(262 days)
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.
Hughes Bowel and Madder System model MeD-18 helps persons with incontinence manage of overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins.
Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their comditon promptly and with complete discretion at the first sign of bladder or bowel release day or night.
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.
The device functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage.
The provided document is a 510(k) summary for the Hughes Bowel and Bladder System Model MeD-18. This document, primarily from 1997, is concerned with establishing substantial equivalence to a predicate device for regulatory clearance, rather than detailing a clinical study with acceptance criteria and performance metrics in the way a modern AI/ML device submission would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in the provided text. The device described is a physical enuresis alarm, not an AI/ML diagnostic or predictive device.
The document states:
- The device is an "enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected..."
- It "helps persons with incontinence manage or overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins."
- It "functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage."
This type of device would typically rely on engineering specifications for its components (e.g., sensor sensitivity, vibration motor reliability, battery life, material biocompatibility, electromagnetic compatibility) and perhaps user studies for usability and effectiveness in real-world scenarios. However, none of these details are available in the provided FDA 510(k) summary.
In summary, the provided text does not contain the information necessary to describe acceptance criteria and associated study details as requested for an AI/ML device.
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510(k) Sunimary for K971442
JAN - 8 1998
Sponsor:
HuMed, Inc. Charles Hughes, President 709 N. Memorial Parkway Huntsville, Alabama 35801
K971442
P101
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.
Hughes Bowel and Bladder System model MeD-18 helps persons with incontinence manage or overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins.
Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their conditon promptly and with complete discretion at the first sign of bladder or bowel release day or night.
The device functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black against a white background.
JAN - 8
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Charles Hughes President HuMed, Inc. 709 N. Memorial Parkway Huntsville, AL 35801
Re: K971442
Hughes Bowel and Bladder System Model MeD-18 Dated: December 15, 1997 Received: December 18, 1997 Regulatory Class: II 21 CFR 876.2040/Procode: 78 KPN
Dear Mr. Hughes:
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, 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 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 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 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 yitro 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,
h. William Yri
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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Page_of_
510(k) Number (if known); K 2 7/1442
Device Name Husbal Reach and Blaker System nell-18
Indications For Use:
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.
Hughes Bowel and Madder System model MeD-18 helps persons with incontinence manage of overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins.
Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their comditon promptly and with complete discretion at the first sign of bladder or bowel release day or night.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R Ratliff
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971442
Prescription Use__ OR Over-The-Counter Use_
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 876.2040 Enuresis alarm.
(a)
Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.(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.