MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,

K033903 · Cook Urological, Inc. · MQH · Jan 16, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033903
• Device Name: MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
• Applicant: Cook Urological, Inc.
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.6130
• Device Class: Class 2

Intended Use

The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.

Device Story

Assisted reproduction microtools; borosilicate glass pipettes; used in clinical embryology laboratories. ICSI pipettes inject single sperm into oocytes; holding pipettes stabilize oocytes via vacuum; denuding pipettes remove cumulus cells; assisted hatching/zona drilling pipettes create holes in zona pellucida for embryo hatching or blastomere removal. Operated by embryologists/clinicians under microscope. Facilitates fertilization and embryo development in IVF procedures.

Clinical Evidence

Bench testing only; Mouse Embryo Toxicity testing performed on borosilicate glass materials to confirm safety.

Technological Characteristics

Borosilicate glass construction; manual micro-manipulation tools; non-powered; sterile; single-use.

Indications for Use

Indicated for use in assisted reproduction procedures involving oocytes and embryos. Used by clinicians for sperm injection, oocyte holding, cumulus cell removal, and zona pellucida drilling/hatching.

Regulatory Classification

Identification

Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

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 the assisted reproduction microtools (pipettes) are manufactured from glass, 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

• Intracytoplasmic Micropipet and Holding Micropipet (Humagen Fertility Diagnostics, Inc.)
• Laboratory Micropipette Art. No. 33311 (SWEMED LAB International AB)
• Laboratory Micropipette Art. No. 22218 (SWEMED LAB International AB)
• ICSI pipettes, holding pipettes, denuding pipettes and assisted hatching/zona drilling pipettes (Cook Australia)

Submission Summary (Full Text)

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K033903

Cook Ob/Gyn 1100 W. Morgan Street Spencer, IN 47460 USA Phone: [phone] Fax: [phone] www.cookgroup.com

# COOK

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Submitted By:

Brenda Davis Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 [phone] bdavis(@cookuro.com December 16, 2003

#### Device:

Trade Name:

Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes

| Proposed Classification Name: | Class II Assisted Reproduction Microtools |
|-------------------------------|-------------------------------------------|
| | 85MQH |
| CFR Reference: | 884.6130 |

#### Predicate Devices:

Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used other devices as well as Cook Australia devices as our predicate to illustrate safety and effectiveness.

The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, and Assisted Hatching/Zona Drilling Pipettes are substantially equivalent to other pipettes in terms of indications for use, design, construction and materials equivalence.

Specifically, these devices are similar to the Intracytoplasmic Micropipet and Holding Micropipet manufactured by Humagen Fertility Diagnostics, Inc., 2345 Hunter's Way (No. 2), Charlottesville, VA 22901-7928, the Laboratory Micropipette Art. No. 33311 and Laboratory Micropipette Art. No. 22218 manufactured by SWEMED LAB International AB, Box 4014 S-421 04 V. Frolunda, Sweden and the (ICSI) pipettes, holding pipettes, denuding pipettes and assisted hatching/zona drilling pipettes manufactured and distributed in Europe by Cook Australia, 12 Electronics Street, Brisbane Industrial Park, Eight Miles Plains, Queensland, 4113, Australia.

### Device Description:

The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.

#### Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2004

Ms. Brenda Davis Regulatory Affairs, Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460 USA

Re: K033903

Trade/Device Name: Intracytoplasmic Sperm Injection (ICSI), Micro-injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted hatching/Zona Drilling Pipettes Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: 85 MQH Dated: December 16, 2003 Received: December 17, 2003

Dear Ms. Davis:

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 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.

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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 Office of Compliance 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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

Page 2

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# Indications for Use

510(k) Number (if known): K033903

| Device Name: | Intracytoplasmic Sperm Injection (ICSI) Micro-Injection<br>Pipettes, Holding Pipettes, Denuding Pipettes, Assisted<br>Hatching/Zona Drilling Pipettes |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection<br>Pipettes are used for the intracytoplasmic single sperm<br>injection of oocytes. The Holding Pipettes are used to hold<br>the oocyte in position with the application of vacuum. The<br>Denuding Pipettes are used to remove the cumulus cell<br>layers. The Assisted Hatching/Zona Drilling Pipettes are<br>used to make a hole in the zona pellucida to enable<br>blastomere removal or embryo assisted hatching. |

Prescription Use (Part 21 CFR 801 Subpart D)

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ANDYOR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lynn

(Division Sign-Off) Division Reproductive, Abdominal, and Radiological Device 310(k) Number

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