(68 days)
Not Found
Not Found
No
The summary describes a physical medical device (a ureteral stent) and does not mention any software, image processing, or AI/ML terms.
Yes
The device facilitates drainage from the kidney to the bladder, which is a therapeutic function aimed at alleviating a medical condition or improving physiological function.
No
The device, a Modified Ureteral Stent, is intended to facilitate drainage from the kidney to the bladder. Its function is interventional (drainage), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states "Modified Ureteral Stent," 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 clearly states that the device is a "Modified Ureteral Stent intended to facilitate drainage from the kidney to the bladder". This describes a device that is physically placed within the body to perform a function (drainage).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro means "in glass").
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological markers, or any other activity typically associated with IVDs.
Therefore, the Modified Ureteral Stent is a medical device used in vivo (within the body) for drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Modified Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement transurethrally, percutaneously, or via open surgery by a trained physician.
Product codes
78FAD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested.
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
510(k) Premarket Notification Modified Ureteral Stent November 26, 1997
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
K974541 p.ofl
SECTION VIII 510)K) SUMMARY
FEB - 9 1998
510 (k) Summary Of Safety And Effectiveness
| Sponsor: | Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lorraine M. Hanley
Manager, Regulatory Affairs
or
Terry Myers
Regulatory Affairs Associate |
| Submission Date: | November 26, 1997 |
| Common/Usual Names: | Modified Ureteral Stent |
| Trade/Proprietary Name: | To Be Determined |
| Device Classification
and Name: | According to CFR 21 Part 876, Section 4620 the Ureteral Stent
is a Class II device.
Product Code: 78FAD |
| Substantial Equivalence: | The proposed modified device is Substantially Equivalent to devices previously cleared by the FDA via the 510(k) Notification process and indicated for use as a Ureteral Catheter to provide drainage from the kidney to the bladder. |
| Performance: | The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested. |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1998
Ms Terry Myers Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 Re: K974541 Modified Ureteral Stents Dated: January 22, 1998 Received: January 26, 1998 Regulatory class: II 21 CFR §876.4620/Product code 78 FAD
Dear Ms. Myers:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commence prior to May 28, 1976, the enactment date of the Medical 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 (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 310(k) premarket notification. The FDA finding of substantial couivalence of your device to a legally marketed prodicate 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 directic 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/cdrl/dsmamain.html".
Sincerely yours,
hJliau 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
2
510(k) Premarket Notification Modified Ureteral Stent November 26, 1997
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
SECTION I INDICATIONS FOR USE
Page . of of l 1
510(k) Number (if known): 长974541
Device Name:
Modified Ureteral Indwelling Catheter/Stent
Indications For Use:
The Modified Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement transurethrally, percutaneously, or via open surgery by a trained physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
\documentclass{article}
\usepackage{amsmath}
\begin{document}
[ \checkmark ]
\end{document}
(Per 21 CFR 801.109)
or
Over-The-Counter Use __
\documentclass{article}
\usepackage{amsmath}
\begin{document}
[ Robert \mathcal{D} \text{Stalling} ]
\end{document}
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
(Optional Format 1-2-96)
510(k) Number _