RAPID-I

K090832 · Vitrolife Sweden AB · MQK · Dec 23, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090832
• Device Name: RAPID-I
• Applicant: Vitrolife Sweden AB
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

Rapid-i™ is a cryopreservation device that is intended to be used to contain, vitrify and maintain 4-8 cell stage embryos.

Device Story

Rapid-i™ is a cryopreservation microtool used in assisted reproduction laboratories to vitrify 4-8 cell stage embryos. The device consists of a Polymethyl Methacrylate (PMMA) stick and a Polyvinyl Chloride (PVC) straw equipped with a stainless steel weight. Embryos are loaded onto the stick and placed within the straw for vitrification. The design minimizes contamination risk from liquid nitrogen by maintaining a physical distance of at least 45-50 mm between the embryo and the liquid nitrogen surface, with the intervening space occupied by air. The device is used by embryologists to preserve embryos for future use, facilitating clinical decision-making regarding fertility treatments. The system relies on surface tension to secure the embryo during insertion and removal, preventing contact with the straw walls.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Polymethyl Methacrylate (PMMA) stick (80 mm x 2 mm), Polyvinyl Chloride (PVC) straw (165 mm x 3 mm), stainless steel weight. Sterilization: Ionizing radiation. Packaging: TYVEK® bag. Design features include a geometry that maintains a minimum 45 mm air gap from liquid nitrogen to prevent contamination.

Indications for Use

Indicated for the containment, vitrification, and maintenance of 4-8 cell stage embryos in an assisted reproduction laboratory setting.

Regulatory Classification

Identification

Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, 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

• CryoTip™ (K041562)

Submission Summary (Full Text)

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## DEC 2 3 2009

K690232

#### X. PREMARKET NOTIFICATION SUMMARY

Submitted by:

Vitrolife Sweden AB Box 9080 SE-400 92 Göteborg SWEDEN

Contact Person:

Mr Kjell Kjörk Vitrolife Sweden AB Box 9080 SE-400 92 Göteborg SWEDEN Phone [phone] [phone] Fax Mail [e-mail]

Date Prepared:

Trade Name:

Rapid-i™

MQK

8 December 2009

Common Name:

Cryopreservation container and microtool

Classification Name:

Assisted Reproduction Labware (21 C.F.R. § 884.6160)

Product Code:

Predicate Device:

CryoTip™ (K041562)

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### Description of the Device:

Rapid-i™ is a modification of the CryoTip™ microtool from Irvine Scientific Sales Co., Inc. (K041562), has similar intended use as the predicate device, and similar technological characteristics related to safety and effectiveness. This submission contains information demonstrating substantial equivalence between these two devices.

Rapid-i™ is a device intended for the vitrification of 4-8 cell stage embryos through vitrification. Rapid-iTM consists of the following two items:

- . A Polymethyl Methacrylate (PMMA) stick, 80 mm long and 2 mm in diameter
- A Polyvinyl Chloride (PVC) straw, 165 mm long and 3 mm in . diameter, equipped with a stainless steel weight
- � The two parts are packed in a TYVEK® bag and sterilised by ionizing radiation

The likelihood of contamination from the liquid nitrogen is very small since the distance is from the surface of the liquid nitrogen to the opening of the straw is at least 50 mm and most of that distance is occupied by air at 20℃. Liquid nitrogen will make the transition to gas at -196°C. It is even more unlikely that any viral contaminants which could be present in the liquid nitrogen would contaminate the embryo of the same reason.

The samples can not thaw when the straw is sealed after placement in liquid nitrogen if the instructions in the Package Insert are followed.

The minimum distance from the surface of the liquid nitrogen and the top of the straw is 45 mm. It is evident from the geometry that the embryo can not come in contact with the straw during insertion or removal. The surface tension keeps the embryo safely in place.

#### Intended Use

Rapid-i™ is a cryopreservation device that is intended to be used to contain, vitrify and maintain 4-8 cell stage embryos.

#### Technological Characteristics:

The device Rapid-i™ is a modification of CryoTip™ (K041562). Rapid-i™ has similar intended use as the predicate device (K041562), and similar technological characteristics related to safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows a partial view of a logo or emblem. The left side features the words "DEPARTMENT OF HEALTH &" arranged vertically along a curved path. To the right of the text is a stylized graphic consisting of three curved, parallel lines that resemble a bird in flight or a flowing ribbon. The overall impression is that of a government health organization.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

# DEC 2 3 2009

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

Mr. Kjell Kjörk Pharmacist, Senior Regulatory Affairs Manager Vitrolife Sweden AB Box 9080, SE-400 92, Göteborg SWEDEN

Re: K090832 Trade/Device Name: Rapid-i™ Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: December 9, 2009 Received: December 11, 2009

Dear Mr. Kjörk:

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 indicons 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, intring 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 (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. Your wort 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

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Page 2 -

Enclosure

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### XI. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K090832

Device Name:

Rapid-i™

Indications for Use:

Rapid-i™ is a cryopreservation device indicated to be used to contain, vitrify and maintain 4-8 cell stage embryos

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 C.F.R. § 801.109)

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Over-the Counter Use_

Aozin Whing

OR

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