NUNC IVF DISHES AND NUNC IVF 4-WELL DISH

K070047 · Nunc A/S · MQK · May 18, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070047
• Device Name: NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
• Applicant: Nunc A/S
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: May 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Intended Use

Preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF) or other in vitro fertilization techniques, and cell culture.

Device Story

Nunc IVF PetriDishes and 4-Well Dishes are injection-molded polystyrene labware used in IVF clinics for handling human gametes and embryos. Devices consist of single or 4-well dishes with lids; 4-well configuration features a cut-off corner for lid orientation to minimize cross-contamination. Dishes are stackable and designed for one-handed lid removal. Used by embryologists or lab technicians in clinical settings for cell culture and IVF procedures. Devices are disposable, single-use, and terminally sterilized via gamma irradiation. Polystyrene material is USP Class VI compliant. Output is a sterile, non-pyrogenic, non-embryotoxic environment for gamete/embryo manipulation, supporting clinical decision-making by providing a controlled vessel for fertilization and development.

Clinical Evidence

No clinical data. Bench testing only: USP Class VI cytotoxicity testing, LAL testing for pyrogenicity, and 1-cell mouse embryo assay (MEA) for embryotoxicity.

Technological Characteristics

Injection-molded virgin crystal-grade polystyrene; sterile (SAL 10^-6) via gamma irradiation; non-pyrogenic; non-embryotoxic. Configurations: single-well (35, 60, 90 mm) and 4-well. Features: stackable, cut-off corner for lid orientation. No software or electronic components.

Indications for Use

Indicated for use in in vitro fertilization (IVF) techniques and cell culture for the preparation, storage, manipulation, or transfer of human gametes or embryos.

Regulatory Classification

Identification

Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.

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 it is a dish or plate intended for general assisted reproduction technology procedures, 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

• Nunc IVF Multidish 4 Well Nunclon (K040717)

Submission Summary (Full Text)

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Section E - Summary

Date: March 8, 2007 Page_E |

K07 0047

#### COMPANY

MAY 1 8 2007

:

| Name | Nunc A/S, Thermo Fisher Scientific |
|---------|------------------------------------|
| Address | Kamstrupvej 90 |
| | DK-4000 Roskilde |
| | Denmark |

Registration No. 3003150158

Jana S. Hellmann, QA/RA Director Contact Person

| Tel No. | [phone] |
|---------|---------------------------------|
| Fax No. | [phone] |
| E-mail | [e-mail] |

Date of Summary: December 22, 2006

#### DEVICE

| Trade names | Nunc IVF PetriDish |
|---------------------|---------------------------------------------------------|
| | Nunc IVF 4-Well Dish |
| Common name | IVF tissue culture dishes |
| Classification name | Assisted reproduction labware, 21 CFR884.6160, Code MQK |

| Trade Name | Configuration | Catalogue number |
|----------------------|-------------------------|------------------|
| Nunc IVF PetriDish | Dish 35x10 mm, with lid | 150255 |
| Nunc IVF PetriDish | Dish 60x15 mm, with lid | 150270 |
| Nunc IVF PetriDish | Dish 90x17 mm, with lid | 150360 |
| Nunc IVF 4-Well Dish | 4-Well dish with lid | 179830 |

### PREDICATE DEVICE

Trade name Nunc IVF Multidish 4 Well Nunclon Common name Plastic single use labware dish Manufacturer Nunc A/S Catalogue No 144444 510(k) No. K040717

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#### DEVICE DESCRIPTION

The Nunc IVF PetriDishes and the Nunc IVF 4-well Dish are injection molded polystyrene dishes with either a single well or 4 wells and a polystyrene lid.

The single well dishes are available in diameters of 35, 60 and 90 mm.

Both single well and 4-well configurations are made with a clear polystyrene lid.

The polystyrene used for the dishes and lids is a virgin crystal-grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity. The polystyrene is identical with the same Polystyrene use in the predicate device.

For the 4-well configuration, the interface between the dish and the lid is designed with one cut off corner, hence the lid cannot be turned, and therefore cross contamination can be minimized. The dish is designed in such a way that when the lid is mounted on the dish, dishes can be stacked. The lid can be removed with one hand, which eases the use of the plate.

Nunc IVF PetriDishes (Single well dishes), are packed in pouches of x units in a box for a total of Y units, as defined below:

| Trade Name | Configuration | Packaging |
|--------------------|-------------------------|------------------------------------------------|
| Nunc IVF PetriDish | Dish 35x10 mm, with lid | 10 units in a box for a<br>total of 500 plates |
| Nunc IVF PetriDish | Dish 60x15 mm, with lid | 10 units in a box for a<br>total of 400 plates |
| Nunc IVF PetriDish | Dish 90x17 mm, with lid | 10 units in a box for a<br>total of 150 plates |

Nunc IVF 4-well Dishes, are packed in pouches of 4 units in a box for a total of 120 plates.

