INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING

K983596 · Cook Ob/Gyn · MQH · Feb 5, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983596
• Device Name: INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
• Applicant: Cook Ob/Gyn
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Feb 5, 1999
• Decision: SESE
• Submission Type: Traditional
• 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

Manual micro-tools for assisted reproduction; includes micro-injection, holding, denuding, and zona drilling pipettes. Used in clinical embryology laboratories by trained professionals. Micro-injection pipettes facilitate single sperm injection into oocytes; holding pipettes stabilize oocytes via vacuum; denuding pipettes remove cumulus cells; zona drilling pipettes create openings in the zona pellucida for hatching or biopsy. Devices are passive glass instruments; no electronic or automated components. Benefit: enables precise micromanipulation of gametes and embryos during IVF procedures.

Clinical Evidence

Bench testing only. Mouse Embryo Toxicity (MET) testing performed on borosilicate glass material to ensure biocompatibility and safety for gametes/embryos.

Technological Characteristics

Manual micro-tools constructed entirely from borosilicate glass. Passive devices; no energy source, connectivity, or software. Sterilization method not specified.

Indications for Use

Indicated for use in assisted reproductive technology procedures including intracytoplasmic sperm injection, oocyte holding, cumulus cell removal, and zona pellucida drilling for blastomere removal or assisted 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 (Humagen Fertility Diagnostics, Inc.)
• 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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K983596

### 10(k) Premarket Notification tracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes Cook OB/GYN

11

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

#### Submitted By:

FEB

Debbie Schmitt Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 [phone] October 13, 1998

#### 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 Intractoplasmic 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 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 blastomere removal or 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/2 description: The image shows a logo or seal with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN". Inside the circle is a stylized graphic of three overlapping figures or shapes, possibly representing people or abstract forms. The overall design is simple and monochromatic.

5 1999 FEB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debbie Schmitt Regulatory Affairs Manager Cook Ob/Gyn® 1100 West Morgan Spencer, IN 47460

Re: K983596

Intracytoplasmic Sperm Injection Micro-Injection Pipettes, Holding Pipettes and Assisted Hatching/Zona Drilling Pipettes Dated: December 23, 1998 Received: December 28, 1998 Regulatory Class: II 21 CFR 884.6130/Procode: 85 MQH

Dear Ms. Schmitt:

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, 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 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 requlation 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,

Cont. Daniel C. Schultz, M.D.

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

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## PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT JOE 35 S

K983596

510(k) Number (if known): Not yet assigned

Device Name:

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

Indications for 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------------|--------------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K983596/S002 |

| Prescription Use | OR | Over-The-Counter Use |
|------------------|----|----------------------|
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