(250 days)
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.
The FLEXILOG LS, Esophagea1 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.
The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification 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.
The provided document is a 510(k) premarket notification for the FLEXILOG LS Esophageal Sphincter Detector. It does NOT contain information about acceptance criteria or a study proving that a device meets such criteria.
The document includes:
- Trade Name: FLEXILOG LS
- Common Name: Esophageal Sphincter Detector
- Classification Name: Monitor, esophageal motility and tube
- Indications for Use: For the location of the lower and/or upper esophageal sphincter and the measuring of the nares to esophageal sphincter distance, prior to accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.
- Description: A single-channel pressure monitoring system that provides transducer excitation, amplification, and signal transmission to a computer via an optically isolated RS232 connector. The pressure signal is displayed on a computer VDU without analysis or data saving options.
- Technological Characteristics: Similar to predicate devices (FLEXILOG LS Lower Esophageal Sphincter Detector, RMS III, the LES Locator, Digitrapper MKIII, Digitrapper MD) but with electronics in a standalone box, not integrated with ambulatory pH recorders, and not requiring connection to a pH recorder. Displays data on a computer screen.
- Testing: Only a general statement is provided: "The FLEXILOG LS has been shown to accurately measure and display pressure." No specific study details, methodology, sample sizes, ground truth establishment, or acceptance criteria are given.
- Predicate Devices: Oakfield Instruments Limited, FLEXILOG LS; Sandhill Medical Inc., RMS III; Biolab, The LES Locator; Synectics Medical Limited, Digitrapper MKIII; Synectics Medical Limited, Digitrapper MD PC Polygraph HR.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is a circular logo with the text "REGISTERED FIRM" around the outside of the circle. Inside the circle is a heart shape with a triangle inside of it. The logo on the right is a square logo with a check mark at the top. Underneath the check mark is the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES". Underneath the logos is the text "Certificate No: FM20708".
OAKFIELD INSTRUMENTS LTD
HEALTH CARE PRODUCTS
PAGE OF 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
00 - 6 p
Oakfield Instruments Limited. Oakfield Industrial Estate, Stanton Harcourt Road. Eynsham, WITNEY Oxfordshire, OX8 IJA, 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, Highlands Ranch, Biolab CO 80126, U.S.A.
Synectics Medical Limited. 215 Willow Road. ENFIELD, Middlesex, EN1 3BT.
The LES Locator
Digitrapper MKIII Digitrapper MD PC Polygraph HR
Description
The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification 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.
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Image /page/1/Picture/0 description: The image contains two logos. The logo on the left is a circular logo with the text "REGISTERED FIRM" surrounding a heart-shaped symbol. The logo on the right is a square logo with a checkmark above the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES". Below the logos is the text "Certificate No: FM20708".
OAKFIELD INSTRUMENTS LTD
HEALTH CARE PRODUCTS
PAGE 2 OF 2 Oakfield Industrial Estate. Stanton Harcourt Road, Eynsham, Witney, Oxon, OX8 1JA Tel: (+44) 1865 882532 Fax: (+44) 1865 883970
-2-
Indications
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 MKII 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.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
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 Witnev. Oxon. OX8 1JA UNITED KINGDOM
AUG - 6 1907
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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 (OS) 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 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/dsmamain.html".
Sincerely vours.
H. Thiau Yu
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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RE: 510K Submission - FLEXILOG LS Esophageal Sphincter Detector
510(k) Number (if known):
Device Name: OES opinage Ar SANCIER Va PR
Indications For Use:
The FLEXILOG LS, Esophagea1 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)
Calin M. Pollard
on of Reproductive, Abdominal, ENT. and Radiological Devic
510(k) Number K964804
Prescription Use
(Per 21 CFR 801.109)
$\checkmark$
OR
Over-The-Counter Use
(Optional Format 1-2-96)
C-1
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).