(604 days)
Not Found
Not Found
No
The summary describes a physical catheter used for pressure and volume measurements, with no mention of AI, ML, image processing, or data analysis techniques typically associated with AI/ML.
No
The device is used to measure sensory pressures and volumes, which is a diagnostic function, not a therapeutic one. It provides information about the condition but does not treat it.
Yes
Explanation: The device measures "sensory pressures and volumes," which fall under the category of physiological measurements for assessment, indicating a diagnostic purpose.
No
The device description explicitly states "Y-type Gastric Catheter; Y-type Rectal Catheter," indicating physical hardware components (catheters) are part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure sensory pressures and volumes in the stomach and anorectal region. This is a measurement taken directly from the patient's body, not on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The device is a catheter, which is a tool used to access internal body cavities.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures typically associated with IVDs.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used for physiological measurement in vivo.
N/A
Intended Use / Indications for Use
The Mui Scientific Y-type Barostat Gastric Catheter is used as part of a barostat system to measure sensory pressures and volumes in the stomach.
The Mul Sclentific Y-type Barostat Rectal Catheter is used as part of a barostat system to measure sensory pressures and volumes in the anorectal region.
Product codes
78 FFX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
stomach, anorectal region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract eagle or bird-like figure with three curved lines representing its body and wings.
1 1999 II IN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sam Jundler President G & J Electronics Inc. 6 Dornfell Street Willowdale, Ontario CANADA M2R 2Y6
Re: K973844
Mui Scientific Y-Type Gastric and Rectal Barostat Catheters Dated: March 8, 1999 Received: March 9, 1999 Requiatory Class: II 21 CFR §876.1725/Procode: 78 FFX
Dear Mr. Jundler:
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 legally marketed predicate 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 Cosmelic 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 requirements, 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 requlations.
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), piease 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/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
06/01/09 - 17:15 FAX 301 201 2330
FDA/CDRH/ODE/DRAERD
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Page 1 of 2
(Optional Formal 1-2-96)
510(k) Number (if known); | K973844 |
---|---|
Device Name: | Y-type Gastric Catheter: |
Indications For Use:
The Mui Scientific Y-type Barostat Gastric Catheter is used as part of a barostat system to measure sensory pressures and volumes in the stomach.
(PLEASE DO NOT WRITE DELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NHEIDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973844/5
scription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
2
08/01/90 17:15 FAX 301 594 2330
FDA/CDRH/ODE/DRAERD
$\underset{002}{q}$
Page 2 of 2
510(k) Number (if known): | K973844 |
---|---|
Device Name: | Y-type Rectal Catheter: |
Indications For Use:
The Mul Sclentific Y-type Barostat Rectal Catheter is used as part of a barostat system to measure sensory pressures and volumes in the anorectal region.
(PLEASE DO NOT WRITE BEFLOW TIMS LINE - CONTINUE GIN ANOTHER I'ACE IF NEEDED)
Conourrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973844/5003
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)