V-DENUPET

K192146 · Vitromed GmbH · MQH · Jan 28, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K192146
• Device Name: V-DENUPET
• Applicant: Vitromed GmbH
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Jan 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6130
• Device Class: Class 2

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.

Device Story

V-DENUPET is a single-use, polycarbonate micropipette used in assisted reproductive technology (ART) laboratories. The device functions as a manual tool for the aspiration and transfer of oocytes and embryos. It features a 90 mm length and a 900 µm proximal outer diameter designed to connect to an external aspiration device. The distal end is available in various inner diameters (125–600 µm) to accommodate specific denudation or handling tasks. Clinicians operate the device manually to manipulate gametes and embryos under a microscope. By facilitating precise handling and cumulus removal, the device supports the preparation of oocytes for fertilization procedures. It is provided sterile via gamma irradiation.

Clinical Evidence

Bench testing only. Performance validated via sterilization validation (ISO 11137), package integrity (ASTM F88, ASTM F2054, ASTM F1929), and 36-month shelf-life testing. Biological safety confirmed via Mouse Embryo Assay (MEA) (≥80% hatched blastocysts at 96h) and endotoxin testing (<0.05 EU/device).

Technological Characteristics

Polycarbonate micropipette; 90 mm length; 900 µm proximal outer diameter; distal inner diameters 125–600 µm. Manual operation via external aspiration. Sterile (10^-6) via gamma irradiation. Single-use. Complies with ISO 11137-1/2, ASTM F88, ASTM F2054, ASTM F1929, and USP <85>.

Indications for Use

Indicated for removal of cumulus oocyte complexes from oocytes prior to ICSI and IVF, and for handling oocytes and embryos during ART procedures. Not intended for biopsy of cells from oocytes or embryos.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EZ-Tip Vial of 20 (K161275)

Submission Summary (Full Text)

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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 ([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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary K192146

| 510(k) Owner | VITROMED GmbH<br>Hans-Knöll-Str. 6<br>07745 Jena<br>Germany<br>Franziska Buch<br>Phone: [phone]<br>Facsimile: [phone]<br>Email: [e-mail] |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Robyn Scopis<br>Regulatory Specialists, Inc.<br>628 El Mirador Drive<br>Fullerton, CA 92835<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | January 27, 2020 |
| Product Information | V-DENUPET<br>Assisted reproduction micropipette<br>Assisted Reproduction Microtools<br>884.6130<br>Class II<br>MQH - Microtools, Assisted Reproduction (Pipettes) |
| Trade Name | |
| Common Name | |
| Regulation Name | |
| Regulation Number | |
| Regulatory Class | |
| Product Code | |
| Predicate | Research Instruments Ltd.<br>EZ-Tip Vial of 20<br>K161275 |
| | The predicate device has not been subject to a<br>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<br>K161275 | Comparison |
| Indications<br>for Use | V-DENUPET is used for<br>the removal of cumulus<br>oocyte complexes (COC)<br>from an oocyte prior to<br>Intracytoplasmic Sperm<br>Injection (ICSI) and In<br>Vitro Fertilization (IVF) as<br>well as for the handling of<br>oocytes and embryos<br>during assisted<br>reproductive techniques<br>(ART). V-DENUPET is not<br>intended for biopsy of<br>cells from oocytes or<br>embryos. | EZ-Tip pipettes are for<br>denudation, i.e.<br>removing the cumulus<br>from an oocyte prior to<br>Intracytoplasmic Sperm<br>Injection (ICSI) and In<br>Vitro Fertilization (IVF)<br>and for handling<br>gametes, embryos and<br>biopsied cells (polar<br>bodies, blastomeres and<br>trophectoderm) during<br>assisted reproductive<br>techniques (ART). EZ-<br>Tips are not intended for<br>biopsy of cells from<br>oocytes or embryos. | Different<br>Both subject and<br>predicate devices are<br>intended for use in<br>oocyte denudation<br>procedures and<br>handling oocytes and<br>embryos; however, the<br>predicate can also be<br>used for handling<br>biopsied cells. This<br>difference does not<br>represent a different<br>intended use between<br>the subject and<br>predicate device. |
| Materials | Polycarbonate | Polycarbonate | Same |
| Sterility | Sterile (10-6) Gamma<br>Irradiated | Sterile (10-6) Gamma<br>Irradiated | Same |
| Proximal<br>Outer<br>Dimension | 900 µm | 900 µm | Same |
| Distal Inner<br>Diameter | Size range<br>125 µm to 600 µm | Size range<br>75 µm to 600 µm | Different<br>The V-DENUPET is<br>within the cleared<br>range of the predicate<br>device. This difference<br>does not raise different<br>questions of safety or<br>effectiveness (S&E). |
| Length | 90 mm | 90 mm | Same |
| Mouse<br>Embryo<br>Assay<br>(MEA) | 1-Cell MEA<br>≥80% hatched blastocysts<br>at 96 h | 1-Cell MEA<br>≥80% hatched blastocysts<br>at 120 h | Different<br>The Mouse Embryo<br>Assay (MEA)<br>assessment time is<br>shorter for the V-<br>DENUPET, but is the<br>standard assessment<br>time for this assay.<br>Therefore, this<br>difference does not<br>raise different<br>questions of S&E. |
| Endotoxin<br>(LAL) | <0.05 EU/device | <20 EU/device | Different<br>The endotoxin<br>specification for the<br>subject device is lower<br>than the predicate<br>device. This difference<br>does not raise different<br>questions 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
- 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<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.