(26 days)
No
The summary describes a physical medical device (a ureteral stent) and its intended use and physical characteristics. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making components. The performance studies focus on physical and functional equivalence to a predicate device, not algorithmic performance.
Yes
The device is intended to facilitate drainage from the kidney to the bladder, which is a therapeutic function addressing a medical condition.
No
Explanation: The device is described as facilitating drainage from the kidney to the bladder, which is a therapeutic function, not a diagnostic one. It is a ureteral stent, which is used to keep a ureter open, not to diagnose a condition.
No
The device description clearly describes a physical ureteral stent, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate drainage from the kidney to the bladder." This is a therapeutic and drainage function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device (a stent) designed to be inserted into the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information.
- Using reagents or laboratory equipment for analysis.
This device is a medical device used for a procedural purpose (drainage), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Loop Tail Ureteral Stent is intended to facilitate drainage from the kidney to the bladder.
Product codes
78 FAD
Device Description
The Loop Tail Ureteral Stent is a dual durometer ureteral stent with a renal pigtail and a bladder loop configuration. A "long" and "short" loop version will be available, in sizes 5, 6, 7, and 8 Fr., and lengths ranging from 10cm to 30cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney to the bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The results of physical comparison and functional testing support a determination of substantial equivalence for the proposed device when compared to the predicate device. The proposed device is substantially equivalent to currently marketed ureteral stent devices in terms of performance characteristics, biocompatibility, and intended use.
Key Metrics
Not Found
Predicate Device(s)
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
Special 510(k) Premarket Notification Loop Tail Ureteral Stent
MAR 1 7 2003
Boston Scientific Corporation February 14, 2003
510 (k) SUMMARY 1030503 SPONSOR: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760 Donna M. Gardner CONTACT PERSON: Senior Regulatory Affairs Specialist Or Lorraine M. Hanley Director Regulatory Affairs DEVICE: To Be Determined Trade Name: Ureteral Stent Common Name: Class II, per 21 CFR Part 876.4620 Classification: PREDICATE DEVICE: Contour Polaris Ureteral Stent (K010002) DESCRIPTION: The Loop Tail Ureteral Stent is a dual durometer ureteral stent with a renal pigtail and a bladder loop configuration. A "long" and "short" loop version will be available, in sizes 5, 6, 7, and 8 Fr., and lengths ranging from 10cm to 30cm. The Loop Tail Ureteral Stent is intended to facilitate drainage INTENDED USE: from the kidney to the bladder. TECHNOLOGICAL CHARACTERISTICS: The intended use and the materials are identical to the predicate device. The proposed device is designed with a bladder loop configuration, whereas the predicate device has a bladder pigtail. FDA's "Guidance for the Content of Premarket Notifications for PERFORMANCE DATA: Ureteral Stents", and the results of physical comparison and functional testing support a determination of substantial equivalence for the proposed device when compared to the predicate device. The proposed device is substantially equivalent to currently marketed ureteral stent devices in terms of performance characteristics, biocompatibility, and intended use.
Proprietary and Confidential Information of Boston Scientific Corporation
000031
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna M. Gardner Senior Regulatory Affairs Specialist Microvasive Urology Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
MAR 1 7 2003
Re: K030503
Trade/Device Name: Contour Polaris Ureteral Stent Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 FAD Dated: February 14, 2003 Received: February 19, 2003
Dear Ms. Gardner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Special 510(k) Premarket Notification Loop Tail Ureteral Stent
INDICATIONS FOR USE STATEMENT K030503
| 510(k) Number | To be determined K030503 |
|---|---|
| Device Name | To be determined (Ureteral Stent) |
| Indications For Use | The Loop Tail Ureteral Stent is intended to facilitate drainage from the kidney to the bladder. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ (Per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
David A. Logman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
000017