KRYO ART CONTROLLED RATE FREEZER

{0}------------------------------------------------ | MAR | 1 9 2004 | |-----|----------| |-----|----------| K032086/S Summary of Safety Information IINF 9 2003 Premarket Notification, Section 510(k) LANER, PLC. JUNE 9, 2003 Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority: - 1. Device Name: Kryo ART Controlled Rate Freezer Trade Name: Common Cryo Freezer Name(s): Classification Assisted reproduction accessories. Name(s): - Establishment Name & Registration Number: 2. PLANER, plc. Name: Owner/Op. ID Number: 9054044 - Windmill Road Address: Sunbury Middlesex TW16 7HD United Kingdom 44 (0) 1932 755000 --44 (0) 1932 755001 www.planer.co.uk #### 3. Classification(s): ## § 884.6120 Assisted reproduction accessories. (a) Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include: (1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova). (2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures. (3) Collection tube warmers, used to maintain the temperature of egg (0007te) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation. (4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature. (5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature. (b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). Classification Panel: Obstretics/Gynecology Product Code(s): MOG #### Equivalent Predicate Device: 4. PLANER, plc. believes that the Kryo ART Controlled Rate Freezer is substantially equivalent to the following device system marketed by Thermo Forma, Inc. of Marietta, Ohio. K021042, CryoMed IVF Controlled Rate Freezer. {1}------------------------------------------------ 6032086 page up The Thermo Forma, Inc. device is cleared for marketing, having met the requirements for a finding of substantial I he ficting I online, no. device to stison device represents a freezer system and accessories that performs substantially the same function as the present Kryo ART Controlled Rate Freezer. Equivalence can be seen in the basic design, materials, intended use and performance characteristics. #### Device Description: ડ. The Kryo ART range of controlled rate freezers have been specifically designed and configured for use in the I the my ring range of commonted freezers are available in three chamber sizes depending on the number of samples to be frozen; 1.7 liters, 3.3 liters and 16 liters. All models incorporate the critical features expected from a high specification biological chamber and the-180°C to +40°C temperature range allows flexibility for a wide range of applications and protocols. All of the chamber sizes are controlled by the MRV controller system, which has been created to offer multiple protocols while remaining simple to program and operate. All systems include power failure protection, which allows the controller to continue monitoring during mains power failures. ‫(17 a All software is designed, developed and maintained in accordance with the Company's internal procedures. These procedures form part of the full Quality System, which is approved to ISO 9001:1994, ISO 13485:1996 and EN 46001:1996 Performance testing is complete. Units were tested according to a specific protocol. Testing demonstrates the functional suitability of the Kryo ART Controlled Rate Freezer for their intended purpose. The Kryo ART brand of controlled rate freezes are intended to freeze gametes or embryos at a user determined rate. #### Applicant Name & Address: 6. . . . Windmill Road Sunbury Middlesex TW16 7HD United Kingdom 44 (0) 1932 755000 44 (0) 1932 755001 www.planer.co.uk #### Company Contact: 7. Regulatory Affairs Windmill Road Sunbury Middlesex TW16 7HD United Kingdom 44 (0) 1932 755000 44 (0) 1932 755001 www.planer.co.uk #### 8. Submission Correspondent: Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a series of three abstract, bird-like shapes stacked vertically, creating a sense of movement or flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 9 2004 PLANER, plc. % Mr. David Schlerf Official Correspondent Buckman Company, Inc. 200 Gregory Lane, Suite C-100 PLEASANT HILL CA 94523-3389 Re: K032086 Trade/Device Name: Kryo ART Controlled Rate Freezer Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: 85 MQG Dated: November 10, 2003 Received: December 22, 2003 Dear Mr. Schlerf: 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 (PMA), 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 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 CFF) 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. {3}------------------------------------------------ Page 2 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 the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Brydon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications for Use: 510(k) Number: K032086 ### Kryo ART Controlled Rate Freezer Device Name: # Indications For Use: The Kryo ART brand of controlled rate freezers are intended to be used to freeze gametes or embryos at a user determined rate. Prescription Use (Part 21 CFR 801 Subpart D) 19/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Syverson (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number. Page 1 of __ 1 ___