(381 days)
Not Found
No
The device description and performance studies focus on a tissue culture medium and its ability to support cell growth, with no mention of AI or ML technologies.
No.
The document states that MSC SFM is a liquid tissue culture medium product for "human ex-vivo tissue and cell culture processing applications," specifically for the "growth and expansion of human mesenchymal stem cells (MSCs)." This indicates it's used for preparing cells outside the body, not for direct therapeutic intervention on a patient.
No
This device is a tissue culture medium used for growing and expanding human mesenchymal stem cells, not for diagnosing a condition or disease.
No
The device is a liquid tissue culture medium product, which is a physical substance, not software. The description focuses on its chemical composition and biological function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "human ex-vivo tissue and cell culture processing applications." This means the medium is used to grow and maintain cells outside of the body for various purposes, such as research or potential therapeutic applications.
- Lack of Diagnostic Purpose: An IVD is specifically intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The description of MSC SFM does not mention any diagnostic purpose. It's used for cell expansion and maintenance, not for analyzing a sample to diagnose a condition.
- Device Description: The description focuses on the composition and function of the medium in supporting cell growth and expansion, not on its use in a diagnostic test.
- Performance Studies: The performance studies described are related to the medium's ability to support cell growth, shelf life, and biocompatibility – all relevant to its use in cell culture, but not to diagnostic accuracy.
In summary, MSC SFM is a cell culture medium used for growing cells outside the body, which falls under the category of laboratory reagents or cell culture products, not IVDs.
N/A
Intended Use / Indications for Use
MSC SFM is a liquid tissue culture medium product intended for human ex-vivo tissue and cell culture processing applications.
Product codes
NDS
Device Description
MSC SFM is a serum-free medium specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). MSC SFM contains MSC SFM Basal Medium and MSC SFM supplement, MSC SFM supplement is a growth factor that should be added to the MSC SFM Basal Medium when use. Using MSC SFM, human MSCs can be expanded for multiple passages while maintaining their trilineage mesoderm potential (i.e., ability to differentiate into osteogenic and adipogenic lineages). Each container is aseptically filled.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data was collected as part of the performance studies.
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 Yocon Biology's equivalent tests are described below.
- Validation of aseptic processing compliance with GMP requirements regarding aseptic processing
- Sterility Assurance Level (SAL) greater than or equal to 10-3
- Appearance and clarity
- Osmolality Testing
- pH value Testing
- Sterility Testing
- Endotoxin Testing
- Performance Assay
Shelf Life: YOCON BIOLOGY TECHNOLOGY COMPANY performs shelf-life testing for subject device using retained product stored at 2-8 degrees C, and subject device is performed performance testing over 12 months. The test results support a shelf life of 12 months for MSC SFM.
Biocompatibility: The Biological Evaluation compliance with the standards of ISO 10993-1, "Biological Evaluation of Medical Devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Endotoxin and Pyrogen contamination: Bacterial Endotoxin less than 0.25 EU/mL (USP monograph 85)
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
September 6, 2024
Yocon Biology Technology Company Haifeng Li OA Manager 3/F, Bldg. B, No.7, Fengxian Rd. YongFeng Base Haidian District Beijing, Beijing 100094 China
Re: K232543
Trade/Device Name: MSC SFM 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: August 5, 2024 Received: August 7, 2024
Dear Haifeng Li:
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows the name "Maura Rooney" followed by "-S". The text is in a simple, sans-serif font and is prominently displayed against a white background. The letters are large and easy to read.
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
3
Indications for Use
510(k) Number (if known) K232543
Device Name MSC SFM
Indications for Use (Describe)
MSC SFM is a liquid tissue culture medium product 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)
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."
4
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
1. Submitter's Information
| Name: | YOCON BIOLOGY TECHNOLOGY COMPANY |
|---|---|
| Address: | 3/F, Bldg. B, No.7, Fengxian Rd. YongFeng Base, Haidian District, Beijing China |
| 100094 | |
| Contact Person: | Haifeng Li |
| E mail: | ra@yocon.com.cn |
| Tel: | +86-10-58711655 |
- Date Prepared: December 6th, 2023
3. Device Information:
| Trade/Device Name: | MSC SFM |
|---|---|
| Device Common Name: | MSC SFM |
| Regulation Number: | 21 CFR 876.5885 |
| Regulation Name: | Tissue Culture Media For Human Ex Vivo Tissue And Cell Culture Processing Applications |
| Regulation Class: | II |
| Product Code: | NDS |
Predicate Device (K103302)
| Trade/Device Name: | StemPro MSC SFM Medium |
|---|---|
| Device Common Name: | StemPro MSC SFM |
| Manufacturer | Life Technologies Corporation |
| Regulation Number: | 21 CFR 876.5885 |
| Regulation Name: | Tissue Culture Media For Human Ex Vivo |
| Tissue And Cell Culture Processing Application | |
| Regulation Class: | II |
| Product Code: | NDS |
4. Device Description
MSC SFM is a serum-free medium specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). MSC SFM contains MSC SFM Basal Medium and MSC SFM supplement, MSC SFM supplement is a growth factor that should be added to the MSC SFM Basal Medium when use. Using MSC SFM, human MSCs can be expanded for multiple passages while maintaining their trilineage mesoderm potential (i.e., ability to differentiate into osteogenic and adipogenic lineages). Each container is aseptically filled.
