PROMOTOR

K023106 · Ceres Fertility, Inc. · MQL · Nov 5, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023106
• Device Name: PROMOTOR
• Applicant: Ceres Fertility, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Nov 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

Device Story

Promotor is a cell isolation media system (Stock, Lower, and Upper Layer) used in clinical laboratory settings for the separation and purification of human sperm. The device is utilized by embryologists or laboratory technicians during assisted reproduction procedures. It functions as a density gradient medium to isolate motile sperm from semen samples. The output is a purified sperm preparation intended for use in fertility treatments. The device aids in selecting high-quality sperm, potentially improving outcomes for patients undergoing assisted reproductive technologies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cell isolation media consisting of Stock, Lower, and Upper layers. Functions as a density gradient medium for sperm purification. Class II device under 21 CFR 884.6180.

Indications for Use

Indicated for use as cell isolation media for the separation and purification of human sperm in assisted reproduction procedures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 NOV

Ceres Fertility, Inc. % Grace Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito IRVINE CA 92606

Re: K023106

Trade/Device Name: Promotor Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements

Regulatory Class: II Product Code: 85 MQL Dated: September 17, 2002 Received: September 18, 2002

Dear Ms. Holland:

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 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 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 this 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" (21 CFR Part 807.97). 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

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Page__________________________________________________________________________________________________________________________________________________________________________

Indications For Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

1

Device Name:Promotor Stock, Lower and Upper Layer

Indications For Use:

Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:left;">✓</div> |
|----------------------|---------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

| REGULATORY SPECIALISTS, INC. | <table><tr><td>(Division Sign-Off)</td></tr><tr><td>Division of Reproductive, Abdominal,</td></tr><tr><td>and Radiological Devices</td></tr></table> | (Division Sign-Off) | Division of Reproductive, Abdominal, | and Radiological Devices | Page 7 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------|--------------------------|--------|
| (Division Sign-Off) | | | | | |
| Division of Reproductive, Abdominal, | | | | | |
| and Radiological Devices | | | | | |

| 510(k) Number | |
|---------------|--|
|---------------|--|