(269 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a density gradient medium for sperm separation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is intended for separating sperm for assisted reproduction procedures, which is a laboratory preparation task, not a therapeutic intervention on a patient.
No
Explanation: The device is intended for the separation of motile sperm for use in assisted reproduction procedures, which is a preparatory step and not used for diagnosing a condition or disease.
No
The device description clearly states it is a sterile colloidal suspension with silicate particles, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures." This process is performed in vitro (outside the living body) on a biological sample (ejaculate).
- Device Description: The device is a "sterile colloidal suspension" used to process a biological sample.
- Performance Studies: The performance studies include evaluating the effect of the device on sperm characteristics like motility, morphology, and purity, which are measurements taken in vitro on the processed sample.
- Key Metrics: The key metrics include the "Human Sperm Survival Assay (HSSA)," which is a test performed in vitro to assess the viability of sperm after exposure to the device.
- Predicate Device: The predicate device (K153267; ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80) is also a sperm separation medium used in assisted reproduction, which are typically classified as IVDs.
While the device itself is a reagent/medium used in the process, its intended use and the nature of the procedures it supports (assisted reproduction, which involves in vitro handling of gametes) firmly place it within the scope of In Vitro Diagnostics. It is used to prepare a biological sample for subsequent diagnostic or therapeutic procedures performed in vitro.
N/A
Intended Use / Indications for Use
V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
V-GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes that is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures. Available as a 100 % stock solution (V-GRAD 100) and as 40% or 80% ready-to-use solutions (V-GRAD 40 and V-GRAD 80) with HEPES buffered Human Tubular Fluid (HTF) medium.
V-GRAD 100 is a stock solution for preparing a density gradient system for semen preparation. The V-GRAD Kit consists of two bottles of V-GRAD 40 and V-GRAD 80.
V-GRAD is aseptically filtered and provided in pre-sterilized 12 mL glass bottles closed with flourotec rubber stoppers and flip-tear off caps or 100 mL PET(G) bottles closed with HDPE screw caps. V-GRAD has a shelf-life of one year when stored at 2-8°C and can be used for up to seven days after bottle opening.
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
Prescription Use Only
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 device:
- . Aseptic filtration and aseptic filling validation, per ISO 13408-1:2008 - Aseptic Processing of Health Care Products – Part 1 General Requirements (including Amendment 1 (2013)) and ISO 13408- 2:2018 – Aseptic Processing of Health Care Products - Part 2 Sterilizing Filtration.
- Shelf-life testing was conducted to support the 12-month shelf-life for the subject . device through demonstration that the product specifications (shown below) were met at time 0 and after accelerated aging in accordance with ASTM F1980-21. Testing was also included on aged samples demonstrating that medium in bottles can maintain their specifications after seven days of simulated use conditioning after bottle opening. Testing conducted is shown below:
- Appearance: Pink rose color (V-GRAD 40), light pink color (V-GRAD 80), colorless (V-GRAD 100)
- pH: 7.2-7.9
- Osmolality (mOsm/kg): 310-340 (V-GRAD 40 and V-GRAD 80), 300-330 (V--GRAD 100)
- -Endotoxin (EU/mL): : No growth
- . Transportation testing per ASTM D4169-22 and USP .
- . Sperm separated using the subject device were evaluated for motility, morphology, and purity. The results demonstrate that the subject device has comparable performance with the predicate device and other cleared devices of this type.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Human Sperm Survival Assay (HSSA): ≥ 80% of control motility at 24 hours after -1 hour exposure to test medium
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 21, 2025
VITROMED GmbH c/o Greg Holland Sr. Partner Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606
Re: K241833 Trade/Device Name: V-GRAD (V-GRAD Kit, V-GRAD 40, V-GRAD 80, V-GRAD 100) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Received: February 19, 2025
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Michael T. Bailey -S
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
V-GRAD (V-GRAD Kit, V-GRAD 40, V-GRAD 80, V-GRAD 100)
Indications for Use (Describe)
V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
| 510(k) Summary |
|---|
| K241833 |
| 510(k) Owner | VITROMED GmbH
Raiffeisenstr. 15a
40764 Langenfeld
Germany
Phone: +49 2173-20041-30
Facsimile: +49 2173-20041-58
Contact: Ines Diener
Email: ines@vitromed.com |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent | Greg Holland
Regulatory Specialists, Inc.
