PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA

K991381 · Pacific Andrology, Inc. · MQL · Sep 24, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991381
• Device Name: PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA
• Applicant: Pacific Andrology, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.

Device Story

PureCeption™ consists of a multi-phase media system (Lower Phase, Upper Phase, and Sperm Washing Media) used for sperm preparation. The device is utilized in clinical laboratory settings by embryologists or laboratory technicians to process human semen samples. The system facilitates the separation, washing, and isolation of motile sperm from seminal plasma and debris via density gradient centrifugation. The resulting isolated sperm are intended for use in assisted reproductive technology (ART) procedures. The output is a purified sperm pellet, which the clinician uses to perform fertilization procedures, potentially improving the success rate of ART by selecting high-quality, motile sperm.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Density gradient media system comprising Lower Phase, Upper Phase, and Sperm Washing Media. Formulation includes HEPES-buffered Ham's F-10 and Human Serum Albumin (HSA). Designed for in vitro use in laboratory centrifugation protocols. Non-electronic, chemical-based device.

Indications for Use

Indicated for in vitro procedures involving sperm separation, washing, and isolation in clinical laboratory settings.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 4 1999

Pacific Andrology, Inc. c/o Mr. Greg Holland Regulatory Consultant Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K991381

PureCeption™ Lower Phase, PureCeption™ Upper Phase, and PureCeption™ Sperm Washing Media with HEPES-buffered Ham's F-10 and HSA Dated: August 20, 1999 Received: August 23, 1999 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL

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 indude 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 dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Eederal 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 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.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnosic devices), piease 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,

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 - Pacific Andrology, Inc. - Sperm Isolation Medium

Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_K991381

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|--------------------------------------------------|----|
| | OR |
| Over-The-Counter Use<br>(Optional Format 1-2-96) | |

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K991381 |
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