FLEXILOG LS

{0} Certificate No FM20708 OAKFIELD INSTRUMENTS LTD HEALTH CARE PRODUCTS K964804 PAGE 1 OF 2 Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, Witney, Oxon, OX8 1JA Tel: (+44) 1865 882532 Fax: (+44) 1865 883970 Re: FDA 510(K) Submission - FLEXILOG LS Esophageal Sphincter Detector D ## 510K SUMMARY Oakfield Instruments Limited, Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, WITNEY, Oxfordshire, OX8 1JA, United Kingdom. TEL: (+44) 1865 882532 FAX: (+44) 1865 883970 John Giddings, Sales & Marketing Manager 20th November 1996 Trade Name: FLEXILOG LS Common Name: Esophageal Sphincter Detector Classification Name: Monitor, esophageal motility and tube Substantial equivalence is claimed to the following devices: Oakfield Instruments Limited, FLEXILOG LS Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, WITNEY, Oxfordshire, OX8 1JA Sandhill Medical Inc, RMS III 8955 South Ridgeline Blvd #500, The LES Locator Highlands Ranch, Biolab CO 80126, U.S.A. Synectics Medical Limited, Digitrapper MKIII 215 Willow Road, Digitrapper MD ENFIELD, PC Polygraph HR Middlesex, EN1 3BT. ## Description The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification, digitisation and transmission of the signal to a computer via an optically isolated RS232 connector. The pressure signal is displayed on the computer VDU via a Microsoft Windows display program. The program does not provide any analysis or data saving options. The electronics module is designed to be compatible with catheter tip perfused pressure transducers currently available in the US market. {1} Certificate No. FM20708 OAKFIELD INSTRUMENTS LTD HEALTH CARE PRODUCTS K964804 PAGE 2 OF 2 Oakfield Industrial Estate, Stanton Harcourt Road, Eynsham, Witney, Oxon, OX8 1JA Tel: (+44) 1865 882532 Fax: (+44) 1865 883970 ## Indications -2- The FLEXILOG LS is used for the location of the lower and/or upper esophageal sphincter and the measuring of the nares to esophageal sphincter distance. This procedure being carried out prior to the accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux. ## Technological Characteristics The FLEXILOG LS is a single channel pressure system similar to those in the predicate devices; FLEXILOG LS Lower Esophageal Sphincter Detector, RMS III, the LES Locator, Digitrapper MKIII and Digitrapper MD. However, the electronics are contained in a standalone box, not contained with the ambulatory pH recorder box as in the RMS III, Digitrapper MKIII and Digitrapper MD. Nor does it require to be connected to a pH recorder as does the LES locator. Pressure data is displayed on a computer screen as with the multi channel Biolab and PC Polygraph HR systems. ## Testing The FLEXILOG LS has been shown to accurately measure and display pressure. {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. John Giddings Sales Manager Oakfield Instruments Ltd. Oakfield Industrial Estate Stanton Harcourt Road, Eynsham Witney, Oxon, OX8 1JA UNITED KINGDOM Re: K964804 FLEXILOG LS Oesophageal Sphincter Detector Dated: May 2, 1997 Received: May 9, 1997 Regulatory class: II 21 CFR §876.1725/Product code: 78 KLA Dear Mr. Giddings: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmanain.html". Sincerely yours,  Enclosure {3} RE: 510K Submission - FLEXILOG LS Esophageal Sphincter Detector 510(k) Number (if known): Device Name: FLEXILOG LS OESOPHAGEAL SPINCER DETECTOR Indications For Use: The FLEXILOG LS, Esophageal Sphinctor Locator, is to be used for the manometric location of the lower and upper esophageal sphincters. That is the measurement of the distance from the nares to the sphincter. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Colin M. Pollard (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K964804 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)