(30 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (ureteral stent) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a ureteral stent used for temporary drainage to relieve obstruction, which falls under the definition of a therapeutic intervention.
No
Explanation: The UroSurge SpiraFlo Ureteral Stent is used for temporary drainage to relieve obstruction, which is a therapeutic function, not a diagnostic one. It is a stent, which is a therapeutic device.
No
The device description clearly indicates a physical medical device (UroSurge SpiraFlo Ureteral Stent) used for temporary drainage, not a software-only application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- UroSurge SpiraFlo Ureteral Stent Function: The description clearly states that the UroSurge SpiraFlo Ureteral Stent is used for "temporary drainage from the ureteropelvic junction to the bladder." This is a device that is inserted into the body to perform a physical function (drainage).
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any bodily fluids or tissues outside of the body. Its purpose is mechanical drainage within the urinary tract.
Therefore, based on the provided information, the UroSurge SpiraFlo Ureteral Stent is a medical device, but it falls under a different category than In Vitro Diagnostics. It is an implantable or interventional device.
N/A
Intended Use / Indications for Use
The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
Product codes
78 FAD
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
ureteropelvic junction to the bladder
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
Mr. Steven J. Preiss Vice President, Clinical & Regulatory Affairs UroSurge, Inc. 2660 Crosspark Road Coralville, IA 52241
Re: K992391 UroSurge SpiraFlo Ureteral Stent Dated: July 15, 1999 Received: July 19, 1999 Regulatory Class: II 21 CFR §876.4620/Procode: 78 FAD
Dear Mr. Preiss:
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 Regulations, 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 regulation (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
Indications For Use Statement
TO BE ASSIGNED 510(k) Number (if known):
Device Name:
UroSurge SpiraFlo Ureteral Stent
Indications For Use:
The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days.
This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
David A. Bynum
Reproductive, Abdominal, ENT, 510(k) Number
(Optional Format 1-2-96)