ISOLATE

K971809 · Irvine Scientific Sales Co., Inc. · MQL · Jul 3, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971809
• Device Name: ISOLATE
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

The product is intended for use in the preparation of human sperm for intrauterine insemination (IUI).

Device Story

ISolate is a sperm separation medium consisting of a colloidal suspension of silica particles modified with hydrophilic silane in a buffered physiological solution. It is used in clinical laboratory settings by trained personnel to process semen samples. The device is provided as a kit of two solutions (Upper and Lower) of differing densities or as a single stock solution. These are used to create a step-gradient in a centrifuge tube. Semen is layered onto the gradient and centrifuged; this process separates motile, viable sperm from non-viable sperm, other cell types, and soluble biochemicals/proteins. The resulting purified sperm pellet is collected for use in IUI. By isolating high-quality motile sperm, the device aims to improve the success rate of intrauterine insemination procedures compared to raw semen samples.

Clinical Evidence

Bench testing only. Semen samples (fresh and cryopreserved) were processed in parallel using ISolate, predicate devices, and Percoll. Endpoints included recovery, motility, viability, forward progression, and normal forms. Results demonstrated that ISolate-prepared samples were substantially equivalent to those prepared with predicate devices.

Technological Characteristics

Colloidal suspension of silica particles covalently modified with hydrophilic silane in a buffered physiological solution. Operates via density gradient centrifugation. Formats include a two-solution kit (Upper/Lower density) or a single stock solution. Non-automated, manual laboratory preparation.

Indications for Use

Indicated for the preparation of human sperm for intrauterine insemination (IUI) in patients undergoing fertility treatment.

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.

Predicate Devices

• Sperm Select (K872849)
• Modified Ham's F-10 (K894432)

Reference Devices

• Percoll

Submission Summary (Full Text)

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#### K971809 Pig3 510 (k) Summary K.

Irvine Scientific Sales, Co., Inc. Submitted by: JUI = 3 1997 2511 Daimler Street Santa Ana, California 92705-5588

> Phone: [phone] Fax: [phone]

Contact: Dr. Ken Lydersen

Date: May 12, 1997

Device Identification:

- · Trade Name: ISolate
- · Common Name: Sperm Separation Medium
- Classification Name: Cervical Cap (per 21CFR 884.5250)

Predicate Devices:

| • Sperm Select | (K872849) |
|-----------------------|-----------|
| • Modified Ham's F-10 | (K894432) |

# Description:

The product is a colloidal suspension of silica particles which have been covalently modified with hydrophilic silane. The colloid is formulated in a buffered physiological solution compatible with human sperm. The product is packaged in two formats. One format consists of a kit of two solutions which differ only in the concentration of the colloidal silica, and therefore in their density. The two solutions, labeled "Upper" and "Lower", are utilized to form a step-gradient in a centrifuge tube. The other product format is a single solution which can be utilized as a "stock solution" to create a different step gradient from that provided by the kit. This latter solution is identical to the "Lower" (i.e., higher density) solution.

### Intended Use:

The product is intended for use in the preparation of human sperm for intrauterine insemination (IUI).

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K971809 p273

Technological Characteristics:

Sperm separation media are used to separate motile sperm from the other constituents of semen (i.e., non-viable sperm, other cell types, soluble biochemicals and proteins). Centrifugation is the technology most commonly used to separate sperm from the soluble components of semen. Centrifugation followed by aspiration of the supernatant and resuspension of the pellet in a medium such as Modified Ham's F-10 is the most straightforward method of sperm preparation, resulting in a "washed" sperm preparation. If separation of motile sperm from other cellular constituents is desired, the pellet is incubated under a layer of medium (i.e., Modified Ham's F-10) instead of being resuspended. The motile sperm "swim-up" into the fresh medium, resulting in a sperm preparation with an increased % motility, but a decreased recovery.

The centrifugation of semen in a medium with high density is an approach which can separate motile, viable sperm from other cellular constituents without the reliance on "swim-up". This method has been used extensively with a colloidal silica product (Percoll) formulated with a variety of physiological buffers. Isolate utilizes a similar colloidal silica product to accomplish sperm separation.

Another approach is to utilize a medium with a high viscosity. If a highly viscous solution is layered over a semen sample and incubated for a sufficient length of time, motile sperm, but not other cells, will migrate into the viscous solution and allow the recovery of a fraction of the original sperm containing a high proportion of motile sperm.

Although the centrifugation of viable sperm through a high density medium is commonly used, there are no devices approved for sperm separation utilizing this technology. Modified Ham's F-10 (K894432) is a predicate device approved for sperm preparation utilizing centrifugation and washing or "swim-up". Sperm Select (K872849) is another predicate device which utilizes high viscosity medium. For the purposes of this application, ISolate has been compared to Modified Ham's F-10, as used in Washing and Swim-Up, and Sperm-Select.

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# Performance Data:

Semen samples (fresh and cryopreserved) were processed in parallel using ISolate and the predicate devices, as well as Percoll in some cases. The resulting purified sperm preparations were assayed for recovery, motility, viability, forward progression and normal forms. The results showed that sperm prepared with ISolate resulted in preparations which were substantially equivalent to those from the predicate devices.

# Conclusion:

The conclusion from the performance testing and the biocompatibility testing is that ISolate yields substantially equivalent results to the predicate devices in the preparation of human sperm for intra-uterine insemination (IUI).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ken Lydersen, Ph.D. Vice President, Technical and Regulatory Affairs Irvine Scientific Sales, Co., Inc. 2511 Daimler Street Santa Ana, California 92705 . 川 Re: K971809

ISolate Sperm Separation Media Dated: May 12, 1997 Received: May 15, 1997 Regulatory class: unclassified Product code: 85 MQL

Dear Dr. Lydersen:

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 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.

3 1997

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 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/odrit/dsmamain.html"

Sincerely yours

W.Liau Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Satterly
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices K971809 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use . (Per 21 CFR 801.109)

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Over-The-Counter Use_

(Optional Format 1-2-96)

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