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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a device called "MSC SFM" by Yocon Biology Technology Company. This document primarily describes the regulatory review process and establishes substantial equivalence to a predicate device.

Crucially, this document is for a "Tissue Culture Media For Human Ex Vivo Tissue And Cell Culture Processing Applications" (Product Code: NDS). This is a biological reagent, not an AI/ML-driven medical device that analyzes images or patient data to produce diagnostic or prognostic outputs. Therefore, many of the requested elements regarding acceptance criteria and study design for AI/ML devices (e.g., number of experts for ground truth, MRMC study, effect size of human improvement with AI, standalone performance) are not applicable to this type of product and are not found in the provided text.

The acceptance criteria discussed in this document pertain to the performance and safety of the tissue culture media itself, not the performance of an AI algorithm.

However, based on the information provided, here's what can be extracted and inferred, addressing the spirit of the request where applicable to this specific product, and explicitly stating when information is not applicable or not provided in the document for AI/ML-specific criteria.

Device Type: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications (Biological Reagent)

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to performance standards established in the FDA 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. While the specific numerical acceptance criteria for each test are not explicitly detailed in this 510(k) summary, the types of tests performed and the general findings are mentioned.

Acceptance Criteria (Type of Test)	Reported Device Performance / Compliance
Validation of aseptic processing (compliance with GMP requirements)	"determine that SAL 10-3 compliance with GMP requirements regarding aseptic processing."
Sterility Assurance Level (SAL)	"SAL ≥10-3" (This is a target, stated as met via validation.)
Appearance and clarity	Tested (Results implicitly comply as conclusion is substantial equivalence)
Osmolality Testing	Tested (Results implicitly comply)
pH value Testing	Tested (Results implicitly comply)
Sterility Testing	Tested (Results implicitly comply)
Endotoxin Testing	"Bacterial Endotoxin <0.25EU/mL (USP <85>)"
Performance Assay (Demonstrate lack of potential toxicity and support of tissue/cell growth)	"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."
Shelf Life (at 2-8°C)	"The test results support a shelf life of 12 months for MSC SFM."
Biocompatibility	"Compliance with the standards of ISO 10993-1, 'Biological Evaluation of Medical Devices'."

Note: The FDA 510(k) summary typically summarizes the results of the testing that support substantial equivalence, rather than providing the detailed raw data or specific numerical acceptance ranges for each test (unless failure of a specific range was a critical point to address). The "Special Controls Guidance Document" would contain the full details of the appropriate acceptance criteria.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: The document does not specify exact sample sizes for each test (e.g., how many batches were tested for sterility, how many cells for performance assay). It refers to "non-clinical data" and "Performance Assay."
Data Provenance: The manufacturing company is YOCON BIOLOGY TECHNOLOGY COMPANY, located in Beijing, China. The testing would have been conducted by the manufacturer, presumably in China. The data would be prospective in the sense that it was generated for the purpose of demonstrating device performance for this FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. This is a biological reagent, not an AI/ML device requiring human expert annotation of data for ground truth. The "ground truth" for this product is based on established laboratory testing methods, chemical properties, and biological assays (e.g., cell viability, proliferation, differentiation markers, endotoxin levels).

4. Adjudication Method for the Test Set

Not Applicable. As there are no human expert readers generating subjective interpretations, there is no need for an adjudication method. Laboratory tests have defined protocols and result interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI/ML device meant to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This document describes a tissue culture medium, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this tissue culture media is established through a combination of:

Laboratory Standard Tests: Such as USP <85> for Endotoxin, pH, Osmolality, Sterility Testing.
Biological Performance Assays: Demonstrating the medium's ability to "support of tissue and cell growth" and "lack of potential toxicity" for human mesenchymal stem cells (MSCs), including maintaining their "trilineage mesoderm potential."
Compliance with Standards: Adherence to ISO 10993-1 for biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device with a training set. The "training" for this product would be the research and development involved in formulating the medium to meet the desired performance characteristics.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" during product development would be empirical lab results guiding formulation optimization, similar to the performance tests listed in section 7.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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 China100094
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 VivoTissue And Cell Culture Processing Application
Regulation Class:	II
Product Code:	NDS

4. Device Description

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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 deviceK103302	Comments
Manufacturer	YOCON BIOLOGYTECHNOLOGY COMPANY	Life TechnologiesCorporation	--
Trade name	MSC SFM	StemPro MSC SFM Medium	--
Classification'sname andRegulationName	Regulation Number: 21 CFR876.5885	Regulation Number: 21 CFR876.5885	Same
	Regulation Name: Media,Culture, Ex Vivo, Tissue AndCell	Regulation Name: Media,Culture, Ex Vivo, Tissue AndCell
	Regulation Class: Class IIProduct Code: NDS	Regulation Class: Class IIProduct Code: NDS
Indications foruse	MSC SFM is a liquid tissueculture medium productsintended for human ex-vivotissue and cell cultureprocessing applications.	StemPro MSC SFM Mediumis a liquid tissue culturemedium products intendedfor human ex-vivo tissue andcell culture processingapplications.	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 thepredicate device is notavailable because theformulation is confidential.

	HCl, Vitamin B12, i-Inositol,Calcium Chloride (CaCl2)Anhydrous, MagnesiumChloride(MgCl2 anhydrous),Magnesium Sulfate(MgSO4)-7H2O, PotassiumChloride (KCl), SodiumBicarbonate(NaHCO3), Sodium Chloride(NaCl), Sodium Phosphatedibasic(Na2HPO4)-7H2O, SodiumDihydrogenPhosphate-1H2O, D-Glucose (Dextrose),Hypoxanthine Na, SodiumPyruvate, Biotin, Cupricsulfate, Iron(III)nitratenonahydrate(Fe[NO3]3·9[H2O]), FerrousSulfate(FeSO4-7H2O),Linoleic Acid, Lipoic Acid,Putrescine2HCl, SodiumSelenite(Na2SeO3),Recombinant HumanTransferrin, RecombinantHuman serum albumin,Recombinant Human Insulin,Recombinant HumanFibronectin, EGF
Demonstratelack of potentialtoxicity ofmaterials in themedia to cells ortissue anddemonstratesupport of tissueand cell growth	Performance Assay	StemPro MSC SFMPerformance Assay	Different,The performance assaydata of predicate device isnot available because thisinformation is confidential.We have conducted non-clinical testing. Results ofthe testing demonstrate alack of potential toxicity ofthe materials in the mediato cells or tissue anddemonstrates support oftissue and cell growth.

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Endotoxin andPyrogencontamination	BacterialEndotoxin<0.25EU/mL(USP<85>)	Limulus Ameobocyte (LAL)test (25 USP Monograph<85>)	Same
Validation ofAsepticProcessing andSterilityAssurance Level(SAL)	Through the validation ofAseptic processing andSterility Assurance Level(SAL), determine that SAL l0-3 compliance with GMPrequirements regardingaseptic processing.	Through the validation ofAseptic processing andSterility Assurance Level(SAL), determine that SAL l0-3 compliance with GMPrequirements regardingaseptic 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.

Regulation Number and Section

§ 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.”