SYDNEY IVF SPERM CRYOPRESERVATION BUFFER

K061371 · Cook Urological, Inc. · MQL · Aug 17, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061371
• Device Name: SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
• Applicant: Cook Urological, Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Aug 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.

Device Story

Sydney IVF Sperm Cryopreservation Buffer is an aqueous solution used by IVF technicians in clinical laboratory settings. It acts as a protective buffer for sperm samples—including washed spermatozoa, MESA (microsurgical epididymal sperm aspiration), and TESA (testicular sperm extraction) samples—during the cryopreservation and thawing process. By mitigating cellular damage during these procedures, the buffer helps maintain sperm viability for future use in assisted reproductive technology. The device is a chemical reagent and does not involve automated processing or software.

Clinical Evidence

Bench testing only. The device passed performance requirements for pH testing, osmolality testing, two-cell mouse embryo (MEA) testing, and bacterial endotoxin (LAL) testing.

Technological Characteristics

Aqueous solution for sperm cryopreservation. Characteristics include controlled pH and osmolality. No software or electronic components.

Indications for Use

Indicated for use as a buffer to prevent damage to sperm samples, including washed spermatozoa, MESA, and TESA samples, during cryopreservation and thawing processes.

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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# 613-

Traditional 510(k) Submission Sydney IVF Sperm Cryopreservation Buffer COOK UROLOGICAL INCORPORATED 10 May 2006

AUG 1 7 2006

# 510(k) SUMMARY

Submitted By:

Brenda Davis Regulatory Affairs Technical Writer Cook Urological Incorporated 1100 West Morgan Street Spencer, IN 47460 [phone] x 7257 28 April 2006

Device: Trade Name:

Sydney IVF Sperm Cryopreservation Buffer

Proposed Classification Name:

Reproductive Media and Supplements 21 CFR Part 884.6180 (87MQL) Class II

## Predicate Devices:

Sydney IVF Sperm Cryopreservation Buffer is comparable to predicate devices described by criteria set forth in the final rule [63 FR 48428].

## Device Description

Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples.

#### Substantial Equivalence

Sydney IVF Sperm Cryopreservation Buffer is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

## Test Data

Sydney IVF Sperm Cryopreservation Buffer was subjected to the following tests to assure satisfactory operating performance:

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Traditional 510(k) Submission Sydney IVF Sperm Cryopreservation Buffer COOK UROLOGICAL INCORPORATED 10 May 2006

- r pH Testing
- Osmolality Testing "
- Two-cell Mouse Embryo (MEA) Testing 1
- 동 Bacterial Endotoxin (LAL) Testing

The Sydney IVF Sperm Cryopreservation Buffer passed the requirements of all 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/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 7 2006

Ms. Brenda Davis Regulatory Affairs Technical Writer Cook Urological, Inc. 1100 West Morgan Street SPENCER IN 47460

Re: K061371

Trade/Device Name: Sydney IVF Sperm Cryopreservation Buffer Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplement Regulatory Class: II Product Code: MQL Dated: May 10, 2006 Received: May 19, 2006

# 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular logo with the letters "DA" in the center. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in a stylized font. Three stars are arranged at the bottom of the logo. The logo appears to be a commemorative emblem for a centennial celebration.

Protecting and Promoting Public Health

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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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ... .

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K061371

Traditional 510(k) Submission Sydney IVF Sperm Cryopreservation Buffer COOK UROLOGICAL INCORPORATED 10 May 2006

# INDICATIONS FOR USE

510(k) Number (if known): _K06 137 /

Device Name: __Sydney IVF Sperm Cryopreservation Buffer_

Sydney IVF Sperm Cryopreservation Buffer is intended for use as Indications for Use: a buffer to prevent damage to sperm samples during cryopreservation and thawing.

Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broaden

Division of Reproduction,
and Radiological Devices
510(k) Number

17.00 I .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .