(246 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a stent and associated components, with no mention of AI or ML.
Yes
The device is designed for internal drainage from the ureteropelvic junction to the bladder, which is a therapeutic intervention for a medical condition.
No
The device is a medical stent intended for internal and external drainage in the urinary system, not for diagnosing conditions. Its description focuses on materials, dimensions, and drainage function, with performance tests related to physical properties and safety rather than diagnostic capabilities.
No
The device description clearly outlines physical components made of materials like polyurethane, polyethylene, and tetrafluoroethylene, and the performance studies focus on physical properties and functionality of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for internal and external drainage of the ureter, which is a therapeutic and drainage function within the body. IVDs are used to examine specimens from the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a stent and associated components for placement within the urinary tract. This is a medical device for intervention and drainage, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Seidmon Antegrade AQ Stent is a medical device used for drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Seidmon Antegrade AQ Stent is internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent as well as providing external drainage in patients age 18 years and older when treated as adults.
Product codes (comma separated list FDA assigned to the subject device)
FAD
Device Description
The Seidmon Antegrade AQ Stent Set contains a nephroureteral stent with hydrophilic coating, a Luer lock drainage adapter, and a Peel-Away Introducer. The stent tubing is made of radiopaque polyurethane and is provided in 6.0 French diameter with 50 centimeters in overall length (28 centimeters ureteral working length). The Luer lock drainage adapter is to be used with a drainage bag to provide the external drainage. The Peel-Away Introducer consists of a polyethylene dilator and a tetrafluoroethylene sheath, which is used to facilitate percutaneous placement of the nephroureteral stent. The dilator is provided in 8.0 French diameter and 37 centimeters length. The sheath is provided in 10.0 French diameter and with 32 centimeters working length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction to the bladder
Indicated Patient Age Range
18 years and older
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 following tests have been conducted to demonstrate that the Seidmon Antegrade AO Stent Set met applicable design and performance requirements.
- . Sterilization and EO Residuals
- Packaging and Distribution ●
- . Biocompatibility
- Dimensional Verification and Compatibility .
- Pigtail Restoration/Recovery ●
- Curl Retention
- Tensile ●
- Lubricity ●
- Functional Use Flow Rate and Liquid Leakage ●
- Radiopacity ●
- Magnetic Resonance (MR) Imaging Safety .
- Shelf Life/Stability .
Conclusion: All predetermined acceptance criteria of the testing were met. Therefore, the results of these tests support a conclusion that the subject device performs as intended and support a determination of substantial equivalence to the predicate device.
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.
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
September 28, 2018
Cook Incorporated Rebecca Odulio (Li-Chun-Liu) Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K180216
Trade/Device Name: Seidmon Antegrade AO Stent Set Regulation Number: 21 CFR& 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: September 7, 2018 Received: September 10, 2018
Dear Rebecca Odulio (Li-Chun-Liu):
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark R. Kreitz -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
510(k) Number (if known) K180216
Device Name Seidmon Antegrade AQ Stent Set
Indications for Use (Describe)
The Seidmon Antegrade AQ Stent is internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent as well as providing external drainage in patients age 18 years and older when treated as adults.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K180216 Page 1 of 3 OOK INCORPORATED BLOOMINGTON, IN 47404 U. NE: 812.339.2235 TOLL FREE: 800.457.4 VWW.COOKMEDICAL
Section 2.0 510(k) Summary
Seidmon Antegrade AO® Stent Set (21 CFR §807.92) Date Prepared: September 27, 2018
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact Information: | Rebecca Odulio (Li-Chun Liu) |
| Andrew Breidenbach | |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| This Submission: |
|---|
| Device Name: |
| Common Name: |
| Classification Number: |
| Classification Name: |
| Product Code: |
| Product Code Name: |
| Regulatory Class: |
Traditional 510(k) Premarket Notification Seidmon Antegrade AQ Stent Set Ureteral Stent 21 CFR §876.4620 Ureteral Stent FAD Stent, Ureteral Class II
Predicate Device:
Expel Nephroureteral Drainage Stent with Twist-Loc Hub System (K141344) is the predicate device for the Seidmon Antegrade AQ Stent Set.
Device Description:
The Seidmon Antegrade AQ Stent Set contains a nephroureteral stent with hydrophilic coating, a Luer lock drainage adapter, and a Peel-Away Introducer. The stent tubing is made of radiopaque polyurethane and is provided in 6.0 French diameter with 50 centimeters in overall length (28 centimeters ureteral working length). The Luer lock drainage adapter is to be used with a drainage bag to provide the external drainage. The Peel-Away Introducer consists of a polyethylene dilator and a tetrafluoroethylene sheath,
4
which is used to facilitate percutaneous placement of the nephroureteral stent. The dilator is provided in 8.0 French diameter and 37 centimeters length. The sheath is provided in 10.0 French diameter and with 32 centimeters working length.
Indications for Use:
The Seidmon Antegrade AQ Stent Set is intended for internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent as well as providing external drainage in patients age 18 years and older when treated as adults.
Comparison to Predicate:
The subject device has similar indications for use, methods of operation, and fundamental technological characteristics as the predicate. The differences between the subject device and the predicate device include language used in indications for use, minor dimensional variations, materials, indwelling time, device design features, and accessories provided. Characteristics of the subject device that differ from the predicate device are supported by testing. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device.
Technological Characteristics:
The following tests have been conducted to demonstrate that the Seidmon Antegrade AO Stent Set met applicable design and performance requirements.
- . Sterilization and EO Residuals
- Packaging and Distribution ●
- . Biocompatibility
- Dimensional Verification and Compatibility .
- Pigtail Restoration/Recovery ●
- Curl Retention
- Tensile ●
- Lubricity ●
- Functional Use Flow Rate and Liquid Leakage ●
- Radiopacity ●
- Magnetic Resonance (MR) Imaging Safety .
- Shelf Life/Stability .
5
Conclusion:
All predetermined acceptance criteria of the testing were met. Therefore, the results of these tests support a conclusion that the subject device performs as intended and support a determination of substantial equivalence to the predicate device.