PRAGER SHELL

{0}------------------------------------------------ #### ESI. Inc. Prager Shell #### Page 5-1 # 10082893 ## DEC 0 5 2008 ESI Inc. 510(k) Submission Prager Shell® 510(k) Summary September 3, 2008 (1) Submitter Information Name: ESI, Inc. Address: 2915 Everest Ln N. Plymouth, MN 55447 Telephone Number: 763-473-2533 Contact Person: Dr. George Myers Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703 Date Prepared: September 3, 2008 (2) Name of Device: Trade Name: Prager Shell Common Name: Rigid Water Path for Ultrasonic Transducers Classification Name: Scleral Shell (Accessory to ultrasound system). (3) Equivalent legally-marketed devices: Preamendment device Water Bath for Sonometrics Coleman A-B scan system. (4) Description The shell is a cylinder with an open top and open bottom,. The open bottom end is contoured at the rim to conform to the curvature of the eye. The ultrasonic transducer is placed in the Prager {1}------------------------------------------------ Shell® from above. Once placed on the eye the shell is filled with balanced salt solution (BSS) and the probe distal end is immersed in the BSS. It is not sold sterile and is reusable. Tubing kits are available to connect the shell to the BSS source. These kits are distributed by ESI but not manufactured by it. (5) Intended Use The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye. It is intended for A-scan biometry of the eye. (6) Technological Characteristics The Prager Shell is made of a biologically-compatible rigid plastic. Each model fits the transducers of specific ultrasound manufacturers. They are fitted with mechanisms so that they may be locked in place on the transducers (7) Performance data (a) Non-clinical tests Biocompatibility tests have been done. (b) Clinical tests Not required (8) Conclusions The Prager Shell is equivalent in safety and efficacy to the legally marketed predicate device. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### DEC 0 5 2008 ESI, Inc. % Mr. George Myers President Medsys, Inc. 377 Route 17 S HASBROUCK HEIGHTS NJ 07604 Re: K082893 Trade/Device Name: Prager Shell Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: September25, 2008 Received: September 30, 2008 #### Dear Mr. Myers: 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. {3}------------------------------------------------ #### Page 2 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.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 | |----------------|---------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Arputh Whang Joyce M. Whang, Ph.D. Acting 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): KOB2093 Device Name: Prager Shell Indications For Use: The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye for A-scan biometry of the eye. Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) Heilus Reimer Sign-Off) (Division (Division Sign-Oil) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number