(141 days)
Used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction. Intended for one-time use only.
The Resonance™ Metallic ureteral stent is a device which is intended to achieve normal urine flow from the kidney to the urinary bladder in situations where obstructive pathological processes prevent it. The stent extends from the renal pelvis to the urinary bladder via the ureter and is placed by either endoscopic retrograde or percutaneous antegrade insertion.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Resonance™ Metallic Ureteral Stent (K063742).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance | Study Type |
|---|---|---|---|
| Non-Clinical Testing | Flow | Equivalence to predicate devices | Bench |
| Elongation / Yield | Equivalence to predicate devices | Bench | |
| Tensile Strength | Equivalence to predicate devices | Bench | |
| Stent Migration | Equivalence to predicate devices | Bench | |
| Retention | Equivalence to predicate devices | Bench | |
| Clinical Testing | Adverse Events | (Not specified, but gathered for evaluation) | Clinical |
| Stent Function | (Not specified, but gathered for evaluation) | Clinical |
Note: The document states that the non-clinical testing was "carried out to determine the equivalence of the Resonance™ Metallic ureteral stent to the predicate devices and to verify the safety and effectiveness of the stent." While it confirms the tests were done and found equivalence, it does not provide specific numerical acceptance criteria or performance values beyond this general statement. Similarly, for clinical testing, it notes the information gathered but doesn't quantify performance against specific criteria in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for either non-clinical or clinical testing in this document excerpt.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The device manufacturer is Cook Ireland Ltd, implying potential European involvement, but this is not confirmed for the clinical data. The clinical testing was done "to primarily gather information on adverse events and stent function," suggesting it was prospective, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The type of testing described (bench and clinical for adverse events/function) wouldn't typically involve human experts establishing a "ground truth" in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
- This information is not provided as the nature of the device (a physical stent) and the described testing (bench and clinical for safety/function) does not lend itself to an adjudication process in the contextual sense of expert review for diagnostic accuracy.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers interpret medical images or data. The Resonance™ Metallic Ureteral Stent is a physical medical device, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The device is a physical stent, not an algorithm.
7. The Type of Ground Truth Used
- For non-clinical testing: The "ground truth" was established by predicate device equivalence for performance characteristics (flow, elongation/yield, tensile strength, stent migration, retention). This relies on the established safety and effectiveness of the predicate devices.
- For clinical testing: The "ground truth" related to adverse events and stent function would be determined through direct observation and patient outcomes during the clinical study. It's not the same type of "ground truth" as in a diagnostic study (e.g., pathology for image interpretation).
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The Resonance™ Metallic Ureteral Stent is a physical device, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided as there is no "training set" for this type of device.
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Section 5.0 510(k) Summary
K063742
Name: Address:
Phone:
Contact Persons:
Fax:
Cook Ireland Ltd O'Halloran Road National Technology Park Limerick, Ireland
353 61 334440 353 61 334441 Emmett Devereux, Quality & Regulatory Manager Sinead Burke, Regulatory Affairs Supervisor
353 61 334440 353 61 334441 December 14, 2006
Resonance™ Metallic Ureteral stent
Ureteral stent
Stent, ureteral
Bioteq Double Pigtail Ureteral Stent set (K033210) Cook Endo-Sof™ Double Pigtail Stent (K961446)
The Resonance™ Metallic ureteral stent is a device which is intended to achieve normal urine flow from the kidney to the urinary bladder in situations where obstructive pathological processes prevent it. The stent extends from the renal pelvis to the urinary bladder via the ureter and is placed by either endoscopic retrograde or percutaneous antegrade insertion.
Phone: Fax: Date:
Trade Name:
Common Name:
Classification Name:
Legally Marketed Devices:
Description of the Device:
MAY 8 2007
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Comparison of Characteristics:
Indications for use:
Used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction. Intended for one-time use only.
We believe the proposed device the Resonance TM Metallic ureteral stent to be substantially equivalent to the currently marketed predicate devices Bioteq Double Pigtail Ureteral Stent set as cleared by (K033210) and Endo-Sof™ Double Pigtail Stent as cleared under (K961446).
Non clinical testing was carried out on the stent to determine the equivalence of the Resonance TM Metallic ureteral stent to the predicate devices and to verify the safety and effectiveness of the stent. The following is a summary of the testing carried out: flow, elongation / yield and tensile strength, stent migration and retention.
Clinical testing was carried out to primarily gather information on adverse events and stent function.
Performance Data:
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUM." is arranged in a circular fashion around the eagle.
MAY 8 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Sinead Burke Regulatory Affairs Supervisor Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick IRELAND
K063742 Re:
Trade/Device Name: Resonance™ Metallic Ureteral Stent Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: FAD Dated: April 23, 2007 Received: April 26, 2007
Dear Ms. Burke:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the circle.
Protecting and Promoting Public Health
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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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:
| 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 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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Section 4.0 Indications for Use
510(k) Number (if known): KN63742
Device Name: Resonance™ Metallic Ureteral stent
Indications for Use:
Used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction. Intended for one-time use only.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Nancy C Boydon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of 1
§ 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).