3722 Ave. Sausalito
Irvine, CA 92606
Phone: 949.262.0411
Fax: 949.552.2821
Email: greg@regulatoryspecialists.com |
| Summary Date | March 21, 2025 |
| Trade Name | V-GRAD (V-GRAD Kit, V-GRAD 40, V-GRAD 80, V-GRAD 100) |
| Common Name | Assisted Reproduction Media |
| Classification Name | Reproductive Media and Supplements |
| Regulation | 884.6180 |
| Class | Class II |
| Product Code | MQL (Media, Reproductive) |
| Predicate Device | K153267
ORIGIO A/S
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO
Gradient 40/80
The predicate device has not been subject to a
design-related recall. |
Device Description
V-GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes that is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures. Available as a 100 % stock solution (V-GRAD 100) and as 40% or 80% ready-to-use solutions (V-GRAD 40 and V-GRAD 80) with HEPES buffered Human Tubular Fluid (HTF) medium.
5
V-GRAD 100 is a stock solution for preparing a density gradient system for semen preparation. The V-GRAD Kit consists of two bottles of V-GRAD 40 and V-GRAD 80.
V-GRAD is aseptically filtered and provided in pre-sterilized 12 mL glass bottles closed with flourotec rubber stoppers and flip-tear off caps or 100 mL PET(G) bottles closed with HDPE screw caps. V-GRAD has a shelf-life of one year when stored at 2-8°C and can be used for up to seven days after bottle opening.
Indications for Use
V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.
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:
| | K241833
V-GRAD (V-GRAD Kit
V-GRAD 40, V-GRAD
80, V-GRAD 100) | K153267
ORIGIO Gradient
100, ORIGIO
Gradient 90,
ORIGIO Gradient
40/80 | Comparison |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | V-GRAD is intended
for separation of
motile sperm from
ejaculates by the
density gradient
method for use in
assisted reproduction
procedures. | ORIGIO® Gradient™ 100, ORIGIO®
Gradient™ 90 and
ORIGIO® Gradient™
40/80 are for the
separation of motile
sperm from the
ejaculate by the
density gradient
method. | There are
differences in the
wording of the
indications for use
statements for the
subject and
predicate device;
however, both have
the same intended
use, i.e., separation
of motile sperm from
the ejaculates by the
density gradient
method. |
| Conditions for
Use | Prescription Use Only | Prescription Use Only | Same |
| | K241833
V-GRAD (V-GRAD Kit
V-GRAD 40, V-GRAD
80, V-GRAD 100) | K153267
ORIGIO Gradient
100, ORIGIO
Gradient 90,
ORIGIO Gradient
40/80 | Comparison |
| Available
Variants | - V-GRAD 100
- V-GRAD 40
- V-GRAD 80
- V-GRAD Kit
(containing V-
GRAD 80 and V-
GRAD 40) | - ORIGIO
Gradient™ 100 - ORIGIO
Gradient™ 90 - ORIGIO
Gradient™ 40/80 | Different: There are
differences in the
medium variants for
the subject and
predicate devices;
however, these
differences do not
raise different
questions of S&E. |
| Gradient
Medium
Density (%
silica) | 40%, 80%, 100% | 40%, 80%, 90%, 100% | Different: The
gradient medium
density for the
subject and
predicate devices is
different; however,
this difference does
not raise different
questions of S&E. |
| Formulation | Physiological salts;
energy substrates;
buffering agents;
silane-coated silica;
gentamicin sulfate;
phenol red; water | Not known | Different: The
formulation of the
predicate device is
not known; however,
the differences in
media product
formulations do not
raise different
questions of S&E |
| Sterilization | Aseptic filtration | Aseptic filtration | Same |
| Sterility | No growth | No growth | Same |
| pH | 7.20 – 7.90 | 7.95 – 8.495 | Different: The
subject device has a
lower pH range than
the predicate device.
This difference in pH
range does not raise
different questions
of S&E. |
| | K241833
V-GRAD (V-GRAD Kit
V-GRAD 40, V-GRAD
80, V-GRAD 100) | K153267
ORIGIO Gradient
100, ORIGIO
Gradient 90,
ORIGIO Gradient
40/80 | Comparison |
| Endotoxin
(EU/ml) | : No growth - . Transportation testing per ASTM D4169-22 and USP .
- . Sperm separated using the subject device were evaluated for motility, morphology, and purity. The results demonstrate that the subiect device has comparable performance with the predicate device and other cleared devices of this type.
Conclusions
The results of the performance testing described above demonstrate that V-GRAD is as safe and effective as the predicate device and support a determination of substantial equivalence.