(182 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the sperm washing and gradient media, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is intended for the preparation and washing of sperm, or separation of motile sperm, for use in assisted reproduction procedures; it does not directly treat a disease or condition itself.
No
The devices are solutions used for preparing and washing sperm for assisted reproduction procedures, not for diagnosing a condition. Their purpose is to facilitate the procedure rather than to identify a disease, condition, or its extent.
No
The device is a physical solution (liquid medium) contained in bottles, not software.
Based on the provided information, these devices are not In Vitro Diagnostics (IVDs).
Here's why:
- Intended Use: The intended use is for the preparation and washing of sperm for use in assisted reproduction procedures and intrauterine insemination. This is a process performed on the biological sample (sperm) to prepare it for a medical procedure, not to diagnose a condition or provide information about a patient's health status.
- Device Description: The devices are described as ready-to-use solutions for preparing sperm. They are media used in the process of handling and preparing the sperm sample.
- Performance Studies: The performance studies focus on the physical and biological properties of the media themselves (pH, osmolality, sterility, sperm survival in the media, etc.) and the effectiveness of the gradient medium in separating sperm. They do not involve testing the media with patient samples to diagnose or monitor a condition.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. These devices are used to process a biological sample for a procedure, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
Vita Vitro® Sperm Washing Medium is intended for preparation and washing of sperm for use in assisted reproduction procedures. Vita Vitro® Sperm Washing Medium is also intenderine insemination procedures.
VitaVitro® Sperm Gradient Medium is intended for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
VitaVitro® Sperm Washing Medium and VitaVitro® Sperm Gradient Medium are ready-to-use solutions intended for preparing sperm for use in assisted reproductive procedures:
- VitaVitro® Sperm Washing Medium is for sperm washing and for intrauterine insemination procedures.
- VitaVitro® Sperm Gradient Medium is for sperm density-gradient centrifugation and separation from seminal fluid.
Both devices have a similar base formulation; however, the VitaVitro® Sperm Gradient Medium formulation differs as it contains silane silica and does not contain Human Serum Albumin (HSA). The silane silica in the VitaVitro® Sperm Gradient Medium (upper layer 80%) generates the density gradient for sperm separation procedures.
The subject devices are aseptically filtered, colorless solutions, contained in transparent and sterilized (gamma irradiation) polyethylene terephthalate glycol (PETG) bottles, sealed with high density polyethylene (HDPE) closures, provided in cardboard boxes, individually labeled and with an instruction for use provided as a package insert.
The devices are provided in the following volumes:
- VitaVitro® Sperm Washing Medium: 30mL, 60mL, and 125mL
- VitaVitro® Sperm Gradient Medium: 12mL, 30mL, and 125mL
Both devices have a two-year shelf-life when stored as recommended. These devices are for single-used only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following studies have been performed to support substantial equivalence to the predicate devices. Results confirm that the design inputs and performance specifications for the device are met.
- Sterile filtration and aseptic fill validation, per ISO 13408-1:2008 (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).
- Transportation testing per ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems).
- Shelf-life testing to support the two-year shelf-life by demonstrating that the product specifications listed in Table 4 were met at time 0 and after accelerated aging in accordance with ASTM F1980-16.
- Biocompatibility testing was conducted in support of the VitaVitro® Sperm Washing Medium that will have direct contact with the patient during IUI procedures. 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 the device formulation to be non-cytotoxic, non-sensitizing, and non-irritating.
- Sperm assessment for motility, morphology, viability, and purity before and after separation procedures using VitaVitro® Sperm Gradient Medium to assess the effectiveness of the device when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Human Sperm Survival Assay (HSSA): ≥ 80% of control motility at 24h
- Endotoxin:
§ 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
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February 1, 2022
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: K212410
Trade/Device Name: VitaVitro® Sperm Washing Medium, VitaVitro® Sperm Gradient Medium Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: December 16, 2021 Received: December 30, 2021
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.
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) K212410
Device Name
VitaVitro® Sperm Washing Medium, VitaVitro® Sperm Gradient Medium
Indications for Use (Describe)
Vita Vitro® Sperm Washing Medium is intended for preparation and washing of sperm for use in assisted reproduction procedures. Vita Vitro® Sperm Washing Medium is also intenderine insemination procedures.
