V-DENUPET is used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of oocytes and embryos during assisted reproductive techniques (ART). V-DENUPET is not intended for biopsy of cells from oocytes or embryos.

Device Description

The V-DENUPET is a polycarbonate micropipette. All tips are 90 mm in length, and depending on the size of the tip have a volumetric capacity of 20-25 µl. All pipettes have an outer diameter of 900 µm at the proximal end that is connected to an aspiration device.

The V-DENUPET is supplied in a range of inner diameter sizes at the distal end as shown below:

Sizes 125 µm, 135 µm, 140 µm, 150 µm, and 175 µm are suitable for oocyte . denudation.
Sizes 175 µm, 200 µm, 275 µm, 300 µm, and 600 µm are suitable for oocyte . and embryo handling.
V-DENUPET micropipettes are radiation sterilized and provided in a sterile pouch containing a polypropylene vial containing 10 micropipettes. Each pipette is for single-use only.

AI/ML Overview

The provided text describes the V-DENUPET, a micropipette used in Assisted Reproductive Technologies (ART). However, it does not include acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/algorithm performance. The document is an FDA 510(k) summary for a medical device (a micropipette), focusing on non-clinical performance testing for physical characteristics, sterility, and biocompatibility, not for an AI device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, study details, sample sizes, expert qualifications, or MRMC studies, as this information is not present in the provided text.

The closest relevant information from the document is related to the device's performance criteria, not an AI algorithm:

Acceptance Criteria and Reported Device Performance (Non-AI device)

Acceptance Criteria (V-DENUPET)	Reported Device Performance (V-DENUPET)
Sterilization Validation	Per ISO 11137-1:2006 and ISO 11137-2:2013
Package Integrity Testing	Seal strength (ASRM F88/F88M-15 equivalent), Burst (ASTM 2054-07), Dye Penetration (ASTM F1929-98)
Shelf Life Testing (Device Function)
- MEA testing (1-Cell)	≥80% hatched blastocysts at 96 hours (at Time 0 and 36 months)
- Endotoxin (LAL, USP<85>)	<0.05 EU/device (at Time 0 and 36 months)
- Device dimensions	Maintained (at Time 0 and 36 months)
- Appearance/cleanliness	Maintained (at Time 0 and 36 months)

I cannot answer the following questions based on the provided text, as it pertains to an AI/algorithm study, and the document describes a physical medical device:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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January 28, 2020

VITROMED GmbH % Robyn Scopis CEO Regulatory Specialists, Inc. 628 El Mirador Drive Fullerton, CA 92835

Re: K192146

Trade/Device Name: V-DENUPET Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted Reproduction Microtools Regulatory Class: II Product Code: MQH Dated: December 16, 2019 Received: December 30, 2019

Dear Robyn Scopis:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 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,

for Monica D. Garcia, Ph.D. Acting 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) K192146

Device Name V-DENUPET

Indications for Use (Describe)

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)

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510(k) Summary K192146

510(k) Owner	VITROMED GmbHHans-Knöll-Str. 607745 JenaGermanyFranziska BuchPhone: +49 36 41 5 39 19 76Facsimile: +49 36 41 5 39 19 77Email: qm@vitromed.com
Contact person	Robyn ScopisRegulatory Specialists, Inc.628 El Mirador DriveFullerton, CA 92835Phone: 949.262.0411Fax: 949.552.2821Email: robyn@regulatoryspecialists.com
Date Prepared	January 27, 2020
Product Information	V-DENUPETAssisted reproduction micropipetteAssisted Reproduction Microtools884.6130Class IIMQH - Microtools, Assisted Reproduction (Pipettes)
Trade Name
Common Name
Regulation Name
Regulation Number
Regulatory Class
Product Code
Predicate	Research Instruments Ltd.EZ-Tip Vial of 20K161275
	The predicate device has not been subject to adesign-related recall.

Device Description

The V-DENUPET is supplied in a range of inner diameter sizes at the distal end as shown below:

Sizes 125 µm, 135 µm, 140 µm, 150 µm, and 175 µm are suitable for oocyte . denudation.

