(164 days)
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No
The summary describes a cell culture medium and its performance characteristics, with no mention of AI or ML technology.
No.
This device is a culture medium used for processing human tissue and cell cultures ex vivo, not for direct therapeutic application in patients.
No
MoFi is a liquid culture medium used for growing cells ex vivo, providing nutrients for their survival and growth, not for diagnosing diseases or conditions. The "Intended Use / Indications for Use" section specifies its use in "human ex vivo tissue and cell culture processing applications."
No
The device description clearly states it is a liquid culture medium, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "human ex vivo tissue and cell culture processing applications." While not a direct diagnostic test itself, the medium is intended for use in the processing of human tissues and cells outside the body (ex vivo). This processing is often a crucial step in various diagnostic procedures, such as cell culture for identifying pathogens, genetic testing, or preparing samples for other diagnostic analyses.
- Device Description: The description details its composition as a liquid culture medium for culturing human cells. This aligns with the typical function of IVD reagents and media used in laboratory settings for diagnostic purposes.
- Regulatory Language: The statement "When used as a medical device, Federal Law restricts this device to sale by or on the order of a physician" is a strong indicator that the device is regulated as a medical device, and given its intended use, it falls under the IVD category.
- Predicate Device: The predicate device listed (K100616; KnockoutTM SR Medium and KnockoutTM SR Xenofree Medium) are also cell culture media used in laboratory settings, often for applications that include diagnostic procedures. This further supports the classification of MoFi as an IVD.
While the document doesn't describe a direct diagnostic test performed by the device itself, its role in the processing of human samples for potential diagnostic use places it within the scope of IVD regulation. IVDs are not limited to devices that directly provide a diagnostic result, but also include reagents, instruments, and systems intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
MoFi is a liquid culture medium 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
MoFi is a basal medium based on Iscove's Modified Dulbecco's Medium (IMDM) and cell-degradabe polysaccharide, made of water, carbohydrate, amino acid and salt. It can be mixed with various serums or additional additives to form a complete medium, which can be used to culture suspension/adherent primary cultured cells or cell lines. MoFi provides cells with energy to maintain survival and promote growth.
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)
The results showed that both KSR and MoFi passed the acceptance criteria of cell viability, and the cell morphology of four kinds of cells cultured in both MoFi and the predicate is normal and typical. This indicates that MoFi possess an equivalent function as the predicate and no safety issues occur.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
July 12, 2024
DuoGenic StemCells Corporation Hong-Lin Su Chairman No. 18, Ln. 10, Taiping 21st St., Taiping Dist. Taichung City, Taiwan 41161 Taiwan
Re: K240247
Trade/Device Name: "MoFi" Cell Culture Basal Medium Regulation Number: 21 CFR 876.5885 Regulation Name: Tissue Culture Media For Human Ex Vivo Tissue And Cell Culture Processing Applications Regulatory Class: Class II Product Code: NDS Dated: June 14, 2024 Received: June 14, 2024
Dear Hong-Lin Su:
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 (the 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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
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Sincerely,
Maura Rooney -S
Maura Rooney Assistant 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
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Indications for Use
Submission Number (if known)
Device Name
"MoFi" Cell Culture Basal Medium
Indications for Use (Describe)
MoFi is a liquid culture medium intended for human ex vivo tissue and cell culture 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)
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"MoFi" Cell Culture Basal Medium
510(k) Premarket Notification
Ch. 5 – 510(k) Summary
Date: 03/07/2024
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 872, this information serves as a Summary of Safety and Effectiveness for the use of the "MoFi" Cell Culture Basal Medium (hereinafter referred to as MoFi).
| Submitted by | DuoGenic StemCells corporation |
|---|---|
| Date | 2024/07/03 |
| Contact Person | Chih-Yao Lin |
| Applicant Address | No. 18, Ln. 10, Taiping 21st St., Taiping Dist., |
| Taichung City, Taiwan (R.O.C.) | |
| Telephone Number | +886-4-2276-6193 |
| Proprietary Name | "MoFi" Cell Culture Basal Medium |
| Common Name | MoFi |
| Device Trade Name | MoFi |
| Review Panel | Gastroenterology/Urology |
| Classification Name and Reference | 876.5885 Tissue culture media for human ex vivo |
| tissue and cell culture processing applications. Class | |
| II (special controls). | |
| Device Product Code and Panel Code | NDS |
| Predicate Device | KnockoutTM SR Medium and KnockoutTM SR |
| Xenofree Medium | |
| Predicate Submission Number | K100616 |
1. Intended Use and Indications for Use
MoFi is a liquid culture medium intended for human ex vivo tissue and cell culture processing applications.
2. Device Description
2.1 Description:
MoFi is a basal medium based on Iscove's Modified Dulbecco's Medium (IMDM) and cell-degradabe polysaccharide, made of water, carbohydrate, amino acid and salt. It can be mixed with various serums or additional additives to form a complete medium, which can be used to culture suspension/adherent primary cultured cells or cell lines. MoFi provides cells with energy to maintain survival and promote growth.