VitaVitro® Sperm Gradient Medium is intended for separation of motile sperm from seminal fluid for use in assisted reproduction 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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3
Image /page/3/Picture/0 description: The image shows the logo for VitaVitro. The logo consists of a stylized green checkmark-like symbol with three rounded points. To the right of the symbol is the text "VitaVitro" in a sans-serif font, also in green. The logo is simple and modern, likely representing the company's name and brand identity.
510(k) SUMMARY K212410
1. Submission Sponsor
Shenzhen VitaVitro Biotech Co., Ltd. R601, Building B, Hai Ke Xing Tech Park Baoshan Road No. 16 Shenzhen 518118 Guangdong China Contract Person: Mr. Donghai Pan Title: International Regulatory Specialist Tel: 86-755-84511813 Fax: 86-755-85235226 Email: pandh@vitavitro.com
2. Date Prepared
January 26, 2022
3. Device Identification
| Trade Name: | VitaVitro® Sperm Washing Medium, VitaVitro® Sperm Gradient Medium |
|---|---|
| Common Name: | Sperm Washing Medium, Sperm Gradient Medium |
| Regulation Number: | 21 CFR 884.6180 |
| Regulation Name: | Reproductive Media and Supplements |
| Regulatory Class: | Class II |
| Product Code: | MQL (Media, Reproductive) |
4. Predicate Device
Table 1. Predicate Devices
| Subject Devices | VitaVitro® Sperm Washing Medium | VitaVitro® Sperm Gradient Medium | |
|---|---|---|---|
| Predicate | |||
| Devices | Trade Name | SepaSperm Washing Solution | SepaSperm Solution |
| Manufacturer | Kitazato Corporation | ||
| 510(k) No. | K190199 | ||
| Regulatory Class | Class II | ||
| Product Code | MQL (Media, Reproductive) |
4
The predicate devices have not been subject to any design-related recalls.
5. Device Description
VitaVitro® Sperm Washing Medium and VitaVitro® Sperm Gradient Medium are ready-to-use solutions intended for preparing sperm for use in assisted reproductive procedures:
- VitaVitro® Sperm Washing Medium is for sperm washing and for intrauterine insemination procedures.
- VitaVitro® Sperm Gradient Medium is for sperm density-gradient centrifugation and separation from seminal fluid.
Both devices have a similar base formulation; however, the VitaVitro® Sperm Gradient Medium formulation differs as it contains silane silica and does not contain Human Serum Albumin (HSA). The silane silica in the VitaVitro® Sperm Gradient Medium (upper layer 80%) generates the density gradient for sperm separation procedures.
The subject devices are aseptically filtered, colorless solutions, contained in transparent and sterilized (gamma irradiation) polyethylene terephthalate glycol (PETG) bottles, sealed with high density polyethylene (HDPE) closures, provided in cardboard boxes, individually labeled and with an instruction for use provided as a package insert.
The devices are provided in the following volumes:
- VitaVitro® Sperm Washing Medium: 30mL, 60mL, and 125mL
- VitaVitro® Sperm Gradient Medium: 12mL, 30mL, and 125mL
Both devices have a two-year shelf-life when stored as recommended. These devices are for single-used only.
6. Indications for Use
| No. | Device Name | Indications for Use |
|---|---|---|
| 1 | VitaVitro® Sperm | |
| Washing Medium | VitaVitro® Sperm Washing Medium is intended for preparation and washing of | |
| sperm for use in assisted reproduction procedures. VitaVitro® Sperm Washing | ||
| Medium is also intended for use in intrauterine insemination procedures. | ||
| 2 | VitaVitro® Sperm | |
| Gradient Medium | VitaVitro® Sperm Gradient Medium is intended for separation of motile sperm from | |
| seminal fluid for use in assisted reproduction procedures. |
Table 2. Indications for Use
7. Comparison of intended use and technological characteristics of the subject and predicate devices
The table below provides comparisons of the intended use and technological characteristics of the subject and predicate devices.
5
| Parameters for
comparison | Subject Devices
VitaVitro® Sperm Washing
Medium, VitaVitro® Sperm
Gradient Medium | Predicate Devices
SepaSperm Washing Solution,
SepaSperm Washing Solution | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | VitaVitro® Sperm Washing Medium
is intended for preparation and
washing of sperm for use in
assisted reproduction procedures.
VitaVitro® Sperm Washing Medium
is also intended for use in
intrauterine insemination
procedures.
VitaVitro® Sperm Gradient Medium
is intended for separation of motile
sperm from seminal fluid for use in
assisted reproduction procedures. | SepaSperm Washing Solution is
used for preparation and washing
of sperm for use in assisted
reproduction procedures.
