(447 days)
Not Found
No
The device is a liquid culture media, and the description and testing focus on its biological properties and performance in cell culture, with no mention of AI/ML components or functions.
No.
The device is a tissue culture media intended for ex vivo cell and tissue processing, meaning it is used outside the living body to support growth or maintenance of cells and tissues, not to treat a disease or condition in a patient.
No
Explanation: The device is described as a liquid culture media intended for ex vivo cell and tissue processing applications, specifically for supporting the growth or maintenance of human tissue and cells. There is no indication that it is used to diagnose a disease or condition.
No
The device description clearly states that CT-STOR is a liquid culture media, which is a physical substance, not software.
Based on the provided information, CT-STOR is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "for ex vivo cell and tissue processing applications." This describes a product used to support the growth and maintenance of cells and tissues outside of the body, which is a laboratory processing function, not a diagnostic one.
- Device Description: The description explicitly states it is a "tissue culture media intended for human ex vivo tissue and cell culture processing applications." It's designed to provide nutrients for cell survival and development.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze a sample to provide information about a patient's health status.
- Performance Studies: The performance studies focus on the ability of the media to support cell proliferation and stability, which are relevant to its function as a culture medium, not a diagnostic test.
IVDs are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. CT-STOR's purpose is to facilitate the handling and growth of cells and tissues in a laboratory setting, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
CT-STOR is a liquid culture media intended for ex vivo cell and tissue processing applications
Product codes
NDS
Device Description
CT-STOR is a tissue culture media intended for human ex vivo tissue and cell culture processing applications. CT-STOR 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
CT-STOR has been tested on human dermal fibroblasts (HDFa) cells. Primary HDFa cells were purchased from American Type Culture Collection (ATCC, PCS-201-012, Primary Dermal Fibroblast; Normal, Human, Adult (HDFa), Manassas, VA) and plated at 10,000 cells per well on a 24-well plate. Cells were allowed to proliferate in complete growth media for 24 hours (ATCC, PCS-201-030, Fibroblast basal medium with added Fibroblast Growth Kit-Serum-free, PCS-201-040). After 24 hours, cells were switched to either control media (PCS-201-030, Fibroblast basal medium) or test media (CT-STOR, Energy Delivery Solutions, Jeffersonville, IN). HDFa cells were allowed to proliferate for 48 hours with the respective test media. After 48 hours cell proliferation was assessed and seeding comparisons defined.
Results:
CT-STOR Days Aged 8: Seeding Comparison (%) 95.09% (Acceptable Limit: > 75%)
CT-STOR Days Aged 128: Seeding Comparison (%) 173.43% (Acceptable Limit: > 75%)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2021
Energy Delivery Solutions William Ehringer, Ph.D. CEO 3315 Industrial Parkway Jeffersonville, IN 47130
K201789 Re: Trade/Device Name: CT-STOR 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: August 19, 2021 Received: August 20, 2021
Dear William Ehringer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell, Ph.D. Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
CT-STOR
Indications for Use (Describe)
CT-STOR is a liquid culture media intended for ex vivo cell and tissue processing applications
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5. 510(k) Summary
| Owner's Name: | Energy Delivery Solutions |
|---|---|
| Address: | 3315 Industrial Parkway |
| Jeffersonville, IN 47130 | |
| Phone Number: | (812) 920-0596 |
| Contact Person: | William Ehringer, PhD, Kristyn Smith, or Caitlin Stanton |
| Energy Delivery Solutions | |
| Classification Name: | Media, Culture, ex vivo, Tissue and Cell |
| Date of Preparation: | September 11, 2021 |
| Device Name: | CT-STOR |
| Common Name: | Culture Media |
| Regulation Name: | Tissue culture media for human ex vivo tissue and cell culture processing |
| applications. | |
| Regulatory Class: | II |
| Product Code: | NDS |
| Regulation Number: | 21 CFR 876.5885 |
| Panel: | Gastroenterology/Urology |
Legally Marketed Device for Substantial Equivalence Comparison:
CT-STOR is substantially equivalent to the currently marketed device:
- AIM-V® Medium, Invitrogen Corporation; 510(k) K022086 (Invitrogen Corporation) ●
Device Description
CT-STOR is a tissue culture media intended for human ex vivo tissue and cell culture processing applications. AIM-V® is the predicate device and is also a tissue culture media intended for human ex vivo tissue and cell culture processing applications. CT-STOR and AIM-V® are composed of chemically defined nutrient materials in solution (with or without supplements) that are essential
Energy Delivery Solutions 510(k) Submission for CT-STOR CONFIDENTIAL 08/19/2021
4
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.
Intended Use
CT-STOR is a liguid tissue culture media product intended for ex vivo tissue and cell culture processing applications.
