Who is the manufacturer of V-GRAD?

Vitromed GmbH filed the 510(k) submission for V-GRAD (K241833).

What is the FDA product code for V-GRAD?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for V-GRAD?

510(k) clearance (submission type: Traditional).

What are the predicate devices for V-GRAD?

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80 (K153267).

Who can help prepare an FDA 510(k) submission like V-GRAD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

V-GRAD

K241833 · Vitromed GmbH · MQL · Mar 21, 2025 · Obstetrics/Gynecology

Device Facts

Record ID	K241833
Device Name	V-GRAD
Applicant	Vitromed GmbH
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Mar 21, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended Use

V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.

Device Story

V-GRAD is a sterile colloidal suspension containing silicate particles stabilized with covalently bound hydrophilic silanes. It is used in assisted reproduction procedures to separate motile sperm from ejaculates via density gradient centrifugation. The device is provided as a 100% stock solution (V-GRAD 100) or as ready-to-use 40% and 80% solutions (V-GRAD 40, V-GRAD 80) buffered with HEPES-modified Human Tubular Fluid. The clinician layers the gradient media in a centrifuge tube, adds the semen sample, and centrifuges to isolate motile sperm. The resulting high-quality sperm fraction is then used for clinical procedures such as IUI or IVF. The device is intended for professional use in clinical settings. By isolating motile sperm from debris, leukocytes, and immotile sperm, the device facilitates the selection of viable sperm, potentially improving the success rates of assisted reproduction treatments.

Clinical Evidence

Bench testing only. Performance validated through aseptic processing (ISO 13408-1/2), shelf-life testing (ASTM F1980-21), transportation testing (ASTM D4169-22, USP <1207.2>), and sterility (USP <71>). Sperm motility, morphology, and purity were evaluated, demonstrating performance comparable to the predicate device. HSSA results confirmed ≥ 80% of control motility.

Technological Characteristics

Colloidal suspension of silane-coated silica particles in HEPES-buffered HTF medium. Materials include physiological salts, energy substrates, buffering agents, gentamicin sulfate, and phenol red. Dimensions: 12 mL glass bottles or 100 mL PET(G) bottles. Sterilization: Aseptic filtration. Storage: 2-8°C. Shelf-life: 1 year. Standards: ISO 13408-1:2008, ISO 13408-2:2018, ASTM F1980-21, ASTM D4169-22, USP <71>, USP <1207.2>.

Indications for Use

Indicated for the separation of motile sperm from ejaculates using the density gradient method in assisted reproduction procedures.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80 (K153267)

Related Devices

K023403 — SPERMGRAD, MODELS 10022/10063 · Vitrolife Sweden AB · Dec 13, 2002
K212410 — VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium · Shenzhen Vitavitro Biotech Co., Ltd. · Feb 1, 2022
K153267 — ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash · Origio A/S · Jul 22, 2016
K190199 — SepaSperm Washing Solution, SepaSperm Solution · Kitazato Corporation · Sep 26, 2019
K971809 — ISOLATE · Irvine Scientific Sales Co., Inc. · Jul 3, 1997

Submission Summary (Full Text)

{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) K241833 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. 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." {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) | <0.5 | <0.8 | Different: The subject device has a lower endotoxin level than the predicate device. This difference in endotoxin specifications does not raise different questions of S&E. | | Osmolality (mOsm/kg) | 310-340 (V-GRAD 40) 310-340 (V-GRAD 80) 300-330 (V-GRAD 100) | 317-333 (Origio GradientTM 40) 297-313 (Origio GradientTM 80, 90 and 100) | Similar | | Density (g/cm3) | 1.050-1.061 (V-GRAD 40) 1.100-1.111 (V-GRAD 80) 1.125-1.136 (V-GRAD 100) | 1.048-1.062 (Origio GradientTM 40) 1.098-1.112 (Origio GradientTM 80) 1.105-1.119 (Origio GradientTM 90) 1.123-1.137 (Origio GradientTM 100) | Similar | | Storage | 2-8°C | 2-8°C | Same | | HSSA | ≥ 80% of control motility at hours after 1 hour exposure to test medium | ≥ 80% of control | Different: The HSSA exposure time for the predicate device is not known; however, this difference does not raise different questions of S&E. | | Shelf Life | 1 Year | 20 weeks (Origio 100) 36 weeks (Origio 40, 80, and 90) | Different: The subject device has a longer shelf life than the predicate device. Difference does not raise different questions of S&E | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ As shown in the table above, there are differences in the indications for use statements and technological features of the subject and predicate devices. However, the subject and predicate device have the same intended use and the differences in technological features do not raise different questions of safety and effectiveness. # Summary of Non-Clinical Performance Testing 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): <0.5 - Density (g/cm³): 1.050-1.061 (V-GRAD 40), 1.100-1.111 (V-GRAD 80), 1.125--1.136 (V-GRAD 100) - Human Sperm Survival Assay (HSSA): ≥ 80% of control motility at 24 hours after -1 hour exposure to test medium - -Sterility, per USP <71>: No growth - . Transportation testing per ASTM D4169-22 and USP <1207.2>. - . 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.