(267 days)
Not Found
Not Found
No
The device description and performance metrics focus on the physical properties and clinical outcomes of a ureteral stent, with no mention of AI/ML capabilities or related data analysis.
Yes
The device is described as "intended to facilitate the passage of urine from the kidney to the bladder," which is a direct treatment of a medical condition (obstruction of urine flow).
No
Explanation: The device is a stent designed to facilitate urine passage, which is a therapeutic function, not a diagnostic one. It does not perform any assessment or analysis to identify medical conditions.
No
The device description clearly states it is an "extruded polymeric tube" and describes its physical characteristics and placement methods, indicating it 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 "facilitate the passage of urine from the kidney to the bladder." This describes a physical intervention within the body to manage a physiological process.
- Device Description: The device is a "Temporary Ureteral Drainage Stent," which is a physical object placed within the ureter.
- Mechanism of Action: The device works by providing a physical conduit for urine flow.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like urine, blood, or tissue) to provide diagnostic information about a patient's condition. IVDs are used in vitro (outside the body) to perform tests.
This device is a medical device used for therapeutic purposes (facilitating urine drainage), not for diagnostic testing.
N/A
Intended Use / Indications for Use
The proposed device is intended to facilitate the passage of urine from the kidney to the bladder.
Product codes (comma separated list FDA assigned to the subject device)
78FAD
Device Description
The Microvasive® Temporary Ureteral Drainage Stent is 6 Fr x 26.5 cm, with an open-ended coil at each end. The stent is an extruded polymeric tube made of a reversible cross-linked alginate polymer with an incorporated radiopacifier. The device is placed, using standard ureteral stent placement techniques that can be placed transurethrally, percutaneously or via open surgery using endoscopic and/or radiographic techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
KUB films, intravenous pyelogram (IVP)
Anatomical Site
kidney, bladder, ureter, urological system
Indicated Patient Age Range
All patients were ge 18 years of age
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical study was designed as a prospective, single-arm, multi-center trial. The study included 6 investigative sites that could enroll a maximum of 88 total subjects. Each subject had only one TUDS placed following uncomplicated ureteroscopy.
Subjects with a TUDS successfully placed underwent assessments for device presence, position, and morphology at 1, 2, 7 and 14 days post placement. The exams at days 7 and 14 were not required, if there was no evidence of the TUDS at the preceding exam. All subjects in whom a TUDS was successfully placed were assessed at 30 days to evaluate normal renal drainage on the affected side and assess possible adverse events. If the device was still present in the urological system at day 30, the patient was evaluated at day 60 and day 90.
A total of 88 patients had the TUDS placed following uncomplicated ureteroscopy. A total of 88 patients had the TUDS placed. The study period was 30 days for those patients who successfully passed the TUDS within 30 Days. If the stent remained present at the day 30 follow-up visit, the patient returned for Day 60 and Day 90 follow-up visits for additional monitoring.
