(269 days)
The C-Flex Ureteral Stent Sets are intended for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques.
The 3.7 French C-Flex stents are indicated for pediatric patients.
The C-Flex Ureteral Stents are single-lumen, ureteral stents inserted using endoscopic, percutaneous, or open surgical techniques in order to provide temporary internal drainage from the ureteropelvic junction to the bladder. They are long-term indwelling devices not to exceed 6 months in the body.
The C-Flex® Ureteral Stent Set is comprised of a stent, positioner, wire guide, and catheter. The C-Flex stent is constructed from a radiopaque C-Flex material and ranges from 3.7 to 5.0 French in outer diameters with working lengths of 6.0 to 32.0 cm. The stents are available in either specified-length or multi-length stent configurations.
The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a peel-open pouch with a three-year shelf life.
The request is asking for detailed information about the acceptance criteria and the study proving a device meets these criteria based on the provided text. However, the provided text is a 510(k) summary for the C-Flex Ureteral Stent Sets, which demonstrates substantial equivalence to predicate devices. It does not contain the specific, detailed quantitative acceptance criteria or the full study protocols and results in the format requested.
The document lists performance tests conducted (e.g., Retention Strength and Break Strength, Gravity Flow Rate, Radiopacity, Biocompatibility, Magnetic Resonance (MR)) and states that "All predetermined acceptance criteria were met" for some of these, but it does not specify what those acceptance criteria actually were (e.g., a specific tensile strength in Newtons, or a flow rate in mL/min).
Therefore, I cannot fulfill all parts of your request with the information given. I will provide what information is available from the text and explicitly state what is missing.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria (as stated in document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Retention Strength & Break Strength | "All predetermined acceptance criteria were met." (Specific criteria, e.g., minimum Newtons for retention or maximum Newtons for break, are not provided.) | * Retention strength: "shows the curl retention during proper clinical use should retain the C-Flex Ureteral Stent Set within the intended anatomy."* Break strength: "shows the tensile force during proper clinical use should not fracture the C-Flex Ureteral Stent Set."* Tests were conducted following a 30-day artificial urine soak after accelerated aging to the equivalence of three years, both with and without a 30-day urine soak. |
| Gravity Flow Rate | Not explicitly stated what "acceptance criteria" were, or if this was purely a characterization test with no specific pass/fail criteria identified in this summary. | "Testing characterized the gravity flow rate of the C-Flex Ureteral Stent Set. The evaluation was conducted on the stents at time zero." (Specific flow rates are not provided.) |
| Radiopacity | Not explicitly stated what "acceptance criteria" were, or if this was purely a characterization test with no specific pass/fail criteria identified in this summary. | "Testing assessed the radiopacity of the C-Flex Ureteral Stent Set by subjecting it to a comparative fluoroscopic evaluation. Testing was conducted on the stents at time zero." (Specific qualitative or quantitative results are not provided.) |
| Biocompatibility | "All predetermined acceptance criteria were met." (Specific criteria, e.g., ISO 10993 results, are not provided.) | "Testing shows that the proposed device sets conform with the biocompatibility requirements based on its intended use." |
| Magnetic Resonance (MR) | "All predetermined acceptance criteria were met." (Specific criteria, e.g., maximum temperature rise, specific image artifact levels under defined conditions, are not provided.) | "Testing shows that the proposed device sets are MR conditional based on defined, tested conditions." |
Missing Information from the document: The quantitative or qualitative details of the "predetermined acceptance criteria" for any of the tests, and the actual performance results (e.g., specific values for retention strength, break strength, gravity flow rate, or detailed radiopacity observations). The document only provides a high-level summary that the criteria were met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). These appear to be bench tests performed by the manufacturer, not clinical data.
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)
Not applicable. The tests described are bench tests (physical and material properties,
biocompatibility, MR compatibility). They do not involve human interpretation or "ground truth" derived from expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, these are bench tests, not clinical studies requiring adjudication of outcomes or interpretations.
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
Not applicable. The device is a ureteral stent, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or would be relevant for this type of device based on the provided summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device (a ureteral stent), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For bench testing, the "ground truth" is typically established by engineering specifications, material standards, and validated test methods (e.g., ASTM, ISO standards). The document indicates "Biocompatibility – Testing shows that the proposed device sets conform with the biocompatibility requirements," implying adherence to a standard like ISO 10993.
