MSC SFM

K232543 · Yocon Biology Technology Company · NDS · Sep 6, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K232543
• Device Name: MSC SFM
• Applicant: Yocon Biology Technology Company
• Product Code: NDS · Gastroenterology, Urology
• Decision Date: Sep 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5885
• Device Class: Class 2

Intended Use

MSC SFM is a liquid tissue culture medium product intended for human ex-vivo tissue and cell culture processing applications.

Device Story

MSC SFM is a serum-free liquid tissue culture medium consisting of a basal medium and a growth factor supplement. It is used in laboratory settings by trained personnel to support the growth and expansion of human mesenchymal stem cells (MSCs). The medium enables MSC expansion over multiple passages while maintaining trilineage mesoderm differentiation potential (osteogenic and adipogenic). The device is aseptically filled and stored at 2-8°C. It serves as a growth environment for cells intended for ex-vivo processing; it does not provide diagnostic or therapeutic output directly to a patient. Its primary benefit is providing a standardized, serum-free environment for cell culture research and processing applications.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via aseptic processing validation (SAL 10^-3), sterility testing, endotoxin testing (<0.25 EU/mL per USP <85>), osmolality, pH, and performance assays demonstrating MSC growth and expansion capabilities. Biocompatibility evaluated per ISO 10993-1.

Technological Characteristics

Serum-free liquid tissue culture medium. Components include amino acids, vitamins, inorganic salts, and recombinant proteins (transferrin, albumin, insulin, fibronectin, EGF). Aseptically filled. Shelf life of 12 months at 2-8°C. Complies with ISO 10993-1 for biocompatibility and USP <85> for endotoxin limits.

Indications for Use

Indicated for human ex-vivo tissue and cell culture processing applications. No specific patient population, age, or gender restrictions apply as it is a laboratory reagent for cell culture.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• StemPro MSC SFM Medium (K103302)

Submission Summary (Full Text)

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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.

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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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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# 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)

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# 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<br>100094 |
| Contact Person: | Haifeng Li |
| E mail: | [e-mail] |
| Tel: | [phone] |

2. 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<br>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.

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## 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<br>K103302 | Comments |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | YOCON BIOLOGY<br>TECHNOLOGY COMPANY | Life Technologies<br>Corporation | -- |
| Trade name | MSC SFM | StemPro MSC SFM Medium | -- |
| Classification's<br>name and<br>Regulation<br>Name | Regulation Number: 21 CFR<br>876.5885 | Regulation Number: 21 CFR<br>876.5885 | Same |
| | Regulation Name: Media,<br>Culture, Ex Vivo, Tissue And<br>Cell | Regulation Name: Media,<br>Culture, Ex Vivo, Tissue And<br>Cell | |
| | Regulation Class: Class II<br>Product Code: NDS | Regulation Class: Class II<br>Product Code: NDS | |
| Indications for<br>use | MSC SFM is a liquid tissue<br>culture medium products<br>intended for human ex-vivo<br>tissue and cell culture<br>processing applications. | StemPro MSC SFM Medium<br>is a liquid tissue culture<br>medium products intended<br>for human ex-vivo tissue and<br>cell culture processing<br>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,<br>The formulation of the<br>predicate device is not<br>available because the<br>formulation is confidential. |
| | | | |
| | HCl, Vitamin B12, i-Inositol,<br>Calcium Chloride (CaCl2)<br>Anhydrous, Magnesium<br>Chloride<br>(MgCl2 anhydrous),<br>Magnesium Sulfate<br>(MgSO4)-7H2O, Potassium<br>Chloride (KCl), Sodium<br>Bicarbonate<br>(NaHCO3), Sodium Chloride<br>(NaCl), Sodium Phosphate<br>dibasic<br>(Na2HPO4)-7H2O, Sodium<br>Dihydrogen<br>Phosphate-1H2O, D-<br>Glucose (Dextrose),<br>Hypoxanthine Na, Sodium<br>Pyruvate, Biotin, Cupric<br>sulfate, Iron(III)nitrate<br>nonahydrate<br>(Fe[NO3]3·9[H2O]), Ferrous<br>Sulfate(FeSO4-7H2O),<br>Linoleic Acid, Lipoic Acid,<br>Putrescine2HCl, Sodium<br>Selenite(Na2SeO3),<br>Recombinant Human<br>Transferrin, Recombinant<br>Human serum albumin,<br>Recombinant Human Insulin,<br>Recombinant Human<br>Fibronectin, EGF | | |
| Demonstrate<br>lack of potential<br>toxicity of<br>materials in the<br>media to cells or<br>tissue and<br>demonstrate<br>support of tissue<br>and cell growth | Performance Assay | StemPro MSC SFM<br>Performance Assay | Different,<br>The performance assay<br>data of predicate device is<br>not available because this<br>information is confidential.<br>We have conducted non-<br>clinical testing. Results of<br>the testing demonstrate a<br>lack of potential toxicity of<br>the materials in the media<br>to cells or tissue and<br>demonstrates support of<br>tissue and cell growth. |

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| Endotoxin and<br>Pyrogen<br>contamination | Bacterial<br>Endotoxin<0.25EU/mL(USP<br><85>) | Limulus Ameobocyte (LAL)<br>test (25 USP Monograph<br><85>) | Same |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Validation of<br>Aseptic<br>Processing and<br>Sterility<br>Assurance Level<br>(SAL) | Through the validation of<br>Aseptic processing and<br>Sterility Assurance Level<br>(SAL), determine that SAL l0-<br>3 compliance with GMP<br>requirements regarding<br>aseptic processing. | Through the validation of<br>Aseptic processing and<br>Sterility Assurance Level<br>(SAL), determine that SAL l0-<br>3 compliance with GMP<br>requirements regarding<br>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.