IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500

K991348 · Vitrolife Sweden AB · MQL · May 17, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K991348
• Device Name: IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: May 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

IVF™-50, IVF™-500 and IVF™-500 Antibiotic-Free are intended for in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.

Device Story

Bicarbonate-buffered culture media; mixture of balanced salts, human serum albumin, and nutrients; used in assisted reproduction procedures (fertilization, embryo culture, embryo transfer). IVF-50 contains Penicillin-G; IVF-500 available with or without antibiotics. Used in clinical laboratory settings by embryologists/clinicians to support gamete and embryo viability during manipulation. Benefits patient by providing controlled environment for fertilization and development.

Clinical Evidence

No clinical trials; safety and effectiveness established through long-term clinical experience at multiple assisted reproduction facilities. Bench testing includes biocompatibility (cytotoxicity, rabbit vaginal irritation), two-cell Mouse Embryo Assay, Human Sperm Survival Assay, and Limulus Amebocyte Lysate (LAL) assay for endotoxins.

Technological Characteristics

Bicarbonate-buffered culture media; contains balanced salts, human serum albumin, and nutrients. IVF-50 contains Penicillin-G; IVF-500 available with or without Penicillin-G. Subject to lot-specific quality control assays (Mouse Embryo Assay, Human Sperm Survival Assay, LAL Assay).

Indications for Use

Indicated for in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture, and embryo transfer.

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

• Reproductive Media (21 C.F.R. § 884.6180) as provided in the FDA's Notice of Final Rule, 63 Fed. Reg. 48428, 48430 (Sept. 10, 1998)

Submission Summary (Full Text)

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K991348/52
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#### PREMARKET NOTIFICATION SUMMARY

| Submitted by: | Scandinavian IVF Sciences AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenberg<br>SWEDEN |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson<br>Vitrolife AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenberg<br>SWEDEN<br>Tele: [phone]<br>Fax: [phone] |
| Date Prepared: | April 16, 1999 |
| Trade Name: | IVFTM-50, IVFTM-500 and IVFTM-500 Antibiotic-Free |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | Substantial equivalence established by comparison<br>to category of Reproductive Media (21 C.F.R. §<br>884.6180) as provided in the FDA's Notice of Final<br>Rule, 63 Fed. Reg. 48428, 48430 (Sept. 10, 1998)). |

### Description of the Device:

IVF™-50, IVF™-500 and IVF™-500 Antibiotic-Free are bicarbonatebuffered culture media composed of a mixture of balanced salts, Human Serum Albumin and other nutrient substances. IVF™-50 includes Penicillin-G. IVF™-500 is manufactured and sold antibiotic-free or with Pc-G. The media is designed for use during assisted reproduction procedures, including fertilization, embryo culture and embryo transfer.

### Intended Use:

IVF™-50, IVF™-500 and IVF™-500 Antibiotic-Free are intended for in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.

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# Technological Characteristics:

The technological characteristics of IVF™-50, IVF™-500 and IVF™ 500 Antibiotic Free are identical to other legally marketed culture media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements.

# Testing Performed:

Because IVF™-50, IVF™-500 and IVF™-500 Antibiotic Free are intended to come into contact with gametes, embryos and the patient during assisted reproduction procedures, Scandinavian IVF Sciences has conducted biocompatability testing on the media. This testing included cytotoxicity and rabbit vaginal irritation assays.

Prior to and as a condition for market release, each lot of IVF media is assayed by two-cell Mouse Embryo Assay, Human Sperm Survival Assay, Limulus Amebocyte Lysate (LAL) Assay. These assays are interval insu assure that the media is suitable for its intended use and does not contain unacceptable levels of toxins. Information on these assays is provided in the labeling of the products, and lot specific certificates of analysis are arailable upon request.

IVF™-50, IVF™-500 and IVF™-500 Antibiotic Free has been used for fertilization, embryo culture and embryo transfer for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use.

# Additional Information:

Donors of the source material for the human serum albumin are screened for CJD. The source material is also tested for HIV and hepatitis.

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2000

Scandinavian IVF Sciences AB c/o Mr. Gary L. Yingling McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, DC 20006-1108

Re: K991348 IVF™ -50, IVF™ -500, and IVF™ -500 Antibiotic Free (assisted reproduction media) Dated: May 2, 2000 Received: May 17, 2000 Regulatory Class: II 21 CFR §884.6180/Procode: 85MQL

Dear Mr. Yingling:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate every a 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). You may, theefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act included 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 (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, fille 201 Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning wour device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compling at [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 antitled, "Misbranding by reference to premarket notification" (21CFR 807. "Also, prose note the tile the timely.
Ant may be able in Division the Discussion" (21CFR 807.97). Other ge Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or (301) 443-597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel S. Schaffer, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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K9913481
Page 1 of

#### INDICATIONS FOR USE STATEMENT

510(k) Number:

| Device Name: | IVFTM-50, IVFTM-500 and IVFTM-500 Antibiotic- Free Assisted Reproduction Media |
|--------------|--------------------------------------------------------------------------------|
|--------------|--------------------------------------------------------------------------------|

Indications For Use:

For in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.

A Sign-Off)
Evision of Reproductive, Abdominal, ENT,
and Radiological Devices
121189

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ OR

510(k) Number

Over-the-Counter Use

(Per 21 C.F.R. § 801.109)