(125 days)
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No
The summary describes a simple, disposable collection pouch with no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is described as a collection pouch for urine and does not mention any therapeutic action or intent to treat a disease or condition.
No
Explanation: The device is intended to collect urine and direct it away from the body, which is a collection function, not a diagnostic one. It does not analyze, monitor, or detect any medical conditions.
No
The device description clearly states it is a "Female External Urinary Collection Pouch," which is a physical, disposable product, not software.
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 and assist in directing it away from the body." This describes a physical collection and redirection function, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The description is simply "Female External Urinary Collection Pouch," which aligns with a collection device.
- Lack of Diagnostic Elements: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (like urine) for specific substances or markers.
- Providing diagnostic information about a patient's health condition.
- Using reagents or other components for testing.
- Any mention of laboratory procedures or analysis.
Therefore, this device is a medical device for urine collection, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.
Product codes
78 EXI and EYZ
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
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Key Metrics
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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 shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUM" around the left side of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mediquest, Inc. c/o Holland & Associates Mr. Greg Holland 3722 Avenue Sausalito Irvine, California 92606
Re: K971499 Female External Urinary Collection Pouch Dated: July 11, 1997 Received: July 14, 1997 Regulatory Class: I 21 CFR §876.5250/Product Code: 78 EXI and EYZ
Dear Mr. Holland:
AUG 28 1997
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, 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 misbranion.
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 requirement, as set forth in the Quality System Regulation (OS) 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 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), 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,
h7 liau Yu
Lilian 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
1
510(k) Number (if known):
Device Name: Mediquest, Inc.'s Female External Urinary Collection Pouch
: 中国 中
Indications For Use:
As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Dober R 12 (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices ア . . . 510(k) Number Prescription Use_Y ાર Over-The-Counter Usc _______ (Pcr 21 CFR 301.109)
(Optional Format 1-2-96)