Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets

Q: Who is the manufacturer of Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

Coloplast Corp. filed the 510(k) submission for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets (K211911).

Q: What is the FDA product code for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

LJE. as a Class U device in the GU panel.

Q: What is the regulatory pathway for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

Universa Percutaneous Drainage Catheter (K140085).

Q: Who can help prepare an FDA 510(k) submission like Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K211911 · Coloplast Corp. · LJE · Mar 10, 2022 · GU

Device Facts

Record ID	K211911
Device Name	Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
Applicant	Coloplast Corp.
Product Code	LJE · GU
Decision Date	Mar 10, 2022
Decision	SESK
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.

Device Story

Kolibri Percutaneous Nephrostomy Catheters/Kits and Direct Puncture Sets provide percutaneous drainage of the upper urinary tract. Catheters feature J or Malecot distal tips to maintain position; manufactured from Vortek (polyether block amide). Kits include stylets, silicone sleeves, stopcocks, Luer connectors, urine bag connectors, guidewires, dilators, and Chiba needles. Direct Puncture Sets include stainless-steel trocar needles and stylets. Devices are used by clinicians in clinical settings for adult patients. Catheters are inserted percutaneously to facilitate urine drainage. Output is the physical drainage of urine; clinicians monitor output to manage urinary tract conditions. Benefits include short-term relief of urinary obstruction or drainage needs.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-1), EO residuals (ISO 10993-7), sterilization validation (ISO 11135), bacterial endotoxins (ANSI/AAMI ST72, USP <85>), visual inspection, dimensional verification, flow rate, loop strength, tensile testing, simulated use, and implant simulation. All acceptance criteria were met.

Technological Characteristics

Materials: Polyether block amide (Vortek). Configurations: J-tip or Malecot (4-wing). Sizes: 6-20 Fr. Lengths: 29-36 cm. Sterilization: Ethylene oxide. Connectivity: None (mechanical drainage).

Indications for Use

Indicated for short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.

Predicate Devices

Universa Percutaneous Drainage Catheter (K140085)

Reference Devices

Vortek Double Loop Ureteral Stent (K180057)

Related Devices

K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set · Cook Incorporated · Mar 27, 2019
K140085 — UNIVERSA PERCULTANEOUS DRAINAGE CATHETER · Cook Incorporated · Nov 18, 2014
K180029 — Malecot Nephrostomy Catheter/Stent Set · Cook Incorporated · Sep 21, 2018
K220036 — Wellead Ureteral Catheter · Well Lead Medical Co., Ltd. · Dec 16, 2022
K250824 — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set · Boston Scientific Corporation · Apr 15, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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. {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 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 {2}------------------------------------------------ ## 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) #### 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}------------------------------------------------ ### 510 (k) Summary ## 1. Submitter Information | 510 (k) submitter | Coloplast A/S | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | Holtedam 1 3050 Humlebaek Denmark | | Contact Person | Angela Kilian Head of Regulatory Affairs, North America 1601 West River Road, Minneapolis, MN 55411 Office : 612-422-7956 Email : 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 the Device | Universa Percutaneous Drainage Catheter | Vortek Double Loop Ureteral Stent | | Classification Name | Unclassified | Stent, Ureteral | | Regulation Classification | 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 | {4}------------------------------------------------ #### 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 & Predicate Device(s): | K211911 | K140085 (Predicate Device) | K180057(Reference Device) | | |-------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | General Device Characteristics | | | | | | Indication For Use | For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients | The Universa Loop/Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system. | The double loop ureteral stents are used for: drainage of the upper urinary tract over fistulas or ureteral obstacles and for healing of the ureter | Similar to the predicate | | Device Type | Catheter, Nephrostomy | Catheter, Nephrostomy | Stent, Ureteral | Same as the | {5}------------------------------------------------ | | Product Codes: LJE | Product Codes: LJE | Product Code: FAD | predicate Device | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | Device Components | Kolibri® Percutaneous Nephrostomy Catheter includes either a J or Malecot catheter, and some combination of silicone sleeve, stopcock, Luer, urine bag connector and stylet in some models. | The Universa Percutaneous Drainage Catheter Sets available as a loop catheter or a Malecot catheter. Suprapubic sets includes drainage catheter, connecting tube, straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. | The Vortek Double Loop Ureteral Stents are supplied in kits, which contain a double-loop ureteral stent, a steerable pusher or a non-steerable pusher with clamp and a guidewire. | Similar to the predicate | | Catheter tube Material | Polyether block amide | Polyurethane | Polyether block amide | Different from the predicate but similar to reference device | | Length | 29 - 36 cm | 15 - 30 cm | 12 - 30 cm | Different from the predicate | | Catheter French 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 the predicate | | Tip Configuration | J and Malecot | Loop and Malecot | Double loop | Similar to the predicate | | Duration of Use | up to 30 days and cumulative use up to 90 days | 4 weeks | 6 months | Similar to the predicate | | Intended patient Population | Adults only | Adults only | Adults and pediatric (infants, and adolescents) population | Similar to the predicate | 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: {6}------------------------------------------------ - 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.