Key Results:
Study success was found to be 78.2% (68/87; 17 absence of stent and 3 interventions occurred, within the first 48 hours; 1 patient had both an absence of stent and intervention). The Alternate Endpoint, Overall clinical success was found to be 94.3% (83/88) with the 90 day study period. There were no deaths among the TUDS patients studied. There were no reported unanticipated adverse events. Mean time to eliminate the TUDS from the body was 21 days. Successful placement1 was 98.9% (88/89)*. Males with Early Migration: 12.1% (7/58). Females with Early Migration: 34.5% (10/29). Time required to eliminate TUDS from ureter: 13.0 (+/- 11.3) days, Median = 8 days. Time required to eliminate TUDS from body: 21.0 (+/- 17.8) days, Median = 15 days. Retained stent fragments at 90 days in renal pelvis: 3.4% (3/87). Patient satisfaction5: 88.8% satisfied (71/80).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 0 8 2002
| Section V. 510(k) SUMMARY of Safety and Effectiveness | |
|---|---|
| Sponsor: | Boston Scientific/ Microvasive |
| One Scientific Place | |
| Natick, MA 01760-1537 | |
| Contact Person: | Janet A. McGrath |
| Sr. Global Regulatory Affairs Specialist | |
| OR | |
| Lorraine M. Hanley | |
| Director, Global Regulatory Affairs | |
| Submission Date: | October 31, 2001 |
| Common/Usual Name: | Ureteral Stent, Indwelling Ureteral Catheter |
| Trade/Proprietary Name: | To Be Determined |
| Device Classification | |
| and Name: | Class II: Ureteral Stent, 21CFR 876.4620 |
| Indications for Use: | The proposed device is intended to facilitate the passage of urine from |
| the kidney to the bladder. | |
| Substantial | |
| Equivalence: | The proposed device is substantially equivalent to ureteral stents |
| classified by the Code of Federal Regulations 21CFR 876.4620 and | |
| FDA product code 78FAD, based on a review of the FDA's 510(k) | |
| Decision-making Process. | |
| Product Testing: | To determine appropriate testing for the device, FDA's Draft Guidance |
| Ureteral Stents was utilized. The functional bench test results | |
| demonstrate that the proposed device is substantially equivalent to the | |
| predicate devices in terms of characteristics tested. The proposed | |
| device meets the biocompatibility requirements of ISO 10993 for its | |
| intended use. A clinical trial involving 88 patients was conducted on | |
| the placement of the TUDS device. | |
| Device Description: | The Microvasive® Temporary Ureteral Drainage Stent is 6 Fr x 26.5 |
| cm, with an open-ended coil at each end. The stent is an extruded | |
| polymeric tube made of a reversible cross-linked alginate polymer with | |
| an incorporated radiopacifier. The device is placed, using standard | |
| ureteral stent placement techniques that can be placed transurethrally, | |
| percutaneously or via open surgery using endoscopic | |
| and/or | |
| radiographic techniques. |
1
Clinical Studies
The purpose of the clinical study to evaluate the safety and effectiveness of the Microvasive™ Temporary Ureteral Drainage Stent (TUDS) to facilitate short-term drainage of fluid from the kidney to the bladder.
The clinical study was designed as a prospective, single-arm, multi-center trial. The study included 6 investigative sites that could enroll a maximum of 88 total subjects. Each subject had only one TUDS placed following uncomplicated ureteroscopy.
Subjects with a TUDS successfully placed underwent assessments for device presence, position, and morphology at 1, 2, 7 and 14 days post placement. The exams at days 7 and 14 were not required, if there was no evidence of the TUDS at the preceding exam. All subjects in whom a TUDS was successfully placed were assessed at 30 days to evaluate normal renal drainage on the affected side and assess possible adverse events. If the device was still present in the urological system at day 30, the patient was evaluated at day 60 and day 90.
The study had two primary endpoints:
-
. Primary effectiveness endpoint -
Study success defined as adequate short term drainage defined as the presence of the stent in the ureter and the lack of surgical or other intervention to treat symptoms on the stented side during the first 48 hours following placement. -
. Primary safety endpoint -
Assessment of adverse events (incidence, relationship to device, severity) -
. Alternate Endpoint-
Overall clinical success was also calculated and was defined as adequate drainage with no intervention (regardless of stent presence) and no definitely device-related serious adverse events (SAEs) throughout the 90 day follow-up period.
Study
A total of 88 patients had the TUDS placed following uncomplicated ureteroscopy. All patients were ≥ 18 years of age and required short-term stenting to facilitate drainage.
Radiological assessments (i.e., KUB films) for presence, position, and morphology of the device and assessment of adverse events were performed at the scheduled follow-up visits. All subjects were also assessed at 30 days post-placement to evaluate normal renal function by intravenous pyelogram (IVP) on the affected side and to assess adverse events.
A total of 88 patients had the TUDS placed. The study period was 30 days for those patients who successfully passed the TUDS within 30 Days. If the stent remained present at the day 30 follow-up visit, the patient returned for Day 60 and Day 90 follow-up visits for additional monitoring.
