K Number
K232125
Device Name
V-PVP
Manufacturer
Date Cleared
2024-03-20

(247 days)

Product Code
Regulation Number
884.6180
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
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.
More Information

Not Found

No
The device description and performance studies focus on the chemical composition and biological effects of a solution used for sperm immobilization, with no mention of AI or ML technologies.

No.

The device is intended as an aid in the immobilization and isolation of individual sperm cells, not for direct therapeutic treatment or diagnosis of a disease or condition. While it plays a role in a medical procedure (ICSI), its function is preparatory rather than directly therapeutic.

No

This device is intended to aid in the immobilization and isolation of sperm cells for ICSI procedures, which is a preparatory step for a medical procedure, not a diagnostic one. It does not provide information about a patient's health status or condition.

No

The device description clearly states that 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 indicates it is a chemical substance, not software. The performance studies also focus on chemical and biological properties, not software validation.

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states that V-PVP is "intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures." ICSI is a laboratory procedure performed in vitro (outside the body) to assist with fertilization.
  • Device Description: The description details the composition of the solution, which is a reagent used in a laboratory setting for a diagnostic or therapeutic procedure performed in vitro.
  • Performance Studies: The performance studies include tests like MEA (Mouse Embryo Assay) and HSSA (Human Sperm Survival Assay), which are standard in vitro tests used to assess the suitability of media and reagents for assisted reproductive technologies.
  • Predicate Device: The predicate device listed (K001967; InVitroCare, Inc. PVP - Polyvinylpyrrolidone) is also a product used in in vitro fertilization procedures, further supporting the classification of V-PVP as an IVD.

IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While V-PVP isn't directly diagnosing a disease, it is a critical component used in vitro in a procedure (ICSI) that is part of the process of treating infertility, which falls under the scope of IVD regulation.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

MQL

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.

Mentions image processing

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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 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 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: 7.25-7.45 O
    • Osmolality, per USP: 300-330 mOsm/kq о
    • Endotoxin, per USP : : No growth o
  • Transportation testing per ASTM D4169-22 and USP .
  • . Comparative assessment of sperm immobilization of the subject device (7% PVP) to a 10% PVP comparator device.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K001967

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.

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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

1

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

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,

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) OwnerVITROMED GmbH
Raiffeisenstr. 15a
40764 Langenfeld
Germany
Phone: +49 2173-20041-30
Facsimile: +49 2173-20041-58

Submission Correspondent:

Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949.262.0411 Fax: 949.552.2821 Email: greq@requlatoryspecialists.com

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
K001967
Indications for UseV-PVP is intended for use as
an aid in the immobilization
and isolation of individual
sperm cells prior to
intracytoplasmic sperm
injection (ICSI) procedures.PVP (polyvinylpyrrolidone)
reagent is intended for use in
assisted reproductive
technology procedures
involving the manipulation of
gametes. Specifically, PVP is
intended for use as a
medium for the
immobilization and isolation
of single sperm cells during
intracytoplasmic sperm
injection (ICSI) procedures.There are differences in
the subject and predicate
device indications for use
statements; however,
both have the same
intended use (i.e., for
immobilization and
isolation of a single sperm
for use in ICSI fertilization
procedures).
Conditions of UseRx OnlyRx OnlySame
Device materialsPolyvinylpyrrolidone, human
serum albumin, physiological
salts, HEPES HTF, pyruvate,
lactate, glucose, gentamicinPolyvinylpyrrolidone, human
serum albumin, HEPES HTF,
sodium bicarbonate,
gentamicinDifferent - The formulas
of the subject and
predicate devices are not
the same. Differences in
media formulations do not
raise different questions
of safety and
effectiveness (S&E).
Concentrations7%10%Different - The PVP
concentration in the
subject device is lower
than in the predicate
device. Differences in
PVP concentrations do
not raise different
questions of S&E.
Aseptically FilteredYesYesSame
SterilitySterile (No Growth)
USPSterile (No Growth)
USPSame

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| | V-PVP (subject device) | InVitroCare, Inc.
PVP
K001967 | Comparison |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| pH | 7.25-7.45 | 7.25-7.45 | Same |
| Osmolality
(mOSM/kg) | 300-330 | Unknown | Different - The osmolality
acceptance specification
for the predicate device is
not known; however, this
difference does not raise
different questions of
S&E. |
| Endotoxin
(EU/ml) | : 7.25-7.45 O
- Osmolality, per USP: 300-330 mOsm/kq о
- Endotoxin, per USP : : No growth o

  • Transportation testing per ASTM D4169-22 and USP .
  • . 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.