ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM

K963064 · Laborie Medical Tech Corp. · FFX · Jun 5, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963064
• Device Name: ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
• Applicant: Laborie Medical Tech Corp.
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: Jun 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Intended 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.

Device Story

The Ano-Rectal Manometry (ARM) Option is an add-on module for Laborie's existing PC-based urodynamic systems. It utilizes the same pressure transducers as the host urodynamic system but operates within a different measuring range to facilitate ano-rectal pressure quantification. The device is used in clinical settings by healthcare professionals to perform standard manometric measurements. The system processes pressure signals to provide quantitative data, which clinicians use to assess ano-rectal function and inform clinical decision-making regarding patient gastrointestinal health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based system; utilizes pressure transducers adapted for ano-rectal measuring ranges; software-based signal processing for pressure quantification.

Indications for Use

Indicated for patients requiring quantification of ano-rectal pressures for standard ano-rectal manometric measurements.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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510(k) Number (if known): K963064

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.


(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

D. L. R. Nattling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963064

Prescription Use ☑ OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)