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.

AI/ML Overview

The provided text describes the acceptance criteria and performance testing for a medical device called V-PVP, specifically for its premarket notification (K232125).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several specifications for V-PVP and indicates that shelf-life testing demonstrated the product met these specifications at time 0 and after accelerated aging. While specific numerical results for each test (e.g., exact pH measured) are not provided, the "acceptance criteria" themselves are listed as the "product specifications."

Acceptance Criteria (Product Specifications)	Reported Device Performance (as demonstrated by Shelf-life testing)
Clarity/Color: Pink rose color, no precipitates	Met specification
pH, per USP<791>: 7.25-7.45	Met specification
Osmolality, per USP<785>: 300-330 mOsm/kg	Met specification
Endotoxin, per USP <85>: < 0.5 EU/mL	Met specification
MEA: 1-Cell System: ≥80% of embryos developed to expanded blastocyst at 96h after 30-minute contact to V-PVP	Met specification
HSSA: ≥ 80% of control motility at 24h after 30 minute contact to V-PVP	Met specification
Sterility, per USP<71>: No growth	Met specification

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the performance tests conducted (e.g., number of replicates for pH, Osmolality, Endotoxin, MEA, HSSA, Sterility tests).

The data provenance is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective. However, based on the context of premarket notification for a new device, these would typically be prospective studies performed by the manufacturer to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily laboratory-based (chemical, physical, biological assays), not reliant on expert interpretation of complex clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The performance tests are objective laboratory assays with well-defined measurement methods and acceptance ranges, not requiring human adjudication of ambiguous results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. V-PVP is a reproductive media/supplement, not an AI-powered diagnostic device that would involve human readers or MRMC studies. The "Comparative assessment of sperm immobilization of the subject device (7% PVP) to a 10% PVP comparator device" mentioned is a direct comparison of the substance's efficacy, not a human-AI interaction study.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. V-PVP is a chemical solution, not an algorithm or software. Its performance is evaluated through laboratory assays, not by an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests is established by objective laboratory measurements and universally accepted biological and chemical standards.

pH, Osmolality, Endotoxin: Measurements against recognized USP standards.
MEA (Mouse Embryo Assay): A standard biological assay to assess toxicity or suitability for embryo development, with a specified percentage of embryo development as the "ground truth."
HSSA (Human Sperm Survival Assay): A standard biological assay to assess the compatibility and non-toxicity to human sperm, with a specified percentage of control motility as the "ground truth."
Sterility: Absence of microbial growth, a standard microbiological "ground truth."
Clarity/Color: Visual inspection against an expected appearance.

8. The Sample Size for the Training Set

This information is not applicable. V-PVP is a formulated chemical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

Summary

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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.

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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 (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) Owner	VITROMED 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.

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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
		PVPK001967
Indications for Use	V-PVP is intended for use asan aid in the immobilizationand isolation of individualsperm cells prior tointracytoplasmic sperminjection (ICSI) procedures.	PVP (polyvinylpyrrolidone)reagent is intended for use inassisted reproductivetechnology proceduresinvolving the manipulation ofgametes. Specifically, PVP isintended for use as amedium for theimmobilization and isolationof single sperm cells duringintracytoplasmic sperminjection (ICSI) procedures.	There are differences inthe subject and predicatedevice indications for usestatements; however,both have the sameintended use (i.e., forimmobilization andisolation of a single spermfor use in ICSI fertilizationprocedures).
Conditions of Use	Rx Only	Rx Only	Same
Device materials	Polyvinylpyrrolidone, humanserum albumin, physiologicalsalts, HEPES HTF, pyruvate,lactate, glucose, gentamicin	Polyvinylpyrrolidone, humanserum albumin, HEPES HTF,sodium bicarbonate,gentamicin	Different - The formulasof the subject andpredicate devices are notthe same. Differences inmedia formulations do notraise different questionsof safety andeffectiveness (S&E).
Concentrations	7%	10%	Different - The PVPconcentration in thesubject device is lowerthan in the predicatedevice. Differences inPVP concentrations donot raise differentquestions of S&E.
Aseptically Filtered	Yes	Yes	Same
Sterility	Sterile (No Growth)USP <71>	Sterile (No Growth)USP <71>	Same

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	V-PVP (subject device)	InVitroCare, Inc.PVPK001967	Comparison
pH	7.25-7.45	7.25-7.45	Same
Osmolality(mOSM/kg)	300-330	Unknown	Different - The osmolalityacceptance specificationfor the predicate device isnot known; however, thisdifference does not raisedifferent questions ofS&E.
Endotoxin(EU/ml)	<0.5	Unknown	Different - The endotoxinacceptance specificationfor the predicate device isnot known; however, thisdifference does not raisedifferent questions ofS&E.
Compatibility withhuman sperm	Human Sperm SurvivalAssay (HSSA): ≥ 80% ofControl Motility at 24hr after30 min contact to V-PVP	Unknown	Different - Compatibilityof the predicate devicewith human sperm is notknown; however, thisdifference does not raisedifferent questions ofS&E.
Mouse EmbryoAssay (MEA)	1-Cell System: ≥80% ofembryos developed toexpanded blastocyst at 96hafter a 30-minute contact toV-PVP	≥80% 1-cell to expandedblastocyst within 96 hours.	Different - The MEAspecifications are differentbetween the subject andpredicate devices;however, the differencesdo not raise differentquestions 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.

Regulation Number and Section

§ 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.