OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE

K053494 · Fertipro NV · MQL · Mar 23, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K053494
• Device Name: OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
• Applicant: Fertipro NV
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Mar 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching. Gradient System is used for separation and purification of human sperm for assisted reproduction procedures. SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

Device Story

FertiPro Reproductive Media Bundle consists of three distinct products for assisted reproduction. Oil for Tissue Culture: colorless liquid paraffin used as an overlay for tissue culture to prevent evaporation and contamination during IVF, embryo culture, and micromanipulation (ICSI/assisted hatching). Gradient System: solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES buffer; used for sperm separation and purification. SpermFreeze: HEPES-buffered cryopreservation medium containing 0.4% human serum albumin for human sperm storage. Devices are used in clinical laboratory settings by embryologists or laboratory technicians. Output is processed biological samples (sperm/embryos) prepared for fertilization or storage. Clinical benefit includes facilitating successful ART outcomes through optimized culture, isolation, and preservation environments.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparison of formulation, packaging, and performance testing against predicate devices.

Technological Characteristics

Oil for Tissue Culture: colorless liquid paraffin. Gradient System: silane-coated silica particles in EBSS with HEPES buffer (45%, 90%, 100% concentrations). SpermFreeze: HEPES-buffered medium with 0.4% human serum albumin. All devices are chemical/reagent-based reproductive media. No software or electronic components.

Indications for Use

Indicated for use in assisted reproductive technology (ART) procedures. Oil for Tissue Culture: covers tissue cultures for IVF, embryo culture, ICSI, and assisted hatching. Gradient System: separation and purification of human sperm. SpermFreeze: cryopreservation of human sperm.

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

• OIL FOR TISSUE CULTURE (K011462)
• ENHANCE-S PLUS H (K030116)
• ENHANCE SPERM FREEZE (K030117)

Submission Summary (Full Text)

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Premarket Notification ~ FertiPro Reproductive Media Bundle

MAR 2 3 2006

Image /page/0/Picture/2 description: The image shows the text "5. 510(k) Summary" at the top left. To the right of this text is an image of a baby. Further to the right is the text "FertiPro N.V."

Industriepark Noord 32 - 8730 Beemem - Belgium - Tel [phone] - Fax [phone]

Submitter's name: Address:

Phone: Fax number:

Name of contact person:

FertiPro N.V. Industriepark Noord 32 Beernem West-Vlaanderen, Belgium 8730 [phone] [phone]

Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone] Email: [e-mail]

Date the summary was prepared: December 13, 2005

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Oil for Tissue Culture Oil for Tissue Culture Mineral Oil Reproductive media

Gradient System Sil-Select Plus Gradient System Reproductive media

SpermFreeze SpermFreeze SpermFreeze Reproductive media

Page 14

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K.J.5.544
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The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

| Device | Ref# | Decided |
|------------------------|---------|------------|
| OIL FOR TISSUE CULTURE | K011462 | 06/13/2001 |
| ENHANCE-S PLUS H | K030116 | 02/12/2003 |
| ENHANCE SPERM FREEZE | K030117 | 03/20/2003 |

Description of the devices:

Oil For Tissue Culture is a colorless liquid paraffin.

Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%.

SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.

Indications:

Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.

Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.

SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

Summary of the technological characteristics of our device compared to the predicate device:

The predicates and these devices were compared in the following areas and found to have exact technological characteristics and to be equivalent.

Formula Special controls Packaging Performance Testing

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of a bird in flight. The bird is stylized and has three lines representing its body. The text "NATIONAL INSTITUTE OF JUSTICE - OJJDP" is written around the perimeter of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### MAR 2 3 2006

FertiPro N.V. % Ms. Grace Holland Regulatory Specialist Regulatory Specialist, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K053494

Trade/Device Name: Oil for Tissue Culture, Gradient System, and SpermFreeze Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: February 22, 2006 Received: February 24, 2006

Dear Ms. Holland:

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 the cholobals) to regary many date of the Medical Device Amendments, or to devices that have been May 20, 1778, no 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 do not require approvisions of the Act. 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 n your as , 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.

Please be advised that FDA 's issuance of a substantial equivalence determination docs not mean that FI)A has made a determination that your device complies with other requirements of the Act or any Foderal states 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 clectronic 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 FIXA 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 11 you don't the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notific.umn" ( 1 CFR 807.97). You may obtain other general information on your responsibilities under the Ave institution Division of Small Manufacturers, International and Consumer Assistance at its toll-free mimber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Brigdon

Namev 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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## 4. Indications for Use Statement Indications for Use

510(k) Number (if known): K053494

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications.for Use:

Oil For Tissue Culture is used in covering tissue culture in in-vitro Off of the more of the end micromanipulative procedures such as ICSI and assisted hatching.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (FLLASE DO NOT WARTE BEEGH THES CANS CHE CA
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division: Criminal

Page _1_ of _3

Division
Division: Laparoscopic abdominal,
and Robotic devices
510(k) Number K053494

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### Indications for Use

510(k) Number (if known): K053494

Device Name: Gradient System

Indications for Use:

Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (FLEASE DO NOT MATE BECON THIS END COMPORT CONSULTION ------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tlan curic Brixton
Division Sign Off

Page 2 of 3

productive, Abdominal, and Radiological Devi 510(k) Number

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Premarket Notification - FertiPro Reproductive Media Bundle

# Indications for Use

510(k) Number (if known): K053494

Device Name: SpermFreeze

Indications for Use:

SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Broadlon

Page _3_ of _3

(Division Sign-Off))
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053494