Principles of Operation and Technological Characteristics
CT-STOR is a serum-free medium developed in 2016 to support cells and tissues for ex vivo preservation. CT-STOR is substantially equivalent to AIM-V®, which is a serum-free medium developed in 1987 in collaboration with Dr. Steven Rosenberg (National Cancer Institute) to support adoptive immunotherapy (lymphokine-activated killer (LAK) cells) clinical trials that were being conducted by Dr. Rosenberg and collaborating investigators. Tissue culture media products for human ex vivo tissue and cell culture applications have been explored and tested as described in peer-reviewed literature.
The formula for CT-STOR has remained the same since it was first manufactured with only a few minor alterations to composition. CT-STOR is prepared from a formulation of Dulbeco's Modified Eagle Medium (DMEM), adenosine-5'-triphosphate (ATP), purified soy phosphatidylcholine, 2,3-Dioleoyloxy-propyl-trimethylammoniumchloride (DOTAP) and ascorbic acid (Vitamin C). Each of the components of CT-STOR play a significant role in ex vivo maintenance of cells and tissues.
The central role of ATP in cell and tissue viability and maintenance has been studied since the discovery of ATP in 1929 [Khakh B., 2009]. Slight changes in intracellular ATP can play a significant role in cell function or dysfunction, and thus cellular control of intracellular ATP is critical [Khakh B., 2009]. When cells or tissues are removed from the body, there is a disruption in cell ATP production due to hypoxia [Kim J., 2014]. Addition of ATP to cell and tissue culture media results in trophic signaling and also in helping maintain intracellular ATP levels [Burnstock, G., 2016]. CT-STOR contains micromolar quantities of ATP that are protected and encapsulated in lipid vesicles, which has been shown to increase growth factor expression and decrease inflammatory markers [Castro, A., 2019].
The role of lipids in cell maintenance is three fold. First, lipids play a structural role in cellular membranes [Whitford W., 2004]. A small cell may contain 10° phospholipids in the cell membrane, which if not supplemented in some form will lead to cell death [Alberts B., 2002]. Lipid supplementation to culture media has typically occurred by the addition of serum albumin, which acts as a carrier for lipids [Whitford W., 2004]. In serum-free media, the lipids can come from various sources, such as adding a media supplement (e.g. ExCyte, Millipore), or by adding liposomes, lipid dispersions, or micro-emulsions [Savonniere S., 1996]. Secondly, lipids act as an energy store. For example, a phosphatidylcholine with two palmitic fatty acids yields 258 ATP molecules [Bhagavan, N., 2002]. In some cells, such as cardiomyocytes, the preferred energy source is by beta-oxidation of fatty acids, specifically oleic acid [Lopaschuk, G., 2010]. Third,
5
lipids play a significant role in cell transport and signal transduction. Lipids are the important in endosomes, golgi vesicles, and vacuoles, as well as in several kinases.
Ascorbic acid plays a significant role in cell and tissue viability during isolation [Shaghaghi, H., 2015]. As a powerful anti-oxidant, ascorbic acid acts as a reactive oxygen species (ROS) scavenger during hypoxia [Guauquil, V., 2004]. When ROS levels in cell and tissue culture media are increased significant destruction of cell membranes, proteins. DNA and RNA does occur. Thus, addition of ascorbic acid to culture media can decrease ROS-induced cell damage.
Conclusion
CT-STOR and AIM-V® Medium are used for human ex vivo tissue and cell culture processing applications and have the same principles of operation, technical characteristics, efficacy (generic cellular growth and maintenance) and safety (consistent in chemical content and formulation. biocompatibility with cells, and purity). Their efficacy in supporting survival, growth, development, and maintenance of human cells or tissue culture systems has been well established in scientific publications included in this submission. Both CT-STOR and AIM-V® are manufactured in accordance with OSR requirements and are labelled as aseptically processed. Thus, CT-STOR is substantially equivalent to the legally marketed device intended for the human ex vivo tissue and cell culture processing applications.
Indications for Use
CT-STOR is a liquid culture media intended for ex vivo cell and tissue processing applications.
Summary of Non-Clinical Testing
CT-STOR has been tested on human dermal fibroblasts (HDFa) cells when demonstrating performance testing for CT-STOR stability (i.e. validation). Primary HDFa cells were purchased from American Type Culture Collection (ATCC, PCS-201-012, Primary Dermal Fibroblast; Normal, Human, Adult (HDFa), Manassas, VA) and plated at 10,000 cells per well on a 24-well plate. Cells were allowed to proliferate in complete growth media for 24 hours (ATCC, PCS-201-030, Fibroblast basal medium with added Fibroblast Growth Kit-Serum-free, PCS-201-040). After 24 hours, cells were switched to either control media (PCS-201-030, Fibroblast basal medium) or test media (CT-STOR, Energy Delivery Solutions, Jeffersonville, IN). HDFa cells were allowed to proliferate for 48 hours with the respective test media. After 48 hours cell proliferation was assessed and seeding comparisons defined (see below table).
| CT-STOR Days Aged | Seeding Comparison (%)
Acceptable Limit: > 75% |
|-------------------|---------------------------------------------------|
| 8 | 95.09% |
| 128 | 173.43% |