(262 days)
For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.
The Kolibri® Percutaneous Nephrostomy Catheters are available in two configurations based on the tip configuration termed either J or Malecot. The distal end of the J catheter resembles a loop, and the distal end of the Malecot catheter has 4-wings which form an open basket to hold the catheter in place. J and Malecot catheters are single lumen catheters with outer diameters ranging from 6 Fr to 20 Fr. The J and Malecot catheters are manufactured from the material branded Vortek by Coloplast. The catheters are supplied either individually or as part of a kit. The following components are included depending on the specific configuration:
- · Stylet
- · Silicone sleeve
- · Stopcock
- Female Luer
- Urine bag connector
- Guidewire (kits only)
- · Dilator set(s) (kits only)
- · Chiba needles (kits only)
The dilators. Chiba Needles, and quidewires are all packaged separately. The J and Malecot catheters are supplied sterile via ethylene oxide for single use.
Kolibri Direct Puncture Set
The Direct Puncture Set consists of an 8 Fr or 10 Fr J catheter with a silicone sleeve, stopcock, urine bag connector, transparent reinforced tube, stainless-steel trocar needle, and stainlesssteel stylet. The Direct Puncture Set is supplied sterile via ethylene oxide for single use.
The provided text is a 510(k) summary for the Kolibri® Percutaneous Nephrostomy Catheters, Kolibri® Percutaneous Nephrostomy Kits, and Kolibri® Direct Puncture Sets. This document is a premarket notification to the FDA, demonstrating that the new device is substantially equivalent to a legally marketed predicate device.
However, the document does not describe an acceptance criteria table or a study that proves the device meets specific performance acceptance criteria related to a diagnostic or AI-driven medical device. Instead, it outlines the device's technical characteristics, its comparison to a predicate device, and a list of biocompatibility, sterilization, and bench tests performed to demonstrate substantial equivalence for a mechanical catheter device.
Therefore, I cannot extract the information required for your request in the format you specified, as the input document does not contain data related to a clinical study or performance metrics for a diagnostic or AI-based device. The device described is a medical instrument (catheter), and the "performance data" refers to its physical and material properties, not diagnostic accuracy, sensitivity, specificity, or AI performance.
If you have a document that describes the acceptance criteria and study for a diagnostic or AI-driven medical device, please provide that, and I will do my best to extract the requested information.
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March 10, 2022
Coloplast Corp Angela Kilian Head of Regulatory, North America 1601 West River Road North Minneapolis, MN 55411
Re: K211911
Trade/Device Name: Kolibri® Percutaneous Nephrostomy Catheters, Kolibri® Percutaneous Nephrostomy Kits, Kolibri® Direct Puncture Sets Regulatory Class: Unclassified Product Code: LJE Dated: February 11, 2022 Received: February 11, 2022
Dear Angela Kilian:
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,
Jessica K. Nguyen, 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) K211911
Device Name
Kolibri® Percutaneous Nephrostomy Catheters, Kolibri® Percutaneous Nephrostomy Kits , Kolibri® Direct Puncture Sets
Indications for Use (Describe)
For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.
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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510 (k) Summary
1. Submitter Information
| 510 (k) submitter | Coloplast A/S |
|---|---|
| Address | Holtedam 13050 HumlebaekDenmark |
| Contact Person | Angela KilianHead of Regulatory Affairs, North America1601 West River Road, Minneapolis, MN 55411Office : 612-422-7956Email : usaby@coloplast.com |
Preparation date March 09, 2022
2. Device Name
| Trade Name of the Device | Kolibri® Percutaneous Nephrostomy Catheters |
|---|---|
| Kolibri® Percutaneous Nephrostomy Kits | |
| Kolibri® Direct Puncture Sets | |
| Common Name | Percutaneous Nephrostomy Catheter |
| Classification Name | Unclassified |
| Classification Regulation | Unclassified |
| Device Class | Unclassified |
| Panel | Gastroenterology/Urology |
| Product Code | LJE |
3. Predicate and Reference Devices
| Predicate Device | Reference Device | |
|---|---|---|
| Owner | Cook Incorporated | Coloplast Corp |
| Trade Name of theDevice | Universa Percutaneous DrainageCatheter | Vortek Double LoopUreteral Stent |
| Classification Name | Unclassified | Stent, Ureteral |
| RegulationClassification | Unclassified | 21 CFR 876.4620 |
| Device Class | Unclassified | II |
| Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Product Code | FEW, KOB, LJE | FAD |
| 510(k) Number | K140085 | K180057 |
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4. Device Description
Kolibri® Percutaneous Nephrostomy Catheters and Kits
The Kolibri® Percutaneous Nephrostomy Catheters are available in two configurations based on the tip configuration termed either J or Malecot. The distal end of the J catheter resembles a loop, and the distal end of the Malecot catheter has 4-wings which form an open basket to hold the catheter in place. J and Malecot catheters are single lumen catheters with outer diameters ranging from 6 Fr to 20 Fr. The J and Malecot catheters are manufactured from the material branded Vortek by Coloplast. The catheters are supplied either individually or as part of a kit. The following components are included depending on the specific configuration:
- · Stylet
- · Silicone sleeve
- · Stopcock
- Female Luer
- Urine bag connector
- Guidewire (kits only)
- · Dilator set(s) (kits only)
- · Chiba needles (kits only)
The dilators. Chiba Needles, and quidewires are all packaged separately. The J and Malecot catheters are supplied sterile via ethylene oxide for single use.
