(200 days)
The ConvertX™ Nephroureteral Stent System with releasable drainage catheter is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage.
For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the ureteropelvic junction to the bladder.
The ConvertX Nephroureteral Stent System is a sterile, single-use non-vascular intervention device inserted using percutaneous access techniques to re-establish internal drainage between the ureteropelvic junction and the bladder, and stent the ureter. The ConvertX System allows for external drainage and access as needed.
The ConvertX Nephroureteral Stent System is a single lumen device that has a detachable ureteral stent with proximal and distal pigtails. Both proximal and distal pigtails contain drainage holes. The proximal pigtail forms in the renal pelvis, while the distal pigtail forms in the bladder. The distal pigtail has a tapered, atraumatic tip. Drainage can occur internally (from the ureteropelvic junction to the bladder) or externally (from the ureteropelvic junction to the outside of the patient). A loop suture is attached to the proximal pigtail enabling the pigtail, straightened for delivery, to be closed in the renal pelvis.
The ConvertX Nephroureteral Stent System's Hub has three ports which are used for both ends of the loop suture, external drainage of urine and the ureteral stent release wire. One end of the loop suture and the release wire are connected to pull tabs. The releasable drainage catheter and loop suture may be detached from the ureteral stent when external drainage is no longer necessary, leaving the stent in place. While still attached, the releasable drainage catheter may be used to withdraw the ureteral stent. The ConvertX Nephroureteral Stent System is radiopaque throughout its length.
The ConvertX Nephroureteral Stent System is comprised of the following components:
- Ureteral Stent
- Releasable Drainage Catheter with Hub
The following accessories are provided with the ConvertX Nephroureteral Stent System: - Metal Stiffening Cannula
- Luer Cap
The provided text describes the 510(k) premarket notification for the ConvertX™ Nephroureteral Stent System. The document focuses on establishing substantial equivalence to predicate devices through non-clinical performance testing. It does not include information about studies involving human subjects or AI algorithms.
Therefore, many of the requested criteria related to clinical studies, AI performance, ground truth establishment, expert involvement, and sample sizes for training/testing sets cannot be extracted from this document.
Here's an attempt to answer the applicable parts of your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The ConvertX Nephroureteral Stent System, including its packaging, met the predetermined acceptance criteria. No new safety or performance issues were raised during testing." However, the specific numerical or descriptive acceptance criteria for each performance test are not detailed in this summary. Instead, it lists the types of tests performed.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Met predetermined acceptance criteria | Met predetermined acceptance criteria. No new safety or performance issues were raised during testing. |
| Compliance with standards | Complied with ASTM F1828-97, ASTM F623-99, ISO 10555-1:2013, FDA Guidance for Ureteral Stents, ASTM F2182-11a, ASTM F2119-07, ASTM F2052-15, ASTM F2503-13, and ASTM F640-12. |
| Indications for Use | Intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access and providing external drainage. For patients where external drainage is not desired, the releasable catheter can be removed, leaving the stent for internal drainage. (See full description in "Indications for Use" section). |
| Performance/Technological Characteristics | See the comparison table below |
Comparison Table of ConvertX Nephroureteral Stent System vs. Predicate Devices (Contains performance characteristics, implicitly showing the ConvertX meets similar performance as predicates)
| Performance / Technological Characteristic | ConvertX Nephroureteral Stent System | Expel Nephroureteral Stent System Twist Loc Hub (K141344) | Expel Ureteral Stent System (K141344) |
|---|---|---|---|
| Indications for Use | The ConvertX Nephroureteral Stent System with releasable drainage catheter is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage. For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the ureteropelvic junction to the bladder. | The Expel Nephroureteral Stents are delivered percutaneously and are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage. | The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. |
| Common Name | Ureteral Stent | Ureteral Stent | Ureteral Stent |
| Classification | Class II, Performance Standards | Class II, Performance Standards | Class II, Performance Standards |
| Regulation Number | 21 CFR 876.4620 | 21 CFR 876.4620 | 21 CFR 876.4620 |
| Product Code | FAD | FAD | FAD |
| Single Use Only | Yes | Yes | Yes |
| Provided Sterile | Yes | Yes | Yes |
| Sterilization Method | EtO | EtO | EtO |
| Diameters | 10.3 French | 8.3 and 10.3 French | 8.3 and 10.3 French |
| Stent Lengths | 20, 22, 24, 26, 28 cm | 22, 24, 26, 28 cm | 22, 24, 26, 28 cm |
