VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

Q: Who is the manufacturer of VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

Shenzhen Vitavitro Biotech Co., Ltd. filed the 510(k) submission for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium (K200408).

Q: What is the FDA product code for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

Q: What is the regulatory pathway for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

Global® Total® for Fertilization w/ HSA (K142991); Quinn's HTF Medium with HEPES (K991395); Sydney IVF Follicle Flush Buffer (K153290).

Q: Who can help prepare an FDA 510(k) submission like VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K200408 · Shenzhen Vitavitro Biotech Co., Ltd. · MQL · Oct 16, 2020 · Obstetrics/Gynecology

Device Facts

Record ID	K200408
Device Name	VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
Applicant	Shenzhen Vitavitro Biotech Co., Ltd.
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Oct 16, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended Use

VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

Device Story

VitaVitro media products (Fertilization Medium, Gamete Buffer Medium, Flushing Buffer Medium) are specialized solutions for assisted reproductive technology (ART). Fertilization Medium supports gamete preparation and fertilization; Gamete Buffer Medium facilitates short-term handling outside incubators (e.g., washing, ICSI); Flushing Buffer Medium assists in oocyte retrieval during follicle flushing. Used in clinical IVF laboratories by embryologists and clinicians. Products are aseptically filled in PETG bottles, single-use, and stored at 2-8°C. These media provide the necessary chemical environment (pH, osmolality, nutrients) to maintain gamete/embryo viability during laboratory manipulation, directly supporting successful fertilization and embryo development outcomes.

Clinical Evidence

Bench testing only. Performance validated via pH testing (7.2-7.6), osmolality (260-290 mOsm/kg), endotoxin (<0.25 EU/ml), and Mouse Embryo Assay (MEA) showing ≥80% expanded blastocyst development. Sterility confirmed per USP <71>. Biocompatibility for Flushing Buffer Medium (cytotoxicity, sensitization, irritation) performed per ISO 10993. Shelf-life validated via accelerated aging.

Technological Characteristics

Aqueous-based reproductive media containing glucose, salts, amino acids, taurine, EDTA, phenol red, gentamicin sulfate, and HSA. Packaged in PETG bottles. Aseptically processed and sterile-filtered. pH 7.2-7.6; osmolality 260-290 mOsm/kg. Biocompatibility testing per ISO 10993-1, 10993-5, and 10993-10. Transportation testing per ASTM D4169-2016. Sterilization validation per ISO 13408-1 and 13408-2.

Indications for Use

Indicated for use in human assisted reproduction procedures, specifically for the preparation, handling, and washing of gametes and embryos, and for oocyte collection and follicle flushing.

Regulatory Classification

Identification

Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

Global® Total® for Fertilization w/ HSA (K142991)
Quinn's HTF Medium with HEPES (K991395)
Sydney IVF Follicle Flush Buffer (K153290)

