(15 days)
The Applied Medical Pediatric 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) in patients 2 years of age and older. 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 Pediatric Ureteral Stent is substanually equvalant to its predicates devices the Cook Sof-Flex Pediatric Double Pigtail Stent and the Applied Medical Ureteral Stent in design methodology, principle of operation and clinical utility. The device introduces no new safety or effectiveness issues when used as instructed.
The provided text describes a 510(k) summary for a medical device, the Pediatric Ureteral Stent, and its substantial equivalence to predicate devices. It outlines the performance tests conducted but does not provide detailed acceptance criteria values or specific device performance results in a numeric format. It also does not mention any studies involving human readers, ground truth establishment for a test or training set, or sample sizes related to AI/algorithm development.
Therefore, I can extract the information primarily related to the performance tests and the general nature of the comparison, but much of the requested information (especially points 2-9) is not present in the provided text.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document states that performance tests were selected based on the FDA guidance document "Guidance for the Content of Premarket Notifications for Ureteral Stents". It lists the types of characteristics tested but does not provide specific numerical acceptance criteria or the reported device performance values.
| Acceptance Criteria (Characteristic) | Reported Device Performance (Not quantified in the document) |
|---|---|
| Flow rate | Tested in predicate and Applied Medical devices |
| Elongation and Tensile Strength | Tested in predicate and Applied Medical devices |
| Curl Strength (Coil retention) | Tested in predicate and Applied Medical devices |
| Coefficient of Friction | Tested in predicate and Applied Medical devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. The document refers to "predicate device (Cook Sof-Flex 3F Pediatric Ureteral Stent) and in the Applied Medical devices" being tested, implying physical testing of medical devices, not data sets for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The context is for a physical medical device, not an AI or image analysis device that would require expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text, as it's not relevant for the type of device and testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in the provided text. This document describes a traditional 510(k) for a physical medical device, not an AI/ML-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical ureteral stent, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as the device is a physical ureteral stent. For the performance tests listed (Flow rate, Elongation, Tensile Strength, Curl Strength, Coefficient of Friction), the "ground truth" would be the direct physical measurement of these characteristics according to established test methods.
8. The sample size for the training set
This information is not applicable as the device is a physical ureteral stent and not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical ureteral stent and not an AI or machine learning model.
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MAR 2 9 2006
510(k) SUMMARY
510(k) NUMBER: PENDING
SUBMITTED BY: Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 (949) 713-8327
CONTACT PERSON: Cheryl Blake V.P. Regulatory Affairs and Quality Systems
DATE OF PREPARATION: March 9, 2006
NAME OF DEVICE: Pediatric Ureteral Stents
CLASSIFICATION NAME:Ureteral Stent, 21 CFR 876.4620.
TRADE NAME: Not Determined
SUMMARY STATEMENT:
The Applied Medical Pediatric 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) in patients 2 years of age and older. 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 Pediatric Ureteral Stent is substanually equvalant to its predicates devices the Cook Sof-Flex Pediatric Double Pigtail Stent and the Applied Medical Ureteral Stent in design methodology, principle of operation and clinical utility. The device introduces no new safety or effectiveness issues when used as instructed.
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Performance tests were selected based on the FDA document titled "Guidance for the Content of Premarket Notifications for Ureteral Stents", which advises that the 510(k) submission should include the following data to demonstrate substantial equivalence: Flow rate, Elongation and Tensile Strength, Curl Strength (Coil retention), and Coefficient of Friction. These characteristics were tested in the predicate device (Cook Sof-Flex 3F Pediatric Ureteral Stent) and in the Applied Medical devices.
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Image /page/2/Picture/1 description: The image shows a black and white logo of the Department of Health & Human Services. The logo features a stylized bird with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the bird. The overall design is simple and symbolic, representing the department's mission related to health and human welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2006
Applied Medical Resources Corporation c/o Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131-1230
Re: K060673
Trade/Device Name: Pediatric Ureteral Stent Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: FAD Dated: March 13, 2006 Received: March 14, 2006
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have revient of 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 the encreate, to e enactment date of the Medical Device Amendments, or to devices that have been Nury 20, 1770, and coance 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 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 Applorary, to they of casyer 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 toase of a rise 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 For at backed and registration and 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 (QS) (2) CFR Parl 820); 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) This letter will allow you to begin harketing your antial equivalence of your device to a legally premarket notification. The FDA miding of saostantial of a lovice 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), pleased If you desire specific advice for your device on our labeling - 5
contact the Office of Compliance at one of the following numbers, based 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, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on your - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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): __
Device Name: ____Pediatric Ureteral
Stent
Indications for Use:
The Applied Medical Pediatric Ureteral Stent is indicated to relieve The Applied Medical Podiaths oienian and malignant conditions in the ureter obstruction from a vancity of bonly stone fragments, or other ureteral such as presence of stones andrer tone in ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with abuominal organs, retropentonounlibrooms, in patients 2 years of age and extracorporeal shookwave illulompoy) (2017) 1) 1975 - 1995 - 1995 - 1995 - 1995 - 19 to edema or following accidental, or planned ureteral perforation/incision to to edema of following acclasion for the healing ureter. In the latter provide drainage and a ocallord for with a urethral drainage circumstance it is usually assum may be placed using retrograde catheter (C.g. I oney Outhotohio it it it it is a percutaneously using standard radiographic technique, or at open surgery.
The stent is also indicated for use as a temporary indwelling ureteral The Steff is also malouted for azge through obstructed or strictured ureters.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Larson
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page I of /_
§ 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).