(71 days)
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No
The summary describes a standard urinary catheter and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
No
The device is described as draining urine from the bladder, which is a diagnostic or management function, not a therapeutic one that treats a disease or condition.
No
The device is described as a urinary incontinence device designed to drain urine, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states "Urinary Catheter," which is a physical medical device, 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 "drain urine from the bladder" as a "urinary incontinence device." This is a direct therapeutic or management function performed on the patient's body.
- Device Description: It's described as a "Urinary Catheter." Catheters are medical devices used to drain fluids from the body, not to perform tests on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (urine, blood, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests in vitro (outside the living body)
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This urinary catheter's function is purely for drainage and management of incontinence, which is a direct medical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Apogee Medical,Inc. Urinary Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder
Product codes
78 GBM
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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§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a bird or a person with outstretched arms. The symbol is positioned in the center of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the top and sides of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 SFP.
Mr. Brent D. Robling President Apogee Medical, Inc. 7517-101 Precision Drive Raleigh, NC 27613
Re: K992137 Urological Catheter Dated: June 18, 1999. Received: June 24, 1999 Regulatory Class: II 21 CFR §876.5130/Procode: 78 GBM
Dear Mr. Robling:
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 legally marketed predicate 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, 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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 the Electronic Product 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1_of_1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Dovice Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use:
The Apogee Medical,Inc. Urinary Catheter is intended to . ...
. be used as a urinary incontinence device designed to drain urine from the bladder
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON LEOTHER PAGE IT NEEDED)
Concurrence of CDRH, Office of Device Eva(ODE)
Prescription Use
(Per 21 CFR 801.109)
Optional F
(Division Sign-Off)
Division of Reproductive, Abdominal, ÉNT,
and Radiological Devices
510(k) Number. K992137
Optional Format 3-10-98)