SPERMGRAD, MODELS 10022/10063

K023403 · Vitrolife Sweden AB · MQL · Dec 13, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023403
• Device Name: SPERMGRAD, MODELS 10022/10063
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Medium for In Vitro Fertilization Procedures

Device Story

SpermGrad™ is a physiological salt buffer containing silane-coated, colloidal silica particles. Used in assisted reproduction laboratories for gradient sperm separation. The device is intended for use after appropriate dilution. It functions as a density gradient medium to isolate motile sperm from semen samples. The output is a purified sperm fraction used by embryologists or laboratory technicians to facilitate in vitro fertilization procedures. The device benefits patients by improving the quality of sperm used in reproductive treatments.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and composition similarity to the predicate device.

Technological Characteristics

Physiological salt buffer containing silane-coated, colloidal silica particles. Device is a liquid medium for laboratory use. No specific ASTM standards or software components described.

Indications for Use

Indicated for gradient sperm separation.

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

• ISolate® (K991341)

Submission Summary (Full Text)

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#### PREMARKET NOTIFICATION SUMMARY X.

| Submitted by: | Vitrolife Sweden AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenburg<br>SWEDEN |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Nina Arvidsson<br>Vitrolife Sweden AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenburg<br>SWEDEN |
| | Mr. Gary L. Yingling<br>Mr. Michael H. Hinckle<br>Kirkpatrick & Lockhart, LLP<br>1800 Massachusetts Avenue, NW<br>Washington, DC 20036-1800 |
| Date Prepared: | October 07, 2002 |
| Trade Name: | SpermGrad™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | ISolate® (510(k) # K991341) |
| Description of the Device: | Physiological salt buffer containing silane-coated,<br>colloid silica particles. For use after appropriate<br>dilution. |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Indications for Use: | For gradient sperm separation. |
| Technological Characteristics: | The technological characteristics of SpermGrad™<br>are identical to the predicate device in all material<br>respects. |

:

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Nina Arvidsson RA Officer Vitrolife Sweden AB Mölndalsvägen 30 SF-412 63 Gothenburg SWEDEN

#### Re: K023403

Trade/Device Name: SpermGrad™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II

Product Code: 85 MQL Dated: October 7, 2002 Received: October 10, 2002

### Dear Ms. Arvidsson:

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 (OS) 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. Snigdon

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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## INDICATIONS FOR USE STATEMENT

#### 510(k) Number:

K023403

# Device Name:

Indications For Use:

SpermGrad™ Assisted Reproduction Media

For gradient sperm separation.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 C.F.R. § 801.109)

()R

( )ver-the Counter Use______

David C. Tilling

(Division Sign-Off)
Division of Reproductive, Abdominal
3 and Radiological Devices
510(k) Number
K123403