(256 days)
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is comprised of a balloon catheter, ureteral stent, flexible stylet, Y-connecting tube and syringe. The balloon catheter can be sold separately with the stylet and syringe. The radiopaque balloon catheter has an outer diameter of 14.0 French and a tip diameter of 17.0 French, with a working length of 25 centimeters. The clear polyethylene balloon measures 15 centimeters in length and has an inflated diameter of 12 millimeters. The flexible stylet is 8.5 French and is manufactured from polyurethane material. The flexible stylet, designed to be inserted through the proximal end of the balloon catheter, extends 2 millimeters from the balloon catheter tip when assembled. The stent is manufactured from radiopaque polyurethane with an outer diameter of 5.0 French and a length of 75 centimeters. The stent is designed with two adjustable and removable adapters located at the proximal end of the stent. The Y-connecting tube is made of non-radiopaque polyvinylchloride material with an outer diameter of 14.0 French, and a length of 30 centimeters. A 10 mL Luerlock syringe is also provided in the set and is used to inflate the balloon through the inflation check valve.
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is supplied sterile in a Tyvek peel open pouch and labeled with a three-year shelf life. The subject device has a maximum indwell time of 96 hours (4 days) for the stent and 48 hours (2 days) for the balloon catheter and is labeled as a single-use device.
The provided FDA 510(k) premarket notification for the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set describes various performance tests to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for diagnostic accuracy or clinical effectiveness in the way an AI/ML device study might.
However, based on the information provided, I can infer the "acceptance criteria" and the "study" are the battery of engineering and material tests conducted to ensure the device's physical and functional properties meet expected standards for safety and effectiveness, similar to its predicates.
Here's a breakdown based on your request, interpreting "acceptance criteria" as meeting the performance requirements demonstrated by the listed tests:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an engineering device, acceptance criteria are typically validated through testing to confirm specific physical and functional properties. The document lists the tests performed, implying that successful completion of these tests (i.e., the device performed as intended during the test) constitutes meeting the acceptance criteria. Specific numerical acceptance values are not provided in this summary, but the conclusion states the device "will perform as intended" and "does not raise different questions of safety and/or effectiveness."
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred from successful testing) |
|---|---|
| Material Safety & Biocompatibility | Biocompatible (demonstrated by biocompatibility testing) |
| Sterility | Sterile (demonstrated by sterility testing) |
| Packaging Integrity & Shelf-Life | Maintained integrity and sterility over shelf-life (demonstrated by packaging, distribution, stability, and shelf-life testing) |
| Balloon Catheter Performance | - Compatibility: Compatible with specified accessories/procedures. - Dimensions: Conformed to specified dimensions (e.g., 14 Fr outer diameter, 17 Fr tip diameter, 25 cm working length, 12 mm inflated diameter). - Inflation Volume: Performed as specified for inflation. - Rated Burst Pressure: Withstood specified pressure (40 psi). - Tensile Strength: Withstood specified tensile forces. - Radiopacity: Sufficiently radiopaque for visualization. |
| Stent Performance | - Compatibility: Compatible with specified accessories/procedures. - Dimensions: Conformed to specified dimensions (e.g., 5 Fr outer diameter, 75 cm total length, 33 cm working length). - Tensile Strength: Withstood specified tensile forces. - Flow Rate: Maintained adequate flow rate. - Kink & Lumen Patency: Maintained patency and resisted kinking. - Radiopacity: Sufficiently radiopaque for visualization. |
| Stylet Performance | - Compatibility: Compatible with the balloon catheter. - Dimensions: Conformed to specified dimensions (e.g., 8.5 Fr). - Tensile Strength: Withstood specified tensile forces. |
| Set (Catheter & Stent) Performance | - Liquid Leakage & Gravity Flow: Performed without leakage and allowed proper gravity flow. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many catheters were burst-tested, how many stents were kink-tested). These are typically standard engineering tests performed on a statistically relevant sample size from manufacturing lots, but the exact numbers are not detailed in this 510(k) summary. The data provenance is from laboratory testing conducted by the manufacturer, Cook Incorporated. Therefore, it is prospective data for the device's performance under specific test conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device. "Ground truth" established by experts is relevant for diagnostic or AI/ML devices where human interpretation or clinical outcomes define the truth. For this medical device, the "ground truth" for the tests is defined by the physical and chemical properties of the materials and the mechanical performance under controlled laboratory conditions, verified by standardized testing methods.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. Here, the "truth" is determined by objective engineering measurements against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to assess the impact of a diagnostic tool (often AI-assisted) on human reader performance. This device is a surgical/drainage catheter, not a diagnostic imaging device, and there is no AI assistance involved.
