ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M

K991388 · Pacific Andrology, Inc. · MQH · Sep 13, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991388
• Device Name: ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
• Applicant: Pacific Andrology, Inc.
• Product Code: MQH · Obstetrics/Gynecology
• Decision Date: Sep 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pacific Andrology, Inc. Microtools are a family of precision pipettes that are used for assisted reproduction procedures. They are designed, for use to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction methods. ICSI micropipettes are used for the intracytoplasmic single sperm injection of oocytes. Assisted hatching micropipettes are used to effect a hole in the zona pellucida by chemical means. The Holding Micropipettes are used to hold the oocyte in position during single sperm injection with the Intracytoplasmic sperm injection (ICSI) Micropipette, to hold the embryo during the assisted hatching or during partial zona dissection procedures. Partial zona dissection micropipettes are used to facilitate assisted hatching by mechanically creating a hole in the zona pellucida. The Denuding Pipettes are used to remove cumulus cell layers from oocytes.

Device Story

Pacific Andrology Microtools are precision pipettes for assisted reproduction. Device family includes ICSI micropipettes for sperm injection; assisted hatching micropipettes for chemical zona pellucida perforation; holding micropipettes for oocyte/embryo stabilization; partial zona dissection micropipettes for mechanical zona perforation; and denuding pipettes for cumulus cell removal. Used in clinical laboratory settings by embryologists or trained reproductive specialists. Pipettes facilitate physical handling and manipulation of gametes/embryos under microscopic visualization. Output is the physical movement or modification of the biological sample to support fertilization or embryo development. Benefits include enabling micromanipulation techniques necessary for successful assisted reproductive technology (ART) outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Precision glass pipettes designed for micromanipulation. Specific configurations include ICSI, holding, denuding, and zona dissection tips. Non-powered, manual instruments. Sterilization method not specified.

Indications for Use

Indicated for use in assisted reproduction procedures, including ICSI, assisted hatching, and partial zona dissection, involving the manipulation, injection, holding, or transfer of human gametes or embryos.

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.

Submission Summary (Full Text)

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

SEP 1 3 1999

Pacific Andrology, Inc. C/O Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, California 92606 Re:

K991388 Assisted Reproduction Microtools Dated: July 28, 1999 Received: July 29, 1999 Regulatory Class: II 21 CFR 884.6130/Procode: 85 MQH

Dear Mr. Holland:

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 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 Reculations, 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,
Dan Letitia

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

Image /page/0/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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Premarket Notification - Advanced Reproductive Technologies -- Microtools, K99138

ATTACHMENT A

Page_1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Microtools_ Device Name:

Indications For Use:

Pacific Andrology, Inc. Microtools are a family of precision pipettes that are used for assisted reproduction procedures. They are designed, for use to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction methods.

ICSI micropipettes are used for the intracytoplasmic single sperm injection of oocytes.

Assisted hatching micropipettes are used to effect a hole in the zona pellucida by chemical means.

The Holding Micropipettes are used to hold the oocyte in position during single sperm injection with the Intracytoplasmic sperm injection (ICSI) Micropipette, to hold the embryo during the assisted hatching or during partial zona dissection procedures.

Partial zona dissection micropipettes are used to facilitate assisted hatching by mechanically creating a hole in the zona pellucida.

The Denuding Pipettes are used to remove cumulus cell layers from oocytes. (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 | K991388 |

| Prescription Use | <div></div> | OR | Over-The-Counter Use | |
|------------------|-------------|----|----------------------|--|
|------------------|-------------|----|----------------------|--|

Holland & Associates

(Per 21 CFR 801.109)

(Optional Format 1-2-96)