SUNIVF DISHES

K080395 · <Genx> Intl., Inc. · MQK · Aug 13, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K080395
• Device Name: SUNIVF DISHES
• Applicant: <Genx> Intl., Inc.
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Aug 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Intended Use

The SunIVF Universal™ Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional invitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation.

Device Story

SunIVF dishes are sterile, single-use laboratory containers designed for assisted reproductive technology (ART) procedures. Devices serve as physical vessels to hold human gametes (sperm, oocytes) and embryos during clinical laboratory workflows, including culture, micromanipulation, cryopreservation, and vitrification. Operated by embryologists or laboratory technicians in clinical IVF settings. Dishes provide a controlled environment for handling and observation under microscopy. No electronic or automated components; purely mechanical labware.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile, single-use laboratory dishes for ART. Materials and dimensions are standard for cell culture and micromanipulation. No energy source, software, or electronic components.

Indications for Use

Indicated for holding human sperm, oocytes, and embryos during assisted reproductive technology (ART) procedures including IVF, ICSI, assisted hatching, biopsy, cryopreservation, vitrification, washing, handling, and culture.

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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 8 2008

Mr. Michael D. Cecchi President <GenX> International. Inc. 393 Soundview Road GUILFORD CT 06443

Re: K080395

Trade/Devices Name: See enclosed list Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Dated: July 19, 2008 Received: July 25, 2008

Dear Mr. Cecchi:

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 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 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/cdfb/industry/support/index.html.

Sincerely yours.

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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## Trade Names of Devices Cleared in <GenX> International, Inc. Submission K080395

All of the devices below are assisted reproductive labware devices (884.6160, product code MQL, Class II)

and the same of the same of the same of the same of the season of the season

:

- SunIVF Universal Dish .
- SunIVF Micromanipulation Dish .
- . SunIVF ICSI Dish
- SunIVF Freezing Dish 1 .
- . SunIVF Freezing Dish 2
- SunIVF Vitrification Dish .
- SunIVF Rotational Dish .
- SunIVF General Flat Dish 35 X 10 mm .
- SunIVF General Flat Dish 60 X 15 mm .
- SunIVF General Flat Dish 90 X 17 mm .

.

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510 (k) Number (if known): K080395

Device Names: SunIVF Universal™ Dish

Indication for Use:

The SunIVF Universal™ Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional invitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| Over-the Counter Use | |

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

| 510(k) Number | K080395 |
|---------------|---------|
|---------------|---------|

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INDICATIONS FOR USE

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510 (k) Number (if known): K080395

Device Names: SunIVF Micromanipulation™ Dish

Indication for Use:

:

The SunIVF Micromanipulation™ Dish is intended to be used to hold human THE Gall VF Mioromanipuliation vitro procedures of assisted human reproduction, oooyted and omaryou untryou wire sperm injection, assisted hatching, and biopsy.

(Please Do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|------------------|----------------------|
| or | Over-the Counter Use |

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

| 510(k) Number | K080395 |
|---------------|---------|
|---------------|---------|

#### B.1

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510 (k) Number (if known): K080395

Device Names: SunIVF ICSI™ Dish

Indication for Use:

The SunIVF ICSI™ Dish is intended to be used to hold human oocytes and sperm during the procedure of fertilization by intracytoplasmic sperm injection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or Over-the Counter Use **__**

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INDICATIONS FOR USE

510 (k) Number (if known): K080395

Device Names: SunIVF Freezing Dish 1

Indication for Use:

The SunIVF Freezing Dish 1 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗ or Over-the Counter Use

liven
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080395
-

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INDICATIONS FOR USE

510 (k) Number (if known): K080395

Device Names: SunIVF Freezing Dish 2

Indication for Use:

The Sun!VF Freezing Dish 2 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Over-the Counter Use

Jubut Leenen

or

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

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510 (k) Number (if known): K080395

Device Names: SunIVF Vitrification Dish

Indication for Use:

The SunIVF Vitrification Dish is intended to be used to hold human oocytes and embryos during the procedures of vitrification.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or

Over-the Counter Use

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

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INDICATIONS FOR USE

510 (k) Number (if known): K080395

Device Names: SunIVF Rotational Dish

Indication for Use:

The SunIVF Rotational Dish is intended to be used to hold human oocytes and embryos during handling and culture.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use or

Over-the Counter Use __

Huld Reiner

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

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510 (k) Number (if known): K080395

Device Names: SunlVF General Flat Dish – 35 X 10 mm

Indication for Use:

The SunIVF General Flat Dish – 35 X 10 mm is intended to be used for washing and handling of human oocytes and embryos.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or

Over-the Counter Use _

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

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510 (k) Number (if known): K080395

SunIVF General Flat Dish – 60 X 15 mm Device Names:

Indication for Use:

The SunIVF General Flat Dish – 60 X 15 mm is intended to be used for washing and handling of human oocytes and embryos.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use_

or

Over-the Counter Use _________________________________________________________________________________________________________________________________________________________

Julia Lemm

(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number _

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510 (k) Number (if known): K080395

SunIVF General Flat Dish – 90 X 17 mm Device Names:

Indication for Use:

The SunIVF General Flat Dish – 90 X 17 mm is intended to be used for washing and handling of human oocytes and embryos.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use A

ог

Over-the Counter Use

Helb Remm

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