(136 days)
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None
No
The provided 510(k) summary describes a simple external urine collection system and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
A therapeutic device is one that treats a disease or condition. This device is for external urine collection, which manages a symptom (incontinence) but does not treat the underlying condition itself.
No
The BeSECURE External Urinary Collection System is described as an "external urine collection system," which is a therapeutic or assistive device, not one used for diagnosis.
No
The provided 510(k) summary describes an "External Urinary Collection System," which inherently implies a physical device for collecting urine, not a software-only application.
Based on the provided information, the BeSECURE External Urinary Collection System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an external urine collection system for the incontinent patient." This describes a device used to collect a bodily fluid, not to perform a diagnostic test on that fluid.
- Lack of Diagnostic Information: The description does not mention any analysis, testing, or diagnostic purpose for the collected urine. IVDs are specifically designed to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- No Mention of Laboratory Use: The description doesn't suggest the device is used in a laboratory setting or for any kind of in vitro analysis.
Therefore, the BeSECURE External Urinary Collection System appears to be a medical device for collection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The BeSECURE External Urinary Collection System is an external urine collection system for the incontinent patient.
Product codes
78 FAQ, KNX
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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 is a circular seal for the Department of Health & Human Services (USA). The seal features the department's name in a circular arrangement around the edge. In the center of the seal is an abstract emblem, possibly representing an eagle or a similar bird, with stylized lines forming its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1997
Mr. Frank A. Manfredi President Urology Research International P.O. Box 602544 Cleveland, Ohio 44102
Re: K971271 BeSECURE External Urinary Collection System Dated: July 14, 1997 Received: July 15, 1997 Regulatory class: II 21 CFR 8876.5250/Product code: 78 FAQ, KNX
Dear Mr. Manfredi:
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, 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 (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 equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and chat, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Pailure 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 market 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 (2) CFR Part 801 and additionally 809.10 for in yitto 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 (30) 443-6597 or at its internet address http://www.fda.gov/cdrl/dsmamain.html".
Sincerely yours.
H.J.Liau Yu
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
5 ! 0(k) Number (if known): K971271_______________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for use
ー………………
The BeSECURE External Urinary Collection System is an external urine collection system for the incontinent patient.
(PLEASE DO NOT WRITE BEIJOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDI!!))
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Rober 2 Nothing | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K971271 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use |
(Optional Format 1-2-96)
2