GENX MICROTOOLS

K993884 · <Genx> Intl., Inc. · MQJ · Feb 14, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993884
• Device Name: GENX MICROTOOLS
• Applicant: <Genx> Intl., Inc.
• Product Code: MQJ · Obstetrics/Gynecology
• Decision Date: Feb 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6150
• Device Class: Class 2

Intended Use

Used to micromanipulate, hold, or transfer oocytes or embryos for assisted hatching, intsacytoplasmic sperm injection (ICSI) or other assisted reproduction methods.

Device Story

GenX ICSI Microtools consist of borosilicate glass tubes drawn into micro-pipettes; designed for micromanipulation, holding, or transferring oocytes/embryos. Used in clinical assisted reproduction laboratories by embryologists/technicians. Operation involves applying suction to hold cells in place or using the hollow tip to draw in and inject cells into a larger cell mass. Tools are angled at the tip to remain parallel to the dish surface. Benefits include facilitating precise gamete/embryo handling during ICSI and assisted hatching procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Borosilicate glass micro-pipettes; rigid and flexible variants. Sterilized via gamma radiation (28kGy +/- 15%) per ANSI/AAMI/ISO 11137-1994 standards. Manual operation; no electronic or software components.

Indications for Use

Indicated for use in assisted reproduction procedures, including assisted hatching and intracytoplasmic sperm injection (ICSI), to micromanipulate, hold, or transfer oocytes or embryos.

Regulatory Classification

Identification

Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.

Special Controls

*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device 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

• Humagen ICSI Microtools
• Cook IVF ICSI Microtools

Submission Summary (Full Text)

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

SINIL nolaing & ICSI FINAL

## FEB 1 4 2000

<genX> international, Inc. 510(K) Premarket Notification

Huge lots

# 510(K) Summary

K993884

- DEVICE NAME a) Proprietary Name: <genX> Microtools
Classification Name: Assisted Reproduction Microtools

- b) Submitted by: <genX International, inc. 170 Fort path Rd. Madison. CT 06443
ESTABLISHMENT REGISTRATION No .: 9003605

Tel: [phone] Fax: [phone]

Contact Individual: Michael D. Cecchi President

- C) CLASSIFICATION: Class II Assisted Reproductive Microtools Product:
<genX> ICSI Microtools <genX> Holding Micro Pipettes <genX> ICSI Micro Pipettes

Procode: 85 MQJ CFR#: 884.6150

- d) PERFORMANCE STANDARDS Performance Standards under Section 514 of the ACT have not been developed for this device. However, Special controls have been identified by the FDA to provide reasonable assurance of safety and effectiveness of the device in assisted reproductive procedures.
- PROPOSED LABELS, LABELING, AND ADVERTISING e) The proposed labeling and instruction material is included in this package in the appropriate section.
- INDICATION FOR USE AND DESCRIPTION f) The <genX> ICSI Microtools are intended Used to micromanipulate, hold, or transfer oocytes or embryos for assisted hatching, intsacytoplasmic sperm injection (ICSI) or

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

Image /page/1/Picture/0 description: The image shows handwritten text. The text includes the word "Page" followed by the number "206-3". Above the word "Page" is the letter "D" and the number "7775554". The handwriting is somewhat rough and the image quality is not very clear.

other assisted reproduction methods. The catalog numbers are GIPR-025 for Rigid and GARF-025 for flexible

The basic design is a borosilicate glass tube, drawn to form a microinjection and/or microholding holding instrument. Each is angled towards the tip end to allow the instrument to be parallel to the surface of the dish.

By apply suction the holding pipette is able to hold the cell in place, and the micro injection tool may pull cells into the hollow middle and then inject these cells into a larger cell mass.

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

GMIP nolding & ICSI FINAL

K943854
Page 3 of 3

<genX> international, Inc. 510(K) Premarket Notification

C.1

- g) Sterilization Procedures and Facilities
The tools are individually packaged and then gamma radiated. All tools manufactured, will be Gamma Radiation by and according to the guidelines in place.

Dosage level: 28kGy +/- 15%

After sterilization the contractor will issue a "Certificate of Sterilization".

Validation assurance is in accordance with ANSI / AAMI / ISO 11137-1994 Standards.

See Section 11.0

After sterilization a " Certificate of Sterilization" will be issued by the contractor.

#### Statement of Substantially Equivalence h)

<genX> international Inc., considers <genX>ICSI Microttools to be substantially equivalent in design and intended use to a number of predicated ICSI Microttols legally marketed in United States. These tools are manufactured and distributed by Humagen and Cook IVF.

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

Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal are three stylized human figures, possibly representing a family or community.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 4 2000

Mr. Michael D. Cecchi President <genX> international, Inc. 170 Fort Path Road Madison, CT 06443

Re: K993884 <genX> ICSI Microtools Dated: November 14, 1999 Received: November 16, 1999 Requlatory Class: II 21 CFR §884.6150/Procode: 85 MQJ

Dear Mr. Cecchi:

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, 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 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 requlations,

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance 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

{4}------------------------------------------------

#### INDICATIONS FOR USE

| 510 (k) Number ( if known ) | 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |

Device Names: <genX> ICSI Microtools

Indication for Use:

"Used to micromanipulate, hold, or transfer gametes or embryos for assisted hatching, intsacytoplasmic sperm injection (ICSI) or other assisted reproduction methods"

### (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, ENT, and Radiological Devices 510(k) Number

C