(240 days)
Not Found
No
The device description and performance studies focus on the chemical composition, sterility, and biological performance of fertilization media, with no mention of AI/ML or related technologies.
No
The device is a medium for handling human gametes and embryos, and for use in IVF procedures. It does not directly treat a disease or condition.
No
Explanation: The devices are media products intended for the preparation, handling, and flushing of gametes and embryos during in vitro fertilization procedures. They are used to facilitate the process, not to diagnose a condition or disease.
No
The device description clearly states that the devices are media products provided in bottles, which are physical components, not software. The performance studies also focus on the chemical and biological properties of the media.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the media are for "preparation and handling of human gametes and for in vitro fertilization." In vitro fertilization is a process that occurs outside of the body, involving the manipulation of biological samples (gametes).
- Device Description: The description details media products used in the process of in vitro fertilization, which is an in vitro procedure.
- Performance Studies: The performance studies include testing like MEA (Mouse Embryo Assay), which is a common test for media used in assisted reproductive technologies, further supporting its use in an in vitro setting.
While the device description mentions contact with the patient for the Flushing Buffer Medium, the primary function and intended use of all three media are for handling and manipulating biological samples (gametes and embryos) in vitro as part of the IVF process. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
MQL
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 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.
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
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): ): 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:
- Cytotoxicity per ISO 10993-5: 2009
- Sensitization per ISO 10993-10: 2010
- Irritation per ISO 10993-10: 2010
The testing demonstrated that VitaVitro® Flushing Buffer Medium is non-sensitizing, and nonirritating.
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.
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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). |
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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 | 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): ): 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.