There were no deaths among the TUDS patients studied. There were no reported unanticipated adverse events. Adverse events reported for the TUDS patients were similar to those reported in the literature for plastic ureteral stents. See Tables in the Adverse Events section for a listing of the adverse events observed in the study patients. Mean time to eliminate the TUDS from the body was 21 days. Warning: Clinical study shows that stent fragments may remain in the urinary system for over 90 days and may require removal.
2
Study success was found to be 78.2% (68/87; 17 absence of stent and 3 interventions occurred, within the first 48 hours; 1 patient had both an absence of stent and intervention). The Alternate Endpoint, Overall clinical success was found to be 94.3% (83/88) with the 90 day study period. Tables 1 to 3 summarize the demographic, follow-up study visits, and clinical endpoint results for the TUDS study.
| Category | Value ± SD, (range), n=88 |
|---|---|
| Gender (%male) | 65.9% |
| (58 male, 30 females) | |
| Age | 44.8±13.1 |
| (18.0, 73.0) | |
| Height (in) | 68.4±4.4 |
| (58.0, 76.0) | |
| Weight (lb) | 186±42.8 |
| (95.0, 300.0) | |
| Body Mass Index | 27.8±4.9 |
| (19.0, 42.0) |
Table 1 Demographic Information
Table 2 Follow-up patient information for: Device is out of the Ureter and Kidney Device is out of the Body
| Follow-Up Visit | Device is out of the
Ureter and Kidney | Device is out of the Body |
|-------------------|-------------------------------------------|---------------------------|
| Baseline | 0 | 0 |
| Day 1 | 9 | 0 |
| Day 2 | 7 | 3 |
| Day 7 | 22 | 22 |
| Day 14 | 24 | 31 |
| Day 30 | 14 | 15 |
| Day 60 | 4 | 6 |
| Day 90 | 0 | 0 |
| > 90 | 7 | 7 |
| Unscheduled visit | 0 | 4 |
3
| Clinical Endpoint Results | |
|---|---|
| Endpoint | Result |
| Successful placement1 | 98.9% (88/89)* |
| Study success2 | 78.2% (68/87) |
| Overall clinical success3 | 94.3% (83/88) |
| Males with Early Migration | 12.1% (7/58) |
| Females with Early | |
| Migration | 34.5% (10/29) |
| Time required to eliminate | |
| TUDS from ureter | 13.0 (±11.3) days |
| Median = 8 days | |
| Time required to eliminate | |
| TUDS from body | 21.0 (±17.8) days |
| Median = 15 days | |
| Retained stent fragments at | |
| 90 days in renal pelvis | 3.4% (3/87)^ |
| Tolerability of TUDS4 | |
| (Moderate to most severe | |
| pain) | Day 1: |
| Flank pain - 23.0% (20/87) | |
| Urethral pain - 27.9% | |
| (24/86) | |
| Day 30: | |
| Flank pain - 8.7% (7/80) | |
| Urethral pain – 2.5% (2/80) | |
| Patient satisfaction5 | 88.8% satisfied (71/80) |
Table 3
- (1) patient required (2) stents
Successful placement of TUDS device
2 Study success defined as adequate short term drainage defined as the presence of the stent in the ureter and the lack of surgical or other intervention to treat symptoms on the stented side during the first 48 hours following placement.
3 Alternate Endpoint Defined as adequate drainage with no intervention (regardless of stent presence) and no definitely device-related serious adverse events (SAEs) throughout the 90 day follow-up period.
4 Tolerability of the TUDS passage through the urinary tract when compared to uretharal discomfort recorded at baseline
a courted and and with the stent and with elimination of the stent from the urinary tract
^ Of the 3 patients with retained stent fragments. 2 patients elective ESWL treatments which were successful and 1 patient declined intervention and is being monitored by her physician. All of these patients were free of retentive symptoms.
The Primary Safety Endpoint: Assessment of adverse events (compared to published clinical studies of plastic ureteral stents), indicated that there were no unanticipated adverse events reported and all adverse events resolved by the end of the study without any permanent sequelae. A list of reported adverse events is presented in Table 4.
