V-PVP

K232125 · Vitromed GmbH · MQL · Mar 20, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K232125
• Device Name: V-PVP
• Applicant: Vitromed GmbH
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Mar 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Device Story

V-PVP is a clear, aseptically filtered solution used in assisted reproductive technology (ART) laboratories. It consists of polyvinylpyrrolidone (PVP), human serum albumin, physiological salts, HEPES HTF, pyruvate, lactate, glucose, and gentamicin. The device is used by embryologists or clinicians during ICSI procedures to immobilize and isolate single sperm cells, facilitating their selection and injection into oocytes. By increasing the viscosity of the medium, the device slows sperm motility, allowing the operator to capture a single sperm cell with an injection pipette. This process is essential for successful fertilization in patients undergoing ICSI. The product is supplied in 0.5 mL volumes within 2 mL polypropylene copolymer bottles, with a one-year shelf-life and seven-day stability after opening.

Clinical Evidence

Bench testing only. Performance validated via sterile filtration/aseptic fill (ISO 13408-1/2), shelf-life/accelerated aging (ASTM F1980-21), and transportation testing (ASTM D4169-22). Biological safety and efficacy confirmed via USP <71> sterility, USP <85> endotoxin (<0.5 EU/mL), Mouse Embryo Assay (MEA: ≥80% blastocyst development), and Human Sperm Survival Assay (HSSA: ≥80% control motility).

Technological Characteristics

Solution containing 7% polyvinylpyrrolidone, human serum albumin, physiological salts, HEPES HTF, pyruvate, lactate, glucose, and gentamicin. pH 7.25-7.45; osmolality 300-330 mOsm/kg. Aseptically filtered; sterile (USP <71>). Packaging: 0.5 mL in 2 mL polypropylene copolymer bottles. Shelf-life: 1 year.

Indications for Use

Indicated for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) 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

• InVitroCare, Inc. PVP - Polyvinylpyrrolidone (K001967)

Submission Summary (Full Text)

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March 20, 2024

VITROMED GmbH % Greg Holland Sr. Partner Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606

Re: K232125

Trade/Device Name: V-PVP Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: February 16, 2024 Received: February 20, 2024

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.

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# K232125 - Greg Holland

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Monica D. Garcia -S

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) K232125

Device Name V-PVP

Indications for Use (Describe)

V-PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary K232125

| 510(k) Owner | VITROMED GmbH |
|--------------|------------------------------|
| | Raiffeisenstr. 15a |
| | 40764 Langenfeld |
| | Germany |
| | Phone: [phone] |
| | Facsimile: [phone] |

Submission Correspondent:

Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone] Email: [e-mail]

Summary Date

Trade Name Common Name Regulation Name Regulation Number Product Code Class

Predicate

March 18, 2024

V-PVP Assisted Reproduction Media Reproductive Media and Supplements 884.6180 MQL (Media, Reproductive) Class II

InVitroCare, Inc. PVP - Polyvinylpyrrolidone K001967

The predicate device has not been subject to a design-related recall.

# Device Description

V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracvtoplasmic sperm iniection (ICSI) procedures.

V-PVP is a clear solution with a formulation consisting of polyvinylpyrrolidone, human serum albumin, physiological salts, HEPES Human Tubal Fluid (HTF), pyruvate, lactate, qlucose, and gentamicin. This product is aseptically filtered into 2 mL bottles with caps made from polypropylene copolymer and is provided in a volume of 0.5 mL. V-PVP has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.