6. Standalone (Algorithm Only) Performance
Not applicable. This is not an AI/ML algorithm or software device. Its performance is entirely physical and mechanical.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Specifications: Defined physical dimensions, material properties, and performance limits (e.g., burst pressure, flow rate, tensile strength).
- Standardized Test Methods: Adherence to recognized industry standards for testing sterility, biocompatibility, mechanical properties, etc.
- Bench Testing Data: Quantitative and qualitative results from laboratory evaluations.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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July 16, 2019
Cook Incorporated Ian Herrman Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K183051
Trade/Device Name: Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Kaye Nephrostomy Tamponade Balloon Catheter Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LJE Dated: June 10, 2019 Received: June 11, 2019
Dear Ian Herrman:
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. 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. 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.
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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); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183051
Device Name
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
Kaye Nephrostomy Tamponade Balloon Catheter Set
Indications for Use (Describe)
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
| 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) |
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Image /page/3/Picture/0 description: The image is a logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font. The word "MEDICAL" is written in white, smaller, sans-serif font and is located below the word "COOK".
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON, IN 47402-04 W.COOKMEDIC
510(k) Summary
K183051 Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set 21 CFR §807.92 Date Prepared: July 16, 2019
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Primary Contact: | Ian Herrman |
| Secondary Contact: | Karthik Pillai, Ph.D. |
| Applicant Address: | Cook Incorporated750 Daniels WayBloomington, IN 47404 |
| Phone Number: | (812) 335-3575 x104034 |
| Fax Number | (812) 332-0281 |
Device Information:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Trade/Device Name: | Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetKaye Nephrostomy Tamponade Balloon Catheter Set |
| Device Common Name: | Catheter, Nephrostomy |
| Regulation Number: | N/A |
| Regulation Name: | N/A |
| Classification Product Code: | LJE |
| Device Class: | Unclassified |
| Review Panel: | Gastroenterology/Urology |
Predicate Devices:
- Malecot-Nephrostomy Tamponade Catheter, Cook Incorporated, K915209
- Expel™ Nephroureteral Stent System with Twist-Loc Hub, Boston Scientific, K141344 .
Device Description:
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is comprised of a balloon catheter, ureteral stent, flexible stylet, Y-connecting tube and syringe. The
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balloon catheter can be sold separately with the stylet and syringe. The radiopaque balloon catheter has an outer diameter of 14.0 French and a tip diameter of 17.0 French, with a working length of 25 centimeters. The clear polyethylene balloon measures 15 centimeters in length and has an inflated diameter of 12 millimeters. The flexible stylet is 8.5 French and is manufactured from polyurethane material. The flexible stylet, designed to be inserted through the proximal end of the balloon catheter, extends 2 millimeters from the balloon catheter tip when assembled. The stent is manufactured from radiopaque polyurethane with an outer diameter of 5.0 French and a length of 75 centimeters. The stent is designed with two adjustable and removable adapters located at the proximal end of the stent. The Y-connecting tube is made of non-radiopaque polyvinylchloride material with an outer diameter of 14.0 French, and a length of 30 centimeters. A 10 mL Luerlock syringe is also provided in the set and is used to inflate the balloon through the inflation check valve.
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is supplied sterile in a Tyvek peel open pouch and labeled with a three-year shelf life. The subject device has a maximum indwell time of 96 hours (4 days) for the stent and 48 hours (2 days) for the balloon catheter and is labeled as a single-use device.
