ENHANCE-S PLUS

K991322 · Conception Technology, Inc. · MQL · Jul 26, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991322
• Device Name: ENHANCE-S PLUS
• Applicant: Conception Technology, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 26, 1999
• 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

Enhance-S Plus is a cell isolation medium designed for the separation and purification of human sperm. It is used in clinical laboratory settings by embryologists or trained laboratory personnel during assisted reproduction procedures. The device functions as a chemical medium to facilitate the isolation of viable sperm cells from semen samples. By providing a controlled environment for sperm processing, it assists in preparing high-quality sperm for fertilization techniques. The output is a purified sperm preparation intended for use in clinical fertility treatments, potentially improving the success rates of assisted reproduction by ensuring the selection of viable sperm.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cell isolation medium for sperm purification. Chemical composition-based separation. Class II device under 21 CFR 884.6180.

Indications for Use

Indicated for use as a cell isolation medium for the separation and purification of human sperm during 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

JUL 26 1999

Conception Technologies, Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606

Re: K991322 Enhance-S Plus Dated: May 11, 1999 Received: June 10, 1999 Requlatory 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, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act indude requirements for annual registration. Iising 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 Requirations, 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 Compiiance 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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Page__________________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K991322 |
|---------------------------|---------|
|---------------------------|---------|

Enhance-S Plus Device Name:_______________

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 NUEDED)

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| Prescription Use | <div style="display:inline-block; vertical-align:top;">✓</div> | OR | Over-The-Counter Use________ |
|----------------------|----------------------------------------------------------------|----|------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1 2 96) |

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

| §10(k) Number | K991322/S⁰⁰¹ |
|---------------|--------------|
|---------------|--------------|

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