Related Devices

K234023 — Oocyte Flushing & Retrieval Medium; Gamete Buffer · Gimbo Medical Technology Shenzhen Co., Ltd. · May 10, 2024
K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium · William A. Cook Australia Pty. , Ltd. · Jan 27, 2016
K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Aug 27, 2025
K242107 — CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) · Casebioscience, Inc. · Mar 21, 2025
K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin · Fertipro NV · May 30, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ 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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human figures, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. October 16, 2020 Shenzhen VitaVitro Biotech Co., Ltd. Donghai Pan International Regulatory Specialist R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No. 16 Shenzhen, Guangdong 518118 China Re: K200408 Trade/Device Name: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium Regulation Number: 21 CFR § 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: September 4, 2020 Received: September 14, 2020 Dear Donghai Pan: 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) 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 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). Sincerely. For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology 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) K200408 # Device Name VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium # Indications for Use (Describe) VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg height="15" width="15"> <rect height="15" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> <path d="M 2 2 L 13 13 M 13 2 L 2 13" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div> <svg height="15" width="15"> <rect height="15" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | | 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}------------------------------------------------ # 510(k) Summary K200408 #### 1. Submission Sponsor Shenzhen VitaVitro Biotech Co., Ltd. R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No.16 Shenzhen, Guangdong, 518118, P. R. China Contract Person: Jenny Lin Title: General Manager Tel: 86-755-84511813 Fax: 86-755-85235226 Email: jenny@vitavitro.com #### Date Prepared 2. October 15, 2020 ### Device Identification 3. | Trade/Device Name: | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium | |------------------------|--------------------------------------------------------------------------------------------------------| | Common Name: | Assisted Reproduction Medium | | Regulation Number: | 21 CFR 884.6180 | | Regulation Name: | Reproductive Media and Supplements | | Device Classification: | Class II | | Product Code: | MQL (Media, Reproductive) | #### 4. Predicate Device | Subject Device | VitaVitro® Fertilization Medium | VitaVitro® Gamete Buffer Medium | VitaVitro® Flushing Buffer Medium | | |---------------------|--------------------------------------------|----------------------------------|---------------------------------------|--------------------------------------| | Name | Global® Total® for Fertilization w/ HSA | Quinn's HTF Medium with HEPES | Sydney IVF Follicle Flush Buffer | | | Predicate Device | Manufacturer | Lifeglobal Group, LLC | Advanced Reproductive Technologies | William A. Cook Australia Pty Ltd | | | 510(k) No. | K142991 | K991395 | K153290 | The predicate devices have not been subjected to any design related recalls. ### 5. DEVICE DESCRIPTION This submission includes three media products: - . VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. Media provided in volumes of 30 ml and 60 ml. - . VitaVitro® Gamete Buffer Medium intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). Media provided in a {4}------------------------------------------------ single volume of 60 ml. - . VitaVitro® Flushing Buffer Medium intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection. Media provided in volumes of 60 ml and 125 ml. All devices are aseptically filled into radiation-sterilized PETG bottles, are single-use only, and have a shelf-life of six-months when stored as recommended at 2-8°C. Additional information on the formulation of the subject devices is provided in Section 7 of this summary. ### INDICATIONS FOR USE: 6. The subject device Indications for Use statements (IFU) are shown below: | No. | Device Name | INDICATIONS FOR USE | |-----|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | VitaVitro® Fertilization Medium | VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. | | 2 | VitaVitro® Gamete Buffer Medium | VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). | | 3 | VitaVitro® Flushing Buffer Medium | VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures. | A comparison of the subject and predicate device intended use is shown below: | Subject Device IFU statement | Predicate Device IFU Statement | Intended Use Comparison | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. | Global Total Fertilization with HSA: Oocyte culture and fertilization | The IFU statement wording is different but the intended use is the same i.e. (handling of human gametes and in vitro fertilization). | | VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). | Quinn's HTF medium with HEPES was developed for in vitro procedures involving manipulations of gametes and embryos not requiring the use of a CO2 incubator. Such procedures include oocyte recovery, gamete washing, micromanipulation, embryo transfer and cryopreservation. | The intended use of the subject and predicate device is the same regarding short-term handling procedures of human gametes and embryo outside of an incubator. However, the predicate device has additional uses beyond that of the subject device (embryo transfer and cryopreservation). These differences do not represent a new intended use, but rather a more limited intended use for the subject device. | | VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization | Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection. | The intended use of the predicate and subject device is the same (follicle flushing and oocyte collection). | {5}------------------------------------------------ procedures. ## 7. Substantial Equivalence Discussion A comparison of the technological features of the subject and predicate device are described in the table below: | Device & Predicate Device(s): | K200408 Vita Vitro® Fertilization Medium, Vita VitroⓇ Gamete Buffer Medium, and Vita Vitro® Flushing Buffer Medium | K142991 Global Total Fertilization with