The Nunc IVF tissue culture dishes are terminally sterilized by gamma irradiation to achieve SAL of 106. The dishes are non-pyrogenic as tested by LAL, and nonembryotoxic as tested by one cell mouse embryo assay (MEA).

The Nunc IVF tissue culture dishes are disposable and intended for single use.

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## INTENDED USE

Preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF) or other in vitro fertilization techniques, and cell culture.

Comparison to predicate device:

| Nunc IVF 4-Well Dish<br>and<br>Nunc IVF PetriDish,<br>35x10mm, 60x15mm,<br>90x17mm | Nunc IVF Multidish<br>4 Well Nunclon | |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Preparing, storing,<br>manipulating or<br>transferring human<br>gametes or embryos for<br>in vitro fertilization<br>(IVF) or other in vitro<br>fertilization techniques,<br>and cell culture. | Preparing, storing,<br>manipulating or<br>transferring human<br>gametes or embryos for<br>in vitro fertilization<br>(IVF) or other in vitro<br>fertilization techniques,<br>and cell culture. |
| Indication for use | In vitro fertilization<br>technique, cell culture | In vitro fertilization<br>techniques, cell culture |
| Contraindication | N/A | N/A |
| Patient/embryo contact<br>material | Polystyrene surface | Polystyrene surface<br>treated |
| Design features -<br>IVF 4-Well Dish | The bottom of the plate is<br>optimised flat and<br>optically clear. The lid<br>and the plate have a cut<br>off corner which requires<br>that the lid always has<br>the same orientation; thus<br>cross contamination can<br>be minimized. The lid<br>can be handled by one<br>hand while other lab<br>equipment can be<br>handled by the other<br>hand. The plates can be<br>stacked. | The bottom of the plate is<br>optimised flat and<br>optically clear. The lid<br>and the plate have a cut<br>off corner which requires<br>that the lid always has<br>the same orientation; thus<br>cross contamination can<br>be minimized. The lid<br>can be handled by one<br>hand while other lab<br>equipment can be<br>handled by the other<br>hand. The plates can be<br>stacked. |
| Design features -<br>IVF PetriDish | N/A | The bottom of the plate is<br>optimised flat and<br>optically clear. The lid<br>and the plate have a cut<br>off corner which requires<br>that the lid always has<br>the same orientation; thus<br>cross contamination can<br>be minimized. |
| | | be minimized. The lid<br>can be handled by one<br>hand while other lab<br>equipment can be<br>handled by the other<br>hand. The plates can be<br>stacked. |
| Safety features | N/A | N/A |
| Other relevant<br>characteristics | Sterile (SAL 10-6) Tested non-pyrogenic by LAL Passed 1-cell mouse embryo test | Sterile (SAL 10-6) Tested non-pyrogenic by LAL Passed 1-cell mouse embryo test |

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The Nunc IVF PetriDishes and Nunc IVF 4-Well Dish (hereinafter called Nunc IVF tissue culture dishes) and the predicate device Nunc IVF Multidish 4 Well Nunclon, have similar applications which include cell culture and IVF. Both devices are sterile with SAL of 106. They are tested non-pyrogenic by Limulus Amebocyte Lysate (LAL) and nonembryo toxic as tested by the mouse embryo assay (MEA). The plates are made of the same material (Polystyrene), and they are both gamma irradiated.

The differences between the Nunc IVF tissue culture dishes and the Nunc IVF Multidish 4 Well Nunclon is that the Nunc IVF tissue culture dishes have not been surface treated, and the configuration of the single well devices are not identical to the Nunc IVF Multidish 4 Well Nunclon. These differences do not affect the safety and effectiveness of the device.

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Image /page/4/Picture/0 description: The image shows a circular logo with the words "U.S. Department of Health & Human Services" written around the perimeter. Inside the circle is a stylized graphic of three curved lines that resemble a person with outstretched arms. The lines are thick and black, and they create a sense of movement and energy.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Jana S. Hellmann OA/RA Director Nunc A/S, Thermo Fisher Scientific Kamstrupvej 90 DK-4000 Roskilde DENMARK

**MAY 18 2007**

Re: K070047

· Trade/Device Name: Nunc IVF Dishes and Nunc IVF 4-Well Dish Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: May 3, 2007 Received: May 7, 2007

Dear Ms. Hellmann:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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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Protesting and Promoting Public Health

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K070047

Device name: Nunc IVF 4-Well Dishes

Indications For Use:

Nunc IVF 4-Well Dishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro ferilization techniques and cell culture.

Prescription Use_ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Dey 510(k) Number

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## Indications for Use

510(k) Number (if known): K070047

Device name: Nunc IVF PetriDishes (35 x 10 mm, 60 x 15 mm and 90 x 17 mm)

Indications For Use:

Nunc IVF PetriDishes are intended for preparing, storing, manipulation or transferring human gametes or embryos for in-vitro fertilization (IVF), or other in vitro fertilization techniques and cell culture.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Sheldon
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070047

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