| Guidewire Compatibility | 0.038" | 0.038" | 0.038" |
| Stent Material | Polyurethane | Polyurethane | Polyurethane |
| Drainage Catheter Material | Polyurethane | Polyurethane | NA |
| Loop Suture Material | Polyethylene | Nylon | Nylon |
| Tapered Stent Tip | Yes | Yes | Yes |
| Radiopaque | Yes | Yes | Yes |
| MRI Compatible | Yes | Yes | Yes |
| Urine Compatible | Yes | Yes | Yes |
| Maximum Indwelling Time | Not to exceed 30-days | Not to exceed 30-days | Not to exceed 90-days |
| Delivery Method | Percutaneous | Percutaneous | Percutaneous |
| Method of conversion from nephroureteral stent to ureteral stent | Disconnect | Removal / Exchange | NA |
| Biocompatibility | Meets requirements of 10993-1 | Meets requirements of 10993-1 | Meets requirements of 10993-1 |
| Accessory Devices | Stiffening Cannula, Luer Cap | Cannulas, Plug/Cap, Stabilizer, Pigtail Straightener | Cannulas, Stabilizer, Pigtail Straightener |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing (e.g., mechanical, material, and compatibility tests), not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable. The provenance of the data is from BrightWater Medical's internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was non-clinical performance testing against engineering and material specifications, not a study requiring expert clinical ground truth.
4. Adjudication method for the test set
Not applicable. See point 3.
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. This device is a physical medical device (stent), not an AI algorithm, and the documentation describes non-clinical performance testing, not a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This documentation is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" would be the engineering specifications, material standards (e.g., ASTM, ISO), and regulatory requirements (e.g., FDA guidance documents). The device was tested to meet these predefined physical and performance characteristics.
8. The sample size for the training set
Not applicable. This is not a study involving a "training set" for an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2016
Brightwater Medical Bob Smouse CEO/ CMO 816 W. Bennett Ct. Dunlap. IL 61525
Re: K161277
Trade/Device Name: ConvertX™ Nephroureteral Stent System Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD Dated: October 13, 2016 Received: October 17, 2016
Dear Bob Smouse,
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. 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. 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
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the quality systems (OS) 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 yours,
For Division
Douglas Silverstein -S 2016.11.22 12:05:41 -05'00'
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
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Indications for Use
510(k) Number (if known) K161277
Device Name
ConvertX Nephroureteral Stent System
Indications for Use (Describe)
The ConvertX Nephroureteral Stent System with releasable drainage catheter is delivered percutaneously and is intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage.
For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the ureteropelvic junction to the bladder.
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.
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Image /page/3/Picture/0 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet made up of three curved lines in different shades of blue and green. To the right of the droplet is the text "BrightWater" in a light blue sans-serif font, with the word "Medical" below it in a smaller font size.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with 21 CFR §807.92 the following summary of information is provided:
| Submitted By | BrightWater Medical816 W. Bennett Ct.Dunlap, IL 61525U.S.A. |
|---|---|
| Contact Person | Bob Smouse, M.D.Chief Executive Officer / Chief Medical OfficerPhone: 1-650-210-8100Email: bsmouse@brightwatermed.com |
| Date Prepared | October 13, 2016 |
| Proprietary Name | ConvertX™ Nephroureteral Stent System |
| Common Name | Ureteral Stent |
| Classification | Class II |
| Regulation Number | 21 CFR 876.4620 |
| Classification Panel | Gastroenterology/Urology |
| Product Code | FAD |
| Predicate Device | K141344, Expel Nephroureteral Stent System with Twist-Loc Huband Expel Ureteral Stent System |
| Intended Use /Indications for Use | The ConvertX Nephroureteral Stent System with releasabledrainage catheter is delivered percutaneously and is intended toestablish internal drainage from the ureteropelvic junction to thebladder while maintaining external access to the stent, as well asproviding external drainage.For patients for whom external drainage is not, or no longerdesirable, the releasable drainage catheter may be removed, leavingthe stent to provide internal drainage from the ureteropelvicjunction to the bladder. |
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Image /page/4/Picture/0 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet made up of three curved lines in different shades of blue and green. To the right of the droplet are the words "BrightWater" in a light blue sans-serif font, with the word "Medical" underneath in a smaller font.