HSA (predicate for Vita Vitro® Fertilization Medium) | K991395 Quinn's HTF Medium with HEPES (predicate for Vita VitroⓇ Gamete Buffer Medium) | K153290 Sydney IVF follicle flush buffer (predicate for Vita Vitro® Flushing Buffer Medium) | Comments | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Formulation | Glucose Sodium Lactate Sodium Pyruvate HEPES* HEPES Sodium* Sodium Bicarbonate Sodium Chloride Potassium Chloride Potassium Phosphate Magnesium Sulphate Calcium Chloride Amino acids Taurine Sodium Citrate EDTA Phenol red Gentamicin sulfate HSA** | Sodium Chloride Calcium chloride Potassium Phosphorus Magnesium Sulfate Sodium Bicarbonate Glucose Sodium Lactate Sodium Pyruvate Amino acids Glycine glutamine EDTA Phenol red Gentamicin sulfate HSA Water | Not known | D-Glucose Gentamicin Calcium -Lactate Glutamine Glycine L-alanine L-asparagine L-aspartic acid L-glutamic acid L-proline L-serine Magnesium sulphate Potassium chloride Potassium phosphate Purified water Sodium bicarbonate Sodium chloride Sodium pyruvate Taurine | Different: The materials in the formulations of the subject and their respective predicate devices are not identical or is not known (i.e., predicate for VitaVitro® Gamete Buffer Medium). These differences do not raise different questions of Safety and Effectiveness (S&E). | | | | | | | | | Packaging | 30 and 60 ml PETG square bottle – Fertilization Medium 60 ml PETG square bottle – Gamete Buffer Medium 60 and 125 ml PETG square bottle – Flushing Buffer Medium | 50 and 100 ml | Not known | 20, 50, and 100 ml borosilicate Type 1 glass vial with Fluorotec coated rubber stopper | Different: Bottle sizes between the subject devices and their respective predicates are not the same or are not known (i.e., predicate for VitaVitro® Gamete Buffer Medium). Differences in packaging do not raise different questions of S&E. | | Shelf-life | 6 months | 10 weeks | Not known | 20 weeks | Different: Shelf-life of the subject devices and their respective predicates are not the same or is not known (i.e., predicate for VitaVitro® Gamete Buffer Medium). Differences in shelf-life do not raise different questions of S&E. | | pH | 7.2-7.6 | 7.2-7.4 | Not known | 7.37.50 | Different. The subject devices pH range is greater than their respective predicate devices (i.e., 7.6) or is not known (i.e., predicate for VitaVitro® Gamete Buffer Medium). Differences in pH do not raise different questions of S&E. | | Osmolality | 260-290 | 260-270 | Not known | 285-295 | Different. The subject devices osmolality specifications are different than their respective predicate devices or is not known | | | | | | | | | | | | | | (i.e., predicate for VitaVitro® Gamete Buffer Medium). Differences in osmolality do not raise different questions of S&E. | | Endotoxin | <0.25 | <0.5 EU/ml | Not Known | <0.40 EU/Ml | Different: The endotoxin specifications for the subject devices is lower than their respective predicates or is not known (i.e., predicate for VitaVitro® Gamete Buffer Medium). Differences in endotoxin specifications do not raise different questions of S & E. | | MEA | 1-cell MEA: ≥80% expanded blastocyst at 96 hours after a 24-hour exposure to media (Fertilization media). 1-cell MEA: ≥80% expanded blastocyst at 96 hours after a 2-hour exposure to media (Gamete Buffer Medium and Flushing Buffer Medium). | 1-cell MEA≥80% blastocysts at 96 h of culture | Not Known | >80% 2-Cell MEA | Different: The MEA specifications for the subject devices (e.g., embryo type, exposure to test media, etc.) is different than their respective predicates or is not known (i.e., predicate for VitaVitro® Gamete Buffer Medium). Differences in MEA specifications do not raise different questions of S & E. | | Sterility | No growth | SAL 10-3 | Not Known | Aseptically filtered | Different: The sterility specification is different than its respective predicate devices or is not known ((i.e., predicate for VitaVitro® Gamete Buffer Medium). This difference does not raise different questions of | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | | | | | | S&E. | |--|--|--|--|--|------| |--|--|--|--|--|------| *not included in Fertilization Medium **not included in Flushing Buffer Medium The technological characteristics of the subject devices and their respective predicate devices are not the same as stated in the table above (e.g., formulation, packaging, shelf-life, device specifications, etc.). However, the differences in technological characteristics do not raise different questions of safety and effectiveness as compared to their respective predicate devices. #### Summary of Non-Clinical Performance 8. VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, and VitaVitro® Flushing Buffer Medium underwent the following testing to assess their performance and demonstrate substantial equivalence to their respective predicate devices. The testing and specifications below, unless otherwise stated, apply to each of the subject media products: - . pH testing: 7.20 - 7.60 - Osmolality testing: 260 290 mOsm/kg . - Endotoxin (per USP<85>): <0.25 EU/ml ● - . MEA; - I 1-cell MEA: ≥80% expanded blastocyst at 96 hours after a 24-hour exposure to media (Fertilization media). - ı 1-cell MEA: ≥80% expanded blastocyst at 96 hours after a 2-hour exposure to media (Gamete Buffer Medium and Flushing Buffer Medium). - . Sterility Testing (per USP <71>): No growth - . Shelf-life testing was conducted at time 0 and after accelerated aging (equivalent to six months of real-time aging) to ensure the product specifications listed above were met. - . Transportation testing per ASTM D4169-2016 (Standard Practice for Performance Testing of Shipping Containers and Systems) - . Sterilization validation was conducted in accordance with ISO 13408-1: 2015 (Aseptic processing of health care products - Part 1: General requirements) and ISO 13408-2: 2018 (Aseptic processing of health care products -Part 2: Sterilizing filtration). - . Biocompatibility testing was conducted on VitaVitro® Flushing Buffer Medium as this device will have direct contact with the patient during use. Testing was conducted in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included: - I Cytotoxicity per ISO 10993-5: 2009 - . Sensitization per ISO 10993-10: 2010 - I Irritation per ISO 10993-10: 2010 The testing demonstrated that VitaVitro® Flushing Buffer Medium is non-sensitizing, and nonirritating. #### 9. Conclusion The results of the performance testing described above demonstrate that the subject media products are as safe and effective as their respective predicate devices and support a determination of substantial equivalence.