(61 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
A therapeutic device is one that treats a disease or condition. This device is described as "used to pass fluids to or from the urinary tract," which indicates a diagnostic or supportive function, not a direct treatment.
No
The device is described as passing fluids to or from the urinary tract, which is a therapeutic or supportive function, not a diagnostic one. It does not mention analyzing or detecting conditions.
No
The device is described as a "Urological Catheter," which is a physical medical device used to pass fluids. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pass fluids to or from the urinary tract." This describes a device that interacts directly with the body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
An Advanced Urological Catheter is a medical device used for procedures within the urinary tract, which is an in vivo application.
N/A
Intended Use / Indications for Use
The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.
Product codes
EZL, FCM
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
urinary tract
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
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB 8
2006
W. Cary Dikeman President EntraCare LLC 11315 Strang Line Road LENEXA KS 66215
Re: K053429
Trade/Device Name: Advanced Urological Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Product Codes: EZL and FCM Regulation Number: 21 CFR §876.5250 Regulation Name: Urine collector and accessories Product Code: FCN Regulatory Class: II Dated: January 20, 2006 Received: January 23, 2006
Dear Mr. Dikeman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we no re roved your and have determined the device is substantially equivalent to legally marketed rererched wices 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 the Medical Don't he Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), as buobally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these and farmer piovour kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Cary Dikeman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Nancy brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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K053429
Page 1 of 7
Indications for Use
510(k) Number (if known): KOSSE29
Device Name: Advanced Urological Catheter
Indications for Use:
The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
November 2005 EntraCare LLC: AUC
(Division Sign-Off)/ Division of Reproductive, Abdo minal, and Radiological Devices
510(k) Number K053429
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