SYDNEY IVF PVP

K031304 · Cook Urological, Inc. · MQL · Mar 23, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K031304
• Device Name: SYDNEY IVF PVP
• Applicant: Cook Urological, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Mar 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Sydney IVF™ PVP consists of a sperm medium containing 10% Polyvinylpyrrolidone (PVP) and is intended for use as an aid in the immobilization and isolation of indivudal sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Device Story

Sydney IVF™ PVP is an aqueous solution containing 10% polyvinylpyrrolidone (PVP). Used in clinical laboratory settings by embryologists or clinicians during ICSI procedures. The medium increases viscosity to reduce sperm motility, facilitating the capture and isolation of individual sperm cells using an ICSI pipette. Provided in glass vials with FluroTech-coated stoppers. Benefits include improved handling and selection of sperm for fertilization.

Clinical Evidence

Bench testing only. Biocompatibility and performance testing were conducted to ensure the medium functions as intended for sperm immobilization.

Technological Characteristics

Aqueous solution containing 10% polyvinylpyrrolidone (PVP). Provided in glass vials with FluroTech-coated stoppers. 200 µL fill volume. Non-electronic, chemical-based medium.

Indications for Use

Indicated for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) 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.

Predicate Devices

• 63 FR 48428 (September 10, 1998)

Submission Summary (Full Text)

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# 510(k) Summary as Required by Section 807.92(a)

| Submitted By: | COOK OB/GYN TM<br>Regulatory Affairs<br>1100 West Morgan Street<br>Spencer, Indiana, 47460 |
|-----------------|--------------------------------------------------------------------------------------------|
| Telephone: | 812-829-6500 |
| Facsimile: | 812-829-2022 |
| Contact: | Brenda Davis |
| Date Submitted: | April 8, 2003 |

## Names of Device:

| Trade Name: | Sydney IVF™ PVP |
|----------------------|----------------------------------------------------------------|
| Common/Usual Name: | Sperm Immobilization Medium |
| Classification Name: | Reproductive media and supplements<br>21 CFR, 884.6180 (85MQL) |
| Predicate Device: | 63 FR 48428, September 10, 1998 |

#### Device Description:

Sydney IVE™ PVP is an aqueous solution containing 10% polyvinylpyrrolidone (PVP), and is used to reduce the motility of sperm and make it easier to collect them with an ICSI Pipette. Sydney IVF™ PVP is provided in glass vials with FluroTech-coated stoppers available in 200 µL fill volumes.

#### Intended Use:

Sydney IVF™ PVP consists of a sperm medium containing 10% oyunoy in the reserved is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

#### Substantial Equivalence:

Sydney IVE™ PVP is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

## Discussion of Tests and Test Results:

Sydney IVF™ PVP was subjected to testing to assure biocompatibility and satisfactory operating performance. Sydney IVF™ PVP passed the requirements of all tests.

### Conclusions Drawn from Tests:

This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2004

Ms. Brenda Davis Regulatory Affairs/Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460-6500

Re: K031304

Trade/Device Name: Sydney IVF"" PVP Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: December 23, 2003 Received: December 24, 2003

Dear Ms. Davis:

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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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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# Indications for Use

510(k) Number (if known): K 031304

Device Name: Sydney IVF™ PVP

Indications For Use:

Sydney IVF™ PVP consists of a sperm medium containing 10% Polyvinylpyrrolidone (PVP) and is intended for use as an aid in the immobilization and isolation of indivudal sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segner

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