Intended Use:
MEDICA
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, ureteral drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The set sold without the stent component has the following intended use:
The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
Comparison to Predicates:
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set and the predicate devices, the Malecot-Nephrostomy Tamponade Catheter (K915209) and the Expel™ Nephroureteral Stent System with Twist-Loc Hub (K141344), are substantially equivalent in that these devices share similar indications for use, methods of operations and fundamental technological characteristics. The Malecot-Nephrostomy Tamponade Catheter (K915209) is the predicate specifically for the balloon catheter component of the subject device set. The Expel™ Nephroureteral Stent System with Twist-Loc Hub
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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. The registered trademark symbol is to the right of the word "COOK".
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
(K141344) is the predicate specifically for stent component of the subject device set. Comparisons between each predicate and the corresponding subject device component are presented in the following tables.
Balloon Catheter and Stylet:
| DeviceCharacteristics | Predicate DeviceK915209 - Malecot-Nephrostomy TamponadeCatheter | Subject DeviceK183051 - KayeNephrostomyTamponade BalloonCatheter | Comparison |
|---|---|---|---|
| Indications for Use | The Malecot-NephrostomyTamponade Catheter is usedfor nephrostomy drainageand low pressure dynamictamponade to preventhemorrhage followingpercutaneous stone removal. | Used for nephrostomydrainage, and dynamictamponade to preventhemorrhage innephrolithotomy andpercutaneous stoneremoval procedures. | The subject and the predicatedevice are both used fornephrostomy drainage, anddynamic tamponade to preventhemorrhage following percutaneousstone removal. The slight differencein wording does not raise newquestions of safety andeffectiveness (S&E) as the balloonsare labeled with the same maxvolume and pressure. |
| Placement Method | Percutaneous | Identical | Identical |
| Maximum IndwellTime | 5 days | 2 days (48 hours) | The subject device has a shortermaximum indwell time than thepredicate. This shorter indwell timedoes not raise any new questions ofS&E. |
| General Design | Balloon Catheter with styletand syringe accessories | Identical | Identical |
| Materials | Balloon: PolyethyleneCatheter Tubing:Polyethylene, non-radiopaque tubing | Balloon: PolyethyleneCatheter Tubing:Ethylene-vinyl acetatecopolymer, radiopaque | Material differences in thesecatheters do not raise new questionsof S&E as demonstrated bybiocompatibility and performancetesting. |
| Balloon Length | 15 cm | Identical | Identical |
| Balloon Diameter | 12 mm | Identical | Identical |
| Max inflationpressure | 40 psi | Identical | Identical |
| Catheter Length | 25.7 cm | 25 cm | The slight difference in length doesnot raise questions of S&E. |
| Catheter Tip | 16 Fr malecot tip | 17 Fr dual sideport tip | The difference in tip diameter anddrainage opening type does notraise different questions of S&E |
| Catheter ShaftDiameter | 16 Fr | 14 Fr | The subject device catheter shafthas a smaller outer diameter thanthe predicate device. Performancetesting indicates the difference inouter diameter raises no newquestions of S&E. |
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Image /page/6/Picture/0 description: The image shows the contact information for Cook Incorporated. The address is 750 Daniels Way, P.O. Box 489, Bloomington, IN 47402-0489 U.S.A. The phone number is 812.339.2235, and the toll-free number is 800.457.4500. The website is www.cookmedical.com.
The total length of the predicate stent is 65 cm with a working length
subject device is 75cm with a
of 22-28 cm. The total length of the
Regarding technological characteristics, the subject and predicate balloon catheter (K141344) devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., tip drainage design, dimensions, materials, etc.) The differences identified do not raise different questions of safety and/or effectiveness as compared to the predicate device, as stated in the table.