4
| Reported Adverse Events | ||
|---|---|---|
| Adverse event | Literature range | TUDS study |
| Flank pain/Loin Discomfort | 17 - 50% | 12.5% n=11/88 at 1-30 days |
| Flank pain when voiding | 15-54% | 0% reported |
| Hydronephrosis | up to 25% | 3.4% n=3/88 at 2, 7 and 90 days |
| Suprapubic pain/lower abdominal pain | 20 - 50% | 8% n=7/88 at 1-30 days |
| Suprapubic pain when voiding | 49% | 0% reported |
| Trigonal irritation | 19% | 0% reported |
| Urinary frequency | 42 - 85% | 51.8% n= 44/85 at day 1 |
| 49.1% n= 28/57 at day 14 | ||
| Nocturia | 43-56% | 0% reported |
| Urinary urgency | 8 - 59% | 67% n= 59/88 at baseline |
| 54.8% n= 46/84 at day 1 | ||
| Dysuria | 31-40% | 0% reported |
| Urethral discomfort | - | 22.7% n= 20/88 at baseline |
| 27.9% n= 24/86 at day 1 | ||
| 5.3 n= 3/57 at day 14 | ||
| Incontinence | 3% | 2.3% n=2/88 at 7 days |
| Hematuria | 40 - 64% | 1.1% n=1/88 at day 1 |
| Stent migration | 3 - 10% | 19.5%* n= 17/87 |
| 3.4%* n= 3/87 | ||
| Stent encrustation | up to 10% | 0% reported |
| Stent/Ureteral Obstruction | 2.3% n=2/88 at 2 and 14 days | |
| Stent fracture | 0.6% | 0% reported |
| UTI | 3 - 35% | 2.3% n= 2/88 at 30 days |
| Bacteriuria | 29.9% | 0% reported |
| Additional stent specific procedures | up to 10% | 3.4% n=3/88 thru 48 hrs |
| 8.0% n=7/88 thru 90 days | ||
| Extravasation | - | 0% |
| Hemorrhage | - | 0% |
| Sepsis | - | 0% |
| Ureteral Reflux | - | 0% |
| Perforation of urinary tract | - | 0% |
| Peritonitis | - | 0% |
| Loss of renal function | - | 0% |
| Stone Formation | - | 0% |
| Urinary Retention | - | 0% |
| Stent fragment retention in | - | 0% |
Table 4
*Even though seventeen (19.5%) of the 87 evaluable patients studied had an early migration of their TUDS device, only three (3.4%) of the 87 evaluable patients needed intervention for symptoms following the stent migration. Adverse events related to interventions within the first 48 hours;
1 patient left flank pain, received IV pain medication .
1 patient right flank pain, hydronephosis, received IV pain medication ● .
1 patient left flank pain, stent repositioned by cystoscopy
Adverse events related to interventions after 48 hours;
- 1 patient left flank pain, ureteroscopy •
1 patient right distal ureteral obstruction, cystoscopy .
Note: By definition, there were no migrations after 48 hours of TUDS indwell (i.e., late migrations) since the stent is expected to degrade and pass out of the ureter after 48 hours.
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
AUG 0 8 2002
Ms. Janet A. McGrath Specialist, Global Regulatory Affairs Boston Scientific Corporation Microvasive Urology One Boston Scientific Place NATICK MA 01760
Re: K013784
Trade/Device Name: Temporary (dissolvable) Ureteral Drainage Stent (TUDS) Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral stent Product Code: 78 FAD Regulatory Class: II Dated: May 30, 2002 Received: May 31, 2002
Dear Ms. McGrath:
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, 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 (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.
6
Page 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
7
Section I-C. Indications For Use Statement
510(K) Number:
Ureteral Stent
Device Name:
Indications For Use:
The proposed device is intended to facilitate the passage of urine 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
0 r
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
11
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K01378
Premarket Notification Ureteral Stent November 12, 20