NUNC IVF MULTIDISH 4 WELLS NUNCLON

K040717 · Nunc A/S · MQK · Aug 12, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040717
• Device Name: NUNC IVF MULTIDISH 4 WELLS NUNCLON
• Applicant: Nunc A/S
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Intended Use

The plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse plasticware intended for preparing, manipulating or transferring in vitro fertilization techniques, and cell culture.

Device Story

Nunc IVF Multidish 4 wells (Model 144444) is a sterile, non-pyrogenic, single-use plastic culture dish. Designed for use in clinical embryology and cell culture laboratories. Device serves as a vessel for preparing, manipulating, or transferring biological samples during IVF procedures. Operated by embryologists or laboratory technicians in a clinical or research setting. Provides a controlled environment for cell culture and gamete/embryo handling. Benefits include standardized, embryotoxicity-tested material to support viability of sensitive biological samples during IVF workflows.

Clinical Evidence

No clinical data provided. Device is a sterile, single-use plasticware item; substantial equivalence is supported by bench testing for sterility, non-pyrogenicity, and embryotoxicity.

Technological Characteristics

Sterile, non-pyrogenic, single-use plasticware. Designed as a 4-well multidish (Nunclon surface). No energy source, software, or electronic components. Material is medical-grade plastic suitable for cell culture and IVF applications.

Indications for Use

Indicated for use in in vitro fertilization techniques and cell culture for the preparation, manipulation, or transfer of samples.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2004

Mr. Henrik Kvistgaard OA & RA Manager Nunc A/S Kamstrupvej 90 P.O. Box 280, DK-4000 Roskilde DENMARK

Re: K040717

Trade/Device Name: Nunc IVF Multidish 4 wells Nunclon Model Number 144444 Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: 85 MQK Dated: August 2, 2004 Received: August 4, 2004

Dear Mr. Kvistgaard:

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 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.

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 tor 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ought haves of substantial equivalence of your-device to a legally premaired predication. The PDF intally sification 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 If you desire aposition at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the please note the regulation entitled, "Misbranding Other or Othphanes as (21CFR Part 807.97) you may obtain. Other general by recented to premarred nontions on er the Act may be obtained from the Division of Small Intermation on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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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Page DL

510(k) number K040717

Device name: Nunc IVF Multidish 4 Wells nunclon

Indications for use:

The plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse The place is a sectio not pyrogency, manipulating or transferring plasticware interraca for proparing, but in group of the many of the in vitro fertilization techniques, and cell culture

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)

David A. Segram

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number

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