DEVICE DESCRIPTION
The ConvertX Nephroureteral Stent System is a sterile, single-use non-vascular intervention device inserted using percutaneous access techniques to re-establish internal drainage between the ureteropelvic junction and the bladder, and stent the ureter. The ConvertX System allows for external drainage and access as needed.
The ConvertX Nephroureteral Stent System is a single lumen device that has a detachable ureteral stent with proximal and distal pigtails. Both proximal and distal pigtails contain drainage holes. The proximal pigtail forms in the renal pelvis, while the distal pigtail forms in the bladder. The distal pigtail has a tapered, atraumatic tip. Drainage can occur internally (from the ureteropelvic junction to the bladder) or externally (from the ureteropelvic junction to the outside of the patient). A loop suture is attached to the proximal pigtail enabling the pigtail, straightened for delivery, to be closed in the renal pelvis.
The ConvertX Nephroureteral Stent System's Hub has three ports which are used for both ends of the loop suture, external drainage of urine and the ureteral stent release wire. One end of the loop suture and the release wire are connected to pull tabs. The releasable drainage catheter and loop suture may be detached from the ureteral stent when external drainage is no longer necessary, leaving the stent in place. While still attached, the releasable drainage catheter may be used to withdraw the ureteral stent. The ConvertX Nephroureteral Stent System is radiopaque throughout its length.
The ConvertX Nephroureteral Stent System is comprised of the following components:
- Ureteral Stent ●
- Releasable Drainage Catheter with Hub
The following accessories are provided with the ConvertX Nephroureteral Stent System:
- Metal Stiffening Cannula .
- . Luer Cap
SUMMARY OF NON-CLINICAL TESTING
Design verification / performance testing for the ConvertX Nephroureteral Stent System was completed in accordance with applicable sections of ASTM F1828-97 - Standard Specification for Ureteral Stents, ASTM F623-99 - Standard Performance Specification for Foley Catheters, ISO 10555-1: 2013 - Intravascular catheters - Sterile and single-use catheters, Part 1: General requirements, and the FDA Guidance for the Content of Premarket Notifications for Ureteral Stents. MRI Compatibility was evaluated according to ASTM F2182-11a - Standard Test Method for Measurement of Radio Frequency Heating On or Near Passive Implants During Magnetic Resonance Imaging, ASTM F2119-07 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, and ASTM F2503-13 - Standard Practice for Marking Medical Devices and Other Items for Safety in Magnetic Resonance Environment. Radiopacity of the ConvertX
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Nephroureteral Stent System was evaluated in accordance with ASTM F640-12 - Standard Test Methods for Determining Radiopacity for Medical Use.
- Stent / Catheter Dimensions
- · Stiffener Dimensions
- · Straightener to Stent Compatibility
- · Guidewire Compatibility
- · Loop Recovery
- Flow Recovery Post Kinking
- Stent-Catheter Interface Strength
- Kink Resistance
- Stent Shaft Tensile Strength
- Hub to Shaft Tensile Strength
- Hub to Stiffener Strength
- · Stiffener Tip Strength
- · Loop Retention / Removal Force
- Pull wire to Pull Tab Tensile Strength
- Loop Suture to Pull Tab Tensile strength
- · Frictional Force
- · Loop Suture Removal Force
- Lock Suture to Hub Tensile Strength
- · Decoupling Force
- · Resistance to Deformation
- · Urine Compatibility Stent
- · Urine Compatibility -System
- Resistance to Liquid Leakage Under Pressure and During Aspiration/ Vacuum
- Flow Rate
- · Shelf Life
- MRI Compatibility Conditional
- · Sterilization
- · Non-pyrogenic LAL Kinetic Chromogenic
- · Biocompatibility
- · Radiopacity
- · Pouch Seal Strength
The ConvertX Nephroureteral Stent System, including its packaging, met the predetermined acceptance criteria. No new safety or performance issues were raised during testing.