Kolibri Direct Puncture Set
The Direct Puncture Set consists of an 8 Fr or 10 Fr J catheter with a silicone sleeve, stopcock, urine bag connector, transparent reinforced tube, stainless-steel trocar needle, and stainlesssteel stylet. The Direct Puncture Set is supplied sterile via ethylene oxide for single use.
5. Indication For Use
For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.
6. Comparison of the Technological Characteristics with Predicate and Reference Devices
| Device &PredicateDevice(s): | K211911 | K140085 (PredicateDevice) | K180057(ReferenceDevice) | |
|---|---|---|---|---|
| General DeviceCharacteristics | ||||
| Indication ForUse | For short-term (up to 30days) percutaneousdrainage of the upperurinary tract in adultpatients | The UniversaLoop/Malecot DrainageCatheter Set is intendedto provide percutaneousurine drainage from thegenitourinary system. | The double loop ureteralstents are used for:drainage of the upperurinary tract over fistulasor ureteral obstacles andfor healing of the ureter | Similar to thepredicate |
| Device Type | Catheter, Nephrostomy | Catheter, Nephrostomy | Stent, Ureteral | Same as the |
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| Product Codes: LJE | Product Codes: LJE | Product Code: FAD | predicateDevice | |
|---|---|---|---|---|
| DeviceComponents | Kolibri® PercutaneousNephrostomy Catheterincludes either a J orMalecot catheter, andsome combination ofsilicone sleeve,stopcock, Luer, urinebag connectorand stylet in somemodels. | The UniversaPercutaneous DrainageCatheter Sets availableas a loop catheter or aMalecot catheter.Suprapubic sets includesdrainage catheter,connecting tube,straightening stylets,trocar needle withobturator, hollow needle,wire guide, dilators,silicone retention discwith pull tie, or one-waystopcock. | The Vortek Double LoopUreteral Stents aresupplied in kits, whichcontain a double-loopureteral stent, asteerable pusher or anon-steerable pusherwith clamp and aguidewire. | Similar to thepredicate |
| Catheter tubeMaterial | Polyether block amide | Polyurethane | Polyether block amide | Different fromthe predicatebut similar toreferencedevice |
| Length | 29 - 36 cm | 15 - 30 cm | 12 - 30 cm | Different fromthe predicate |
| CatheterFrench Size | 06 Fr. to 14 Fr. (J)8 Fr. to 20 Fr.(Malecot) | 06 to 14 Fr. (Loop)08 to 24 Fr. (Malecot) | CHF 4.8,6,7,8 FR. | Similar to thepredicate |
| TipConfiguration | J and Malecot | Loop and Malecot | Double loop | Similar to thepredicate |
| Duration of Use | up to 30 days andcumulative use up to 90days | 4 weeks | 6 months | Similar to thepredicate |
| IntendedpatientPopulation | Adults only | Adults only | Adults and pediatric(infants, andadolescents) population | Similar to thepredicate |
As evidenced by the above table, both the subject and the predicate devices have the same intended use, but the subject and predicate devices have different technological characteristics. However, performance testing was conducted on the subject catheters, and it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.
7. Performance Data
Below is a list of the tests that have been performed and successfully completed for the subject catheters:
- Biocompatibility testing according to ISO 10993-1:2018 and FDA Guidance "Use of ● International Standard ISO 10993-1" (2016)
- Ethylene oxide residual testing according to ISO 10993-7 ●
- EO sterilization according to ISO 11135:2014 ●
- Bacterial Endotoxins testing according to ANSI/AAMI ST72:2019 and USP <85>
The following list of bench testing was conducted on the subject catheters using established methods to determine the substantial equivalence with the predicate:
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- Visual inspection
- Compatibility Testing .
- Dimensional verification ●
- Flow Rate ●
- Loop strength
- Tensile testing including tip, body, loop, and connector/body junction. .
- . Simulated use
- Implant simulation
- Shelf Life/Expiration date ●
All predetermined acceptance criteria were met.
8. Conclusion
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.
N/A