SepaSperm Washing Solution is
not intended for use in
intrauterine insemination
procedures.
SepaSperm Solution is used for
separation of motile sperm from
seminal fluid for use in assisted
reproduction procedures. | The indications for use
statements for the
VitaVitro® Sperm Washing
Medium and the
SepaSperm Washing
Solution are not identical,
as the VitaVitro® Sperm
Washing Medium can also
be used for intrauterine
insemination (IUI)
procedures. The use for IUI
procedures represents an
additional use of the
VitaVitro® Sperm Washing
Medium, but does not
represent a new intended
use (i.e., washing and
preparing sperm for use in
assisted reproduction
procedures).
The indications for use and
intended use of the
VitaVitro® Sperm Gradient
Medium and the
SepaSperm Solution are
the same. |
| Device
Materials | HEPES Buffered Salt Solution;
Glucose;
Sodium Lactate;
Sodium Pyruvate;
Taurine;
Alanyl Glutamine;
Gentamicin Sulfate;
EDTA;
Water;
Human Serum Albumin (VitaVitro®
Sperm Washing Medium only);
Silane-coated Colloidal Silica
Particles (VitaVitro® Sperm
Gradient Medium only) | HEPES Buffered Salt Solution;
D-glucose;
Dextran;
Polyvinylpyrrolidone;
Gentamicin (with or without);
Water;
Silica (SepaSperm Solution only) | Different: The
formulations and volume
of the subject and
predicate devices are not
identical. Differences in
media product
formulations and volume
do not raise different
questions of safety and
effectiveness (S&E). |
| Packaging | 30mL, 60mL, 125mL bottle | 50mL, 100mL bottle | |
| Sterility | No microbial growth | No microbial growth | Same |
| Osmolality | VitaVitro® Sperm Washing
Medium: 270-300 mOsm/kg
VitaVitro® Sperm Gradient
Medium: | 270-300 mOsm/kg | Different: The osmolality
of the VitaVitro® Sperm
Gradient Medium is higher
than the predicate.
Differences in media |
| Table 3. Comparison Between Subject and Predicate Devices |
|---|
6
| Parameters for
comparison | Subject Devices
VitaVitro® Sperm Washing
Medium, VitaVitro® Sperm
Gradient Medium | Predicate Devices
SepaSperm Washing Solution,
SepaSperm Washing Solution | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Upper layer 40%: 270-330
mOsm/kg
Lower layer 80%: 300-360
mOsm/kg | | osmolality do not raise
different questions of S&E. |
| pH | VitaVitro® Sperm Washing
Medium: 7.2-7.6
VitaVitro® Sperm Gradient
Medium: 7.4-7.8 | 7.2-7.6 | Similar |
| Human Sperm
Survival Assay
(HSSA) | ≥ 80% of control motility at 24h | ≥ 80% of control motility at 24h | Same |
| Endotoxin | ) | N/A | Lower layer 80%: 1.10±0.03 g/mL
Upper layer 40%: 1.05±0.03 g/mL |
| pH (per USP ) | 7.2 - 7.6 | 7.4 - 7.8 |
| Osmolality (per USP ) | 270-300 mOsm/kg | Lower layer 80%: 300-360 mOsm/kg
Upper layer 40%: 270-330 mOsm/kg |
| Endotoxin (per USP ) | ) | No microbial growth | No microbial growth |
| -------------------------- | --------------------- | --------------------- |
|---|
- Sterile filtration and aseptic fill validation, per ISO 13408-1:2008 (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).
- · Transportation testing per ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems).
- Shelf-life testing to support the two-year shelf-life by demonstrating that the product specifications listed in Table 4 were met at time 0 and after accelerated aging in accordance with ASTM F1980-16.
- Biocompatibility testing was conducted in support of the VitaVitro® Sperm Washing Medium that will have direct contact with the patient during IUI procedures. 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 o
- Sensitization per ISO 10993-10: 2010 o
- O Irritation per ISO 10993-10: 2010
The testing demonstrated the device formulation to be non-cytotoxic, non-sensitizing, and non-irritating.
- Sperm assessment for motility, morphology, viability, and purity before and after separation procedures using VitaVitro® Sperm Gradient Medium to assess the effectiveness of the device when used as intended.
9. Conclusion
The results of the performance testing described above demonstrate that the subject media products are as safe and effective as the predicate devices and support a determination of substantial equivalence.