(262 days)
No
The summary describes a physical medical device (catheter and associated components) and its intended use for drainage. There is no mention of software, algorithms, image processing, or any terms related to AI/ML in the device description, intended use, or performance studies.
No.
Explanation: A therapeutic device is used to treat a disease or condition. This device is a drainage catheter, which aids in the temporary removal of fluid but does not directly treat the underlying urinary tract issue.
No.
This device, the Kolibri® Percutaneous Nephrostomy Catheter, is intended for "percutaneous drainage of the upper urinary tract." This indicates a therapeutic or interventional purpose, not a diagnostic one. Diagnostic devices are used to identify a disease or condition, while this catheter is used to treat or manage a condition by draining fluid.
No
The device description clearly outlines physical components such as catheters, stylets, needles, and dilators, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients." This describes a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a catheter designed for drainage, along with associated components for insertion and connection to a urine bag. This is consistent with a medical device used for treatment or management, not for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample for diagnostic purposes. The performance studies focus on biocompatibility, sterilization, and physical properties of the catheter, which are typical for medical devices, not IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
LJE
Device Description
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.
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 stainless-steel stylet. The Direct Puncture Set is supplied sterile via ethylene oxide for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract
Indicated Patient Age Range
Adults only
Intended User / Care Setting
Prescription Use
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)
- 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
Bench testing:
- 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.
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.
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
N/A
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)
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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 |
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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 &
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
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.