| Performance /TechnologicalCharacteristic | Convert XNephroureteral StentSystem | Expel NephroureteralStent System Twist LocHub (K141344) | Expel Ureteral StentSystem (K141344) |
|---|---|---|---|
| Indications for Use | The ConvertXNephroureteral StentSystem with releasabledrainage catheter isdelivered percutaneouslyand is intended toestablish internaldrainage from theureteropelvic junction tothe bladder whilemaintaining externalaccess to the stent, aswell as providingexternal drainage. | The Expel NephroureteralStents are deliveredpercutaneously and areintended to establishinternal drainage from theureteropelvic junction tothe bladder whilemaintaining externalaccess to the stent, aswell as providing externaldrainage. | The Expel Ureteral StentSystem is deliveredpercutaneously and isintended to establishdrainage from theureteropelvic junction tothe bladder and stentingof the ureter for allpatients in whom it isdesirable to place a drainwhich does not extendexternally. |
| Performance /TechnologicalCharacteristic | Convert XNephroureteral StentSystem | Expel NephroureteralStent System Twist LocHub (K141344) | Expel Ureteral StentSystem (K141344) |
| For patients for whomexternal drainage is not,or no longer desirable,the releasable drainagecatheter may beremoved, leaving thestent to provide internaldrainage from theureteropelvic junction tothe bladder. | |||
| Common Name | Ureteral Stent | Ureteral Stent | Ureteral Stent |
| Classification | Class II, PerformanceStandards | Class II, PerformanceStandards | Class II, PerformanceStandards |
| Regulation Number | 21 CFR 876.4620 | 21 CFR 876.4620 | 21 CFR 876.4620 |
| Product Code | FAD | FAD | FAD |
| Single Use Only | Yes | Yes | Yes |
| Provided Sterile | Yes | Yes | Yes |
| Sterilization Method | EtO | EtO | EtO |
| Diameters | 10.3 French | 8.3 and 10.3 French | 8.3 and 10.3 French |
| Stent Lengths | 20, 22, 24, 26, 28 cm | 22, 24, 26, 28 cm | 22, 24, 26, 28 cm |
| GuidewireCompatibility | 0.038" | 0.038" | 0.038" |
| Stent Material | Polyurethane | Polyurethane | Polyurethane |
| Drainage CatheterMaterial | Polyurethane | Polyurethane | NA |
| Loop Suture Material | Polyethelyne | Nylon | Nylon |
| Tapered Stent Tip | Yes | Yes | Yes |
| Radiopaque | Yes | Yes | Yes |
| MRI Compatible | Yes | Yes | Yes |
| Urine Compatible | Yes | Yes | Yes |
| Maximum IndwellingTime | Not to exceed 30-days | Not to exceed 30-days | Not to exceed 90-days |
| Delivery Method | Percutaneous | Percutaneous | Percutaneous |
| Method ofconversion fromnephroureteral stentto ureteral stent | Disconnect | Removal / Exchange | NA |
| PerformanceTechnologicalCharacteristic | Convert XNephroureteral StentSystem | Expel NephroureteralStent System Twist LocHub (K141344) | Expel Ureteral StentSystem (K141344) |
| Biocompatibility | Meets requirements of10993-1 | Meets requirements of10993-1 | Meets requirements of10993-1 |
| Accessory Devices | Stiffening CannulaLuer Cap | Cannulas, Plug/Cap,Stabilizer, PigtailStraightener | Cannulas, Stabilizer,Pigtail Straightener |
PREDICATE DEVICE COMPARISON
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Image /page/7/Picture/0 description: The image contains the logo for BrightWater Medical. The logo consists of a stylized water droplet symbol on the left, composed of three concentric lines in shades of blue and green. To the right of the symbol, the text "BrightWater" is displayed in a light blue sans-serif font, with the word "Medical" appearing below it in a smaller font size and the same color.
CONCLUSION
The ConvertX™ Nephroureteral Stent System has the same intended use and similar technological characteristics as the Expel Nephroureteral Stent System with Twist-Loc Hub and Expel Ureteral Stent System (K141344) marketed by Boston Scientific Corporation. Moreover, performance testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the ConvertX Nephroureteral Stent System is substantially equivalent 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).