(204 days)
The Applied Medical Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL). The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery.
The stent is also indicated for use as a temporary indwelling ureteral catheter to assist in urine drainage through obstructed or strictured ureters.
The Applied Medical Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL). The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery.
The stent is also indicated for use as a temporary indwelling ureteral catheter to assist in urine drainage through obstructed or strictured ureters.
The provided 510(k) summary for the Applied Medical Ureteral Stent (K040760) does not contain a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This means that the regulatory submission relies on the existing safety and effectiveness of previously approved similar devices, rather than presenting a new clinical study with specific acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not applicable or ascertainable from this document.
Here's an attempt to answer the questions based on the available information regarding substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
As per the 510(k) process for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device. There are no explicit, quantifiable acceptance criteria or reported device performance metrics in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (implied: substantial equivalence to predicate devices in intended use, technological characteristics, and safety/effectiveness) | Not explicitly stated (implied: performs as safely and effectively as predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) submission relies on substantial equivalence, not a direct clinical study with a "test set" and a defined sample size for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for a test set is not established in a substantial equivalence submission.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a ureteral stent, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of device and were not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for a substantial equivalence claim is the established safety and effectiveness of the predicate device(s) based on their existing regulatory approvals and usage history. No specific type of ground truth (e.g., pathology, outcomes data) is generated for the new device in this type of submission.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device and does not involve a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of device, ground truth establishment for it is irrelevant.
In summary, the K040760 submission for the Applied Medical Ureteral Stent demonstrates that the device is "substantially equivalent" to predicate devices and introduces no new safety and effectiveness issues. This is a common regulatory pathway for many medical devices, where detailed clinical studies with explicit acceptance criteria and performance metrics (as typically seen in AI device submissions) are not required.
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| OCT | 15 2004 |
|---|---|
| ----- | --------- |
510(k) SUMMARY
| 510(k) NUMBER: | |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688(949) 713-8327 |
| CONTACT PERSON: | Cheryl BlakeV.P. Regulatory Affairs and Quality Systems |
| DATE OF PREPARATION: | March 2, 2004 |
| NAME OF DEVICE: | Ureteral Stents |
| CLASSIFICATION NAME: | Ureteral Stent, 21 CFR 876.4620. |
| TRADE NAME: | Not Determined |
SUMMARY STATEMENT:
The Applied Medical Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL). The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery.
The Applied Medical Ureteral Stents are substantially equivalent to predicate devices and introduce no new safety and effectiveness issues when used as instructed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 15 2004
Ms. Cheryl A. Blake Vice President, Regulatory Affairs and Quality Systems Applied Medical Resources Corporation 22872 Avenida Empresa RANCHO SANTA MARGARITA CA 92688
Re: K040760
Trade/Device Name: Applied Medical Ureteral Stent Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 FAD Dated: September 25, 2004 Received: September 30, 2004
Dear Ms. Blake:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your bother beets is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the closure) to regally manteled of the Medical Device Amendments, or to devices that have been May 20, 1770, the charance 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 do not require approval or a provisions of the Act. The general controls provisions of the Act device, subjor to the generation, 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 n your do route to such additional controls. Existing major regulations affecting your Apploval), It they be babyer 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 I todal to advisod that i 27 t in that your device complies with other requirements of the Act or any I DA mas made and regulations administered by other Federal agencies. You must comply with all the I car it states and regarding, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, mediates, facturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 80 7), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceing your artial equivalence of your device to a legally premarket notification. The PDA midnig of succeanted of succession of this, 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 If you desire specific advice for your corroo on our sames and on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation emised, formation on your responsibilities under the Act from the 607.97). I ou may obtain onler general massage at its toll-free number (800) DVISIon of Stian Manufacturers, Internet address http://www.fda.gov/cdrh/dsmadsmamain.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
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Indications for Use
510(k) Number (if known):____K040760
Device Name: Ureteral Stent
Indications for Use: The Applied Medical Ureteral Stent is indicated to relieve indications for OSe. The Appliod Modical Creceit conditions in the ureter such as obstruction from a vallety of beligh and managers of structions such as those presence of stones and/or storio inagniones, or simmal organs, retroperitoneal association with dreteral strong, caremal of the manage lithotripsy, (ESWL). The stent is also used after ureteroscopy to prevent obstruction due to edema or following Is also used anter ureterdooopy to provide drainage and a scaffold accidential, of planned dreteral ponoration in is usually used in combination with a for the nealing aroter. In the latter on Catheter). The stent may be placed using urethial draillage cathotor (org. Poloy Suinster, or percutaneously using standard radiographic technique, or at open surgery.
The stent is also indicated for use as a temporary indwelling ureteral catheter to assist in urine drainage through obstructed or strictured ureters.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hodgson
(Division Sign-Off) Division of Reproducti ve Ahrom and Radiological Device 510(k) Number
Page 1 of in a
§ 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).