HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM

K011573 · Conception Technologies · MQL · Jul 2, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K011573
• Device Name: HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
• Applicant: Conception Technologies
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 2, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Hyaluronidase in HTF Medium is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

Device Story

Hyaluronidase in HTF Medium is a chemical reagent used in clinical embryology laboratories. It functions by enzymatically digesting hyaluronic acid, the extracellular matrix component binding cumulus cells to oocytes. By removing these cells, the device enables embryologists to visualize and manipulate oocytes for intracytoplasmic sperm injection (ICSI). The product is intended for professional use by trained laboratory personnel in fertility clinics. It serves as a preparatory step in the ICSI workflow, directly facilitating the mechanical handling of oocytes during assisted reproductive technology procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic solution containing hyaluronidase in Human Tubal Fluid (HTF) medium. Designed for in vitro use in assisted reproductive technology. Non-electronic, chemical reagent.

Indications for Use

Indicated for use prior to intracytoplasmic sperm injection (ICSI) procedures to digest hyaluronic acid and remove cumulus cells from oocytes to facilitate handling.

Regulatory Classification

Identification

Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, 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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2001

Conception Technologies, L.P. % Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K011573

Hyaluronidase in HTF Medium; Hyaluronidase in EBSS Medium Dated: May 10, 2001 Received: May 21, 2001 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL

## Dear Ms. Holland:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have reviewed your Security 10(x) notications of them to make to tegally marketed predicate devices device is substantially equivalent (or the mucenture to the Medical Device Amendments, or to devices marketed in merstale commerce provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may ,
that have been reclassified in accordance with the provisions of the F that have been reclassified in accordance will the provisions of the Act. The general controls provisions of the Act .
therefore, market the device, subject to the general co therefore, market the device, subject of the general on the current couring practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premates Approval), it may be subject of President Previously of States I Previ If your device is classince (See above) nine class if (Openal Obtarve) or abe found in the Code of Federal Regulations, to such additional controls. Existing major regulation assumes compliance with the Current Good Manufacturing I itle 21, Parts 800 to 693. A Substant Godration (QS) for Medical Devices: General regulation (21 CFR Part Practice requirements, as set four in the Quality Of them (40) will verify such as unptions. Fallure 820) and that the GMP regulations, the room and Drag Trans. In addition, FDA may publish further announcements to comply will the Unit Tegulation in Testimation in this response to your premarket notification sumission doss not concerning your device in the reacle Regists. I Tease necessed on your career 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 would I fills ledel will allow you to begally 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 If you destre specific advice to your de var used (30 ) 594-4639. Additionally, for questions on the promotion diagnosite devices), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entified, "Misoraning by telefited to prehation" (21 ce re of Manufacturers Assistance at its toll-free number (800) 1638-2041 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 (s)

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Premarket Notification - Conception Technologies, L.P. - Hyaluronidase

Page 1 of

510(k) Number (if known):

Hyaluronidase in HTF Medium Device Name:

Indications For Use:

Hyaluronidase in HTF Medium is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

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

## www.unwana....................................................................................................................................................................

Prescription Use
(Per 21 CFR 801.109)

OR

David C. Kappen

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

REGULATORY SPECIALISTS

Over-The-Counter Use

(Optional Format 1-2-96)

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