8. The sample size for the training set
Not applicable. This device is a physical medical stent, not an AI/machine learning model that requires 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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2017
Cook Incorporated Minjin Choi Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K162104 Trade/Device Name: C-Flex Ureteral Stent Sets Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: March 17, 2017 Received: March 20, 2017
Dear Minjin Choi:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
{1}------------------------------------------------
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
A-5-1
510(k) Number (if known) K162104
Device Name C-Flex Ureteral Stent Sets
Indications for Use (Describe)
The C-Flex Ureteral Stent Sets are intended for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques.
The 3.7 French C-Flex stents are indicated for pediatric patients.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The red background is shaped like a rectangle with a diagonal cut on the bottom right corner.
COOK INCORPORATED 750 DANIELS V
2.0 510(k) Summary
C-Flex® Ureteral Stent Set 21 CFR §807.92 Date Prepared: April 21, 2017
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Minjin Choi |
| Applicant Address: | Cook Incorporated750 Daniels WayBloomington, IN 47404 |
| Contact Phone: | (812) 339-2235 x104901 |
| Contact Fax: | (812) 332-0281 |
Device Information:
Trade Name: Common Name: Classification Name: Classification Regulation: Device Class/Classification Panel: C-Flex® Ureteral Stent Set Stent, Ureteral Ureteral Stent 21 CFR §876.4620, Product Code FAD Class II, Gastroenterology/Urology
Predicate Device:
- Primary predicate device: Universa " Soft Ureteral Stents and Stent Sets (K151051). ■ Secondary predicate device:
Bioteq® Double Pigtail Ureteral Stent Set (K033210).
Device Description:
The C-Flex Ureteral Stents are single-lumen, ureteral stents inserted using endoscopic, percutaneous, or open surgical techniques in order to provide temporary internal drainage from the ureteropelvic junction to the bladder. They are long-term indwelling devices not to exceed 6 months in the body.
The C-Flex® Ureteral Stent Set is comprised of a stent, positioner, wire guide, and catheter. The C-Flex stent is constructed from a radiopaque C-Flex material and ranges from 3.7 to 5.0 French in outer diameters with working lengths of 6.0 to 32.0 cm. The stents are available in either specified-length or multi-length stent configurations.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, bold, white letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white letters on a red background. The red background is shaped like a rectangle with a diagonal cut on the bottom left corner.
The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a peel-open pouch with a three-year shelf life.
Indications for Use:
The C-Flex® Ureteral Stent Sets are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques. The 3.7 French C-Flex stents are indicated for pediatric patients.
Comparison to Predicate Device:
The C-Flex® Ureteral Stent Set and its primary predicate device, the Universa Soft Ureteral Stents and Stent Sets (K151051), are substantially equivalent in that these devices have similar indications for use, methods of operation, designs, and fundamental technological characteristics. The modifications from the predicate device include:
- 트 Extended stent sizes
- 트 Stent material
- Additional accessories
The proposed C-Flex® Ureteral Stent Set is also similar in indications for use, dimensions, and methods of operation to the Bioteg Double Pigtail Ureteral Stent Set (K033210). Differences between the proposed device and the predicate device include:
- 트 Extended stent sizes
- I Stent material
- 트 Additional accessories
Differences between the characteristics of the proposed device set and the predicate devices are supported by testing.
Performance Data:
The following testing was performed in order to demonstrate that the proposed C-Flex® Ureteral Stent Set met applicable design and performance requirements.
- 트 Retention Strength and Break Strength - Retention strength testing shows the curl retention during proper clinical use should retain the C-Flex Ureteral Stent Set within the intended anatomy. Testing also shows the curl retention strength must allow for removal of the C-Flex Ureteral Stent Set from the intended anatomy. Break strength testing shows the tensile force during proper clinical use should not fracture the C-Flex Ureteral Stent Set. Additional retention strength and break strength tests were conducted following a 30-day artificial urine soak after
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The red background is shaped like a banner.
accelerated aging to the equivalence of three years both with and without a 30-day urine soak. All predetermined acceptance criteria were met.
- 트 Gravity Flow Rate - Testing characterized the gravity flow rate of the C-Flex Ureteral Stent Set. The evaluation was conducted on the stents at time zero.
- . Radiopacity - Testing assessed the radiopacity of the C-Flex Ureteral Stent Set by subjecting it to a comparative fluoroscopic evaluation. Testing was conducted on the stents at time zero.
- . Biocompatibility – Testing shows that the proposed device sets conform with the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met.
- . Magnetic Resonance (MR) – Testing shows that the proposed device sets are MR conditional based on defined, tested conditions. All predetermined acceptance criteria were met.
Conclusion:
The results of these tests support a conclusion that the C-Flex® Ureteral Stent Set will perform as intended. The proposed device sets do not raise new questions of safety or effectiveness as compared to the predicate devices.
§ 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).