| DeviceCharacteristics | Predicate DeviceK141344 - ExpelTMNephroureteral StentSystem with Twist-LocHub | Subject DeviceK183051 - KayeNephrostomyTamponade BalloonCatheter Stent | Comparison |
|---|---|---|---|
| Indications for Use | The Expel NephroureteralStents are deliveredpercutaneously and areintended to establishinternal drainage from theureteropelvic junction tothe bladder whilemaintaining externalaccess to the stent, as wellas providing externaldrainage. | Used for nephrostomydrainage, ureteraldrainage, and dynamictamponade to preventhemorrhage innephrolithotomy andpercutaneous stoneremoval procedures. | The subject device has a differentindication for use statementcompared to predicate K141344.However, the stent included in thesubject device has the sameintended use as the predicateK141344, which is internal drainageto the bladder and external drainagefrom the ureteropelvic junctionwhile maintaining external access tothe stent. |
| Maximum IndwellTime | 30 days | 4 days (96 hours) | The subject device stent componenthas a 4 day maximum indwell timewhich is shorter than that of thepredicate. Because the subjectdevice maximum indwell time fallswithin that of the predicate deviceno new questions of S&E are raised. |
| General Design | Single lumennephroureteral stent withdistal and proximalretention pigtails withsideports | Single lumen straightnephroureteral stent withsideports. | The predicate and subject device aresimilar in general design. The maindifference in design is that thepredicate device has pigtails in thebladder and ureteropelvic junctionfor retention. In the subject, deviceretention is assured either throughconnection to the balloon catheterthrough the proximal adapter and/oranchoring the device to the patient.Thus, the difference in design doesnot raise new questions of S&E. |
| Materials | Radiopaque Flexithane | Radiopaque Polyurethane | Material differences between thepredicate and subject devices do notraise new questions of S&E asdemonstrated by biocompatibilityand performance testing. |
Total: 75
(adjustable)
Working length: 33 cm
Stent:
Stent Length
Total: 65
Working length: 22-28 cm
Image /page/6/Picture/4 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font on a red background.
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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON. IN 47402-0489 U.S.A. 2235 TOLL EREE: 800-457.4500 VWW.COOKMEDICAL.COM
Image /page/7/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The red background is shaped like a rectangle with a diagonal cut on the bottom left corner.
| DeviceCharacteristics | Predicate DeviceK141344 - Expel™Nephroureteral StentSystem with Twist-LocHub | Subject DeviceK183051 - KayeNephrostomyTamponade BalloonCatheter Stent | Comparison |
|---|---|---|---|
| working length adjustable up to 33cm. The total length and workinglength of the subject device stentencompasses the predicate stent anddoes not generate any new questionsof S&E. | |||
| Stent Diameter | 8.3 and 10.3 Fr | 5 Fr | The subject device stent has asmaller outer diameter compared tothe predicate device stent. Thesmaller stent outer diameter ensuresthat the predicate can be used in thesame patient anatomy as thepredicate. Performance testing hasdemonstrated that this differencedoes not generate any new questionsof S&E. |
As shown above, the indications for use statement of the subject device set including the stent component is not identical to the predicate device; however, the differences do not represent a new intended use as both the predicate device stent and subject device stent have the same intended use.
Regarding the technological characteristics, the subject and predicate devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., dimensions, materials, indwell time, etc.) The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
Technological Characteristics:
The following tests were performed to demonstrate that The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set met applicable design and performance requirements and support a determination of substantial equivalence:
-
- Biocompatibility
-
- Sterility
-
- Packaging: Distribution and Stability
-
- Shelf-life
-
- Balloon Catheter:
- a. Compatibility
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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 9.2235 TOLLEREE: 800-457.4500 WWW.COOKMEDICAL.COM
Image /page/8/Picture/1 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font.
- b. Dimensional Verification
- Balloon Inflation Volume C.
- d. Balloon Catheter Rated Burst Pressure
- e. Tensile Test
- Radiopacity f.
-
- Stent:
- Compatibility a.
- b. Dimensional Verification
- c. Tensile Test
- d. Flow Rate Test
- Kink and Lumen Patency e.
- Radiopacity f.
-
- Stylet:
- a. Compatibility
- b. Dimensional Verification
- c. Tensile Test
-
- Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set:
- a. Liquid Leakage and Gravity Flow
Conclusion:
The results of these tests provide reasonable assurance that the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set will perform as intended. The subject device does not raise different questions of safety and/or effectiveness as compared to the predicate devices. In conclusion, the results of these tests support a determination of substantial equivalence to the predicate devices.
N/A