V-DENUPET

• K Number: K192146
• Device Name: V-DENUPET
• Manufacturer: Vitromed GmbH
• Date Cleared: 2020-01-28 ( 173 days)
• Product Code: MQH
• Regulation Number: 884.6130

Intended Use

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.

Predicate Devices

K161275

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and biological compatibility of a micropipette, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No
The device is used for the physical removal of cumulus oocyte complexes and handling of oocytes and embryos, which is a procedural/manipulative function, not a therapeutic one. It facilitates ART procedures rather than treating a disease or condition.

Diagnostic

No

The device is used for handling oocytes and embryos and for removing cumulus oocyte complexes, which are procedural steps in assisted reproductive techniques (ART) like ICSI and IVF, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the V-DENUPET is a "polycarbonate micropipette" and details its physical characteristics and components, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the V-DENUPET is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use is for the physical manipulation of oocytes and embryos (removal of cumulus oocyte complexes, handling). This is a procedural tool used in assisted reproductive techniques (ART).
• Device Description: The device is a micropipette, a physical instrument for handling biological material.
• Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample to provide information about a patient's health, condition, or disease. It does not perform any diagnostic test or measurement.
• Performance Studies: The performance studies focus on sterilization, package integrity, shelf life, and basic biological compatibility (MEA testing), which are typical for devices used in handling biological materials, not for diagnostic performance metrics like sensitivity or specificity.

IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The V-DENUPET's function is purely manipulative within the ART process.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

MQH

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.

Mentions image processing

Not Found

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)

Non-Clinical Performance Testing:

1. Sterilization Validation per ISO 11137-1:2006 and ISO 11137-2:2013
2. 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
3. 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) )

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 ([e-mail]) or phone [phone] 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)

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.

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 GmbH
Hans-Knöll-Str. 6
07745 Jena
Germany
Franziska Buch
Phone: [phone]
Facsimile: [phone]
Email: [e-mail] |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Robyn Scopis
Regulatory Specialists, Inc.
628 El Mirador Drive
Fullerton, CA 92835
Phone: [phone]
Fax: [phone]
Email: [e-mail] |
| Date Prepared | January 27, 2020 |
| Product Information | V-DENUPET
Assisted reproduction micropipette
Assisted Reproduction Microtools
884.6130
Class II
MQH - Microtools, Assisted Reproduction (Pipettes) |
| Trade Name | |
| Common Name | |
| Regulation Name | |
| Regulation Number | |
| Regulatory Class | |
| Product Code | |
| Predicate | Research Instruments Ltd.
EZ-Tip Vial of 20
K161275 |
| | The predicate device has not been subject to a
design-related recall. |

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.

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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

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.

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 20
K161275	Comparison
Indications
for Use	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.	EZ-Tip pipettes are for
denudation, i.e.
removing the cumulus
from an oocyte prior to
Intracytoplasmic Sperm
Injection (ICSI) and In
Vitro Fertilization (IVF)
and for handling
gametes, embryos and
biopsied cells (polar
bodies, blastomeres and
trophectoderm) during
assisted reproductive
techniques (ART). EZ-
Tips are not intended for
biopsy of cells from
oocytes or embryos.	Different
Both subject and
predicate devices are
intended for use in
oocyte denudation
procedures and
handling oocytes and
embryos; however, the
predicate can also be
used for handling
biopsied cells. This
difference does not
represent a different
intended use between
the subject and
predicate device.
Materials	Polycarbonate	Polycarbonate	Same
Sterility	Sterile (10-6) Gamma
Irradiated	Sterile (10-6) Gamma
Irradiated	Same
Proximal
Outer
Dimension	900 µm	900 µm	Same
Distal Inner
Diameter	Size range
125 µm to 600 µm	Size range
75 µm to 600 µm	Different
The V-DENUPET is
within the cleared
range of the predicate
device. This difference
does not raise different
questions of safety or
effectiveness (S&E).
Length	90 mm	90 mm	Same
Mouse
Embryo
Assay
(MEA)	1-Cell MEA
≥80% hatched blastocysts
at 96 h	1-Cell MEA
≥80% hatched blastocysts
at 120 h	Different
The Mouse Embryo
Assay (MEA)
assessment time is
shorter for the V-
DENUPET, but is the
standard assessment
time for this assay.
Therefore, this
difference does not
raise different
questions of S&E.
Endotoxin
(LAL)	)