The provided text describes the 510(k) summary for V-ONESTEP, a reproductive medium. Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Subject Device)	Reported Device Performance (Subject Device)	Predicate Device Criteria (for comparison)
pH	7.2-7.4	7.20-7.4 (Likely a range, actual results stated as 7.20-7.4)	7.2-7.6
Osmolality	257-273 mOsm/kg	257-273 mOsm/kg (Likely a range, actual results stated as 257-273 mOsm/kg)	250-290 mOsm/kg
Endotoxin (per USP<85>)	< 0.25 EU/ml	< 0.25 EU/ml	< 0.25 EU/ml
MEA (1-cell Mouse Embryo Assay)	≥ 80% expanded blastocysts at 120 hours	≥ 80% expanded blastocysts at 120 hours	≥ 80% expanded blastocysts within 96 hours
Sterility (per Ph. Eur 2.6.1 harmonized with USP<71>)	No growth	No growth	No growth

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

The text explicitly mentions a "1-cell mouse embryo assay (MEA)" as part of the performance testing.

Sample Size: The text states, "One-cell mouse embryos were exposed to the subject device..." but does not specify the number of embryos used in this assay. It also mentions "in comparison with the control group" but doesn't elaborate on the size of the control group.
Data Provenance: Not specified. It's unclear where the mouse embryos originated or if the study was retrospective or prospective, though performance testing for device clearance is typically prospective lab-based testing.

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

Not Applicable. For this type of device (reproductive media), the ground truth is established through laboratory assays (MEA, pH, osmolality, endotoxin, sterility) rather than expert review of images or clinical outcomes. The device's performance is objectively measured against pre-defined thresholds.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, the ground truth is based on objective laboratory measurements, not expert consensus or adjudication.

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 device is a reproductive medium, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is a fluid for culturing embryos; there is no algorithm or AI component. The "standalone performance" refers to the intrinsic performance of the medium itself as measured by the assays mentioned.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation relies on objective laboratory measurements based on established scientific methods and regulatory standards:
- Chemical parameters: pH, osmolality.
- Biological assay: 1-cell MEA (development to expanded blastocyst stage).
- Contamination assessment: Endotoxin levels, Sterility (no growth).

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The formulation of the medium itself is developed through research and experimentation, but there isn't a "training set" like in machine learning.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question doesn't apply. The development of the medium's formulation would be based on scientific knowledge of embryo development requirements.

Summary

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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.

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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

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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)

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510(k) Summary - K193285

510(k) Owner	VITROMED GmbHHans-Knöell-Str. 607745 JenaGermanyPhone: +49 36 41 5 39 19 76Facsimile: +49 36 41 5 39 19 77
Contact person	Greg HollandRegulatory Specialists, Inc.628 El Mirador DriveFullerton, CA 92835Phone: 949.262.0411Fax: 949.552.2821Email: 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, Ltd1-Step Culture MediumK191063

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

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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):	K193285V-ONESTEPSubjectDevice	K1910631-StepCultureMediumPredicateDevice	Comparison
Indication for Use Statement	V-ONESTEPis intended forthe in vitroculture ofhumanembryosfollowingfertilizationuntil day 5/6 ofdevelopment.	This productis intendedfor the invitro cultureof humanembryosfollowingfertilizationuntil Day 5/6ofdevelopment.	Same: Thesubject andpredicatedevices havethe sameindicationsfor use andintended uses.
Formulation	Calciumlactate 5H20NaHCO3SodiumhyaluronateKCINaClMgSO4,7H2OKH2PO4EDTA,4NaPhenol RedSodium saltCitric acid,3Na saltdihydrateD-Pantothenicacid calciumsalt	PhysiologicalsaltsAmino acidsTaurineAlanyl-glutamineEnergysourcesAntioxidantBufferHSAGentamicinsulphatePhenol Red	Different:The materialsin the subjectand predicatedevices arenot identical.Thisdifferencedoes not raisedifferentquestions ofSafety andEffectiveness(S&E).
	Alanyl-glutamine
	D(+)Glucose
	Sodiumpyruvate
	Gentamicine
	L-Argininehydrochloride
	L-Cystine
	L-Histidinehydrochloride-H2O
	L-Isoleucine
	L-Leucine
	L-Lysinehydrochloride
	L-Methionine
	L-Phenylalanine
	L-Threonine
	L-Tryptophan
	L-Tyrosine
	L-Valine
	L-AsparticAcid
	L-Glutamicacid
	Glycine
	L-Proline
	L-Asparagine.H2O
	L-Serine
	Human SerumAlbumin
Shelf Life	90 days	6 months	Different:Shelf-lifedifferences donot raisedifferentquestions of
			S&E
pH	7.2-7.4	7.2-7.6	Similar
Osmolality	257-273mOsm/kg	250-290mOsm/kg	Similar
Endotoxin	<0.25 EU/ml	< 0.25 EU/ml	Same
MEA	1-cell MEA:≥80%expandedblastocysts at120 hours	1-cell MEA:≥80%expandedblastocystswithin 96hours	Different:The MEAassessmenttime for thesubject deviceis longer thanpredicate. Thelongerassessmenttime for thesubject devicedoes not raisedifferentquestions ofS&E.
Sterility	No growth	No growth	Same

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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

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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.

Regulation Number and Section

§ 884.6180 Reproductive media and supplements.

(a)
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.).(b)
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.