Sydney IVF PVP

K152440 · Willam A. Cook Australia Pty, Ltd. · MQL · Sep 23, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K152440
• Device Name: Sydney IVF PVP
• Applicant: Willam A. Cook Australia Pty, Ltd.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Sep 23, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Sydney IVF PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Device Story

Sydney IVF PVP is a 10% polyvinylpyrrolidone (PVP) solution in bicarbonate-buffered media, supplemented with 10 mg/mL Human Serum Albumin and 0.01 mg/mL Gentamicin. Used by reproductive professionals in clinical settings during Assisted Reproduction Techniques (ART). The solution increases viscosity to facilitate the capture and immobilization of motile sperm for ICSI. The device is provided in glass vials, requiring equilibration to 37°C and 6% CO2 before use. By immobilizing sperm, the medium assists the clinician in isolating individual cells for injection, potentially improving the efficiency of the ICSI procedure.

Clinical Evidence

Bench testing only. Stability studies validated a 20-week shelf-life at 2-8°C. Testing included endotoxin levels (< 0.40 EU/mL), Mouse Embryo Assay (MEA) for embryo toxicity, sterility, and concentrations of pyruvate and ammonia (HSA degradation by-product).

Technological Characteristics

10% polyvinylpyrrolidone solution in bicarbonate-buffered media; contains 10 mg/mL Human Serum Albumin and 0.01 mg/mL Gentamicin. Aseptically filtered. Packaged in borosilicate type 1 glass vials with FluroTec coated rubber stoppers. Requires storage at 2-8°C.

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 in patients undergoing assisted reproduction techniques.

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

• Sydney IVF PVP (K031304)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 23, 2015

Willam A. Cook Australia Pty Ltd Gordana Pozvek, Ph.D. Senior Regulatory Affairs Specialist 95 Brandl Street Eight Mile Plains, Queensland 4113 AU

Re: K152440

Trade/Device Name: Sydney IVF PVP Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: Class II Product Code: MQL Dated: August 24, 2015 Received: August 27, 2015

Dear Gordana Pozvek:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K152440

Device Name Sydney IVF PVP

Indications for Use (Describe)

Sydney IVF PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> |

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif font at the top. Below that, the word "MEDICAL" is written in a smaller, white, sans-serif font.

WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 BRANDL STREET BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA PHONE: [phone] FAX: [phone] WWW.COOKMEDICAL.COM ABN 79 005 526 723

#### SUBMITTED BY:

William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains OLD 4113 Australia

| Contact Person: | Gordana Pozvek Ph.D. |
|-----------------|--------------------------------|
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

#### Date Prepared: September 17, 2015

#### DEVICE IDENTIFICATION:

| Trade Name: | Sydney IVF PVP (product code: K-SIPV-200-5) |
|-------------------|---------------------------------------------------|
| Common Name: | Sperm Immobilization Medium |
| Regulation No: | 21 CFR 884.6180, Reproductive Media & Supplements |
| Regulatory Class: | II |
| Product Code: | MQL - Media, Reproductive |

#### PREDICATE DEVICE:

Sydney IVF PVP (product code: K-SIPV-200) (K031304), Cleared - March 23, 2004.

## DEVICE DESCRIPTION:

Sydney IVF PVP is a 10 % polyvinylpyrrolidine solution in a bicarbonate buffered media supplemented with 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. Sydney IVF PVP is ready to use after equilibration to 37℃ and 6% CO2. It is designed to be used by professionals within Assisted Reproduction. This solution is an aseptically filtered sperm medium containing 10% polyvinylpyrrolidone. The PVP increases the viscosity of the solution to facilitate the capture of motile sperm for intracytoplasmic sperm injection (ICSI) procedures during Assisted Reproduction Techniques (ART) procedures.

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Sydney IVF PVP is provided in glass vials with FluroTec coated rubber stoppers held in place with a tamper evident seal. It is available in a 5 pack carton box with each vial containing 200 µL Sydney IVF PVP.

#### INDICATIONS FOR USE:

Sydney IVF PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

The only difference in the indications for use listed above and that of the predicate device is removal of the statement "Sydney IVF PVP consists of a sperm medium containing 10% polyvinylpyrrolidone (PVP)".

This change does not represent a change in the indications for use.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The Sydney IVF PVP and the predicate device (K031304) have the same fundamental technology and similar technological characteristics including the following:

- Similar chemical formulation
- . Similar performance specifications:
- Endotoxin < 0.40 EU/mL —
- । A Mouse Embryo Assay (MEA) is used to screen the product for embryo toxicity.
- Same method of sterilisation - Aseptically filtered.
- Same packaging borosilicate type 1 vials with FluroTec coated stopper and tamper ● evident seals

The modification that was made to the predicate device was a change in shelf-life from 12 months at -20℃ (for predicate device) to 20 weeks at 2-8℃. In addition, minor changes were made to the formulation and specifications.

The technological characteristics of Sydney IVF PVP are comparable to the predicate device.

#### PERFORMANCE DATA:

The shelf-life of Sydney IVF PVP has been validated in stability studies to 20 weeks at 2 -8°C. Stability tests included endotoxin, MEA, sterility and the concentrations of pyruvate and the HSA degradation by-product ammonia.

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## CONCLUSION:

The results of the testing demonstrate that the Sydney IVF PVP is as safe and effective as the predicate device and supports a determination of substantial equivalence.