FALCON IVF ROUND DISH

K991253 · Becton Dickinson Labware · MQK · May 5, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991253
• Device Name: FALCON IVF ROUND DISH
• Applicant: Becton Dickinson Labware
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: May 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Intended Use

The FALCON® IVF Round Dish is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.

Device Story

FALCON® IVF Round Dish is a sterile, single-use, 60-mm diameter plastic dish used in assisted reproduction laboratories. Manufactured from virgin crystalline polystyrene, the dish features a flat, optically clear surface to facilitate the observation and manipulation of ova and embryos. The lid design supports aseptic handling and consistent venting for proper humidification. The device is used by laboratory personnel to hold gametes or embryos during IVF, GIFT, or related procedures. It is non-pyrogenic and non-embryotoxic, verified via Limulus Amebocyte Lysate (LAL) assay and mouse embryotoxicity assay (MEA).

Clinical Evidence

No clinical data. Bench testing includes Limulus Amebocyte Lysate (LAL) assay for pyrogenicity (< 20 EU/device) and mouse embryotoxicity assay (MEA) 2-cell method for non-embryotoxicity.

Technological Characteristics

60-mm diameter, 24.07 cm² well area, 23.0 mL well volume. Material: Virgin crystalline polystyrene (USP Class IV, V, VI tested). Surface: Treated for hydrophilic properties. Sterilization: Sterile (SAL 10^-6). Form factor: Round dish with lid.

Indications for Use

Indicated for use in preparing, storing, manipulating, or transferring human gametes or embryos for IVF, GIFT, or other assisted reproduction techniques.

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)

{0}------------------------------------------------

5/5/99

# Attachment D 510(k) Summary

The assigned 510(k) number is _ K 9912533

#### Submitter Information (21 CFR 807.92(a)(1))

| Submitter: | Becton Dickinson<br>1 Becton Drive<br>Franklin Lakes, NJ 07417-1880 |
|---------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Morrow<br>Sr. Regulatory Specialist<br>[phone]<br>[phone] (FAX)<br>[e-mail] |
| Summary date: | April 12, 1999 |

#### Device Name/Classification (21 CFR 807.92(a)(2))

| Name: | FALCON® IVF Round Dish |
|-----------------|-----------------------------------------------------------------|
| Classification: | Assisted reproduction labware, Class II, 884.6160, Code: 85 MQK |

#### Substantially Equivalent/Predicate Device (21 CFR 807.92(a)(3))

This product is being submitted according to the Federal Register notice located on page 48428 of Vol.63, No. 175 on September 10, 1998 under the title Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures.

#### Device Description (21 CFR 807.92(a)(4))

The FALCON® IVF Round Dish is sterile (SAL of 10.9), non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of < 20 EU/device), and nonembryotoxic as tested by the mouse embryotoxicity assay (MEA) 2-cell method. The single-use plastic dishes have a diameter of 60-mm, well area of 24.07 cm², and well volume of 23.0 mL. The dish is sold in units of 20 dishes per bag, and 500 dishes per case.

The dishes have perfectly flat, optically clear surfaces for optimum manipulation and observation of the ova and embryos. The lids are designed for aseptic manipulation and consistent venting to maintain proper humidification. The dishes are manufactured from

{1}------------------------------------------------

virgin crystalline polystyrene tested for USP Class IV, V, and VI cytotoxicity. and the surfaces are treated to provide a more wetable or hydrophilic surface for tissue culture.

### Intended Use (21 CFR 807.92(a)(5))

The FALCON® IVF Round Dish is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.

David L. Ball

4/12/99

Date

David Ball Director of Quality Assurance/ Regulatory Affairs Becton Dickinson

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 5 1099

Mr. David Ball Director of Quality Assurance/Regulatory Affairs Becton Dickinson & Company 1 Becton Drive Franklin Lakes, NJ 07417-1884

Re: K991253

FALCON® IVF Round Dish Dated: April 12, 1999 Received: April 13, 1999 Requiatory Class: II 21 CFR 884.6160/Procode: 85 MQK

Dear Mr. Ball:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Attachment C

## Indications for Use

510(k) Number:_K991253

Device Name: FALCON® IVF Round Dish

The FALCON® IVF Round Dish is sterile, nonpyrogenic, embryotoxicity tested, single-use plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|------------------------|--|
| (Per 21 CFR § 801.109) | |

Or

| Over-the-Counter Use | |
|--------------------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Premarket Notification | |
| 510(k) Number | K991253 |

8