(59 days)
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No
The summary describes a simple pressure gauge and does not mention any AI/ML terms, image processing, or data analysis beyond basic pressure measurement.
No
The device is used for monitoring bladder pressure and ensuring timely diagnostics; it does not directly treat or alleviate a medical condition.
No
The document explicitly states, "At no time is this device to be used in place of CMGs for diagnostics." It focuses on monitoring bladder pressure to inform the timing of diagnostic studies, rather than performing diagnosis itself.
No
The device description explicitly states "Single Channel Urological Pressure Gauge," indicating a hardware component (a pressure gauge) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The description clearly states the device is a "Single Channel Urological Pressure Gauge" used for "monitoring of full serial bladder (vesical) pressure." This involves measuring a physical parameter (pressure) within the body, not analyzing a sample taken from the body.
- Intended Use: The intended use is for "long term weekly monitoring of full serial bladder (vesical) pressure" in patients. This is a monitoring function, not a diagnostic test performed on a biological sample.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological sample (blood, urine, etc.).
Therefore, this device falls under the category of a medical device used for monitoring a physiological parameter, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The pressure sensor is for use in the long term weekly monitoring of full serial bladder (vesical) pressure in patients that perform regular clean intermittent catheterizations (CIC). Regular once per week long term monitoring of bladder pressure in patients at risk for developing high bladder pressures and urinary incontinence associated with, urinary tract infections (UTI), vesicoureteral reflux and renal insufficiency. The most significant source of urologic morbidity and mortality in patients with spinal conditions where CIC is used is renal failure secondary to upper tract deterioration from high bladder pressures. Cystometry (CMG) is an integral part in the urologic evaluation of patients prior to the use of this device. At no time is this device to be used in place of CMGs for diagnostics. Patients with CMG leak point pressures greater than 40 cm H20 are at significant risk for upper tract deterioration. The frequency and timing of CMG urodynamic studies in patients with spinal injuries continues to be controversial, but use of this device may insure that full CMGs or other suitable diagnostics are performed on a timely basis by the patients attending physician.
Product codes
78 FAP
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
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Anatomical Site
bladder (vesical)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.1620 Urodynamics measurement system.
(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Image /page/0/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized representation of three human figures, each consisting of a head, torso, and legs, arranged in a row. The figures are depicted in a minimalist style, with simple lines forming their shapes. To the left of the figures, the text "DEPARTMENT OF HEALTH" is arranged vertically, following the curve of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1998
Robert E. Walter President Airtronic Services, Inc. 116 North Lively Blvd. Elk Grove Village, IL 60007 Re: K974775
Single Channel Urological Pressure Gauge Dated: October 31, 1997 Received: December 22, 1997 Regulatory Class: II 21 CFR 876.1620/Procode: 78 FAP
Dear Mr. Walter:
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 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 ander 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 yitte diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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,
Sincerely, Yale,
h. W. Hiau Yin
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
1
510(k) Number (if known): K974775
Sinngle Channel Urological Pressure Guage, Device Name:
Indications For Use:
The pressure sensor is for use in the long term weekly monitoring of full serial bladder (vesical) pressure in patients that perform regular clean intermittent catheterizations (CIC). Regular once per week long term monitoring of bladder pressure in patients at risk for developing high bladder pressures and urinary incontinence associated with, urinary tract infections (UTI), vesicoureteral reflux and renal insufficiency. The most significant source of urologic morbidity and mortality in patients with spinal conditions where CIC is used is renal failure secondary to upper tract deterioration from high bladder pressures.
Cystometry (CMG) is an integral part in the urologic evaluation of patients prior to the use of this device. At no time is this device to be used in place of CMGs for diagnostics. Patients with CMG leak point pressures greater than 40 cm H20 are at significant risk for upper tract deterioration. The frequency and timing of CMG urodynamic studies in patients with spinal injuries continues to be controversial, but use of this device may insure that full CMGs or other suitable diagnostics are performed on a timely basis by the patients attending physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Robert D. Salling/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number 1974775
Prescription Use X (Per 21 CFR 801.109)
જ્વન
Over-The-Counter Use_
(Optional Format 1-2-96)