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Sizes 175 µm, 200 µm, 275 µm, 300 µm, and 600 µm are suitable for oocyte . and embryo handling.
V-DENUPET micropipettes are radiation sterilized and provided in a sterile pouch containing a polypropylene vial containing 10 micropipettes. Each pipette is for single-use only.

Indications for Use

Technological Characteristics

The table below provides a comparison of the indications for use and technological characteristics of the subject device and predicate device:

	Subject Device	Predicate Device
	V-DENUPET	EZ-Tip Vial of 20K161275	Comparison
Indicationsfor Use	V-DENUPET is used forthe removal of cumulusoocyte complexes (COC)from an oocyte prior toIntracytoplasmic SpermInjection (ICSI) and InVitro Fertilization (IVF) aswell as for the handling ofoocytes and embryosduring assistedreproductive techniques(ART). V-DENUPET is notintended for biopsy ofcells from oocytes orembryos.	EZ-Tip pipettes are fordenudation, i.e.removing the cumulusfrom an oocyte prior toIntracytoplasmic SpermInjection (ICSI) and InVitro Fertilization (IVF)and for handlinggametes, embryos andbiopsied cells (polarbodies, blastomeres andtrophectoderm) duringassisted reproductivetechniques (ART). EZ-Tips are not intended forbiopsy of cells fromoocytes or embryos.	DifferentBoth subject andpredicate devices areintended for use inoocyte denudationprocedures andhandling oocytes andembryos; however, thepredicate can also beused for handlingbiopsied cells. Thisdifference does notrepresent a differentintended use betweenthe subject andpredicate device.
Materials	Polycarbonate	Polycarbonate	Same
Sterility	Sterile (10-6) GammaIrradiated	Sterile (10-6) GammaIrradiated	Same
ProximalOuterDimension	900 µm	900 µm	Same
Distal InnerDiameter	Size range125 µm to 600 µm	Size range75 µm to 600 µm	DifferentThe V-DENUPET iswithin the clearedrange of the predicatedevice. This differencedoes not raise differentquestions of safety oreffectiveness (S&E).
Length	90 mm	90 mm	Same
MouseEmbryoAssay(MEA)	1-Cell MEA≥80% hatched blastocystsat 96 h	1-Cell MEA≥80% hatched blastocystsat 120 h	DifferentThe Mouse EmbryoAssay (MEA)assessment time isshorter for the V-DENUPET, but is thestandard assessmenttime for this assay.Therefore, thisdifference does notraise differentquestions of S&E.
Endotoxin(LAL)	<0.05 EU/device	<20 EU/device	DifferentThe endotoxinspecification for thesubject device is lowerthan the predicatedevice. This differencedoes not raise differentquestions of S&E.
Usage	Single Use Only	Single Use Only	Same

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As shown in the table above, the subject and predicate devices have different indications for use statements; however, the intended uses of the predicate and subject devices are the same (i.e., denudation of oocytes and handling of oocytes and embryos during assisted reproduction technology procedures).

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In regards to technological characteristics, the subject and predicate devices have similarities (e.g., material, length, diameter at the proximal end, sterilization method, etc.); however, as noted in the table above, technological differences were identified between the subject and predicate devices (e.g., distal end tip diameter and specifications for MEA and endotoxin testing). As stated in the table, the technological differences between the subject and predicate devices do not raise different questions of safety and effectiveness.

Non-Clinical Performance Testing

The following performance data were provided in support of the substantial equivalence determination:

1. Sterilization Validation per ISO 11137-1:2006 and ISO 11137-2:2013
1. Package Integrity Testing:
- a. Seal strength method equivalent to ASRM F88/F88M-15
- b. Burst Testing ASTM 2054-07
- c. Dye Penetration Testing ASTM F1929-98
1. Shelf Life testing assessing device function at Time 0 and at 36 months:
- a. MEA testing 1-Cell MEA: ≥80% hatched blastocyst at 96h
- b. Endotoxin (LAL, USP<85>) <0.05 EU/device
- c. Device dimensions
- d. Appearance/cleanliness

Conclusion

The results of the testing described above demonstrate that the V-DENUPET is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.6130 Assisted reproduction microtools.

(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.