(359 days)
No
The summary describes a culture medium and its performance testing, with no mention of AI or ML technology.
No
This device is a culture medium for human embryos, which is used for in vitro culture, and not for direct therapeutic treatment on a living organism.
No
V-ONESTEP is a culture medium used for growing human embryos, not for diagnosing medical conditions. The provided studies focus on product quality and sterility, not diagnostic performance.
No
The device description clearly states it is a "medium for culturing human embryos" and is provided in "glass or PETG bottles," indicating it is a physical substance and its packaging, not software. The performance studies also focus on physical and biological properties of the medium.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro culture of human embryos". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a "medium for culturing human embryos," which is a substance used to support biological processes outside of a living organism.
- Performance Studies: The performance studies include tests like pH, osmolality, endotoxin, and MEA (Mouse Embryo Assay), which are standard tests for evaluating the suitability of culture media used in in vitro procedures.
- Predicate Device: The predicate device listed is also a "1-Step Culture Medium," further indicating that this type of product is classified as an IVD.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device isn't directly diagnosing a disease, it is used in the process of assisted reproduction, which involves in vitro procedures to address infertility. Culture media used in such procedures are considered IVDs because they are used to support biological processes outside the body for a medical purpose.
N/A
Intended Use / Indications for Use
V-ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development
Product codes
MQL
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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): ]): No growth
- 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)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 | ): ]): 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.