ICSI-100

K043116 · Vitrolife Sweden AB · MQL · Jan 13, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K043116
• Device Name: ICSI-100
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Medium for In Vitro Fertilization Procedures

Device Story

ICSI™ is a viscous sperm handling solution used in assisted reproduction. It functions as a medium to facilitate the immobilization and isolation of sperm cells before they are injected into an oocyte during intracytoplasmic sperm injection (ICSI) procedures. The device is intended for use by trained clinical professionals in a laboratory setting. By providing a controlled, viscous environment, it assists the embryologist in capturing and manipulating individual sperm, thereby supporting the fertilization process.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use similarity to the predicate device.

Technological Characteristics

Viscous sperm handling solution. Ready-to-use after equilibration at 15-25°C. Class II device under 21 CFR 884.6180.

Indications for Use

Indicated for the immobilization and isolation of sperm prior to intracytoplasmic sperm injection (ICSI).

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

• PVP-Polyvinylpyrrolidone device (K991343)

Submission Summary (Full Text)

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## K43116

## JAN 1 3 2005

## X. PREMARKET NOTIFICATION SUMMARY

| Submitted by: | Vitrolife Sweden AB<br>Faktorvägen 13<br>SE-434 37 Kungsbacka<br>SWEDEN |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Morgan Hugosson<br>Vitrolife Sweden AB<br>Faktorvägen 13<br>SE-434 37 Kungsbacka<br>SWEDEN |
| Date Prepared: | November 1, 2004 |
| Trade Name: | ICSITM |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | PVP-Polyvinylpyrrolidone device (K991343) |
| Description of the Device: | Viscous sperm handling solution. Ready-to-use after<br>equilibration at 15-25°C. |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Indications for Use: | For the immobilization and isolation of sperm prior to<br>intracytoplasmic sperm injection, ICSI. |
| Technological Characteristics: | The technological characteristics of ICSITM are<br>essentially similar to those of the predicate device.<br>None of these changes raise new questions of safety or<br>effectiveness. |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three curved lines representing its wings or body. The logo is black and white.

Public Health Service

JAN 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Morgan Hugosson Regulatory Affairs Officer Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN

Re: K043116 Trade/Device Name: ICSI™, Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II - - -Product Code: 85 MQL Dated: November 1, 2004 Received: November 26, 2004

Dear Mr. Hugosson:

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 street in the enclosure) to legally marketed predicate devices marketed in interstate commons on use a 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, cor (rice) 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 provisions of uts Aug. 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.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 legal|y marketed predicate device results in a classification for your device and thus, permits a vour 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 pumber 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 notification" (21 CFR 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/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): K043116

Device Name: ICSI™ Assisted Reproduction Media

Indications For Use: For the immobilization and isolation of sperm prior to intracytoplasmic sperm injection, ICSI

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maneye Brogdon
```
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043116

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