(314 days)
Not Found
None
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also not provided, which would be a key place to find such information.
No
The device is intended to collect urine for urinary incontinence, which is a supportive function rather than a therapeutic one. It assists with a condition but does not treat or cure it.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "To collect urine to provide assistance for male urinary incontinence." This indicates a collection or assistive function, not a diagnostic one. There is no mention of identifying, analyzing, or determining a medical condition.
No
The intended use describes a device that collects urine, which strongly suggests a physical, hardware-based device, not software. The lack of a device description further prevents confirmation of a software-only nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect urine to provide assistance for male urinary incontinence." This describes a device used externally to manage a physical condition, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No mention of analyzing biological samples: There is no indication that this device analyzes urine or any other biological sample to provide diagnostic information. It is purely for collection.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases, monitor conditions, or determine compatibility. This device's function is solely collection for management of incontinence.
N/A
Intended Use / Indications for Use
To collect urine to provide assistance for male urinary incontinence. This device is intended for non-prescription use and it is re-usable after cleaning and washing. It is intended for non probanpuen ass annected to an indwelling catheter. This device is not designed for pediatric use.
Product codes
78 EXJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not designed for pediatric use.
Intended User / Care Setting
Non-prescription use.
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
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Bouser Health Products c/o Mr. Milton N. Beneke Jr. Medical Device Consultants, Inc. 55 Northern Boulevard Great Neck, New York 11021
Re: K970465
Bouser's Urinal Dated: December 4, 1997 Received: December 9, 1997 Regulatory class: I 21 CFR §876.5250/Product code: 78 EXJ
Dear Mr. Beneke Jr .:
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 interstate in interstate commerce prior to May 28, 1976, the enactnent 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 misbranion.
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 (2) CFR Part 801 and additionally 809.10 for in vitro 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,
William 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
K970465 510(k) Number (if known):
Device Name: _______________________________________________________________________
Indications For Usc:
1 .
To collect urine to provide assistance for male urinary incontinence. This device is intended for non-prescription use and it is re-usable after cleaning and washing. It is intended for non probanpuen ass annected to an indwelling catheter. This device is not designed for pediatric use.
(PLEASE:DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D Satting
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 70465 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use √
(Optional Formel 1-2-96)