Who is the manufacturer of V-ONESTEP?

Vitromed GmbH filed the 510(k) submission for V-ONESTEP (K193285).

What is the FDA product code for V-ONESTEP?

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

What is the regulatory pathway for V-ONESTEP?

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

What are the predicate devices for V-ONESTEP?

1-Step Culture Medium (K191063).

Who can help prepare an FDA 510(k) submission like V-ONESTEP?

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.

V-ONESTEP

K193285 · Vitromed GmbH · MQL · Nov 20, 2020 · Obstetrics/Gynecology

Device Facts

Record ID	K193285
Device Name	V-ONESTEP
Applicant	Vitromed GmbH
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Nov 20, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended Use

V-ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development.

Device Story

V-ONESTEP is a sterile-filtered culture medium used in assisted reproduction laboratories. It provides the necessary physiological environment for human embryos to develop from fertilization through the blastocyst stage (day 5/6). The medium is supplied in 20 ml glass or 10 ml PETG bottles and is intended for use by embryologists in a clinical setting. The device supports embryo development by maintaining specific pH and osmolality levels. Healthcare providers use the medium to culture embryos in an incubator at 37°C with 5% CO2. The output is the successful development of embryos, which facilitates clinical decision-making regarding embryo selection for transfer, potentially improving patient outcomes in fertility treatments.

Clinical Evidence

Bench testing only. Performance was validated through pH testing (7.2-7.4), osmolality (257-273 mOsm/kg), endotoxin levels (<0.25 EU/ml), and 1-cell Mouse Embryo Assay (≥80% expanded blastocysts at 120 hours). Sterility was confirmed per Ph. Eur 2.6.1/USP<71>. Stability and shelf-life (90 days) were verified, including performance 7 days post-opening. Shipping and distribution testing were also conducted.

Technological Characteristics

Aqueous culture medium containing physiological salts, amino acids, energy sources, antioxidants, buffers, and human serum albumin. Formulated with calcium lactate, NaHCO3, sodium hyaluronate, KCl, NaCl, MgSO4, KH2PO4, EDTA, phenol red, and various amino acids. Sterile-filtered; packaged in 20 ml glass or 10 ml PETG bottles. Sterilization validation per ISO 13408-1:2008 and ISO 13408-2:2018. Shelf-life of 90 days at 2-8°C.

Indications for Use

Indicated for the in vitro culture of human embryos following fertilization until day 5/6 of development.

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

1-Step Culture Medium (K191063)

