NUNC IVF CENTERWELL AND ICSI DISHES

K090429 · Thermo Fisher Scientific (Nalge Nunc Intl) · MQK · Sep 18, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090429
• Device Name: NUNC IVF CENTERWELL AND ICSI DISHES
• Applicant: Thermo Fisher Scientific (Nalge Nunc Intl)
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

The dish is intended for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).

Device Story

IVF ICSI Dish is a single-well, injection-molded polystyrene tissue culture dish used in IVF laboratories. It holds oocytes and sperm during intracytoplasmic sperm injection (ICSI) procedures. The device is operated by embryologists in a clinical laboratory setting. The dish features a flat, optically clear bottom to facilitate microscopic observation of gametes during the ICSI process. The lid is designed for one-handed removal and stacking. The device is disposable, single-use, and terminally sterilized via gamma irradiation. By providing a sterile, non-pyrogenic, and non-embryotoxic environment, the dish supports the safe handling and manipulation of gametes, assisting infertile couples in achieving pregnancy.

Clinical Evidence

Bench testing only. The device was validated for sterility (SAL 10^-6 via gamma irradiation), non-pyrogenicity (LAL test), and non-embryotoxicity using a 1-cell mouse embryo assay (MEA), demonstrating ≥80% expanded blastocysts at 96 hours.

Technological Characteristics

Material: Virgin crystal-grade polystyrene (USP 32 <88> Class VI, USP 32 <87>). Dimensions: 50.77 mm diameter, 8.64 mm height (9.75 mm with lid). Design: Single-well, stackable, flat optically clear bottom. Sterilization: Gamma irradiation (SAL 10^-6).

Indications for Use

Indicated for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI) in female patients undergoing IVF procedures.

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

• NewLife™ Dish (K990941)

Submission Summary (Full Text)

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K090429

# SEP 1 8 2009

**ThermoFisher**
SCIENTIFIC

## 510(k) Summary - IVF ICSI Dish

#### COMPANY

Name

Address

Thermo Fisher Scientific Labware & Specialty Plastics Business Unit [Nalge Nunc International] 75 Panorama Creek Drive Rochester, NY 14625-2385 USA

Registration No. Contact Person

Robert Prescott, Manager, Regulatory Affairs and Quality Assurance 1-585-586-8800 ext. 7610 1-585-899-7405 [e-mail]

Date of Summary February 11, 2009

#### DEVICE

Tel No.

Fax No.

E-mail

| Trade name | IVF ICSI Dish |
|---------------------|-------------------------------|
| Common name | IVF tissue culture dish |
| Classification name | Assisted Reproduction Labware |
| 21 CFR | 884.6160 |
| Code | MQK |
| K Number | K090429 |

| Trade Name | IVF ICSI Dish |
|----------------|----------------------|
| Configuration | 1-Well dish with lid |
| Catalog Number | 150265 |

#### PREDICATE DEVICE

Trade name Common name Manufacturer

Catalog No.

510(k) No.

NewLife™ Dish IVF tissue culture dish Humagen Fertility Diagnostics, Inc 2400 Hunter's Way Charlottesville, VA 22911 14-52L K990941

Rochester, NY 14625

Tel. [phone] Fax: [phone]

www.thermofisher.com

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## DEVICE DESCRIPTION - IVF ICSI Dish

The IVF ICSI Dish is an injection molded polystyrene dish with a single dish-sized well. The dish has overall outside dimensions of 1.999" (50.77 mm) diameter and 0.340" (8.64 mm) height without the lid. Addition of the lid increases overall height to 0.384" (9.75 mm).

The dish has a fluid capacity of 12.5 ml, if filled to the top of the sidewall; however, individual IVF clinics typically use a small fraction of that potential volume.

The polystyrene used for the dish and lid are virgin crystal-grade polystyrene, which has successfully passed the USP 32 <88> Class VI test for in vivo cytotoxicity and USP 32 <87> for in vitro cytotoxicity.

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.

The IVF ICSI Dish is packed in strips of 3 dishes with lids and 40 strips in a box for a total of 120 units

The IVF ICSI Dish is terminally sterilized by gamma irradiation to achieve an SAL of 10 °. The dish is non-pyrogenic as tested by LAL, and non-embryo toxic as tested by one-cell mouse embryo assay (MEA),

The IVF ICSI dish is disposable and intended and labeled for single use.

#### INTENDED USE

The dish is intended for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).

