarding aseptic processing |
| Demonstrate Chemical purity | Incoming Raw Material testing using
USP, ACS, FCC, GIBCO, or Cell
Culture requirements |
D. Stability/Shelf-Life
Life Technologies Corporation performs shelf life testing for StemPro® MSC SFM Medium using retained product stored at 20 - 8° C. In addition, a minimum of one new production lot of OpTmizer™ CTS™ T-Cell Expansion SFM 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 OpTmizer™ CTS™ T-Cell Expansion SFM 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
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510(k) Summary - Life Technologies OpTmizer™ CTS™ T-Cell Expansion SFM
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.
E. Conclusion
OpTmizer™ CTS™ T-Cell Expansion SFM and AIM-V® 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). Their efficacy in supporting the survival, growth, development, and maintenance of human cells or tissue culture systems has been well established in scientific publications. Both products (OpTmizer™ CTS™ T-Cell Expansion SFM and AIM-V® Medium) are manufacturer in accordance with QSR requirements and are labeled as aseptically processed. Thus, OpTmizer™ CTS™ T-Cell Expansion SFM is substantially equivalent to the legally marketed device intended for the human ex vivo tissue and cell culture processing applications.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Kelli L. Tanzella, Ph.D. Director, Americas Regulatory Affairs Life Technologies Corporation 3175 Staley Road GRAND ISLAND NY 14072
JUN 2 1 2012
Re: K113566
Trade/Device Name: OpTmizer™ CTS™ T-Cell Expansion Serum Free Medium Regulation Number: 21 CFR§ 876.5885 Regulation Name: Tissue culture media for human ex vivo tissue and cell culture Regulatory Class: II Product Code: NDS Dated: June 11, 2012 Received: June 12, 2012
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 r toase be devices and its in that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or urf I vatural babatos t'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 1
4
device-related 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,
Benjamin K. Evanko
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K | | 3566
Device Name: OpTmizer™ CTS™ T-Cell Expansion Serum Free Medium
Indications for Use:
OpTmizer™ CTS™ T-Cell Expansion Serum Free 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)
X
Prescription Use
(Per 21 CFR 801.109) 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023
OR
(Division Sign-off)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number: K113566
Over-The -Counter Use_ (Optional Format 1-2-96)