- 2.2 Storage condition: 2 - 6°C
- 2.3 Shelf life: 9 months (from the manufactured date)
- 2.4 Volume: 80 mL/bottle
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2.5 Instruction:
- 2.5.1 The preparation of full medium is recommended according to the cell type. Please see the table below. Antibiotics may be added if needed.
- 2.5.2 Temperature and time for pre-warming can be adjusted according to user's need, while it's recommended not to exceed 37°C.
- 2.5.3 This product is recommended to be handled aseptically.
| Concentration
Reagent | Peripheral Blood Cells
(suspension cells) | Mesenchymal Stem Cells
(adherent cells) |
|----------------------------|----------------------------------------------|--------------------------------------------|
| MoFi | 1X | 1X |
| Serum (human or animal) | 10% | 20% |
| L-glutamine | 2 mM | 2 mM |
| Sodium pyruvate | 1 mM | 1 mM |
| Non-essential amino acids | Not applicable (N/A) | 0.1 mM |
| Fibroblast growth factor 2 | N/A | 4 ng/mL |
2.6 Warning and Precautions:
- 2.6.1. Protective glasses, clothing and gloves should be worn during operation.
- 2.6.2. This product is for single use, and should not be re-sterilized and reused.
- 2.6.3. This product should be handled aseptically, and should follow biosafety instructions.
- 2.6.4. This product should be protected from light.
- 2.6.5. This product should not be stored or operated at over 37°C.
- 2.6.6. Please do NOT inject this product into the human body, or allergic reactions may occur.
- 2.6.7. When used as a medical device, Federal Law restricts this device to sale by or on the order of a physician.
3. Device Specification
- Appearance: Transparent yellowish liquid 3.1
- 3.2 pH: 7.0-8.0
- 3.3 Cell viability
- 3.4 Sterility: Negative or not detected
- 3.5 Endotoxin: ex vivo tissue and cell culture
processing applications | A liquid tissue culture media product
intended for human ex vivo tissue and cell
culture processing applications |
| Comparison: Both MoFi and the predicate are used for human ex vivo cell and tissue processing applications. | | |
| Container/
packaging | Bottle: polyethylene terephthalate
copolyester, glycol modified (PETG)2/O2
Closure: high-density polyethylene (HDPE) | Bottle: polyethylene terephthalate (PET)
Closure: high-density polyethylene (HDPE) |
| Comparison: PET and PETG are both suitable containers for cell culture and media storage applications. | | |
| Product
Configuration | Amino acids, salts, vitamins and
carbohydrates | Amino acids, salts, vitamins and
carbohydrates |
| Comparison: Both MoFi and the predicate are chemically-defined culture media and composed of amino acids, salts, vitamins and carbohydrates. | | |
| Aseptically
Processed | Compliance with GMP requirements
regarding aseptic processing | Compliance with GMP requirements
regarding aseptic processing |
| Comparison: The process validation and environmental monitoring of the MoFi process support aseptic processing. Both MoFi and the predicate comply with GMP requirements regarding aseptic processing. | | |
| Storage
Temperature | 2-6°C | 2-8°C |
| Comparison: The difference in storage temperature between MoFi and the predicate does not affect the safety of the product. | | |
| Shelf-life | 9 months | 14 months |
| Comparison: According to the stability data, shelf life of MoFi is recommended to be 9 months. | | |
| Product
Performance | Good cell viability and normal cell
morphology of four kinds of cells
(suspension primary culture cells,
suspension cell lines, adherent primary
culture cells and adherent cell lines) | Good cell viability and normal cell
morphology of four kinds of cells
(suspension primary culture cells,
suspension cell lines, adherent primary
culture cells and adherent cell lines) |
| Comparison: Cells are roughly categorized into four groups, suspension primary culture cells, suspension cell lines, adherent primary culture cells and adherent cell lines. The results showed that both KSR and MoFi passed the acceptance criteria of cell viability, and the cell morphology of four kinds of cells cultured in both MoFi and the predicate is normal and typical. This indicates that MoFi possess an equivalent function as the predicate and no safety issues occur | | |
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"MoFi" Cell Culture Basal Medium
510(k) Premarket Notification
5. Shelf Life
According to the stability test's result, shelf life for MoFi is recommended to be 9 months.
6. Biocompatibility
The biocompatibility evaluation was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
7. Performance Testing
All batches tested met the acceptance criteria of performance testing. The residual endotoxin is well controlled. No bacteria and mycoplasma were detected. The residues of plasticizers, heavy metals and particles are not detected or can be safely ignored.
8. Conclusion
MoFi and Knockout™ SR Medium and Knockout™ SR Xenofree Medium are used for human ex vivo tissue and cell culture processing applications and have the same/similar container, storage temperature, 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. These products (MoFi and Knockout™ SR Medium and Knockout™ SR Xenofiree Medium) are manufactured in accordance with QSR requirements and are labeled as aseptically processed. Thus, MoFi are substantially equivalent to the legally marketed device (K100616) intended for the human ex vivo tissue and cell culture processing applications.