(90 days)
The Kongsberg Instruments Inc. Motility Probe is manufactured for use in the evaluation and diagnosis of gastrum lerological dysfunction related to muscir tonus and the coundination of contractions between muscle groups. The Motility frobe provides several types of information with may be used in these diagnoses. Primary among these is pressure information at multiple sensor sites. Secondary to the pressure information is the ability of the probe to measure pH in the Stomach and esophagus. This can reveal the presence of gastric reflux from the stomach into the esophair.
Motility Probes: models P31-P38, P40-P43, and P50
This document is a 510(k) clearance letter from the FDA for a medical device called "Motility Probes." It does not contain a study proving the device meets acceptance criteria, nor does it provide acceptance criteria or device performance data.
Instead, this letter confirms that the FDA has found the device to be "substantially equivalent" to predicate devices already on the market, based on the information submitted by the manufacturer, Konigsberg Instruments, Inc. This clearance allows the manufacturer to market the device for the stated Indications for Use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The document is a regulatory approval, not a scientific study report.
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মানুষ
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
866 1 1 NH
Ms. Arlin Hanson Materials/Agency Compliance Engineer Konigsberg Instruments, Inc. 2000 Foothill Boulevard Pasadena, California 91107
Re: K980980
Motility Probes: models P31-P38, P40-P43, and P50 Dated: March 13, 1998 Received: March 17, 1998 Regulatory class: II 21 CFR §876.1725/Product code: 78 FFX 21 CFR §876.1400/Product code: 78 FFT
Dear Ms. Hanson:
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 general controls provisions of the Act include requirements for annual registration, iisting of devices, good manufacturing practice, labeling, against misbranding and adulteration.
If your device is classified (see above) into either class II (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 requirements; 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 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/dsmaldsmamain.html",
Sincerely yours
Lillian Yin, Ph.D
Director, Division of Reproducti Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K980980
Device Name: MOTILITY PROBE - P31, P32, P33, P34, P35, P36, P37, P38, P40, P41, P42, P43 AND P50 SERIES. Indications For Use:
The Kongsberg Instruments Inc. Motility Probe is manufactured for use in the evaluation and diagnosis of gastrum lerological dysfunction related to muscir tonus and the coundination of contractions between muscle groups.
The Motility frobe provides several types of information with may be used in these diagnoses. Primary among these is pressure information at multiple sensor sites. Secondary to the pressure information is the ability of the probe to measure pH in the Stomach and esophagus. This can reveal the presence of
gastric reflux from the stomach into the esophair. Is
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Doler D. Ratting
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use_U (Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Formal 1 - 2 - 96)
OR
§ 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).