5
5. Indication for use
MSC SFM is a liquid tissue culture medium product intended for human ex-vivo tissue and cell culture processing applications.
6. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table.
| Feature | Subject device | Predicate device
K103302 | Comments |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | YOCON BIOLOGY
TECHNOLOGY COMPANY | Life Technologies
Corporation | -- |
| Trade name | MSC SFM | StemPro MSC SFM Medium | -- |
| Classification's
name and
Regulation
Name | Regulation Number: 21 CFR
876.5885 | Regulation Number: 21 CFR
876.5885 | Same |
| | Regulation Name: Media,
Culture, Ex Vivo, Tissue And
Cell | Regulation Name: Media,
Culture, Ex Vivo, Tissue And
Cell | |
| | Regulation Class: Class II
Product Code: NDS | Regulation Class: Class II
Product Code: NDS | |
| Indications for
use | MSC SFM is a liquid tissue
culture medium products
intended for human ex-vivo
tissue and cell culture
processing applications. | StemPro MSC SFM Medium
is a liquid tissue culture
medium products intended
for human ex-vivo tissue and
cell culture processing
applications. | Same |
| Ingredients | Glycine, L-Alanine, L-Arginine HCI, Asparagine monohydrate, L-Aspartic acid, L-Cysteine HCI H2O, L-Glutamic Acid, L-Glutamine, L-Histidine HCI H2O, L-Isoleucine, L-Leucine, L-Lysine HCI, L-Methionine, L-Phenylalanine, L-Proline, L-Serine, L-Threonine, L-Tryptophan, Tyrosine, L-Valine, Choline chloride, D-Calcium pantothenate, Folic Acid, Niacinamide, Pyridoxal HCI, Riboflavin, Thiamine | Confidential | Different,
The formulation of the
predicate device is not
available because the
formulation is confidential. |
| | | | |
| | HCl, Vitamin B12, i-Inositol,
Calcium Chloride (CaCl2)
Anhydrous, Magnesium
Chloride
(MgCl2 anhydrous),
Magnesium Sulfate
(MgSO4)-7H2O, Potassium
Chloride (KCl), Sodium
Bicarbonate
(NaHCO3), Sodium Chloride
(NaCl), Sodium Phosphate
dibasic
(Na2HPO4)-7H2O, Sodium
Dihydrogen
Phosphate-1H2O, D-
Glucose (Dextrose),
Hypoxanthine Na, Sodium
Pyruvate, Biotin, Cupric
sulfate, Iron(III)nitrate
nonahydrate
(Fe[NO3]3·9[H2O]), Ferrous
Sulfate(FeSO4-7H2O),
Linoleic Acid, Lipoic Acid,
Putrescine2HCl, Sodium
Selenite(Na2SeO3),
Recombinant Human
Transferrin, Recombinant
Human serum albumin,
Recombinant Human Insulin,
Recombinant Human
Fibronectin, EGF | | |
| Demonstrate
lack of potential
toxicity of
materials in the
media to cells or
tissue and
demonstrate
support of tissue
and cell growth | Performance Assay | StemPro MSC SFM
Performance Assay | Different,
The performance assay
data of predicate device is
not available because this
information is confidential.
We have conducted non-
clinical testing. Results of
the testing demonstrate a
lack of potential toxicity of
the materials in the media
to cells or tissue and
demonstrates support of
tissue and cell growth. |
6
7
| Endotoxin and
Pyrogen
contamination | Bacterial
Endotoxin) | Limulus Ameobocyte (LAL)
test (25 USP Monograph
) | Same |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Validation of
Aseptic
Processing and
Sterility
Assurance Level
(SAL) | Through the validation of
Aseptic processing and
Sterility Assurance Level
(SAL), determine that SAL l0-
3 compliance with GMP
requirements regarding
aseptic processing. | Through the validation of
Aseptic processing and
Sterility Assurance Level
(SAL), determine that SAL l0-
3 compliance with GMP
requirements regarding
aseptic processing | Same |
7. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
Performance:
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 Yocon Biology's equivalent tests are described below.
- -Validation of aseptic processing compliance with GMP requirements regarding aseptic processing
- Sterility Assurance Level (SAL) ≥10-3 -
- Appearance and clarity -
- Osmolality Testing -
- pH value Testing
- -Sterility Testing
- Endotoxin Testing -
- Performance Assay -
Shelf Life:
YOCON BIOLOGY TECHNOLOGY COMPANY performs shelf-life testing for subject device using retained product stored at 2-8°C, and subject device is performed performance testing over 12 months. The test results support a shelf life of 12 months for MSC SFM.
Biocompatibility:
The Biological Evaluation compliance with the standards of ISO 10993-1, "Biological Evaluation of Medical Devices".
8. Conclusion
Yocon MSC SFM is substantially equivalent to StemPRO®MSC SFM Medium 510(k) K103302.