Rochester, NY 44625

Tel: 585,586,8800 Fax: 585,586.3294

.thermofisher.com

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SCIENTIFIC

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## COMPARISON TO PREDICATE DEVICE

| | IVF ICSI Dish | NewLife™ Dish |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The IVF ICSI dish is<br>intended for holding oocytes<br>and sperm during fertilization<br>via intracytoplasmic sperm<br>injection (ICSI). | The NewLife™ Dish is<br>intended to be to hold<br>zygotes/embryos during<br>micromanipulation or other<br>tissue culture procedures in<br>the IVF laboratory.<br>NewLife™ Dishes are used in<br>the tissue culture techniques<br>performed by embryologists<br>when injecting a single sperm<br>into an egg, or assisting an<br>embryo in hatching prior to<br>re-implantation during the<br>procedure of fertilization by<br>intracytoplasmic sperm<br>injection. The dishes are<br>disposable tissue culture<br>labware used in procedures<br>that have been developed to<br>aid infertile couples achieve<br>pregnancy. Specifically, the<br>ICSI procedure is beneficial<br>where male fertility is<br>impaired. |
| | IVF ICSI Dish | NewLife™ Dish |
| Indication for use | The IVF ICSI dish is<br>intended for holding oocytes<br>and sperm during fertilization<br>via intracytoplasmic sperm<br>injection (ICSI). | The NewLife™ Dish is<br>intended to be to hold<br>zygotes/embryos during<br>micromanipulation or other<br>tissue culture procedures in<br>the IVF laboratory.<br>NewLife™ Dishes are used in<br>the tissue culture techniques<br>performed by embryologists<br>when injecting a single sperm<br>into an egg, or assisting an<br>embryo in hatching prior to<br>re-implantation during the<br>procedure of fertilization by<br>intracytoplasmic sperm<br>injection. The dishes are<br>disposable tissue culture<br>labware used in procedures<br>that have been developed to<br>aid infertile couples achieve<br>pregnancy. Specifically, the<br>ICSI procedure is beneficial<br>where male fertility is<br>impaired. |
| Contraindication | N/A | N/A |
| Target Population | Female | Female |
| Patient/embryo<br>contact material | Polystyrene | Polystyrene |
| Design features | The bottom of the dishes is<br>flat and optically clear. The lid<br>can be handled by one hand<br>while other lab equipment<br>can be handled by the other<br>hand. The dishes can be<br>stacked. | The bottom of the dish is flat<br>and optically clear either with<br>or without etched rings. |
| Safety features | N/A | N/A |
| Other relevant<br>characteristics | Sterile (SAL 10-6), via gamma<br>radiation<br>Tested non-pyrogenic by LAL<br>Passed 1-cell mouse embryo<br>test at ≥80% expanded<br>blastocysts at 96 hours | Sterile (SAL 10-6), via<br>gamma radiation<br>Tested non-pyrogenic by LAL<br>Passed 2-cell mouse embryo<br>test at ≥70%<br>hatched/expanded<br>blastocysts at 72 hours |

75 Panorama Creek Drive

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Rochester, NY 14625

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#### Thermo Fisher SCIENTIFIC

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Rochester, NY
14625

Tel: [phone]
Fax: [phone] し

www.lhermofisher.com

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Image /page/4/Picture/0 description: The image shows the logo for Thermo Fisher Scientific. The logo is in black and consists of the company name in a bold, sans-serif font. The word "ThermoFisher" is on the top line, and the word "SCIENTIFIC" is on the second line in a smaller font size.

The IVF ICSI Dish and the predicate device NewLife™ Dish, have similar applications which include the ICSI technique. Both devices are sterile with SAL of 10°. They are tested non-pyrogenic by Limulus Amebocyte Lysate (LAL) and non-embryotoxic as tested by the mouse embryo assay (MEA). The dishes are made of the same material polymer (Polystyrene) and they are gamma irradiated.

The differences between the IVF ICS! Dish and the NewLife™ Dish (predicate device) are that the IVF ICSI Dish is not offered in a configuration with etched circles on the bottom. And the predicate device is tested with the 2-cell mouse embryo assay. There is no consensus among IVF clinics as to a preference for the 1-cell or 2-cell test. These differences do not affect the safety and effectiveness of the device.

75 Panorama Creek Drive

Rochester, NY 14625

Tel: [phone] Fax; 585.586.3294 www.liermofisher.com

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

## SEP 1 8 2009

Mr. Robert Prescott Manager Regulatory Affairs and Quality Assurance ThermoFisher Scientific 75 Panorama Creek Drive ROCHESTER NY 14625

K090429 Re:

> Trade/Device Name: IVF ICSI Dish and IVF Center Well Dish Regulation Number: 21 CFR §884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: August 28, 2009

Received: August 31, 2009

Dear Mr. Prescott:

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 (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 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 (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indication for Use Summary Page: D 1

Date: June 19, 2009

### Indications for Use

510(k) Number (if known): K090429 Device Name: IVF Center Well Dish

Indications for Use:

"The IVF Center Well Dish is intended for preparing and culturing gametes or embryos for use in human In Vitro Fertilization (IVF)"

Prescription Use × (Part 21 CFR 801 Subpart D)

.

AND/OR

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)

Hulut Aseun

(Division Sign-Off) (Division of Reproductive, Abdominal, Division of Reprocal
and Radiological Devices 479 510(k) Number ـ

510(k) application

Thermo Fisher Scientific, 75 Panorama Creek Drive, Rochester, NY 14625