BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH

K081896 · Biogenics, Inc. · MQK · Aug 20, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081896
• Device Name: BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
• Applicant: Biogenics, Inc.
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Aug 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The plate is a sterile non-pyrogenic, Embryotoxicity tested single use plasticware intended for preparing, storing, manipulating or transferring human gametes or intended for preparing, (IVF), or other in vitro fertilization techniques or cell culture.

Device Story

Biogenics BioQuad 4-Well Vented IVF Culture Dish is a sterile, single-use plasticware device. It provides a controlled environment for the preparation, storage, manipulation, or transfer of human gametes and embryos during IVF or related cell culture procedures. Used in clinical laboratory settings by embryologists and laboratory technicians. The device facilitates the handling of biological samples in vitro, supporting standard assisted reproductive technology workflows. It is non-pyrogenic and embryotoxicity tested to ensure sample viability.

Clinical Evidence

No clinical data provided. Device is a sterile, single-use plasticware item; safety is established through non-pyrogenicity and embryotoxicity testing.

Technological Characteristics

Sterile, non-pyrogenic, single-use plasticware. 4-well vented design. Designed for cell culture and IVF applications.

Indications for Use

Indicated for use in clinical laboratories for the preparation, storage, manipulation, or transfer of human gametes or embryos during in vitro fertilization (IVF) or other cell culture 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biogenics, Inc. c/o Mr. Daniel W. Lehtonen Senior Staff Engineer, Medical Devices Intertek Testing Services 2307 East Aurora Road Unit B7 TWINSBURG OH 44087

AUG 2 0 2008

Re: K081896

Trade/Device Name: Biogenics BioQuad™ 4-Well IVF Culture Dish Regulation Number: 21 CFR §884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQL Dated: August 4, 2008 Received: August 5, 2008

Dear Mr. Lehtonen:

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.

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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 or any I out 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C Brogdon

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 STATEMENT

K081896 510K Number:

Device Name: Blogenics BioQuad im 4 Well Vented IVF Culture Dish

Indications for Use:

The plate is a sterile non-pyrogenic, Embryotoxicity tested single use plasticware intended for preparing, storing, manipulating or transferring human gametes or incended for proparing, (IVF), or other in vitro fertilization techniques or cell culture.

Prescription use (Part 21 CFR 801 Subpart D) 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)

Nancy Brogdon
(Division Sign-Off)

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

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