Related Devices

K220715 — ARTSMedia In Vitro Culture Medium (AM-IVC Medium) · Artsmedia Denmark Aps · Feb 10, 2023
K200249 — Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) · Kitazato Corporation · Oct 23, 2020
K170602 — Continuous Single Culture-NX Complete (CSCM-NXC) · Irvine Scientific Sales Co., Inc. · Jun 7, 2017
K133707 — SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS · Origio A/S · Apr 16, 2014
K213293 — V-HEPES PLUS · Vitromed Langenfeld · Sep 14, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 20, 2020 VITROMED GmbH % Greg Holland Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Re: K193285 > Trade/Device Name: V-ONESTEP Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: October 19, 2020 Received: October 20, 2020 Dear Greg Holland: 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. 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. {1}------------------------------------------------ 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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 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-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) K193285 Device Name V-ONESTEP Indications for Use (Describe) V - ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development Type of Use (Select one or both, as applicable) X 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." {3}------------------------------------------------ ## 510(k) Summary - K193285 | 510(k) Owner | VITROMED GmbH Hans-Knöell-Str. 6 07745 Jena Germany Phone: +49 36 41 5 39 19 76 Facsimile: +49 36 41 5 39 19 77 | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person | Greg Holland Regulatory Specialists, Inc. 628 El Mirador Drive Fullerton, CA 92835 Phone: 949.262.0411 Fax: 949.552.2821 Email: greg@regulatoryspecialists.com | | Date Prepared | November 18, 2020 | | Trade/Device Name | V-ONESTEP | | Common Name | Assisted Reproduction Medium | | Regulation Name | Reproductive Media and Supplements | | Regulation Number | 21 CFR 884.6180 | | Product Code | MQL (Media, Reproductive) | | Class | Class II | | Predicate | Shenzhen VitaVitro Biotech Co, Ltd 1-Step Culture Medium K191063 | The predicate device has not been subject to a design-related recall. #### Description V-ONESTEP is a medium for culturing human embryos following fertilization up to day 6 of development. The device is provided sterile-filtered into pre-sterilized 20 ml glass or 10 ml PETG bottles. V-ONESTEP has a shelf-life of 90 days when stored at 2-8°C and can be use for seven days after opening bottles. Additional information on the formulation and specifications of V-ONESTEP are provided in the Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics section of this summary. ### Indications for Use {4}------------------------------------------------ V-ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development. ## Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics A comparison of the intended use and technological features of the subject and predicate devices are described in the table below: | Device & Predicate Device(s): | K193285 V-ONESTEP Subject Device | K191063 1-Step Culture Medium Predicate Device | Comparison | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use Statement | V-ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development. | This product is intended for the in vitro culture of human embryos following fertilization until Day 5/6 of development. | Same: The subject and predicate devices have the same indications for use and intended uses. | | Formulation | Calcium lactate 5H20 NaHCO3 Sodium hyaluronate KCI NaCl MgSO4,7H2O KH2PO4 EDTA,4Na Phenol Red Sodium salt Citric acid, 3Na salt dihydrate D-Pantothenic acid calcium salt | Physiological salts Amino acids Taurine Alanyl- glutamine Energy sources Antioxidant Buffer HSA Gentamicin sulphate Phenol Red | Different: The materials in the subject and predicate devices are not identical. This difference does not raise different questions of Safety and Effectiveness (S&E). | | | Alanyl- glutamine | | | | | D(+)Glucose | | | | | Sodium pyruvate | | | | | Gentamicine | | | | | L-Arginine hydrochloride | | | | | L-Cystine | | | | | L-Histidine hydrochloride- H2O | | | | | L-Isoleucine | | | | | L-Leucine | | | | | L-Lysine hydrochloride | | | | | L-Methionine | | | | | L- Phenylalanine | | | | | L-Threonine | | | | | L-Tryptophan | | | | | L-Tyrosine | | | | | L-Valine | | | | | L-Aspartic Acid | | | | | L-Glutamic acid | | | | | Glycine | | | | | L-Proline | | | | | L- Asparagine.H2 O | | | | | L-Serine | | | | | Human Serum Albumin | | | | Shelf Life | 90 days | 6 months | Different: Shelf-life differences do not raise different questions of | | | | | S&E | | pH | 7.2-7.4 | 7.2-7.6 | Similar | | Osmolality | 257-273 mOsm/kg | 250-290 mOsm/kg | Similar | | Endotoxin | <0.25 EU/ml | < 0.25 EU/ml | Same | | MEA | 1-cell MEA: ≥80% expanded blastocysts at 120 hours | 1-cell MEA: ≥80% expanded blastocysts within 96 hours | Different: The MEA assessment time for the subject device is longer than predicate. The longer assessment time for the subject device does not raise different questions of S&E. | | Sterility | No growth | No growth | Same | {5}------------------------------------------------ {6}------------------------------------------------ As shown in the table above, the subject and predicate device have the same indications for use statements and the same intended use. The technological characteristics of the subject and predicate device are different as the subject device has differences in formulation, shelf-life, and MEA specification. However, these differences do not raise different questions of safety and effectiveness. ## Summary of Non-Clinical Performance The following studies have been performed to support substantial equivalence to the predicate device: - pH testing: 7.20 7.4 ● - Osmolality testing: 257 273 mOsm/kg ● - Endotoxin (per USP<85>): <0.25 EU/ml . - MEA: 1-cell MEA: ≥80% expanded blastocyst at 120 hours . One-cell mouse embryos were exposed to the subject device and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage at 120 hours were assessed in comparison with the control group. - . Sterility Testing (per Ph. Eur 2.6.1 [harmonized with USP<71>]): No growth {7}------------------------------------------------ - Sterilization validation was conducted in accordance with ISO 13408-1:2008 . (R)2011.- 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 - Shelf-life testing was conducted to ensure that device specifications for the ● following parameters are met at time zero and at the end of shelf-life (90 days): pH, osmolality, sterility, 1-cell MEA, and endotoxin. - . Stability testing after bottle opening was conducted to ensure that device specifications for the following parameters are met seven days after opening of bottles: pH, osmolality, sterility, 1-cell MEA, and endotoxin. - Shipping and distribution testing to assess ability of device packaging to . withstand the rigors of shipping) ### Conclusions The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.