(302 days)
The Ano-Rectal Manometry (ARM) Option to Laborie's PC-based urodynamic systems is intended to be used in quantifying ano-rectal pressures. Using the same transducers as for urodynamics but with a different measuring range, the ARM Option can be used for performing standard ano-rectal manometric measurements.
Ano-rectal Manometry Option Device, Model UDS-ARM
The provided document is a 510(k) clearance letter from the FDA for a device called "Ano-rectal Manometry Option Device, Model UDS-ARM" and its Indications for Use statement. This document confirms the device's substantial equivalence to a predicate device but does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methodologies.
The letter is a regulatory approval document and focuses on stating that the device is substantially equivalent to a pre-amendments device, allowing it to be marketed. It does not include the detailed technical or clinical study data that would typically contain the information requested in your prompt.
Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, one would need access to the actual 510(k) submission (K963064) which would contain the performance data and methodology used to demonstrate substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 1997
Mr. Thomas G. Hirte Regulatory Affairs Manager .................. Laborie Medical Technologies Corporation 6 Hurricane Lane Williston, Vermont 05495
Re: K963064
Ano-rectal Manometry Option Device, Model UDS-ARM Dated: May 19, 1997 Received: May 19, 1997 Regulatory class: II 21 CFR §876.1725/Product code: 78 FFX
દ્વાર Dear Mr. Hirte:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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) 594-4616. 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 yours,
Lillian Yin, Ph.D.
Director, Division of Reproduct Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
Anorectal Manometry Option
Indications For Use:
The Ano-Rectal Manometry (ARM) Option to Laborie's PC-based urodynamic systems is intended to be used in quantifying ano-rectal pressures. Using the same transducers as for urodynamics but with a different measuring range, the ARM Option can be used for performing standard ano-rectal manometric measurements.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
|---|---|
| 510(k) Number | K963064 |
| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter Use(Optional Format 1-2-96) |
§ 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).