PICSI SPERM SELECTION DEVICE

{0}------------------------------------------------ ## APR 1 3 2006 ## 510(K) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: K052457. | Trade/proprietary name: | PICSI™ Sperm Selection Device | |-------------------------|---------------------------------------------------------------| | Common or usual name: | Assisted Reproduction Media,<br>Assisted Reproduction Labware | Classification: Assisted Reproduction Media, CFR 884.6180, Class II, Procode 85 MQL; Assisted Reproduction Labware, CFR 884.6160, Class II, Procode 85 MQK PICSI is substantially equivalent to Sperm Catch™ Assisted Reproduction Media, (510(k) K011607, decision date: 8/10/2001) and to FALCON® IVF Round Dish, (510(k) K991253, decision date 5/5/1999) The PICSI™ Sperm Selection Device is a sterile, plastic culture dish with Description: three microdots of hyaluronan hydrogel attached to the dish and three locating lines three microuots of the bottom exterior of the dish to aid the operator to find the microdots. emoussed on the boundtiach themselves to hyaluronan through specific receptors on the Mature hema membrane. At temperatures from 18-28° C, mature sperm attach sperin prasmamy to the hyaluronan microdot and no longer exhibit progressive movement, although their tails beat and they are capable of motility. Such sperm are movement, atthough moved from the hyaluronan by micropipet for intracytoplasmic sperm injection (ICSI). Intended Use: PICSI is intended for the selection of mature sperm for ICSI. | Factor/attribute | PICSI dish | Sperm Catch | FALCON dish | |-----------------------------------------------------------------------------|-------------------------------------------------------|----------------------------------|-------------| | Method of facilitating<br>sperm selection and<br>capture by<br>micropipette | Stops progressive<br>movement | Slows<br>progressive<br>movement | N/A | | Active Ingredient | Hyaluronan<br>(hydrogel<br>attached to Petri<br>dish) | Hyaluronan<br>(solution) | N/A | | Sperm fraction subject | Mature motile | Total motile | N/A | Technological Characteristics Compared to Sperm Catch and to FALCON IVF dish: {1}------------------------------------------------ | to selection | fraction | fraction | fraction | |------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------| | Useful Operating<br>Temperature | 18-28° C | 30-37° C | 0-37°C | | Minimum time for set<br>up and selection of<br>sperm | 15 min | 10 min | N/A | | Storage conditions | Dry, room<br>temperature | (?) Refrigerated | (?) Dry, room<br>temperature | | Shelf Life | 1 y (anticipated to<br>be extended as<br>aging studies are<br>completed) | Unknown | Unknown | | Sterility | Radiation<br>sterilized | Filtration<br>sterilized | Radiation<br>sterilized | | Endotoxin | <1 EU/device | <1 EU/mL | < 20 EU/device | | Biocompatibility | Compatible (1-<br>cell Mouse<br>Embryo Assay,<br>≥75% conversion<br>in 96 h) | Compatible<br>(> 24 h survival<br>in human sperm<br>survival assay) | Compatible (2-cell<br>Mouse Embryo<br>Assay, ≥ 70%<br>conversion<br>in 72 h) | Performance: In a clinical trial involving side-by-side fertilization of oocytes by ICSI, using sperm selected on PICSI and in Sperm Catch, the fertilization rates, quality of the resulting embryos and the disposition of embryos in the PICSI and the Sperm Catch groups were compared. No statistically significant differences were found in fertilization rates, the average number of cells in the 3-day embryos, the number of 3-day embryos with 8 or more cells, the morphological characterization of the 3-, 5- and 6-day embryos and the disposition (outcomes) of the 3- and 6-day embryos. Signature James B. Johnston 22 February 2006 Date K 052457 Premarket Notification [510(k)] Number {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a cross. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 APR 1 8 2006 James B. Johnston, Ph.D. Principal Investigator BIOCOAT Incorporated 211 Witmer Road HORSHAM PA 19044 Re: K052457 Trade/Device Name: PICSI™ Sperm Selection Device Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Product Code: MQK Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Product Code: MQL Regulatory Class: II Dated: February 24, 2006 Received: February 27, 2006 ## Dear Dr. Johnston: 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 (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. Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is circular and contains the text "FDA Centennial" in the center. The years "1906 - 2006" are at the top of the circle. The text "Protecting and Promoting Public Health" is below the logo. {3}------------------------------------------------ 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 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. 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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K052457 Device Name: PICSI Sperm Selection Device Indications For Use: In the treatment of infertile couples by ICSI, PICSI is indicated for the selection of mature sperm for injection. Prescription Use _ X (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) David A. Seymann (Division Sign-Off) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi 510(k) Number. Page 1 of