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# Indications for Use

V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

## Comparison of intended use and technological characteristics of the subject and predicate devices

A comparison of the intended use and technological characteristics of the subject device and the predicate device is shown in the table below:

| | V-PVP (subject device) | InVitroCare, Inc. | Comparison |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | PVP<br>K001967 | |
| Indications for Use | V-PVP is intended for use as<br>an aid in the immobilization<br>and isolation of individual<br>sperm cells prior to<br>intracytoplasmic sperm<br>injection (ICSI) procedures. | PVP (polyvinylpyrrolidone)<br>reagent is intended for use in<br>assisted reproductive<br>technology procedures<br>involving the manipulation of<br>gametes. Specifically, PVP is<br>intended for use as a<br>medium for the<br>immobilization and isolation<br>of single sperm cells during<br>intracytoplasmic sperm<br>injection (ICSI) procedures. | There are differences in<br>the subject and predicate<br>device indications for use<br>statements; however,<br>both have the same<br>intended use (i.e., for<br>immobilization and<br>isolation of a single sperm<br>for use in ICSI fertilization<br>procedures). |
| Conditions of Use | Rx Only | Rx Only | Same |
| Device materials | Polyvinylpyrrolidone, human<br>serum albumin, physiological<br>salts, HEPES HTF, pyruvate,<br>lactate, glucose, gentamicin | Polyvinylpyrrolidone, human<br>serum albumin, HEPES HTF,<br>sodium bicarbonate,<br>gentamicin | Different - The formulas<br>of the subject and<br>predicate devices are not<br>the same. Differences in<br>media formulations do not<br>raise different questions<br>of safety and<br>effectiveness (S&E). |
| Concentrations | 7% | 10% | Different - The PVP<br>concentration in the<br>subject device is lower<br>than in the predicate<br>device. Differences in<br>PVP concentrations do<br>not raise different<br>questions of S&E. |
| Aseptically Filtered | Yes | Yes | Same |
| Sterility | Sterile (No Growth)<br>USP <71> | Sterile (No Growth)<br>USP <71> | Same |

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| | V-PVP (subject device) | InVitroCare, Inc.<br>PVP<br>K001967 | Comparison |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| pH | 7.25-7.45 | 7.25-7.45 | Same |
| Osmolality<br>(mOSM/kg) | 300-330 | Unknown | Different - The osmolality<br>acceptance specification<br>for the predicate device is<br>not known; however, this<br>difference does not raise<br>different questions of<br>S&E. |
| Endotoxin<br>(EU/ml) | <0.5 | Unknown | Different - The endotoxin<br>acceptance specification<br>for the predicate device is<br>not known; however, this<br>difference does not raise<br>different questions of<br>S&E. |
| Compatibility with<br>human sperm | Human Sperm Survival<br>Assay (HSSA): ≥ 80% of<br>Control Motility at 24hr after<br>30 min contact to V-PVP | Unknown | Different - Compatibility<br>of the predicate device<br>with human sperm is not<br>known; however, this<br>difference does not raise<br>different questions of<br>S&E. |
| Mouse Embryo<br>Assay (MEA) | 1-Cell System: ≥80% of<br>embryos developed to<br>expanded blastocyst at 96h<br>after a 30-minute contact to<br>V-PVP | ≥80% 1-cell to expanded<br>blastocyst within 96 hours. | Different - The MEA<br>specifications are different<br>between the subject and<br>predicate devices;<br>however, the differences<br>do not raise different<br>questions of S&E. |
| Shelf Life | 1 Year | 1 Year | Same |

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:

- Sterile filtration and aseptic fill 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

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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:
- Clarity/Color: Pink rose color, no precipitates O
- pH, per USP<791>: 7.25-7.45 O
- Osmolality, per USP<785>: 300-330 mOsm/kq о
- Endotoxin, per USP <85>: < 0.5 EU/mL O
- MEA: 1-Cell System: ≥80% of embryos developed to expanded blastocyst о at 96h after 30-minute contact to V-PVP
- HSSA: ≥ 80% of control motility at 24h after 30 minute contact to V-PVP o
- Sterility, per USP<71>: No growth o
- Transportation testing per ASTM D4169-22 and USP<1207> .
- . Comparative assessment of sperm immobilization of the subject device (7% PVP) to a 10% PVP comparator device.

#### Conclusions

The results of the performance testing described above demonstrate that V-PVP is as safe and effective as the predicate device and support a determination of substantial equivalence.